On December 7, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the MedInvest Oncology Investor Conference, which is being held virtually on December 7 – 10, 2021 (Press release, Kintara Therapeutics, DEC 7, 2021, View Source [SID1234596541]).

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Mr. Hoffman will deliver his corporate presentation on Thursday, December 9, 2021 at 2:50 p.m. EST.

Mr. Hoffman will be available for one-on-one meetings throughout the conference.

On December 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the European Commission has granted Orphan Drug Designation to VIP152, the Company’s PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL) (Press release, Vincerx Pharma, DEC 7, 2021, View Source [SID1234596540]).

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"The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic landscape. We look forward to continued momentum with data presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which include complete disease regression in DLBCL mouse models and modulation of key biomarkers in high-grade B-cell lymphoma cell lines and patients. In addition, we are presenting supportive preclinical mechanistic data in chronic lymphocytic leukemia."

The European Commission grants orphan drug designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union and when no satisfactory method of diagnosis, prevention or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

Vincerx is currently advancing Phase 1b studies of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. The ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

On December 7, 2021 Odyssey Therapeutics, a biotechnology company pioneering next generation precision immunomodulators and oncology medicines, reported the completion of an oversubscribed $218 million Series A financing led by OrbiMed Advisors and co-led by SR One Capital Management with participation from Foresite Capital, Woodline Partners LP, Logos Capital, HBM Healthcare Investments, Colt Ventures, Creacion Ventures, and other institutional investors (Press release, Odyssey Pharmaceuticals, DEC 7, 2021, View Source [SID1234596539]). Carl L. Gordon, Ph.D., Managing Partner of OrbiMed Advisors, will join Odyssey’s board of directors. The financing will be used to advance multiple pipeline programs and Odyssey’s discovery platform aimed at expanding the druggable genome. Founded by Gary D. Glick, Ph.D., the company is led by a team of drug hunters and executives with an extraordinary track record of accomplishment in helping to bring more than 20 drugs to market.

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Anti-inflammation immunotherapies, such as anti-TNF antibodies and JAK inhibitors, and newer oncology immunotherapies and targeted therapies have improved the standard of care for some patients. However, numerous challenges including limited efficacy, inherent or acquired drug resistance, and mechanism-based toxicity restrict broader patient care and limit their benefits.

Building on these past approaches, Odyssey has developed a strategy to create a portfolio of product candidates that will go beyond the limitations of current medicines and enhance the standard-of-care for patients living with inflammatory diseases and cancer. The company is focused on targets and mechanisms that control validated signaling nodes that drive disease, with the goal of creating medicines that achieve optimal product profiles for patients. In addition, Odyssey is applying its highly integrated drug hunting engine and class-leading computational and data sciences platform to challenging, high-value targets with the potential to revolutionize treatment paradigms, but for which traditional discovery approaches have not succeeded.

"A renaissance in medicinal chemistry, coupled with new drug discovery technologies and an expanded understanding of the drivers of immune dysfunction and cancer, has created an unprecedented opportunity to discover new drugs with much greater potential for patients," said Gary D. Glick, Ph.D., Chief Executive Officer of Odyssey Therapeutics. "Odyssey has brought together the financing, technology, and a team with decades of success in drug discovery and development and is poised to capitalize on this opportunity and take precision therapies to the next level: providing patients with better medicines to improve their lives."

"Odyssey has assembled one of the strongest biotech teams I have seen," said Carl Gordon, Ph.D., CFA, OrbiMed Advisors. "Paired with its next-generation scientific approach, Odyssey is positioned to accelerate the discovery and development of transformative medicines to improve the lives of a broad range of patients living with inflammatory diseases and cancer."

Experienced leadership team with proven successes
Odyssey was founded by Dr. Glick and a group of world-renowned drug hunters and academic experts in immunology, cancer biology, synthetic and systems biology, and proteomics. With headquarters and labs in Boston, Odyssey is rapidly expanding with more than 90 scientists and staff.

Odyssey’s founding team has collectively made a number of the most important discoveries in immunology and cancer biology over the last 15 years. These key scientific insights underpin the discovery and rationale of several marketed drugs and medicines in clinical testing. Odyssey is leveraging this in-house intellectual capital not only to select targets but also to determine the therapeutic modality that will have the greatest clinical impact. To transform scientific insights into medicines, Odyssey is organized in a bottom-up manner that cuts across traditional disciplines and maximizes speed, efficiency, and rigor across the organization.

