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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.

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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Toronto’s Xagenic Inc. completes successful beta testing of X1 diagnostic system

Toronto’s Xagenic Inc. completes successful beta testing of X1 diagnostic system

 Toronto-based developer of lab-free molecular diagnostics platform Xagenic Inc. has announced that the Beta version of its fully automated X1 molecular diagnostic testing system has undergone successful testing at an external clinical site.

The external study confirmed the feasibility of point-of-care testing using the X1 system, and that the CT/NG (combined chlamydia and gonorrhoea) test was able to generate results comparable to gold-standard molecular tests normally run at centralized labs.

“We are very excited about the progress of the X1 testing system and demonstrating its clinical utility during Beta testing,” said Xagenic COO Randall Wilhoite. “The information we have collected will inform the completion of the final design for the X1 and the development of menu for this first-in-class POC molecular testing system.”

Successful conclusion of this Beta testing precedes Xagenic’s plans for market launches in Europe and the U.S. in the near future.

Xagenic’s X1 system is a cartridge-based, point-of-care platform to test for infectious diseases, such as flu, strep and upper respiratory infections, although this first assay developed for the X1 system is a combined chlamydia and gonorrhoea (CT/NG) test designed to facilitate screening, diagnosis and rapid treatment of these common sexually-transmitted diseases.

The single-use cartridge system contains a proprietary sensor chip that enables direct detection of chlamydia and gonorrhea without the use of enzymes, and is an electrochemical amplification-based technology protected by 17 patent families globally.

The X1 system is intended to deliver a definitive test result during the time available during a typical on-site office consult with a physician, typically requiring less than a minute of physician hands-on time running with the device.

Normally, tests require that samples to be sent to centralized labs before results are obtained, a process that can last anywhere between two to seven days.

Bringing rapid on-demand testing to physician offices eliminates costs associated with that out-sourced transportation and testing infrastructure, while also improving patient compliance and outcomes, and reducing complications and unnecessary direct costs.

In 2015, Xagenic announced a $15 million round of financing, led by investors that had previously participated in its 2014 $25.5 million Series B round of funding, including Domain Associates, CTI Life Sciences, BDC Capital and the Ontario Capital Growth Corporation.

Between that and Xagenic’s $10 million in Series A funding, the company has raised $52.7-million in financing to date.

Xagenic has origins in the University of Toronto, and was launched in 2010 with $1 million seed money from MaRS Innovation, the Ontario Institute for Cancer Research, the Health Technologies Exchange, and the Ontario Centres of Excellence.

In 2015, Xagenic acquired exclusive rights to a mutation detection technology, developed by Dr. Shana Kelley, whose University of Toronto team has developed a close working relationship over the years with Xagenic.

That team published a study on the technology in Nature Chemistry, outlining its capacity to detect cell-free nucleic acids in blood plasma or serum, meaning that Xagenic’s platform would be able to run a kind of “liquid biopsy” or deliver results without taking a tissue sample.

Headquartered in Toronto, Xagenic also has a San Francisco office.

BioWorld Today: Venous infers: Early work sufficient to attract $21M for Ilkos’ leg ulcers effort

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Venous infers: Early work sufficient to attract $21M for Ilkos’ leg ulcers effort

SEPTEMBER 28 , 2016

By Randy Osborne, Staff Writer
“The beauty of this deal is that it’s not just an out-licensing deal from Servier,” CTI Life Sciences partner Jean-François Leprince told BioWorld Today as he explained newly formed Laval, Quebec based Ilkos Therapeutics Inc., which made its debut with a $21 million three-way investment in equal parts by CTI, the Fonds de solidarité FTQ and Servier Canada.

