On November 18, 2021 BAKX Therapeutics reported it closed $25 million in a Series A fundraising led by AB Magnitude Ventures Group with Ipsen Pharma SA and Sherpa Healthcare Partners (Press release, Bakx Therapeutics, NOV 18, 2021, View Source [SID1234595805]). The new funding will enable the company to drive its BAKX Activator Program into the clinic in hematologic malignancies and solid tumors and to advance additional targets for solid tumors and prevention of resistance. The financing comes on the heels of the company’s recent announcement of a partnership comprising up to $852 million in upfront and potential milestone payments with Ipsen, a global biopharmaceutical company, to research, develop, manufacture and commercialize the company’s lead candidate, BKX-001, as a potential treatment for leukemia, lymphoma and solid tumors.

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Sree Kant, founder and CEO of BAKX Therapeutics, said, "BAKX brings together the world’s most comprehensive knowledge of the mitochondrial apoptosis pathway with industry leading structure-based drug design and computational drug discovery techniques. Our pro-apoptotic programs were developed on the innovative work of our scientific co-founders, Loren D. Walensky of Dana-Farber Cancer Institute and Evripidis Gavathiotis of Albert Einstein College of Medicine, who are the world’s leading experts in pro-apoptotic BAX/BAK activation pathway. Together they uncovered novel methods for solving the unique challenges of exploiting conformationally dynamic proteins to induce cancer cell death while sparing healthy cells."

Kant added, "Following on our collaboration with Ipsen announced in July, the new capital will support more rapid advancement into the clinic of our pipeline of novel therapeutic candidates for solid tumors and turbocharge the deployment of our computational platform to drug conformationally dynamic proteins in the mitochondrial apoptosis pathway. We are grateful to our investors who share our vision and are singularly focused on our aim to develop new therapeutics that successfully address for the first time high-value, well validated, apoptosis targets."

"Many companies have focused on targeting the pro-survival proteins, Bcl-2, Bcl-xl and Mcl-1, which have been effective for treatment of certain leukemias. Unfortunately, they have limitations like resistance in hematological malignancies and inability to achieve dosing efficacy in solid tumors," said Yibing Shan, Ph.D., founding managing director of AB Magnitude Ventures Group, who has also joined BAKX in the role of chief computational scientist. "BAKX instead is successfully activating pro-apoptotic proteins such as BAX and BAK using a combination of unsurpassed target and pathway knowledge, deep expertise in conformationally dynamic protein interactions, and new, highly innovative computational methodologies for identifying cryptic sites and simulating protein interactions in the membrane. I am excited to support the company in this round as well as drive the deployment of the BAKX computational drug discovery platform in the field of apoptosis."

Philippe Lopes-Fernandes, executive vice president and chief business officer at Ipsen, said, "At Ipsen we believe great partnerships create great possibilities and our collaboration with BAKX is an example of this with our investment in the future of BAKX, alongside our collaboration on the BKX-001 program. We support and congratulate BAKX on raising additional capital as we work together to advance BKX-001 in what is a groundbreaking approach to inducing cancer cell death. We share BAKX’s ambition to bring this innovation to people living with cancer around the world."

On November 18, 2021 Apollo Therapeutics, a portfolio-based biopharmaceutical company rapidly advancing transformative treatments based on breakthrough discoveries, reported the appointment of Dr. Sanjay Aggarwal as the company’s chief medical officer (Press release, Apollo Therapeutics, NOV 18, 2021, View Source [SID1234595804]). Dr. Aggarwal will be based in the company’s U.S. facility located at the Cambridge Innovation Center in Cambridge, Mass.

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"Sanjay is a highly accomplished clinical leader whose experience developing promising therapeutics through to regulatory approval will be incredibly valuable to Apollo as we move our lead programs forward," said Dr. Richard Mason, CEO of Apollo. "We are proud to have him as a leader of our newly opened Boston facility where we look forward to growing our presence in the United States."

Dr. Aggarwal joins Apollo with more than 20 years in the biopharmaceutical industry, including extensive experience in building and leading clinical development teams, as well as a track record of taking drugs through development to successful regulatory approvals. Dr. Aggarwal was most recently chief medical officer at Angiocrine Bioscience, a clinical-stage cell and gene therapy company. Before this, he was the architect of the Rezurock (belumosudil) Phase 2 and 3 development programs at Kadmon, leading to its FDA approval for chronic graft versus host disease. Prior to joining Kadmon, Dr. Aggarwal was the global development lead for Kyprolis (carfilzomib) at Amgen, leading to its approval in multiple myeloma in the U.S., E.U. and numerous additional countries.

Earlier in his career, Dr. Aggarwal held positions of increasing responsibility in both biotech (Exelixis, Onyx Pharmaceuticals) and pharma (GSK, Novartis and Sanofi), overseeing development of early- and late-stage assets across several therapeutic areas with roles in the U.S., Europe and Asia-Pacific. He studied mathematics and medicine to earn his medical degree from The University of Cambridge. He has an MBA from The University of Chicago Booth School of Business. Clinically, he trained in internal medicine and public health and is a member of the Royal College of Physicians.

"Apollo has built an impressive pipeline of therapeutic programs based on breakthrough discoveries that hold tremendous promise across multiple disease areas," said Dr. Aggarwal. "I look forward to advancing the lead programs into clinical investigation and working with the team to further build the company by acquiring clinical-stage assets."

