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LIDDS: Major European Investment Funds invest 21,7 MSEK in a direct share issue

On June 7, 2018 LIDDS AB (publ) reported that it has decided on a direct share issue to Nyenburgh Holding BV, AESCAP 2.0 and BWG Invest, all being international funds that invests in closely selected European biotech- and pharma companies (Press release, Lidds, JUN 7, 2018, View Source [SID1234555913]). The raised capital will facilitate a fast acceleration of LIDDS’ development projects, including the immune-oncology field where NanoZolid based immuno-active compounds have shown very promising preclinical effects.

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The direct issue of 1 180 000 shares will add approx. 21,7 MSEK to LIDDS. Nyenburgh Holding will maintain as the third largest shareholder in LIDDS and contributes with financial strength, an excellent network and expertize within the sector. AESCAP 2.0, based in Amsterdam, is a current shareholder in LIDDS that invests in next generation medicines and builds a selected portfolio of only 20 companies across Europe and the US. BWG Invest is a top ten shareholder in LIDDS and strengthens its shareholding position through this direct share issue.

The share price of 18,38 SEK is based on volume weighted average of the share price with a 5 % discount. The share issue decision is based on the shareholders authorization on LIDDS Annual Meeting on May 16, 2018.

– The directed share issue to Nyenburgh Holding, AESCAP 2.0 and BWG Invest is an important validation of the NanoZolid technology and we are very pleased to attract these funds to increase their ownership in LIDDS. The share issue adds longer term financing of the company, resources to reach key milestones in our development projects and provides additional financial strength to conduct an effective business development process, says Monica Wallter, CEO of LIDDS.

LIDDS total number of shares after the direct issue will be 23 051 188 and the share capital will amount to 1 221 712,964 SEK when the new shares are registered with the Swedish Companies Registration Office, Bolagsverket. The dilution of shares is 5,1 %.

LIDDS will with the raised capital further accelerate the exciting NanoZolid development projects with the aim to build alliances, collaborations and license agreements.

The directed share issue to Nyenburgh Holding, AESCAP 2.0 and BWG Invest is further strengthening LIDDS owner structure and it confirms the international interest for LIDDS and the NanoZolid technology.

BioXcel Therapeutics Appoints Vincent J. O’Neill M.D., as Senior Vice President and Chief Medical Officer

On June 7, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, reported the appointment of Dr. Vincent J. O’Neill as Senior Vice President and Chief Medical Officer of BTI (Press release, BioXcel Therapeutics, JUN 7, 2018, View Source [SID1234527395]). Dr. O’Neill has served as Chief Medical Officer of BTI, on a consulting basis, since July 2017. He will continue to be responsible for the clinical strategy and development of BTI’s pipeline assets.

Dr. Vimal Mehta, Founder and Chief Executive Officer of BTI, commented, "We are excited to have Dr. O’Neill on the BTI team at this time when we are executing on our pipeline and moving towards clinical data. During his tenure thus far at BTI, Vince made a number of noteworthy contributions to BTI. He played a particularly important role in the success of our recent initial public offering, initiating our first-in-human clinical trial of BXCL501 and laying the foundation for clinical development of BXCL701. Vince has a wealth of experience in the biopharma landscape, particularly his clinical experience at Genentech. This coupled with his significant expertise in therapeutic development will play a crucial role in implementing and advancing BTI’s pipeline programs through clinical development and commercialization."

Dr. O’Neill has over 16 years of therapeutic and diagnostic product development experience. He has held senior leadership roles at global pharmaceutical companies such as Genentech, Sanofi and GlaxoSmithKline. Prior to joining the Company, Dr. O’Neill served as the Senior Vice President and Chief Medical Officer at Mirna Therapeutics, where he was responsible for clinical development and medical affairs. At Genentech and GlaxoSmithKline ("GSK"), he oversaw the clinical and biomarker development programs for multiple oncology therapeutic assets. He was instrumental in the expanded approvals of Genentech’s oncology therapeutics, Avastin and Tarceva. At GSK, he managed the signal transduction discovery unit and led the first IND application and clinical trial of MEK inhibitor MEKINIST.

