News

Zymeworks Presents Results of the Completed Dose Escalation Portion of the Ongoing Phase 1 Study of ZW25 at the San Antonio Breast Cancer Symposium

ZYME

Continued Clinical Benefit of Single Agent ZW25 in Heavily Pretreated HER2-High Patients

Vancouver, Canada (December 5, 2017) – Zymeworks Inc. (NYSE/TSX: ZYME), a clinical‑stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics, today presented the completed dose escalation portion of its Phase 1 study of ZW25, a novel Azymetric™ bispecific antibody targeting two distinct domains of the HER2 receptor.  The HER2–mediated signaling pathway is believed to contribute to tumor growth in a number of cancers.

A total of 22 patients have been enrolled in the study, including 11 with breast cancer, eight with gastric, gastroesophageal junction, or esophageal (GE) cancer, and three with other HER2‑expressing cancers. Part one of the multi-part study was a standard dose escalation where patients received ZW25 either weekly at 5 mg/kg (n=3), 10 mg/kg (n=6), or 15 mg/kg (n=7) or bi-weekly (once every two weeks) at 20 mg/kg (n=6) in cycles of four weeks each.

Study Highlights:

  • Six Partial Responses (PR) were observed across all dosing groups including two new PRs from the 20 mg/kg bi-weekly cohort.
  • Clinical benefit (Confirmed PR or stable disease (SD) ≥ 6 months) of single agent ZW25 observed in heavily pretreated HER2‑high breast and GE cancer patients.
  • Breast cancer patients received a median of six prior HER2-targeted regimens for metastatic disease; partial response in 56% (5/9) of breast cancer patients with measurable disease, with 89% (8/9) experiencing a decrease in target lesions.
  • Three HER2-high GE cancer patients with measurable disease showed tumor shrinkage, including one Confirmed PR (71% decrease in target lesions) and one SD for > 6 months.
  • ZW25 was well-tolerated at all doses and schedules, with the most common adverse events being diarrhea, infusion reactions, or nausea, all Grade 1 or 2 in severity.
  • The dose escalation portion of the Phase 1 trial is complete and enrollment in the expansion cohorts is underway.

Seventy-nine percent of breast and GE cancer patients with measurable disease (11/14) had a decrease in target lesions per RECIST criteria. The best overall response (BOR) in 17 response-evaluable (defined as undergoing at least one tumor restaging) breast and GE cancer patients was six PR (35%), three SD (18%) and eight progressive disease (PD; 47%).

“The expanding dataset continue to show responses and durable disease control with both weekly and every other week dosing and demonstrate the potential of ZW25 to address unmet need across multiple indications,” said Dr. Diana Hausman, Chief Medical Officer of Zymeworks. “We are seeing meaningful clinical benefit with single agent treatment in breast and gastric cancer patients who have progressive disease after numerous standard of care regimens. These early results, while impressive in their own right, are also distinct from other investigational agents being evaluated in refractory HER2-expressing cancer patients and support the continued evaluation of ZW25 both as a single agent and in combination with other cancer therapeutics.”

Of the eleven breast cancer patients, all were HER2‑high and had received a median of six prior HER2‑targeted regimens for metastatic disease including trastuzumab (n=11), T-DM1 (n=11), pertuzumab (n=9), and lapatinib (n=7) as well as other investigational agents. The BOR in these heavily pretreated patients was five PR (45%), two SD (18%), and three PD (27%), for an overall disease control rate (Complete Response, PR, or SD) of 64%. At least one PR was observed in every dosing group.

Of the eight GE patients, six were evaluable for response, and had received a median of four prior systemic regimens, including trastuzumab in all patients. Three of five patients with measurable disease had a decrease in tumor size, including one patient continuing on treatment with a Confirmed PR and 71% decrease in target lesions, as well as a second patient with SD for over 6 months.

“There is an ongoing need for novel treatments for patients who have exhausted available options for their HER2-expressing cancers,” said Dr. Erika Hamilton, Director of the Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee. “The preliminary anti-tumor activity and tolerability we have seen with single agent ZW25 has been encouraging. We are excited to be enrolling patients in the expansion cohort portion of this study.”

Enrollment is underway for the second part of the study utilizing ZW25 every other week at 20 mg/kg in four expansion cohorts spanning HER2-high breast, HER2-high gastric, HER2‑intermediate breast and other HER2-gene amplified cancers.

“The dose escalation portion of the Phase 1 trial has been a success, demonstrating the tolerability and single agent anti-tumor activity of ZW25,” said Dr. Ali Tehrani, President and CEO of Zymeworks. “These data bring us one step closer to initiating a single agent registrational trial with the goal of submitting an initial Biologics License Application (BLA) for ZW25 in 2021.  We plan to provide an update on the expansion cohort portion of the trial at the American Society of Clinical Oncology Annual Meeting in 2018.”

The poster will be formally presented on Friday December 8th from 5:00-7:00pm CT at the San Antonio Breast Cancer Symposium and is available through their website or through the Investor page of Zymeworks’ website at http://ir.zymeworks.com/events-and-presentations.