Ilkos is developing a compound called S42909 for oral, first-line treatment of venous lower limb ulcers. The candidate was deprioritized from Servier’s research and development lineup, but the firm is still “highly interested” in it, Leprince said – interested enough that the company is overseeing phase IIa trials as part of the arrangement with Ilkos. “They remain investors into the newco in Quebec, and the newco is contracting Servier as, I would say, a service provider,” he said. “We will be using the Servier organization to run the phase IIa trials around Europe, Canada and the U.S.” The $21 million is “more than enough” to finish the dose-ranging trial, which will involve three doses and more than 200 patients, he added.

A nicotinamide adenine dinucleotide phosphate (NADPH) oxidase inhibitor, S42909 “has gone through a very intensive and complete phase Ia trial with more than 200 healthy volunteers,” he said. The outcome turned up data showing S42909 safe and well-tolerated. “We believe, rightly or wrongly – the future will tell – that there is enough de-risking or risk mitigation with this project,” he said. Servier, founded in 1954, is the first French independent pharmaceutical group.

About S42909, Leprince said, “at the very beginning, [venture capital fund CTI] had a little bit of skepticism, because this indication has been the graveyard of many drugs, not to mention the latest cellular therapies. But I must say that the pharmacological properties of the compound have been evidenced by very compelling preclinical results.” Servier, with “global leadership in vein disease” thanks to Daflon (micronized purified flavonoid fraction), makes the ideal partner, in his view. “Would it not have been that way, because of the challenge associated with the indication, we would not have done [the deal]. There is only one company with the kind of expertise in venous insufficiency that can operate a trial like that.”

Specifically, Daflon is indicated for symptoms of venolymphatic insufficiency (heavy legs, pain, restless leg at bedtime) and hemorrhoid attacks.

S42909 “goes one step beyond” Daflon to affect the causes of venous insufficiency, said Leprince. Along with Danny Gagné, manager of the Fonds de solidarité FTQ’s life sciences portfolio, and Frédéric Fasano, Servier Canada’s CEO, he will serve as director of Ilkos. Chairman of the board is Mark Beaudet, co-founder of St. Laurent, Quebec-based Paladin Labs Inc., acquired by Endo International plc, of Dublin, in 2013. (See BioWorld Today, Nov. 6, 2013.)

NEUROPATHY . . . AND ALZHEIMER’S?

In the microcirculation damage of venous insufficiency, three mechanisms are implicated: leukocyte additions to the endothelial wall; oxidative stress; and the presence of metalloproteinase-2. S42909 seems to influence all of those, Leprince said. “You will tell me, ‘OK, it’s animals,’ but we believe those animal models are very predictive of what could happen in humans,” he said. Currently, venous lower limb ulcers are treated with compression bandages and “some local, topical products that are used essentially to address the symptoms, i.e., inflammation [and] infections,” he said. “First, we want to demonstrate the efficacy of the compound in venous disease, which [makes up] 70 percent of the total ulcers. Second, maybe the indication we will be targeting is the prevention of recurrence of the venous ulcers. Healing the ulcers is already quite an achievement, but then you run the risk, especially with aged people, to suffer the recurrence. We may [later] contemplate what we call mixed ulcers, which is a combination of venous and arterial, but we are not yet at the level of arterial disease.”

Ilkos takes its name from the Greek for ulcer, “elkos,” with the first vowel changed to suggest illness and thence healing. “The concept is a kind of quasi-virtual company,” Leprince said. Ilkos will contract with Servier and others, intending along with the phase IIa trial to “stake a post in the ground with the beginning of a clinical development program in Japan,” while conducting some preclinical toxicology studies “which are longer-term, 26- week studies on animals,” he said.

A June paper in Experimental Dermatology described a two-week preclinical experiment in 24 New Zealand white rabbits. Researchers concluded that “S42909 improved [the] healing process by dampening excessive inflammation and facilitating collagen deposition without wound contraction phenomena,” and said the compound “might be a promising therapy to treat chronic wounds [such] as venous leg ulcers.”