Dr. O’Neill received his medical degree and B.Sc. in molecular pathology from the University of Glasgow. He has authored several peer-reviewed publications and conference presentations. Dr. O’Neill is also a member of the Royal College of Physicians."

This role offers me a great opportunity to be a part of a team that is developing drugs that address major unmet medical needs," said Dr. O’Neill. "BTI is at a transformative time of clinical development and the opportunity to grow our pipeline. I believe that BTI has the potential to be at the forefront of developing innovative therapies in neuroscience and immuno-oncology. I am looking forward to working closely with the entire team to bring novel therapies to the market."

Sarepta Therapeutics Appoints Gilmore O’Neill, M.B., M.M.Sc. as Chief Medical Officer

On June 7, 2018 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, reported the appointment of Gilmore O’Neill, M.B., M.M.Sc. as its chief medical officer. Dr. O’Neill will lead all clinical development, medical affairs, pharmacovigilance, and regulatory affairs (Press release, Sarepta Therapeutics, JUN 7, 2018, View Source [SID1234527243]).

Dr. O’Neill joins Sarepta from Biogen, where he held leadership roles of increasing responsibility over a 15-year period in research and development, most recently as senior vice president responsible for all late-stage clinical development. During his tenure, Dr. O’Neill oversaw development programs for Alzheimer’s disease, movement disorders, acute neurology, multiple sclerosis, pain, neuromuscular disease, gene and cell therapy, and rare diseases. He played a leadership role in seeking, receiving and maintaining global marketing approvals for Tecfidera, Zinbryta, Plegridy and Spinraza.

"I feel extremely fortunate to welcome Dr. O’Neill to Sarepta and to our executive team as we advance our 21 pipeline programs and build ourselves into one of the most meaningful precision genetic medicine companies in the world," said Doug Ingram, Sarepta’s president and chief executive officer. "Gilmore is uniquely positioned to successfully lead our development strategy. He has deep expertise in neurobiology, genetic medicine and clinical development, having driven some of biotech’s most successful clinical programs. And his proven leadership ability and passion for our mission of changing lives through genetic medicine will be essential as we advance toward our goals with a sense of urgency, creativity and purpose."

"I was inspired to join the Sarepta leadership team by the quality of Sarepta’s pipeline and the sense of urgency within the Company to advance these programs and improve the lives of patients," said Dr. O’Neill. "I’m looking forward to making a fast start, and one of my most pressing priorities will be to meet with and learn from the DMD patient community."

Dr. O’Neill received a Bachelor of Medicine degree from University College Dublin and a Master of Medical Sciences degree from Harvard University. He is the recipient of numerous awards in science and medicine, including the Lefler Fellowship in the Department of Neurobiology at Harvard Medical School. Dr. O’Neill is the author of numerous publications on multiple sclerosis, has served as a neurology peer reviewer for medical literature, and lectures in the United States and globally on advances in neurology and neurological research.

Dr. O’Neill is licensed to practice medicine in the state of Massachusetts. He is a member of the American Academy of Neurology and a board-certified neurologist (ABPN). He is formerly Chief Resident in Neurology at the Massachusetts General Hospital (MGH) and served, until recently, as a Clinical Instructor in Neurology at Harvard Medical School. He has maintained his clinical appointment at the MGH with a sub-specialty interest in neuromuscular diseases and inherited leukodystrophies.

TRILLIUM THERAPEUTICS APPOINTS YAPING SHOU, MD, PHD AS
CHIEF MEDICAL OFFICER

On June 7, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the appointment of Yaping Shou MD, PhD, as Chief Medical Officer. Dr. Shou joins Trillium from Takeda Pharmaceuticals (Press release, Trillium Therapeutics, JUN 7, 2018, View Source [SID1234527238]).