ZW25 Phase 1 Clinical Trial Details
The dose escalation portion of the study enrolled 22 patients with HER2‑expressing cancers (either HER2 IHC 1+, 2+ or 3+, or FISH‑positive) whose cancer had progressed after treatment with all therapies known to confer clinical benefit. HER2 status was assessed in archived or fresh biopsies locally and at a central laboratory. Patients with HER2‑high breast cancer (HER2 IHC 3+ or IHC2+ and FISH‑positive) had to have received previous treatment with trastuzumab, pertuzumab, and T-DM1. Patients with HER2-high gastric or gastroesophageal cancers had to have been previously treated with trastuzumab.  Patients could have measurable or non‑measurable tumor lesions per RECIST 1.1. Patients with known active brain metastases were excluded from the study. Patients were assessed during treatment for safety, including changes in cardiac function, tumor response per RECIST 1.1 every 8 weeks, ZW25 drug levels, and potential development of anti-drug antibodies. No dose-limiting toxicities were seen at any dose level or schedule. The most common adverse events were diarrhea, infusion reactions, or nausea, all Grade 1 or 2 in severity. There were no treatment-related serious adverse events, cardiac events or decreases in left ventricular ejection fraction.

About ZW25
ZW25 is Zymeworks’ lead product candidate currently being evaluated in a Phase 1 clinical trial in the United States. It is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function and has led to significant anti-tumor activity in preclinical models of HER2-expressing cancer. Zymeworks is developing ZW25 as a best-in-class HER2‑targeted treatment option for patients with any solid tumor that expresses HER2.

About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial.  Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to Zymeworks’ Phase 1 clinical trial, its San Antonio Breast Cancer Symposium presentation, the potential of ZW25, Zymeworks’ estimated timeframe for submitting an initial BLA for ZW25 to the U.S. FDA, and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ registration statement on Form F-1 and in its supplemented PREP prospectus dated April 27, 2017 filed in connection with Zymeworks’ initial public offering on May 3, 2017 (copies of which filings may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts:

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

 

Zymeworks Announces License Agreement with Johnson & Johnson Innovation to Develop and Commercialize Next Generation Bispecific Antibody Therapeutics

ZYME

Zymeworks Announces License Agreement with Johnson & Johnson Innovation to Develop and Commercialize Next Generation Bispecific Antibody Therapeutics

  • Zymeworks licenses the Azymetric™ and EFECT™ platforms to Janssen
  • US$50 million upfront license fee paid to Zymeworks for up to six bispecific programs

VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, today announced it has executed a licensing agreement with Janssen Biotech, Inc. (“Janssen”), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The deal was facilitated by Johnson & Johnson Innovation.

Under the terms of the licensing agreement, Zymeworks will provide Janssen with a worldwide, royalty-bearing license to research, develop, and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks’ Azymetric™ and EFECT™ platforms. Janssen will be responsible for all research, development, and commercial activities under the licensing agreement. Zymeworks will receive an upfront payment of US$50 million and is eligible to potentially receive up to US$282 million in development and up to US$1.12 billion in commercial milestone payments, and tiered royalties on potential sales. Janssen also has the option to develop two additional bispecific programs under the agreement subject to a future option payment.

“We are very pleased to be partnering with Janssen and their world-class scientists,” said Dr. Ali Tehrani, President and CEO of Zymeworks. “This marks our sixth major pharmaceutical partnership and the first since our wholly-owned bispecific product candidate ZW25, which is enabled with the Azymetric™ platform, entered clinical trials. The proceeds from this collaboration will be primarily used to fund the clinical advancement of ZW25, as well as the advancement of our preclinical programs into the clinic.”

November 13 Webcast and Conference Call

Zymeworks will host a webcast and teleconference today at 8:30 a.m. ET (5:30 a.m. PT) to discuss the license agreement. Ali Tehrani, Ph.D., President and Chief Executive Officer and Neil Klompas, Chief Financial Officer at Zymeworks will lead the discussion.

The webcast can be accessed through the Investor page of Zymeworks’ website at http://ir.zymeworks.com/events-and-presentations.

The live call may be accessed by dialing 1-800-319-4610 for North American callers, or 1-604-638-5340 for international callers. Callers should dial in five to ten minutes prior to the scheduled start time, and ask to join the “Zymeworks call”.

A telephone replay of the conference call will be available by dialing 1-800-319-6413 or 1-604-638-9010 and entering access code 1748. The replay will be available after the conclusion of the conference call until November 27, 2017.

About the Azymetric™ Platform

The Azymetric™ platform enables the transformation of monospecific antibodies into bispecific antibodies, which gives them the ability to simultaneously bind two different targets. Azymetric™ bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting leading to greater efficacy while reducing toxicities and the potential for drug-resistance. Azymetric™ bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability, and are also compatible with standard manufacturing processes with high yields and purity, thereby significantly reducing drug development costs and timelines.

About the EFECT™ Platform

The EFECT™ platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up and down-regulation of effector functions. This platform is compatible with traditional monoclonal as well as Azymetric™ bispecific antibodies to further enable the customization of therapeutic responses for different diseases.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to the terms of the licensing agreement with Janssen, potential payments to Zymeworks under the licensing agreement, Zymeworks’ planned use of such payments, and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ registration statement on Form F-1 and in its supplemented PREP prospectus dated April 27, 2017 filed in connection with Zymeworks’ initial public offering on May 3, 2017 (copies of which filings may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com
or
Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

PreciThera, Inc. Completes $36 Million Series A Financing

PreciThera, Inc. Completes $36 Million Series A Financing

Funding to develop novel biologics targeting orphan bone diseases into clinical trials

MONTREALJuly 27, 2017 /CNW/ — PreciThera, Inc. a privately-held, precision medicine company, dedicated to the design and development of innovative biological therapeutics for the treatment of orphan bone diseases, today announced the completion of a Series A Financing of CAD$36 million (US$29 million).  Investors participating in the financing include Sanderling Ventures, Arix Bioscience, Fonds de solidarité FTQ, CTI Life Sciences and Emerillon Capital.

