FLARE THERAPEUTICS APPOINTS AMIT RAKHIT, M.D. AS PRESIDENT AND CHIEF EXECUTIVE OFFICER

July 25, 2022 Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported the appointment of Amit Rakhit, M.D., MBA, as President and Chief Executive Officer (Press release, , AUG 25, 2022, View Source [SID1234618750]). Dr. Rakhit has over 20 years of life sciences leadership experience and joins at a pivotal time as Flare transitions into a clinical-stage company. He succeeds interim CEO Abbie Celniker, Ph.D., a partner at Third Rock Ventures, who will continue to serve as Chair of the Company’s Board of Directors.

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"Flare’s pioneering approach to drugging transcription factors stands to profoundly impact medical practice globally for people living with cancer and other difficult to treat diseases. I am excited to join such a dynamic and experienced leadership team at this important inflection point for the company," said Dr. Rakhit. "The team’s swift progress in identifying dozens of novel druggable pockets, or ‘switch sites’, within therapeutic transcription factor targets of interest and rapid advancement of the lead precision oncology program both inspired my belief in Flare and compelled me to join to help catapult the company into its next stage of growth."

"Dr. Rakhit’s experience includes a rare mix of business acumen, clinical development expertise and passion for leading innovation in new treatment modalities that can benefit patients," said Dr. Celniker. "His leadership and experience will be extremely valuable in driving the strategy forward as we transition our first precision oncology program into the clinic and grow our pipeline of discovery targets in multiple new therapeutic indications."

For more than two decades, Dr. Rakhit has served in key leadership, clinical and operational roles in biotechnology and pharmaceutical companies spanning diverse therapeutic areas including rare disease, neurology, oncology and cardiology. Most recently, he has focused on launching and growing start-up biotechnology companies, overseeing clinical development and commercialization strategy in roles as CEO of Sporos BioVentures and President and Chief Medical Officer of Ovid Therapeutics. Earlier in his career, he was Senior Vice President and Head of Worldwide Medical Affairs at Biogen, Inc. where he led global external collaborations with key stakeholders and executed post-marketing development strategies for the launch and commercialization of key products in rare disease, including Spinraza, and in neurology. Prior to Biogen, he held multiple roles of increasing seniority in global clinical development and medical affairs at Bristol-Myers Squibb, including spearheading global initiatives for Plavix. Dr. Rakhit holds an M.D. from Tufts University School of Medicine and dual MBAs from Columbia University and London Business School. He completed his fellowship in pediatric cardiology at Harvard Medical School and was previously on staff at Boston Children’s Hospital.

About Flare Therapeutics
Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare’s drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of drug programs that address well-validated transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation. Flare Therapeutics was launched in 2021 and is backed by founding investor Third Rock Ventures, as well as Boxer Capital, Nextech Invest, Casdin Capital, Invus Financial Advisors and Eventide Asset Management. For more information, please visit www.flaretx.com.

AlphaBio Completes Trials of Therapy for NSCLC with CNS Metastases

On August 25, 2022 Shanghai Alpha Biopharma reported the last patient visit has taken place in its Phase II/III trial of zorifertinib in patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) and CNS metastases (Press release, ChinaBio, AUG 25, 2022, View Source [SID1234618713]). The trial enrolled 492 patients at 55 study sites. In previous clinical and preclinical tests, zorifertinib showed high blood-brain barrier (BBB) penetration, anti-tumor activity in metastatic CNS lesions, overall efficacy in both CNS and extra-cranial diseases, and a safety profile similar to other EGFR-TKI drugs. AlphaBio acquired zorifertinib from AstraZeneca.

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Sermonix Pharmaceuticals Announces Top-Line Data From ELAINE 1 Phase 2 Study of Lasofoxifene Versus Fulvestrant Is Accepted for a Late-Breaking Oral Presentation at ESMO Congress 2022

On August 25, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported that top-line data from its Phase 2 study of lasofoxifene, its lead investigational drug, versus fulvestrant was accepted for a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, which is being held September 9-13, 2022, in Paris (Press release, Sermonix Pharmaceuticals, AUG 25, 2022, View Source [SID1234618708]).