The company is not alone in NADPH oxidase research. At the start of last year, Geneva-based Genkyotex SA raised CHF20 million (then US$20 million) in a series D round to take forward its pipeline of selective NADPH oxidase inhibitors in a broad range of indications, including diabetic neuropathy. In November 2015, the company gained orphan drug status from the FDA and EMA for GKT137831, its lead drug in the class, targeting systemic sclerosis. Another Swiss firm, Kareus Therapeutics SA, is trying an approach with NADPH in Alzheimer’s disease, though research is early stage. (See BioWorld Today, Jan. 7, 2013, and Jan. 8, 2015.) //

$21 Million Investment in Québec Biotech Start-up to Develop a Treatment for Venous Lower Limb Ulcers

 

$21 Million Investment in Québec Biotech Start-up to Develop a Treatment for Venous Lower Limb Ulcers

Servier Canada, CTI Life Sciences Fund and Fonds de solidarité FTQ each invest $7 million to create ILKOS THERAPEUTICS

Highlights:

  • Total investment of $21 million
  • Clinical development of a first line oral treatment for venous lower limb ulcers
  • Creation of approximately 10 direct jobs and through outsourcing

LAVAL, QC, Sept. 26, 2016 /CNW Telbec/ – The Fonds de solidarité FTQ, CTI Life Sciences Fund and Servier Canada are pleased to announce the creation of ILKOS THERAPEUTICS Inc., a new Québec biotechnology firm tasked with the development of S42909, a compound indicated in the treatment of venous lower limb ulcers.

The Laval-based start-up is the result of a combined $21-million investment by the three equal partners.

According to Normand Chouinard, Executive Vice-President, Investments, at the Fonds de solidarité FTQ, “ILKOS THERAPEUTICS shows once again that Québec can succeed in the life sciences sector. Our quality R&D and service infrastructures, combined with the availability of capital, make Québec an optimal location for the development of new therapies. By leveraging collaboration between venture capital investors such as CTI Life Sciences and the Fonds de solidarité FTQ, and Servier, a French organization with a long-standing presence in the province, Québec is at the vanguard of biomedical innovation. Innovation also involves coming up with new ways to invest by sharing the risk with pharmaceutical firms while capitalizing on their expertise.”

For Ken Pastor, General Partner at CTI Life Sciences Fund, “This initiative reflects our commitment to capitalizing on Québec expertise in order to implement a large-scale mobilizing project. We are pleased to have the Fonds de solidarité FTQ as a partner in this venture and are honoured that Groupe Servier has chosen to join us, particularly since this is the first time this international pharmaceutical firm, which is well established in Québec, is partnering with a VC fund in Canada.”

For his part, Frédéric Fasano, Chief Executive Officer of Servier Canada, said: “For Servier, this new partnership is in keeping with its research investment strategy in Québec. We launched our Centre of Excellence in Clinical Research in 2014, and now we are investing in a biotech firm. The fact is that what we could do on our own in the past is no longer possible without the help of a network of high-calibre partners. The creation of ILKOS THERAPEUTICS will make it possible to continue the clinical development of an innovative drug, which was deprioritized from Servier’s R&D strategic priorities. This innovative project reflects the evolution of our business model.”

This partnership will ensure the development of an original molecule under a global, exclusive licence granted by Servier to ILKOS THERAPEUTICS.

The target indication is the oral treatment of venous lower limb ulcers, a disease that affects 1% to 1.5% of the population, mainly older people. Current treatment, which besides being only moderately effective for complete wound healing and limited to compression bandages and local wound care, is labour intensive, accounting for 1.5% to 2% of the health care budget in countries such as Canada. The new treatment, which seeks to become the first line treatment for venous lower limb ulcers, is a potentially major clinical breakthrough.

The compound has shown promising pharmacological wound healing properties in preclinical trials and was proven to be safe in phase 1 clinical trials on more than 300 healthy volunteers.

The project headed by ILKOS THERAPEUTICS involves demonstrating the efficacy of the compound during a phase 2A multicentre trial conducted in North America and Europe and involving more than 200 patients.

