On February 1, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported the appointment of Steve Morris, M.D. as Chief Medical Officer (CMO) (Press release, Biomea Fusion, FEB 1, 2022, View Source [SID1234607558]). Dr. Morris, who has been serving as a clinical consultant to Biomea since 2020, will now lead the clinical development of BMF-219, an irreversible covalent menin inhibitor, as well as the company’s additional planned clinical programs. BMF-219 is currently in a Phase I clinical trial for the treatment of patients with relapsed/refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations. In January 2022, Biomea announced that it plans to initiate clinical studies of BMF-219 in up to seven liquid and solid tumor types –acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL), multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL), non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer– as well as diabetes.

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"I am thrilled with Steve’s decision to join Biomea full-time as the company’s first CMO," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "Steve is an internationally recognized physician-scientist and translational investigator with over 30 years of clinical and academic research expertise. Through his first-hand experience interrogating the role that menin plays in aggressive cancers both as a researcher and as a practicing oncologist, Steve has a unique perspective on how BMF-219 may benefit patients suffering from genetically driven liquid and solid tumors. He played a critical role in orchestrating our rapid advancement of BMF-219 into the clinic, and we look forward to his continued contributions in this new capacity as our CMO."

Prior to embarking on a career in the biopharmaceutical industry in 2012, Dr. Morris served on the staff at St. Jude Children’s Research Hospital for 25 years. In addition to working as a clinician, he led a basic and translational research laboratory at St. Jude, which discovered and characterized oncogenes that cause a variety of human cancers, most notably anaplastic lymphoma kinase, or ALK. The U.S. Food and Drug Administration (FDA) has approved several ALK inhibitors, the development of which were based on Dr. Morris’ groundbreaking work. Dr. Morris also performed translational research at St. Jude regarding menin-driven leukemias (one of several menin-driven oncology indications being pursued by Biomea) and treated many patients with these malignancies during his career as a practicing oncologist.

"I am excited to continue the extraordinary work we have done at Biomea over the last two years translating the promise of Biomea’s Fusion platform, which allows the rapid targeting of validated cancer biology with breakthrough covalent chemistry, to advance the company’s first clinical-stage irreversible covalent inhibitor, BMF-219," said Dr. Morris. "With the potential to dose patients in up to seven distinct tumor types with BMF-219 in the coming months, 2022 will be a transformational year for Biomea. I look forward to continuing to execute on the robust clinical development plan we announced to further our collective goal of providing effective targeted treatments for patients with limited therapeutic options."

Since leaving academic medicine, Dr. Morris has served as a consultant or CMO for multiple oncology-focused biotech startups, including Biomea. He is a member of the medical honor society Alpha Omega Alpha, an American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Young Investigator Award winner, and an inductee into the American Society for Clinical Investigation. Dr. Morris earned his MD from Louisiana State University Health Science Center, completed an internal medicine residency at the University of Texas Southwestern Health Science Center, and completed training in medical oncology at Yale University School of Medicine.

On February 1, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio" or the "Company"), a biopharmaceutical company pioneering Tissue Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported that management has answered top-voted questions submitted by verified IMMX shareholders at the IMMX Investors Day Event on February 1, 2022 at 9:30am ET (Press release, Immix Biopharma, FEB 1, 2022, View Source [SID1234607575]). ImmixBio welcomed verified shareholders to submit and upvote questions to management from January 6 through January 20, 2022. Answers to top-voted investor questions are viewable at www.immixbio.com/Feb2022QA .

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"Investors are an integral part of our community at ImmixBio," said Ilya Rachman, MD PhD, CEO of ImmixBio. "Today we addressed questions upvoted by our investors, and are looking forward to an ongoing dialogue through our Q&A platform open to all IMMX shareholders."

On February 1, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in an investor conference in February 2022 (Press release, Ideaya Biosciences, FEB 1, 2022, View Source [SID1234607591]).

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Guggenheim Oncology Day
Wednesday, February 9, 2022 at 3:30pm ET

Fireside chat with Yujiro Hata, Chief Executive Officer, hosted by Charles Zhu, Ph.D. Vice President, Biotechnology Equity Research

A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On February 1, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported an update on the Phase III clinical trial, FLAMINGO-01 (Press release, Greenwich LifeSciences, FEB 1, 2022, View Source [SID1234607576]).

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The Company has made significant progress towards study initiation:

– Contract Research Organization (CRO) has been contracted for study start-up, project management, data management, and clinical data monitoring

– Manufacturing of third clinical lot of GP2 using a commercial line has been completed

– Commercial lots of GP2 active ingredient for filing of BLA have been contracted

– Central Laboratory has been contracted for screening of HLA type

– Drug and biological sample storage sites and other study infrastructure have been put in place

– Central Institutional Review Board (IRB) approval has been granted for the study

– Clinical trial sites continue in the study start-up process and the Company continues to solicit additional US and international sites and networks for participation in the study

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On February 1, 2022 Oak Hill Bio ("Oak Hill"), a clinical-stage rare disease therapeutics company developing life-changing medicines for extremely preterm infants and patients suffering from rare autoimmune diseases, reported the Company’s launch and plans to advance a pipeline of promising clinical and preclinical investigational therapeutics acquired and licensed from Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Takeda, FEB 1, 2022, View Source [SID1234607592]).