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The open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study, which began U.S. enrollment in September 2019, assessed the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

Details of the presentation are as follows:

Title: Open-label, randomized study of lasofoxifene (LAS) vs fulvestrant (Fulv) for women with locally advanced/metastatic ER+/HER2- breast cancer (mBC), an estrogen receptor 1 (ESR1) mutation, and disease progression on aromatase (AI) and cyclin-dependent kinase 4/6 (CDK4/6i) inhibitors

Presenter: Matthew P. Goetz

Date, Time and Location: September 10 at 3:05 p.m. CEST, 7.2.E – Évry Auditorium

Session: Mini Oral Session: breast cancer, metastatic

Presentation Number: LBA20

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Finch Therapeutics Regains Full Rights to FIN-524 and FIN-525 Targeted Microbiome Product Candidates in Development for IBD

On August 25, 2022 Finch Therapeutics Group, Inc. ("Finch" or "Finch Therapeutics") (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs, reported that it will regain full development and commercial rights to FIN-524 (previously known as TAK-524) and FIN-525 from Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Takeda, AUG 25, 2022, View Source [SID1234618705]). Following a review of its pipeline, Takeda informed Finch of its decision to terminate its collaboration with Finch, effective November 17, 2022, resulting in the return to Finch of worldwide rights to develop and commercialize FIN-524, FIN-525, and any other microbiome product candidates for inflammatory bowel disease (IBD). FIN-524 and FIN-525 are investigational, orally administered targeted microbiome product candidates composed of bacterial strains selected for their potential immuno-modulatory properties.

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"We are grateful for Takeda’s substantial investment in the FIN-524 and FIN-525 programs and want to thank our dedicated colleagues at Takeda who have worked alongside us to develop these innovative product candidates. We look forward to exploring collaboration opportunities to continue the advancement of these assets, which we believe hold the potential to fulfill the need for a disease-modifying, orally delivered, well-tolerated therapy for IBD patients who are not well served by existing options," said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. "We are currently conducting a review of our portfolio and assessing the financial and strategic impact of the discontinuation of our collaboration with Takeda."

Finch has received more than $44 million from Takeda during the course of the collaboration, including an upfront payment of $10 million, $4 million in milestone payments, and more than $30 million in reimbursement of research and development expenses. Upon termination, Finch will receive a royalty-free license to all data and intellectual property generated during the collaboration, including full rights to a large library of characterized bacterial isolates, data from multiple ex vivo and in vivo studies, a suite of pharmacokinetic and pharmacodynamic assays, and a significant body of chemistry, manufacturing, and controls (CMC) data generated during the investigational new drug (IND)-enabling phase of development.

About FIN-524 & FIN-525 for Inflammatory Bowel Disease

FIN-524 and FIN-525 are investigational, orally administered targeted consortia product candidates composed of both spore-forming and non-spore-forming bacterial strains selected for the treatment of ulcerative colitis and Crohn’s disease, respectively. The product candidates are designed to include strains that target multiple mechanisms of action combined with donor strains linked to remission following microbiota transplantation in patients with inflammatory bowel disease (IBD). The design of FIN-524 and FIN-525 leverage Finch’s machine-learning based platform and data from microbiota transplantation studies in patients with IBD. The manufacture of FIN-524 and FIN-525 is donor independent, with the strains grown from master cell banks.

About Inflammatory Bowel Disease

Ulcerative colitis and Crohn’s disease are the two most common types of inflammatory bowel disease (IBD), an autoimmune condition that causes inflammation of the gastrointestinal (GI) tract. Approximately 10 million people are affected by IBD worldwide, including approximately three million people in the U.S. Symptoms of IBD include severe, chronic abdominal pain, diarrhea, GI bleeding, weight loss, and fatigue. Current treatment options are ineffective for many people living with IBD.

Tiziana Life Sciences Announces Purchase of Common Shares by Executive Chairman

On August 25, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, reported that it has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman has a beneficial interest, purchased 80,000 common shares at $0.75 per share (Press release, Tiziana Life Sciences, AUG 25, 2022, View Source [SID1234618702]).

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The acquisition takes Mr Cerrone’s interests from 37.61% to 37.70%.