Proceeds of the Series A financing will be used to develop novel molecules and to advance PreciThera’s lead candidate through IND and into clinical studies with the goal to establish clinical proof of concept and identify a path to registration.

PreciThera is focusing on orphan bone diseases that cannot be treated via traditional protein replacement therapies. The company utilizes a combination of informatics-based tools to combine information from RNA sequencing and from genomic and clinical databases to validate the major pathway responsible for clinical symptoms in rare genetic disorders. Its precision medicine strategy is particularly well-suited to address genetic diseases that, until now, were classified based on their clinical manifestations and treated with non-specific agents. By leveraging both a novel understanding of the biology of these disorders and its precision medicine strategy, PreciThera aims to achieve truly disease-modifying outcomes for patients.

Industry veterans and scientific experts Dr. Philippe Crine and Dr. Susan Schiavi founded Montreal, Canada-based PreciThera in 2016. Prior to PreciThera, Dr. Crine founded Enobia Pharma, which advanced its lead product, asfotase alfa, into clinical development for treatment of the orphan bone disease hypophosphatasia. Enobia Pharma was acquired for $1.1B in 2012 by Alexion, which now markets the product as Strensiq. Dr. Schiavi brings bone and metabolic disease expertise from her many years as director of Genzyme’s Bone and Mineral Metabolism team in support of the company’s blockbuster drug, Renvela.

Quotes

Dr. Philippe Crine, co-founder of PreciThera, said: “We are grateful for the support of these premier healthcare investors who believe in our vision of novel therapeutic strategies for rare diseases and the potential of precision medicine for speeding up and de-risking drug development in this rapidly expanding area of the pharmaceutical industry. Our mission is to provide highly innovative and life changing therapies to patients with heterogeneous genetic diseases affecting the skeleton who had up to now no or inadequate therapeutic options.”

Pierre Beauparlant, chief executive officer of PreciThera, commented: “This fundraising validates the potential that investors see in PreciThera’s approach. The decision to support the company’s efforts was based on strong scientific research, combined with the great market potential for the company’s drug candidates.”

Peter McWilliams, Ph.D., managing director of Sanderling Ventures, said: “We are pleased to be part of this oversubscribed Series A financing combining a strong syndicate of Quebec based and US based investors to launch PreciThera, another important new venture enhancing the vibrant life science innovation ecosystem in Quebec.”

About Sanderling Ventures
Sanderling Ventures is one of the oldest investment firms dedicated to building new biomedical companies. Sanderling emphasizes early-stage financing and active management of its portfolio companies. Its principals play an active role in new ventures by providing seed and early-stage funding, contributing management leadership and administrative support, developing cost-control strategies to extend available dollars, supplying technical and regulatory expertise where needed, and offering the insight and perspective of those who have “done it before.”
For further information, please visit www.sanderling.com

About Arix Bioscience plc
Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.
Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.
For further information, please visit www.arixbioscience.com

About the Fonds de solidarité FTQ
Fonds de solidarité FTQ is a development capital investment fund that channels the savings of Quebecers into investments. As at May 31, 2017, the organization had $13.1 billion in net assets, and through its current portfolio of investments has helped create and protect 186,440 jobs. The Fonds is a partner in more than 2,700 companies and has 645,664 shareholder-savers.
For further information, please visit http://www.fondsftq.com

About CTI Life Sciences
Based in Montréal, CTI Life Sciences, is a Canadian venture firm that invests in high quality emerging life sciences companies at the pre-clinical and clinical development stage in Canada and in the U.S. CTI Life Sciences has $245 million in assets under management.
For further information, please visit http://www.ctisciences.com

About Emerillon Capital
Based in Montreal, Emerillon Capital is a venture capital fund dedicated to investing and supporting companies with strong technological expertise that are positioned in sectors with strong growth potential. It aims to accelerate commercial start-up and support their expansion. Emerillon Capital invests primarily in Canada. By leveraging the network of CIC Capital, the Canadian subsidiary of CM-CIC Investissement, its lead sponsor, Emerillon Capital offers entrepreneurs a gateway to support their development projects in Europe.
For more information, visit www.emerilloncapital.com/en/

About PreciThera, Inc.
PreciThera, Inc. is a biotechnology company committed to the development of therapies for rare bone diseases using the combined application of computational technology and a deep understanding of disease pathology. The company focuses on heterogeneous genetic disorders that primarily manifest in bone dysfunction. Understanding of novel biology will allow PreciThera’s targeted strategies to meaningfully impact both the skeletal symptoms as well as the extraskeletal issues found in these patients.
For further information, please visit www.precithera.com

For more information, please contact:

PreciThera, Inc.
Pierre Beauparlant, CEO
pbeauparlant@precithera.com
Tel: (514) 700-0764 x 230

Media Relations:
Russo Partners
Alex Fudukidis
alex.fudukidis@russopartnersllc.com
Tel: (646) 942-5632

View original content with multimedia:http://www.prnewswire.com/news-releases/precithera-inc-completes-36-million-series-a-financing-300495038.html

SOURCE PreciThera, Inc. 