As part of a collaboration agreement with ILKOS THERAPEUTICS, Servier will coordinate and oversee the trial through Servier Canada’s Centre of Excellence in Clinical Research.

Mark Beaudet, co-founder of Paladin Labs in 1996 and who headed the lab in Montréal until April, has accepted to chair the board of directors of ILKOS THERAPEUTICS.

Danny Gagné, manager of the Fonds de solidarité FTQ’s life sciences portfolio, Jean-François Leprince, managing partner at CTI Life Sciences Fund, and Frédéric Fasano, Servier Canada’s chief executive officer, will serve as directors.

About CTI Life Sciences

Based in Montreal, CTI Life Sciences Fund L.P. was created in 2006. 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 Québec. Since its second mandate in 2014, CTI Life Sciences Fund manages $245 million of assets. For more information, visit www.ctisciences.com.

About Servier

Servier is an international pharmaceutical company governed by a non-profit Foundation and headquartered in France. With a strong international presence in 148 countries and a turnover of 3.9 billion euro in 2015, Servier employs over 21,200 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiology, oncology, metabolism, neuropsychiatry and rheumatology, as well as by its activities in high quality generic drugs. Being completely independent, the Group reinvests 25% of Servier’s products turnover in Research and Development and all its profits in its growth.

Servier has played a critical role in shaping the medical practice in cardiology and hypertension over the past two decades through its engagement in landmark clinical trials. Servier’s marketed portfolio in cardiovascular consists of 12 major products, generating a turnover of more than 1.5 billion euro in 2015. Currently, there are 12 new fixed-dose combinations and 10 new molecular entities in research or development phase, mainly targeting heart failure. This portfolio of innovative treatments is being developed with partners worldwide.

Servier Canada was created in 1978 and is the third subsidiary of Groupe Servier. Employing upwards of 325 people, including 160 in Québec, it is tasked with registering and commercializing medications for heart disease and type II diabetes, as well as for the clinical development of new drug candidates. In 2014, the company inaugurated its Centre of Excellence in Clinical Research to support clinical studies from phase I to phase III registration. More recently, Servier Canada diversified its drug portfolio to include coagulation and cancer therapies, the result of new partnerships with two U.S.-based companies.

More information on the Group is available at www.servier.fr.

About the Fonds de solidarité FTQ

The Fonds de solidarité FTQ is a capital development fund that channels the savings of Quebecers into investments. With $11.7 billion in net assets as at May 31, 2016, the Fonds has helped create and maintain 187,414 jobs. The Fonds has more than 2,600 partner companies and 618,551 shareholder-savers. www.fondsftq.com.

SOURCE Servier Canada

For further information: Press contacts: Jean-François Leprince, Managing Partner, CTI Life Sciences Fund, Telephone: 514 787-1619, Mobile: 514 889 3858, Email: jfleprince@ctisciences.com; Nadine Doucet, Servier Canada, Telephone: 450 978-9700, ext. 4225, Email: nadine.doucet@servier.com; Patrick McQuilken, Senior Advisor, Press Relations and Communications, Fonds de solidarité FTQ, Telephone: 514 850-4835, Mobile: 514 703-5587, Email: pmcquilken@fondsftq.com

With $150M in the bank, Dalcor seeks phase III success with dalcetrapib

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With $150M in the bank, Dalcor seeks phase III success with dalcetrapib
Seeking to succeed where big pharma failed, start-up Dalcor Pharmaceuticals completed a $100 million series B round to put an exclamation point on the $50 million series A the company closed late in 2015. The company was launched a year ago by Sanderling Ventures LLC with a new take on dalcetrapib – a phase III asset abandoned by Japan Tobacco Inc. and Roche AG after it failed to show efficacy in treating dyslipidemia in patients with coronary heart disease. Dalcor subsequently licensed the second-generation, oral cholesteryl ester transfer protein, or CETP, inhibitor from Roche with the goal of advancing the candidate in a genetically distinct population of patients with cardiovascular disease. The series A/B proceeds will fund a phase III trial of dalcetrapib in an estimated 5,000 patients who recently experienced acute coronary syndrome. An investigational companion diagnostic test developed by Roche Molecular Systems will be used to determine if a patient is eligible to receive the drug.
Source: BioWorld