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Under the terms of the agreements, Takeda will receive an upfront payment, an ownership stake in Oak Hill and potential milestones and royalty payments in exchange for the acquired and licensed programs. Takeda will also support the transition for continued research and development of the acquired programs. The pipeline includes two clinical-stage and four preclinical-stage programs.

Two Takeda executives with direct experience working on the acquired programs will join Oak Hill, including Victoria Niklas, M.D., as Chief Medical Officer, and Norman Barton, M.D., as a senior scientific advisor. Daniel Curran, M.D., Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda, will join the Oak Hill board of directors.

"Oak Hill has a significant opportunity to take these promising programs and advance them through clinical development to bring life-altering new medicines to patients in need," said Josh Distler, J.D., President and Chief Financial Officer of Oak Hill Bio. "We are confident not only in these potentially transformative compounds, but also in the extraordinary team that has come together to deliver these innovative therapies."

Oak Hill’s lead therapeutic candidate, OHB-607 (formerly TAK-607), is a proprietary, recombinant version of insulin-like growth factor 1 (IGF-1), the natural version of which is a key driver of fetal growth and development in utero, and its binding protein, IGFBP-3.

Mothers are the primary source of IGF-1 for the developing fetus, with the fetus producing very little of its own until reaching 30 weeks of gestational age. At birth, extremely premature infants, born at less than 28 weeks of gestational age, have low levels of IGF-1 which are associated with greater complication rates. OHB-607, as a human IGF-1 replacement, is designed to help promote continued development and maturation of vital organs and the vasculature that supports them.

OHB-607 has been evaluated in both preclinical and clinical studies. A Phase 2 clinical trial showed a statistically significant shift towards milder bronchopulmonary dysplasia and a positive trend in reducing intraventricular hemorrhage (pre-specified secondary endpoints), with no significant safety signal observed.

"Every year, hundreds of thousands of infants worldwide are born extremely prematurely and, as a result, suffer from severe complications in their lungs, brain, and eyes that hinder their long-term development and quality of life. While prenatal steroids, surfactants, ventilators and improved resuscitation protocols have increased the survival rate of premature infants, there has been little progress in protecting their not fully developed organs from the trauma of life-saving measures at birth, including supplemental oxygen and breathing machines," said Victoria Niklas, M.D., Chief Medical Officer at Oak Hill Bio and former Global Program Lead for OHB-607 at Takeda. "We are committed to delivering innovation into this area of high unmet medical need for infants born extremely premature. OHB-607 has the potential to be the first breakthrough in more than 30 years to improve outcomes for these infants and their families."

OHB-101 (Formerly TAK-752), a Phase 2a program, is currently being investigated for the treatment of a wide array of rare autoimmune diseases. It is a soluble recombinant version of the FcγR2B receptor that is designed to bind to immune complexes to prevent them from interacting with the fc gamma receptors that drive inflammation and autoimmune cascades. Preliminary clinical studies have been conducted in multiple autoimmune indications, including systemic lupus erythematosus, a rare autoimmune primary glomerular disease, and immune thrombocytopenia, a rare autoimmune blood disorder.

Oak Hill intends to advance the ongoing Phase 2b clinical study of OHB-607 for complications of premature birth in 2022 and initiate two Phase 2b clinical studies of OHB-101 in rare autoimmune diseases. The company also anticipates commencing IND-enabling activities for certain of its four preclinical programs, which include three novel anti-FCγR2B receptor monoclonal antibodies for autoimmune disease and an oral pKAL inhibitor for diabetic macular edema.

"There is a tremendous need for new therapies to prevent the complications of prematurity and for those suffering from rare autoimmune disorders," said Dr. Curran. "Making a strategic investment in Oak Hill Bio and their strong leadership team is an ideal path to continue the development of these promising programs."

Executive Team

Oak Hill’s executive team includes experienced biopharma executives, biotech entrepreneurs and financial operations and capital markets experts as well as rare disease and neonatology experts from Takeda:

Josh Distler, J.D., President and Chief Financial Officer, has extensive experience building and investing in biotechnology companies, having served as Head of Crossover and Quantitative Equity at Athanor Capital, COO of Global Private Investing for D. E. Shaw & Co., Chief Operating Officer at Attenuon, a cancer drug development firm and as a Director of Schrödinger, Inc.
Mark McHale, Ph.D., Chief Scientific Officer, most recently helped found Aslan Pharmaceuticals and served as its Chief Development Officer and Head of R&D. He has also held leadership positions with AstraZeneca and SmithKline Beecham (now GlaxoSmithKline Plc.).
Victoria Niklas, M.D., Chief Medical Officer, has served in several roles at Takeda, including Global Program Leader of the OHB-607 program. She has extensive experience as a translational scientist and academic neonatologist including serving as Chief of the Division of Neonatology for Nemours Children’s Hospital and Professor of Pediatrics, Division Chief and Medical Director, at UCLA’s Olive View Medical Center.