ZYMEWORKS INC. (NYSE: ZYME) RINGS THE NYSE CLOSING BELL®

ZYME

The New York Stock Exchange welcomes executives and guests of Zymeworks Inc. (NYSE: ZYME) in celebration of their recent listing on April 28, 2017. To honor the occasion, Dr. Ali Tehrani, President and Chief Executive Officer, will ring The NYSE Closing Bell®.

 

Zymeworks Announces Pricing of Initial Public Offering

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Zymeworks Announces Pricing of Initial Public Offering

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (“Zymeworks”) today announced the pricing of its initial public offering of 4,500,000 common shares at a price to the public of U.S.$13.00 per share. In addition, Zymeworks has granted the underwriters a 30-day over-allotment option to purchase up to an additional 675,000 common shares at the initial public offering price, less underwriting discounts and commissions. Zymeworks expects to use the net proceeds from the offering to further develop and advance its pipeline of product candidates and to increase its liquidity.

The New York Stock Exchange has approved, and the Toronto Stock Exchange has conditionally approved, the listing of the common shares. The common shares are expected to begin trading on the New York Stock Exchange and on the Toronto Stock Exchange on an “if, as and when issued basis” on April 28, 2017 under the ticker symbol “ZYME.” The offering is expected to close on or about May 3, 2017, subject to the satisfaction of customary closing conditions.

Citigroup Global Markets Canada Inc., Barclays Capital Inc. and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. Canaccord Genuity Corp. is acting as lead manager. Cormark Securities Inc. is acting as co-manager. MTS Securities, LLC served as financial advisor to Zymeworks in the offering.

A registration statement relating to the common shares was declared effective by the U.S. Securities and Exchange Commission on April 27, 2017. A final base PREP prospectus has been filed with, and a receipt has been issued by, the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada containing important information relating to the common shares.

The offering is being made only by means of a prospectus. The prospectus contains important detailed information about the securities offered. A copy of the U.S. final prospectus, when available, related to the offering may be obtained from Citigroup Global Markets Canada Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (800) 831-9146, or by email at prospectus@citi.com; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (888) 603-5847, or by email at Barclaysprospectus@broadridge.com; or Wells Fargo Securities, LLC, Attn: Equity Syndicate, 375 Park Avenue, New York, NY 10152, by telephone: (800) 326-5897, or by email at cmclientsupport@wellsfargo.com. Copies of the registration statement and U.S. final prospectus may also be obtained, when available, from www.sec.gov. A copy of the supplemented PREP prospectus, when available, related to the offering may be obtained from Canaccord Genuity Corp., Attn: Equity Capital Markets, 161 Bay Street, Suite 3000, Toronto, ON M5J 2S1, or by email at Ecm@canaccordgenuity.com; or Cormark Securities Inc., 200 Bay St Suite 2800, Toronto, ON M5J 2J2, by telephone: 416-943-6414, or by email at ssmoroz@cormark.com. A copy of the supplemented PREP prospectus may also be obtained, when available, from www.sedar.com.

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Zymeworks

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Forward-Looking Statements

This press release contains certain forward-looking statements, including statements with regard to the use of proceeds from the offering and the expected closing of the offering. Words such as “expects”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the offering discussed above will be completed on the terms described. Completion of the proposed offering and the terms thereof are subject to numerous factors, many of which are beyond Zymeworks’ control, including, without limitation, failure of customary closing conditions and the risk factors and other matters set forth in Zymeworks’ filings with the U.S. Securities and Exchange Commission and the securities commissions or similar securities regulatory authorities in each of the provinces and territories of Canada. Zymeworks undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

Zymeworks Inc.
Investor Inquiries:
David Matousek, 604-678-1388
Senior Manager, Investor Relations & Corporate Communications
ir@zymeworks.com

Immunovaccine Announces Positive Interim Clinical Data from Ovarian Cancer Study of DPX-Survivac in Combination with Epacadostat

Immunovaccine Announces Positive Interim Clinical Data from Ovarian Cancer Study of DPX-Survivac in Combination with Epacadostat

Preliminary Analysis Supports the Ability of Immunovaccine’s Lead Candidate to Induce T-Cell Infiltration

Early Data Reflect Tolerability and Clinical Potential of the Triple Combination Immunotherapy in Recurrent Ovarian Cancer

Halifax, Nova Scotia; March 29, 2017 – Immunovaccine Inc. (“Immunovaccine” or the “Company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced the first interim data analysis from its ongoing Phase 1b clinical study of its novel T-cell activating immuno-oncology candidate, DPX-Survivac, in combination with epacadostat and low-dose cyclophosphamide. The analysis included the results of blood tests, tumor biopsies and CT scans to assess safety, disease progression and T-cell response for the first four evaluable patients in the trial.

All patients enrolled in the trial have recurrent ovarian cancer with evidence of progressive disease. Based on the interim analysis, the combination therapy appears to have an acceptable safety profile, with a single grade 3 and single grade 4 event reported and no serious adverse events (SAEs) reported.

At the time of the interim analysis, three of four patients exhibited stable disease, while a fourth patient continued to progress and discontinued the trial. In addition, researchers observed:
• Signs of increased T cell activity in tumors in three of the four patients based on RNA sequencing
• Stable disease with signs of tumor shrinkage in the patient who has been in trial for the longest duration thus far (based on CT scan at day 140)

“We are very encouraged by these early data, which are tremendously important to Immunovaccine, as they help to validate the underlying clinical potential of DPX-Survivac,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Research is consistently demonstrating that activating T cells is a crucial mechanism to improving tumor response rates.(i) This desired mechanism of action is exactly what we have developed DPX-Survivac to address, and this data set has provided an encouraging first clinical demonstration of this effect.”