WSJ: Startup Aims to Revive Failed Drug

 
DalCor is mounting 5,000-patient trial of cholesterol drug that Roche shelved after phase 3 failure.
A study led by Jean-Claude Tardif, director of research at the Montreal Heart Institute, identified a genetic variation linked to a benefit for dalcetrapib. The drug failed to show an overall benefit in a study of nearly 16,000 patients.
A study led by Jean-Claude Tardif, director of research at the Montreal Heart Institute, identified a genetic variation linked to a benefit for dalcetrapib. The drug failed to show an overall benefit in a study of nearly 16,000 patients. PHOTO: MONTREAL HEART INSTITUTE
By RON WINSLOW
April 19, 2016 12:04 a.m. ET
A London-based startup is making a risky bet that a surprising genetic variation will enable it to find success in one of the pharmaceutical industry’s biggest flops.DalCor Pharmaceuticals said it has raised $150 million in venture financing to mount a 5,000-patient trial of a cholesterol drug called dalcetrapib that Roche Holding AG shelved after the pill failed to prevent heart attacks and strokes in a phase 3, or late-stage, study of nearly 16,000 patients.

DalCor’s plan is based on a DNA analysis of patients in the Roche study that revealed a variation in a single gene was associated with a 39% reduction in heart attacks and strokes. About 20% of patients had the favorable variant. A corresponding variant in the same gene was linked to a heightened risk.

The company will enroll only patients with the favorable genetic signature in its study, hoping to rescue the drug from the scrap heap.

The trial raises the provocative possibility that other failed drugs might be revived based on genetic variations that affect how patients respond.

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“I don’t know that there’s ever been a drug that failed in a large phase 3 program [where] genetic testing identified a potential subgroup that might benefit,” said Dan Rader, a cholesterol expert at University of Pennsylvania, who is an adviser to the company. “This is a grand experiment on a grand scale.”

The risks are daunting. Dalcetrapib is one of a class of drugs called CETP inhibitors that raise levels of HDL, or good cholesterol, and that a decade ago were touted as certain blockbusters in the battle against cardiovascular disease. Pfizer Inc. and Merck & Co., whose cholesterol-lowering drugs called statins transformed treatment of cardiovascular disease, were among four major companies racing to bring CETP inhibitors to the market.

But in 2006, Pfizer’s torcetrapib was found in a major study to increase risk of death and cardiovascular problems, halting its development in a notorious $800 million bust. Roche scrapped dalcetrapib in 2012. Last October, Eli Lilly & Co. killed its program to develop evacetrapib when it failed to reduce risk of major events despite significant favorable changes in cholesterol.

Only Merck’s anacetrapib and a CETP inhibitor Amgen Inc. acquired in a deal last September remain in testing amid broad skepticism that they will succeed.

“It’s been a terrible bust” Eric Topol, a cardiologist and professor of genomics at Scripps Research Institute, La Jolla, Calif., says of the failures. “It’s hard to imagine that there’s just this one gene that pops out to explain the whole story.”

Dr. Topol also said it isn’t clear scientifically why the variant might be beneficial.

DalCor and its allies are optimistic. The DNA analysis study led by Jean-Claude Tardif, director of research at the Montreal Heart Institute, found the favorable gene variant in 20% of patients. Another 40% had the variant associated with a higher risk of heart attacks and strokes. Those with a third variant fell in between. A second study showed the favorable variant was associated with healthier carotid arteries, providing important support for the original findings.

“It was so striking and so concordant we were convinced the chance” of a false result was “very very low,” Mr. Tardif said.

“We wouldn’t be pursuing this opportunity if the signal wasn’t so clear around a single gene,” added Donald Black, DalCor’s chief medical officer and an inventor of Pfizer’s blockbuster statin Lipitor.