"Yaping’s broad clinical drug development experience in oncology and her demonstrated commitment to translational research makes her a strong addition to Trillium’s senior management team," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "Her arrival is particularly opportune, since we have recently refined and narrowed the focus of our two ongoing TTI-621 trials, based on preliminary clinical proof of concept data, and are on the cusp of dosing our first patient in our TTI-622 trial. We look forward to Yaping’s leadership as we continue to advance our SIRPaFc programs."

Dr. Shou has more than 18 years of industry experience spanning clinical development and translational medicine, with a strong focus in oncology. She most recently served as Executive Medical Director at Takeda Pharmaceuticals, where she also held several other clinical leadership positions over the past seven years. Prior to joining Takeda, Dr. Shou held several clinical oncology positions at Novartis Pharmaceuticals and GlaxoSmithKline. She has contributed to the approval of several targeted therapies for oncology over the years, including lapatinib, pazopanib, nilotinib, sonidegib, and ixazomib. She received her MD degree from Zhejiang University School of Medicine, and her PhD degree from Drexel University College of Medicine and the University of Pennsylvania. Dr. Shou also conducted postdoctoral studies in the Genetics Branch at the National Cancer Institute.

"I am excited to be joining Trillium at this important time in the company’s evolution," said Dr. Shou. "I believe we have the potential to build a CD47 franchise in immuno-oncology that could meaningfully benefit patients."

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

On June 7, 2018 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib (Press release, Pfizer, JUN 7, 2018, View Source [SID1234527237]). The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.

"Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "Today’s filing acceptances are just the latest example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process associated with BRCA mutations. We are now one step closer to offering a potential alternative to chemotherapy for these patients."

The FDA grants Priority Review designation to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2018.

The pivotal, randomized EMBRACA trial evaluated once-daily talazoparib compared to physician’s choice chemotherapy (capecitibine, eribulin, gemcitabine or vinorelbine) in 431 patients with an inherited BRCA1/2 mutation and locally advanced or metastatic triple negative (TNBC) or hormone receptor-positive (HR+)/HER2- breast cancer. The study met its primary endpoint, demonstrating superior progression-free survival (PFS) with talazoparib versus chemotherapy. The PFS benefit was consistent across prespecified subgroups, including those who had a history of brain metastases, patients previously treated with chemotherapy, TNBC patients and those with HR+ disease. Grade ≥3 adverse reactions with talazoparib that occurred with a frequency of at least 10% were anemia (35%), neutropenia (17%) and thrombocytopenia (17%). The primary results were presented at the 2017 San Antonio Breast Cancer Symposium. For more information on the EMBRACA trial, go to www.clinicaltrials.gov.

About Talazoparib

Talazoparib is an investigational anti-cancer medicine called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced gBRCAm breast cancer and early triple negative breast cancer as well as DNA damage repair (DDR)-deficient prostate cancer and in combination with immunotherapy in various solid tumor types. Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

About Germline (Inherited) BRCA-Mutated Breast Cancer

BRCA1 and BRCA2 are human genes that produce proteins involved in DNA repair. When either of these genes is altered or mutated, DNA repair may not progress correctly. This can lead to the development of certain types of cancer such as breast cancer.1,2,3 BRCA mutations can be hereditary (germline) or occur spontaneously (somatic).1 Together, BRCA1 and BRCA2 mutations account for about 25 to 30 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers.4,5 It is estimated that about 72 percent of people who inherit a BRCA1 mutation and about 69 percent who inherit a BRCA2 mutation will develop breast cancer by age 80.1 Epidemiologic studies indicate that individuals with gBRCAm breast cancer are diagnosed at a median age of 40-45, which is approximately 20 years younger than the overall breast cancer population.6

BRCA-mutated breast cancer is considered metastatic if it has spread beyond the breast to other parts of the body, including the bones, liver, lung or brain. There is currently no cure for metastatic breast cancer, the most advanced stage (stage IV) of the disease. The goal of treatment is to delay or slow disease progression while maintaining quality of life.