Immunovaccine is developing DPX-Survivac as a combination therapy that can significantly expand the range of cancers successfully treatable by novel immunotherapeutic agents. Emerging data from other studies have shown limited clinical efficacy of checkpoint inhibitor monotherapy in ovarian cancer, with response rates ranging from 10-15 percent.(ii)

Phase 1b Trial and Early Data

The Phase 1b company-sponsored clinical trial is a single-arm, open-label study of patients who have been diagnosed with platinum-resistant and sensitive ovarian cancer, and who have completed first-line treatment with measurable disease. Investigators plan to enroll up to 40 participants at up to ten sites in the U.S. and Canada. The study’s primary objective is to assess the safety and immunogenicity of the treatment, and to determine changes in the immune cell infiltration into tumors. Secondary objectives include objective response rate, duration of response, and time to progression.

Investigators are evaluating patients over a 12-month treatment schedule, collecting biopsy and blood samples before and after treatment. In addition, investigators are performing CT scans at the outset for each patient, repeating the scans every two months to evaluate status of the disease and to assess potential clinical benefit.

In addition to the early findings related to disease progression and the presence of survivin-antigen specific CD8+ T cells in the blood, analysis of the tumor revealed increases in multiple T cell markers, including cytotoxic markers and checkpoint inhibitor molecules.

“This readout, while from a limited number of patients, is important as it marks the first time DPX-Survivac has been tested in active progressive disease, where we can formally look at its impact on tumor progression and the tumor microenvironment, as well as assess potential clinical benefit,” said Marianne Stanford, PhD, Vice President, Research, at Immunovaccine. “The data set thus far has provided a preliminary indication of DPX-Survivac’s ability to induce T-cell infiltration in the tumor micro-environment. We are very encouraged by this information, and we look forward to the next opportunity to analyze the data and their related implications for this clinical program.”

Immunovaccine expects to complete enrollment and issue topline data by the end of 2017. Patients interested in enrolling in this trial can find more information via clinicaltrials.gov.

This triple combination study is the result of a collaboration between Immunovaccine and Incyte Corporation to assess the safety and effectiveness of DPX-Survivac, along with epacadostat, an investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor, and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease.

About Ovarian Cancer
According to the American Cancer Society (ACS),(iii) ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.

Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund(iv) reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.

About DPX-Survivac
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ platform, which is a patented formulation that provides controlled and prolonged exposure of antigens to the immune system, resulting in a strong, specific and sustained immune response. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA’s.

The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides. This targeted therapy attempts to use the immune system to search actively and specifically for tumor cells and destroy them. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.

DPX-Survivac has been granted Fast Track designation by the U.S. FDA as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival.

About Epacadostat (INCB24360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T-cell generation and blocking effector T-cell activation, thereby facilitating tumor growth by allowing cancer cells to avoid immune surveillance. Epacadostat is a first-in-class, highly potent and selective oral inhibitor of the IDO1 enzyme that reverses tumor-associated immune suppression and restores effective anti-tumor immune responses. In single-arm studies, the combination of epacadostat and immune checkpoint inhibitors has shown proof-of-concept in patients with unresectable or metastatic melanoma. In these studies, epacadostat combined with the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab improved response rates compared with studies of the immune checkpoint inhibitors alone. A Phase 3 study, ECHO-301, evaluating the combination of epacadostat with the anti-PD-1 antibody pembrolizumab for the first-line treatment of patients with advanced or metastatic melanoma is underway. Ongoing Phase 1 and Phase 2 studies are also investigating epacadostat in combination with PD-1 and PD-L1 inhibitors in a variety of other cancer histologies.

About Immunovaccine
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops T-cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Corporation’s patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T-cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing its lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. An investigator-sponsored Phase 2 study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide combined with an approved anti-PD-1 drug in advanced ovarian cancer. The Corporation is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.

Immunovaccine Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals and the matters discussed under “Risk Factors and Uncertainties” in Immunovaccine’s Annual Information Form filed on Sedar. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.

Contacts for Immunovaccine:

MEDIA
Mike Beyer, Sam Brown Inc.

T: (312) 961-2502 E: mikebeyer@sambrown.com

INVESTOR RELATIONS
Pierre Labbé, Chief Financial Officer

T: (902) 492-1819 E: Plabbe@imvaccine.com

Patti Bank, Managing Director, Westwicke Partners
O: (415) 513-1284
T: (415) 515-4572 E: patti.bank@westwicke.com

References:

(i) Patrick A. Ott, F. Stephen Hodi, Howard L. Kaufman, Jon M. Wigginton and Jedd D. Wolchok. Combination immunotherapy: a road map. Journal for ImmunoTherapy of Cancer (2017). 5:16 DOI 10.1186/s40425-017-0218-5

(ii) Gaillard SL, Secord AA, Monk B. 2016. The role of immune checkpoint inhibition in the treatment of ovarian cancer. Gynecologic Oncology Research and Practice. (3)11. DOI: 10.1186/s40661-016-0033-6

(iii) What Are the Key Statistics about Ovarian Cancer?” Cancer.org. The American Cancer Society, 12 Mar. 2015. Web. Accessed 29 Dec. 2015.