Dr. Tardif and Marc Pfeffer, a cardiologist at Harvard-affiliated Brigham and Women’s Hospital, are co-principal investigators of the trial and consultants to DalCor.

The study will enroll patients with an unstable heart condition called acute coronary syndrome—the same type of patient in whom the phase 3 study of dalcetrapib had failed. Half the patients will get dalcetrapib and a statin while a control group will be treated with statins alone. It is likely to be the end of the decade before the results are known.

“Usually with genetics, you have a lot of different genes involved,” says DalCor CEO Robert McNeil.

“When you have something very specific, you say, ‘wow, something is going on here.’”

Founding investors were Sanderling Ventures—which was founded by Dr. McNeil—and Canadian businessman André Desmarais. They were joined by Caisse de dépôt et placement du Québec, the Fonds de solidarité FTQ, and CTI Life Sciences and other undisclosed investors.

Source: WSJ

Zymeworks Names Diana Hausman, M.D. Chief Medical Officer

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April 26, 2016

Vancouver, Canada – Zymeworks Inc., a leader in the development of bi-specific and multi-specific antibodies, announced today that it has appointed Diana Hausman, M.D., to the newly created position of Chief Medical Officer. In this role, Dr. Hausman is responsible for overseeing clinical development and clinical strategy for the company.

“Diana joins our leadership team at a critical time as we transition to a clinical stage company, with our two leading compounds nearing first-in-human trials,” said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. “With Diana’s broad experience leading development programs in a variety of disease areas, we are well positioned to discover and bring forth new medicines for patients with cancer, autoimmune and inflammatory diseases.”

“I’m delighted to be joining the talented team at Zymeworks, which is rapidly becoming a leader in biologics drug discovery and development,” said Dr. Hausman. “This is an incredibly exciting time for the company and, given the promising preclinical data for the two Azymetric™ antibodies and propitious strategic collaborations underway, I look forward to advancing the pipeline and bringing new treatment options to patients who are otherwise ineligible for existing therapies.”

A board certified medical oncologist, Dr. Hausman brings more than 15 years of clinical drug development experience to the management team at Zymeworks. Most recently, she was Chief Medical Officer at Oncothyreon where she overaw the clinical program for their lead Phase 2 targeted anti-HER2 cancer therapy. While there, Dr. Hausman also led planning for the clinical development of a therapeutic vaccine and earlier served as the company’s vice president of clinical development. She has also held positions at Zymogenetics, Berlex, and Immunex working across multiple indications, including oncology, hematology, hepatitis C, and autoimmune disease. Dr. Hausman received her internal medicine training and specialty training in hematology and medical oncology at the University of Washington. She holds an M.D. degree from the University of Pennsylvania and an A.B. in biology from Princeton University.

About Zymeworks Inc.

Zymeworks is a privately held biotherapeutics company that is developing best-in-class Azymetric™ bi-specific antibodies and antibody drug conjugates for the treatment of cancer, autoimmune and inflammatory diseases. The company’s novel Azymetric™, AlbuCORE™, and EFECT™ platforms, its Zymelink™ conjugation platform and cytotoxins, and its proprietary ZymeCAD™ structure-guided protein engineering technology, enable the development of highly potent bi-specific antibodies, multivalent protein therapeutics, and antibody drug conjugates across a range of indications. Zymeworks is focused on accelerating its preclinical biotherapeutics pipeline through in-house research and development programs and strategic collaborations.

Contact:

Media Inquiries
Michael Lampe
(484) 575-5040
michael@scientpr.com

Investor Inquiries
Stephanie Carrington
ICR Inc.
(646)277-1282
stephanie.carrington@icrinc.com

Zymeworks Inc.
Ali Tehrani, Ph.D.
President & CEO
(604) 678-1388
info@zymeworks.com

Source: http://www.zymeworks.com/news/zymeworks-names-diana-hausman-md-chief-medical-officer