On January 3, 2018 Syntimmune, Inc., a clinical-stage biotechnology company focused on FcRn biology, reported that the company has appointed Jean-Paul Kress, M.D., as President and Chief Executive Officer (Press release, Syntimmune, JAN 3, 2018, View Source [SID1234522867]). Dr. Kress, who will also serve as a director of the company, brings senior leadership experience in pharmaceutical and biotechnology firms, with a focus on operations and commercialization of innovative products addressing unmet medical needs across diverse disease indications. David de Graaf, Ph.D., has stepped down from his position as CEO and resigned from the company’s Board of Directors. Syntimmune co-founder Laurence Blumberg, M.D., will continue to serve as Syntimmune’s Chief Operating Officer and as a member of the Board.

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"Jean-Paul possesses decades of experience bringing to market therapies based on breakthrough science," stated Burt Adelman, M.D., Syntimmune’s lead independent director and advisor to the company. "We are very pleased to welcome this industry veteran at the helm of Syntimmune. We believe Jean-Paul’s leadership brings vision and expertise that will be transformational as the company matures toward becoming a late-stage development organization and continues to rapidly advance therapies targeting FcRn biology to patients."

Dr. Blumberg added, "We are grateful for David de Graaf’s many contributions during a period of substantial progress at Syntimmune, during which we initiated two mid-stage clinical trials of our lead candidate, SYNT001, and completed a successful Series B financing that has positioned us well for further advancement."

Prior to joining Syntimmune, Dr. Kress served as Executive Vice President and President, International, and Head of Global Therapeutic Operations at Biogen Inc., overseeing the company’s rare and specialty disease teams. Previously, Dr. Kress was Senior Vice President, Head of North America at Sanofi Genzyme, where he was instrumental in launching several therapeutic products, including dupilumab, the first biologic agent approved in atopic dermatitis. Prior to this, he was President and Chief Executive Officer of Sanofi Pasteur MSD, a vaccines joint venture of Sanofi and Merck & Co. Dr. Kress also held leadership roles at Gilead, serving as Vice President, US Sales and Marketing, and Vice President, General Manager for France. He began his industry career with Eli Lilly in France and held commercial and business development roles in the US and Europe at Abbott (now AbbVie). Dr. Kress received an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.

"I am excited to join the accomplished team at Syntimmune, which possesses world-class expertise in immunology and FcRn biology applicable to a broad range of autoimmune diseases," said Dr. Kress. "Syntimmune has made important strides in advancing its clinical development pipeline, and I look forward to the progress of the company’s ongoing Phase 1b/2a clinical trials of SYNT001 in pemphigus and warm autoimmune hemolytic anemia, as well as the anticipated commencement of clinical studies in additional indications."

On January 3, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies, reported that it will present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, 10 January, 2018 at 8:30 AM Pacific Standard Time (11:30 AM Eastern Time; 5:30 PM CET) (Press release, Molecular Partners, JAN 3, 2018, View Source [SID1234522863]).
The presentation, followed by a Q&A session, will be hosted by Dr. Patrick Amstutz, CEO of Molecular Partners.

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The presentation will be webcast live and can be accessed on the day via this link. A copy of the presentation handout as well as a replay of the webcast will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 30 days following the presentation.

On January 3, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, reported that Matthew R. Patterson, President and Chief Executive Officer, will provide a corporate overview and 2018 outlook at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Audentes Therapeutics, JAN 3, 2018, View Source;p=RssLanding&cat=news&id=2324604 [SID1234522861]). The presentation is scheduled for Wednesday, January 10, 2018, at 2:30 pm PT.

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To access a live webcast of the presentations, please visit the Events & Presentations page within the Investors & News section of the Audentes website. Replays of live webcasts will be available on the Audentes website for approximately 30 days following the conferences.

On January 3, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that AstraZeneca will use the Company’s myChoice HRD Plus in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza (olaparib) and Avastin (bevacizumab) (Press release, Myriad Genetics, JAN 3, 2018, View Source [SID1234522828]). Financial terms were not disclosed.

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Under the agreement, Myriad will use its myChoice HRD Plus test to evaluate patients enrolled in an ongoing Phase III trial. In this collaboration, the companies will use the myChoice HRD Plus test to identify cases with homologous recombination deficiencies (HRD).