(iv) “Ovarian Cancer Statistics.” Cancer Facts and Figures – Data on Specific Cancers. World Cancer Research Fund International. Web. Accessed 29 Dec. 2015.

SutroVax Announces Closing of $64M via Series B Financing

SutroVax Announces Closing of $64M via Series B Financing

  • Announces achievement of pre-clinical proof-of-concept with lead program: Potential best-in-class pneumococcal conjugate vaccine
  • Advancing lead into IND-enabling development to obtain clinical proof-of-concept

Foster City, CA, March 21, 2017SutroVax, a biopharmaceutical company dedicated to the delivery of best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases, today announced the closing of a $60 million Series B financing. The financing was led by new investors Frazier Healthcare Partners and Pivotal bioVenture Partners, and included participation from all existing investors: Abingworth, Longitude Capital, Roche Venture Fund and CTI Life Sciences Fund. In addition to Series B funds raised, the Company’s existing investors are investing an additional $4 million in SutroVax.

SutroVax will use the proceeds from this financing to advance its lead pneumococcal conjugate vaccine (PCV), which prevents invasive pneumococcal disease caused by Streptococcus pneumoniae, and accelerate the Company’s antigen discovery and early-stage development efforts in other disease areas. SutroVax’s broad-spectrum PCV is designed to provide expanded protection against circulating strains of pneumococcus and has the potential to replace the current vaccines used in infants and adults. SutroVax has generated pre-clinical proof-of-concept in head-to-head studies with its broad-spectrum PCV compared to current vaccines using well accepted immunological endpoints.

“The closing of this round, which was highly competitive and oversubscribed, is an important milestone for SutroVax and reflects the significant achievements we have made in developing a pneumococcal conjugate vaccine product candidate with the potential to disrupt a market with annual sales of over $7 billion,” said Grant Pickering, CEO of SutroVax. “This financing enables us to advance our lead PCV program into the clinic and expand our R&D, clinical development and manufacturing organizations.”

SutroVax conjugate vaccines are developed utilizing the Company’s exclusive rights to Sutro Biopharma’s Xpress CF Platform, a cell-free protein synthesis technology. The platform represents a major advancement over conventional conjugate vaccine production methods, by enabling precise and consistent conjugation of antigens to site-specific locations on a protein carrier that do not impede T-cell help resulting in higher-potency conjugates. SutroVax is utilizing these more potent conjugates to develop a broader-spectrum PCV product.

“Frazier Healthcare Partners has followed SutroVax’s progress since its founding and is delighted to make SutroVax its first vaccine investment,” stated Patrick Heron, Managing General Partner.

 

Tachi Yamada, M.D., Frazier Venture Partner, former President of the Bill & Melinda Gates Foundation Global Health Program and former head of GlaxoSmithKline and Takeda Pharmaceuticals R&D added, “SutroVax’s lead product candidate and technology platform has the potential to deliver the next generation of vaccines for major infectious diseases including pneumococcal disease.”

 

“We are pleased to make SutroVax the pioneer investment from Pivotal bioVenture Partners, our recently closed inaugural fund. I am delighted to join with the preeminent group of life sciences investors backing the company,” said Tracy Saxton, Ph.D., Managing Partner. “We are excited by the Company’s differentiated approach and ground-breaking progress in developing a potential best-in-class pneumococcal conjugate vaccine to provide coverage of circulating pathogenic strains outside of the current standard of care.”

 

As part of the financing, Patrick Heron and Tracy Saxton will join the SutroVax Board of Directors.

 

About Frazier Healthcare Partners

 

Founded in 1991, Frazier Healthcare Partners is a leading provider of growth and venture capital to healthcare companies. With nearly $3.0 billion total capital raised, Frazier has invested in over 170 companies, with investment types ranging from company creation and venture capital to buyouts of profitable lower-middle market companies. The firm’s Growth Buyout team invests in healthcare and pharmaceutical services, medical products and related sectors. The Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, WA and Menlo Park, CA, and invests broadly across the US, Canada, and Europe.

 

About Pivotal bioVenture Partners

 

Pivotal bioVenture Partners is a newly launched, San Francisco-based venture capital firm investing in early stage biotechnology companies. Pivotal closed a $300 million fund, and its investment strategy is centered on identifying companies developing differentiated science from discovery to early clinical development with the potential to deliver transformative therapies. The Pivotal team includes experienced life science investors and entrepreneurs with a track record of venture investing and scientific acumen.

 

About Pneumococcal Disease and the Pneumococcal Vaccine Market

 

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. This infection can cause a wide range of serious illnesses including pneumonia, meningitis and blood stream infection as well as ear and sinus infections. According to the Centers for Disease Control and Prevention (CDC), an estimated 900,000 Americans suffer from pneumococcal pneumonia each year and up to 400,000 hospitalizations occur in the US.  In addition, about 18,000 older adults die each year from pneumococcal disease in the U.S. The market-leading vaccine is a 13-valent PCV, Prevnar 13®, that has worldwide sales of approximately $6 billion annually yet does not protect against a significant number of circulating strains of pneumococcus causing invasive disease in adults and children. In the U.S., the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends all children aged two months to five years and immunocompromised children aged six years and older be vaccinated with Prevnar 13®.  In addition, the ACIP recommends all adults aged 65 years and older and immunocompromised adults aged 19 years and older be vaccinated with Prevnar 13®and Pneumovax®, a 23-valent non-conjugate vaccine with over $600 million in annual sales.