On November 18, 2021 Lassen Therapeutics, a biotech company developing breakthrough antibody therapeutics as potential treatments for fibrosis, rare diseases and oncology, reported the appointment of Puneet S. Arora, M.D. as Chief Medical Officer (Press release, Lassen Therapeutics, NOV 18, 2021, View Source [SID1234595803]).

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"As a highly regarded physician-scientist and drug developer, Puneet’s experience in inflammation and immunology will be instrumental to Lassen as we initiate our clinical program for LASN01, our first-in-class anti-IL-11R antibody," said Mark Barrett Chief Executive Officer of Lassen Therapeutics. "In addition, his expertise in antibody therapeutics and novel targets from his experience across the biotech and pharma industries will be invaluable as we build a robust and innovative pipeline in fibrosis, oncology and other therapeutic areas."

Dr. Arora brings extensive expertise in the development of investigational therapies, having most recently served as Head of Clinical, Inflammation and Immunology at Principia Biopharma, a Sanofi company. At Principia, he led clinical development strategy and the clinical team in the design and execution of clinical studies across the company’s portfolio. Dr. Arora managed clinical development for lead programs including early translational development and proof of concept through late development and regulatory submissions. He played a key role in leading the pivotal study clinical and filing teams for the rilzabrutinib program in pemphigus. Prior to his time at Principia, he was Senior Medical Director of Early Clinical Development and Clinical Team Leader at Genentech Research and Early Development working across multiple therapeutic areas. Dr. Arora received his medical degree from the All India Institute of Medical Sciences, completed his residency in internal medicine at the Southern Illinois University School of Medicine, a fellowship in endocrinology at NYU, and earned a Master’s Degree in Clinical Research at the Mayo Clinic as part of the Clinical Research Training Program.

"I am excited to join Lassen at this pivotal time and advance our mission of developing biotherapeutics against compelling new targets that are central to diseases with significant unmet needs," said Dr. Arora. "Lassen is pursuing compelling targets and novel mechanisms of action with the potential to result in important new therapeutics for patients with limited treatment options."

On November 18, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that new interim data published from the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) utilizing its novel predictive and prognostic blood-based host immune classifier (the VeriStrat test) to stratify Immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer(NSCLC) (Press release, Biodesix, NOV 18, 2021, View Source [SID1234595802]). The study, titled "Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer," was published in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC) and can be viewed here.

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Results from the prespecified INSIGHT interim analysis of approximately 2,000 patients with at least one year of follow up showed that patients classified by VeriStrat as host immune classifier hot (HIC-Hot) had better outcomes, on average living 2-3 times longer when compared to patients classified by VeriStrat as HIC-Cold. A classification of HIC-H, also known as VeriStrat Good, implies that the normal tumor-directed immunity is active and patients are potentially responsive to therapies that boost immune response. HIC "cold" classification, also known as VeriStrat Poor, correlates to what experts refer to as an "immune desert," where tumor-directed immunity is compromised. Results additionally suggest that HIC-C (Veristrat Poor) patients should not be treated with single-agent ICI therapy regardless of their PD-L1 expressions.

"Inflammatory biomarker-driven treatment selection of immunotherapy in lung cancer may further improve upon the already astounding results noted with immunotherapy," said Wallace Akerley, M.D., of Huntsman Cancer Institute. "Further, observational studies, like INSIGHT, offer physicians valuable information gleaned from the broader population when determining optimal treatment approaches for their patients with NSCLC."

ICI either single agent or in combination with chemotherapy has helped advance the management and long-term survival of those living with advanced NSCLC. However, it’s not easy to know which patients will experience a favorable response to the various standard of care therapies. There are complex interactions between cancer and the patient’s immune system and this data suggests that using an HIC test alongside PD-L1 results and other clinical factors may help inform treatment response and improve outcomes.

"Biodesix is committed to supporting the lung cancer community by discovering, developing and commercializing proteomic tests while conducting supportive studies that aim to strategically inform patient treatment for better outcomes," said Scott Hutton, CEO of Biodesix. "This new INSIGHT Study data demonstrate how our host immune classifier test, VeriStrat, provides valuable information that can help healthcare professionals make informed decisions when evaluating immunotherapy against the increasingly complex treatment landscape for their patients with NSCLC."

On November 18, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that an exclusive interview with CEO Snehal Patel will air on the upcoming The RedChip Money Report on Bloomberg TV, this Saturday November 20th at 7 pm ET. Bloomberg TV airs in an estimated 73 million homes across the United States (Press release, Greenwich LifeSciences, NOV 18, 2021, View Source [SID1234595801]).

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In the interview Mr. Patel discusses the Phase IIb clinical trial results in HER2 positive patients, where no metastatic breast cancer recurrences were observed over 5 years of follow-up, an overview of the next steps in the upcoming FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase III clinical data publications in 2022, the impact of joining the Russell 2000, and examples of recent comparable strategic transactions in breast cancer and immunotherapy.

To view a preview of the interview, please click here.

About The RedChip Money Report

The RedChip Money Report delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, and financial book reviews, as well as featured interviews with executives of public companies.

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 and the link and trial identifier will be published shortly. 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.