"As the pioneer in companion diagnostics for PARP inhibitors, we are excited to continue our collaboration with AstraZeneca and to apply innovative new technologies like myChoice HRD Plus to increase the number of patients who may benefit from Lynparza," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "myChoice HRD Plus is the most comprehensive test for identifying defects in DNA repair pathways. We are optimistic that myChoice HRD Plus will identify more women with ovarian cancer who could benefit from therapy with Lynparza than previous tests that only identify germline BRCA1/2 mutations."

The ongoing collaboration with AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.

About Ovarian Cancer
Ovarian cancer has the lowest survival rate of all female cancers. Ovarian cancer is diagnosed annually in nearly a quarter of a million women globally, and is responsible for 140,000 deaths each year. Statistics show that just 45 percent of women with ovarian cancer are likely to survive for five years. The majority of patients are only identified in the advanced stages when the disease becomes more difficult to treat.

About myChoice HRD Plus
Myriad’s myChoice HRD Plus is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD Plus test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions) and up to 90 other genes and molecular markers including microsatellite instability associated with DNA repair pathways.

Positive myChoice HRD Plus scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. Learn more: View Source

About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumor DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is currently approved in the United States for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Patients are selected for therapy based on Myriad’s FDA-approved companion diagnostic. It is also approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ USA announced a global strategic oncology collaboration to jointly co-develop and co-commercialize Lynparza.

On January 3, 2018 Boehringer Ingelheim reported an increase in funding for its corporate venture fund, known as the Boehringer Ingelheim Venture Fund (BIVF), from EUR 100 to 250 million (Press release, Boehringer Ingelheim, JAN 3, 2018, View Source [SID1234522826]). The additional funds will be used to invest in promising early stage start-up companies, focusing on regenerative medicine, infectious diseases and immune oncology among others, as well as growing the portfolio in the U.S. and opening doors for the BIVF in digital health. The significant additional funding goes along with a doubling of the number of investment managers.

"We at the BIVF are inspired by the opportunity to increase investments and work across some of the most promising areas of biomedical research to date," says Frank Kalkbrenner, M.D., Corporate Vice President and Head of the BIVF. "We are thrilled to be opening a second U.S.-based office in 2018, which will allow us to collaborate more closely with biotech and start-up companies on the West Coast. This also brings us one step closer in our quest to be at the centre of the global digital health transformation."

The expansion builds on the BIVF’s existing portfolio of 21 biotech and early stage start-up companies focused on various therapeutic areas of interest, including immune-oncology. Recent successes of the portfolio include:

Rigontec is a forerunner in accessing the retinoic acid-inducible gene I pathway, part of the innate immune system, as a novel and distinct approach in cancer immunotherapy to induce both immediate and long-term anti-tumor immunity. Rigontec was acquired by Merck (known as MSD outside of the U.S. and Canada) in September 2017, with an upfront payment of EUR 115 million and additional contingent payments of up to EUR 349 million.
ViraTherapeutics specializes in the development of oncolytic virus therapies. In 2016, BIVF entered into an option agreement with a transaction value of up to EUR 210 million, including co-funding of development activities of ViraTherapeutics’s VSV-GP.
Okairos is pioneering the development of T-cell based vaccines for major infectious diseases, as well as cancer. In 2011, one year after the BIVF was founded, the first investment was made in Okairos. The company was acquired by GlaxoSmithKline in 2013, creating the first successful exit for BIVF.

"The key differentiator for Boehringer Ingelheim’s Venture Fund lies in the close and trusted relationships with the portfolios and entrepreneurs with whom we are privileged to work with," added Kalkbrenner. "Through these connections, we’ve successfully developed a number of biotech start-ups – from creation to exit – and we look forward to the ground-breaking work that lies ahead. We are a team that welcomes new adventure and risk-taking, if it means delivering novel solutions that will one day help patients everywhere lead healthier lives."

Boehringer Ingelheim’s innovation strategy furthers its commitment to push the boundaries of biomedical research and development by accelerating the delivery of first in class breakthrough therapies for patients in need. The BIVF invests in the development of pioneering science, which offers the potential to provide significant benefits for patients, creating options for Boehringer Ingelheim to expand into new areas. It actively works to spin-out and create companies from academia, developing projects over a five to seven year time period with initial investments in seed or series A funding. Staged investments start with EUR 0.5-3 million and can amount to up to EUR 10-15 million in funding.

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