 

About SutroVax

 

SutroVax is an independent vaccine platform and development company whose mission is to deliver best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases. The company is leveraging its exclusive license to Sutro Biopharma’s Xpress CF platform to perform cell-free protein synthesis and site-specific conjugation for the field of vaccines. For more information, visit www.sutrovax.com.

 

# # #

 

Contact:

Julie Rathbun

Rathbun Communications

206-769-9219

julie@rathbuncomm.com

 

 

CellAegis Devices raises $12.8 mln in CTI-led Series C round

CellAegis Devices raises $12.8 mln in CTI-led Series C round


CellAegis Devices (Toronto, Canada) has patented and developed the non-invasive autoRIC Device, which delivers Remote Ischemic Conditioning (RIC) therapy to patients with acute and chronic cardiovascular conditions. © 2000–2015 CellAegis® Devices Inc. All rights reserved.

Toronto medical device company CellAegis Devices Inc has secured about $12.8 million (US$9.5 million) in a Series C financing. The round was led by Canadian venture capital firm CTI Life Sciences Fund and co-led by an undisclosed U.S. strategic investor. MaRS Catalyst Fund, Broadview Ventures and several family offices also invested. With the deal, Dr. Shermaine Tilley, a CTI managing partner, and Broadview’s Christopher Colecchi have joined the board. CellAegis has developed the non-invasive autoRIC Device, which delivers therapy to patients with cardiovascular conditions. It will use the funds raised to support U.S. clinical testing and commercialization.

PRESS RELEASE

CellAegis Devices Announces US$9.5 Million Financing to Support Clinical and Regulatory Advancement of its autoRIC® Device

TORONTO, March 14, 2017 /PRNewswire/ – CellAegis Devices Inc, a Toronto-based medical device company, today announced closing a US$ 9.5 million Series C financing to support a U.S. clinical trial and de novo 510(k) regulatory filing for marketing of its autoRIC Device as an adjunct therapy to stenting. This device automatically delivers Remote Ischemic Conditioning (RIC) to provide a non-invasive, cardio-protective therapy shown to reduce heart damage during heart attacks and other cardiovascular procedures. The autoRIC Device is approved by Health Canada and in Europe where it is being used in multiple large investigator-sponsored trials to assess its efficacy in reducing clinical events after a heart attack.

The financing was led by CTI Life Sciences Fund, a leading Canadian venture capital investor, and co-led by a U.S. based strategic investor. Other investors included MaRS Catalyst Fund, Broadview Ventures and strategic family offices.
Dr. Shermaine Tilley, Managing Partner in CTI Life Sciences Fund, and an appointee from the US Strategic will join CellAegis’ board of Directors. Christopher Colecchi, from Broadview Ventures’, will also serve as a Director.

“We are ready to advance clinical commercialization of autoRIC Device in the EU and Canada, complete the FDA trial and gain approval to open the US market,” said Rocky Ganske, Chief Executive Officer of CellAegis Devices. “This financing adds the experience of seasoned Canadian and U.S. medical technology investors, and demonstrates the support of our existing investors.”

Dr. Tilley stated, “CTI Life Sciences Fund is enthusiastic to provide capital to CellAegis at this important juncture in the company’s development. The autoRIC Device shows promise in significantly improving outcomes in cardiovascular and other organ systems following ischemic events such as heart attacks, and we look forward to facilitating its clinical testing and regulatory submission for the U.S. market.”

*CellAegis autoRIC Device is not cleared or approved for clinical use in the United States.

About CellAegis Devices.
CellAegis Devices (Toronto, Canada) has patented and developed the non-invasive autoRIC Device, which delivers Remote Ischemic Conditioning (RIC) therapy to patients with acute and chronic cardiovascular conditions. This medical procedure protects the heart as well as other organs from ischemia and reperfusion injury. The autoRIC Device has CE Mark and Health Canada approvals for treatment during heart attacks, cardiothoracic or surgical procedures. Investigator sponsored clinical research studies for chronic conditions such as heart failure and stroke are also underway. The autoRIC Device was developed from the clinical work of Dr. Andrew Redington and colleagues at the Hospital for Sick Children in Toronto, and funded in part by the Fondation Leducq’s Transatlantic Networks of Excellence.

About CTI Life Sciences Fund.
CTI Life Sciences Fund L.P. was created in 2006 and is based in Montreal. The firm makes venture capital investments mostly in high quality biotech and medtech companies at the pre-clinical and clinical development stages, in North America, and primarily in Canada. Since its second mandate in 2014, CTI Life Sciences Fund manages $245 million of assets. For more information, please visit www.ctisciences.com.

About Broadview Ventures.
Broadview’s mission is to accelerate the development of promising technology for the diagnosis and treatment of cardiovascular and neurovascular disease through targeted investments. For more information visit http://broadviewventures.org

About MaRS Catalyst Fund.
MaRS Catalyst Fund launched in 2016 provides funding and support to Canadian companies pursuing social and environmental outcomes with business models that scale. MaRS Catalyst focuses on businesses that can deliver better Health outcomes, provide a more sustainable Planet and support happier People through innovative education products and work sustainability services. For more information please visit www.marscatalystfund.ca

**CellAegis and autoRIC are registered Trademarks of CellAegis Devices Inc.

Related Links

http://cellaegisdevices.com

Photo courtesy of CellAegis Devices Inc

Immunovaccine’s Preclinical DPX-NEO Program Demonstrates Positive Anti-Cancer Activity

Immunovaccine’s Preclinical DPX-NEO Program Demonstrates Positive Anti-Cancer Activity

Spotlight Companies |

Immunovaccine (IM.V), a biotechnology company, is dedicated to advancing cancer therapies and infectious disease vaccines. The Halifax-based company’s DepoVax™ platform has been credited as the foundation of all its vaccine development efforts.

According to the company’s official website, DepoVax™ is a patented vaccine delivery formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system. The result is a strong, specific and sustained immune response with the capability for single-dose effectiveness. Currently, the company boasts an impressive product pipeline that includes candidates being developed to address the unmet needs within cancer therapies and and the treatment of infectious diseases.

As with most great works, Immunovaccine has collaborated with some of the most recognizable names in medical research. The company’s partners, among others, include:

  • Pfizer
  • NIH
  • MERCK

In recent news, Immunovaccine announced a key development regarding its preclinical studies. In collaboration with UConn Health, the Immunovaccine’s preclinical DPX-NEO program, which used neoepitope formulated with the DepoVax™ platform in mouse tumor models, have demonstrated positive anti-cancer activity.

“This study provides evidence that the DepoVax™ platform can serve as an optimal enabling formulation technology to deliver strong and sustained immune responses against tumors with neoepitopes, an approach that we believe is a promising option for advancing personalized cancer medicines,” said Frederic Ors, CEO of Immunovaccine. “With our novel DepoVax™ platform and cost-effective, scaleable manufacturing capabilities, we believe Immunovaccine can play an important role advancing clinical progress for neoepitope therapies as this exciting field evolves.”

The biotechnology sector continues to be a fascinating and increasing promising sector with new groundbreaking treatment innovations on the horizon. As reported by Healio, Immunovaccine, as of March of this year, was one of six companies or government agencies working on about 17 RSV vaccine candidates, A vaccine for respiratory syncytial virus, in various stages of clinical trials.

“Our primary indication is in the elderly, who have gotten RSV multiple times, so they have immune responses to F and G and they’re not protected,” Marianne Stanford, PhD, vice president of research at Immunovaccine. “Our hypothesis is, let’s mount an immune response against something that they don’t typically have an immune response to, and then sort of circumvent infection that way. That makes it very different from everything else that’s out there. What we’re trying to do is target immune response not against the virus particle, but against the infected cell.”

Furthermore, earlier this month, KIMT reported that a new vaccine for Glioblastoma, the most common and most severe form of brain cancer, showed promising results for researchers in Buffalo, New York.

Patient Margie Kruse was diagnosed with the cancer last year. Following a Phase II clinical trial for the vaccine currently being conducted at Roswell Park Cancer Institute in Buffalo, her tumor was a no-show in her most recent MRI. “This vaccine has been absolutely a godsend,” Kruse told KIMT.

Thanks to its recent positive preclinical results and its continued efforts to provide rays of hope to patients diagnosed with devastating diseases, the investment community looks forward to future developments from Immunovaccine and the biotech sector as a whole.

To learn more about Immunovaccine, visit www.imvaccine.com.

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Profound Medical Corp. Completes Previously Announced $17.4 Million Bought Deal Offering of Common Shares

Profound Medical Corp. Completes Previously Announced $17.4 Million Bought Deal Offering of Common Shares

THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.

TORONTO, Nov. 14, 2016 (GLOBE NEWSWIRE) — Profound Medical Corp. (“Profound” or the “Company”) (TSX-V:PRN) today announced that it has completed its previously announced bought deal offering of 15,820,000 common shares of the Company (“Common Shares”) at a price of $1.10 per Common Share (the “Offering”) for gross proceeds of approximately $17.4 million. The Offering was completed through a syndicate of underwriters led by GMP Securities L.P., and including Echelon Wealth Partners Inc. and Mackie Research Capital Corp.

The Common Shares were offered by way of a short form prospectus in all of the provinces of Canada as well as in the United States under applicable registration statement exemptions. The Company intends to use the net proceeds from the Offering (a) to support certain costs and expenses of the TACT Pivotal Clinical Trial; (b) for ongoing expansion of infrastructure to execute on European sales and marketing plans; and (c) for general corporate purposes, including working capital.

The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any State in which such offer, solicitation or sale would be unlawful.

About Profound Medical Corp.

The Profound team is committed to the effort to achieve a new therapeutic standard in prostate cancer. For the millions of men currently living with prostate cancer, and the thousands more who are diagnosed with it every year, current treatment options often mean having to make difficult choices based on potential side effects that can significantly impact quality of life. The Company’s mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate cancerous prostate tissue with precision, while actively protecting critical anatomy from potential side effects; a tomorrow where patients have access to a safe, fast and effective treatment option, so they can quickly return to their daily lives.

Established in 2008, Profound is commercializing a novel technology, TULSA-PRO™, which combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects. TULSA-PRO™ is CE Marked and Profound is sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which is designed to further demonstrate the safety and effectiveness of this innovative technology.

Forward Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For investor or media inquiries, please contact:

Steven Kilmer
Investor Relations
Profound Medical Corp.
skilmer@profoundmedical.com
T: 647.872.4849

Rashed Dewan
Vice President, Finance
Profound Medical Corp.
T: 647.476.1350