The Odyssey senior scientific management team includes:

Gary D. Glick, Ph.D., Founder, President, and Chief Executive Officer
Dr. Glick is a chemist and serial biotech entrepreneur with over 15 years’ experience in the biotech industry. He has founded several successful companies, including IFM Therapeutics. While CEO of IFM, the company progressed three programs from ideation to clinical development and executed several major transactions, including the sale of oncology assets to Bristol-Myers Squibb in a transaction valued more than $2.3 billion and the sale of an NLRP3 inhibitor program to Novartis for $1.6 billion. Prior to Odyssey, in 2020, he co-founded and launched Scorpion Therapeutics. Dr. Glick played an instrumental role in the conception and building of the company, and during his tenure as Chief Executive Officer, Scorpion raised $270 million across two financings within nine months of the company’s founding. Dr. Glick received his Ph.D. in Organic Chemistry from Columbia University and completed postdoctoral studies in Organic Chemistry at Harvard University.
Robert Abraham, Ph.D., Executive Vice President, Cancer Biology
Dr. Abraham is a veteran leader in oncology research and development. Prior to Odyssey, Dr. Abraham served as Chief Scientific Officer at Vividion Therapeutics, which was acquired in August 2021 by Bayer for $2 billion. Previously, he held the position of Senior Vice President and Group Head of the Oncology R&D Group in Pfizer Worldwide Research, Development, and Medical. While at Pfizer, he helped launch 10 new oncology medicines, including XALKORI, IBRANCE, BESPONSA, BOSULIF, BAVENCIO, MYLOTARG, TALZENNA, DAURISMO, and LORBRENA, benefiting hundreds of thousands of patients worldwide. Dr. Abraham received his Ph.D. in Pharmacology from the University of Pittsburgh.
Natalie Dales, Ph.D., Senior Vice President, Chemistry and Drug Discovery
Dr. Dales is an accomplished scientist with over 20 years’ small molecule drug discovery experience leading and mentoring teams in pharmaceuticals and biotech. Prior to Odyssey, Dr. Dales was an Executive Director and the Head of Portfolio and Strategy for the Global Discovery Chemistry Group at Novartis. She was also a senior advisor for the Novartis Genesis Labs, an internal innovation incubator which fostered and funded disruptive concepts to accelerate drug discovery. Prior to Novartis, she worked on oncology, cardiovascular, and metabolism programs at Millennium Pharmaceuticals. Dr. Dales received her Ph.D. in Organic Chemistry from the University of Wisconsin.
Joseph McDonald, Ph.D., Chief Data Officer
Dr. McDonald is a distinguished scientist and executive bringing more than 30 years’ experience in the biopharmaceutical industry. Prior to Odyssey, Dr. McDonald served as Executive Director of Machine-Learning and Physics-Based Simulation at BMS and Celgene. In previous roles at Celgene, Avila Therapeutics, and Pfizer, he led increasing roles of responsibility in computational chemistry, patent science, and chemical sample management. Dr. McDonald is also a co-author and inventor of more than 140 papers and applications. Dr. McDonald received his Ph.D. in Biophysics from Roswell Park Memorial Institute and completed postdoctoral studies in Computational Chemistry at Carnegie Mellon University.
Shifeng Pan, Ph.D., Executive Vice President, Head of Discovery
Dr. Pan is a leading medicinal chemist with more than 20 years’ experience. Prior to Odyssey, Dr. Pan served as the Executive Director of Discovery Chemistry at the Genomics Institute of the Novartis Research Foundation (GNF), where he oversaw GNF’s low molecular weight portfolio and all chemistry activities, including medicinal chemistry, chemical technologies, analytical chemistry, and DMPK. He led the discovery of ODOMZO, BRAFTOVI, and MAYZENT, and is the recipient of numerous awards for his accomplishments. Dr. Pan received his Ph.D. in Organic Chemistry from New York University and completed postdoctoral studies in Organic Chemistry at GNF.
David L. Pompliano, Ph.D., Co-Founder and Chief Innovation Officer
Dr. Pompliano is a drug discovery scientist, entrepreneur, and executive with more than 30 years’ experience in the biopharmaceutical industry. Before joining Odyssey, Dr. Pompliano co-founded and served as the Chief Scientific Officer of Revolution Medicines and Lodo Therapeutics, and served as the CEO of BioLeap. Prior to the biotech industry, he served as Worldwide Basic Head of Infectious Diseases at Merck and Vice President of Biology at GlaxoSmithKline, where he led drug discovery teams that produced pre-clinical credentials for more than 30 development candidates and five registered anti-infective and oncology drugs. Dr. Pompliano received his Ph.D. in Chemistry from Stanford University and completed postdoctoral studies in Enzymology and Molecular Biology at Harvard University.
Stephen Soisson, Ph.D., Executive Vice President, Structural Biology and Protein Therapeutics
Dr. Soisson is a leading structural biologist with more than 20 years’ drug discovery experience. Prior to Odyssey, Dr. Soisson served as the Executive Director and Global Head of Structural Chemistry and Structural Protein Sciences at Merck Research Laboratories (MRL) where he architected and oversaw Merck’s network-wide efforts to structurally enable all programs with three-dimensional molecular structures. During his tenure, the structure group contributed to the discovery of virtually all clinical candidates at MRL, including KEYTRUDA, BELSOMRA, and ISENTRESS. Dr. Soisson received his Ph.D. from Johns Hopkins School of Medicine and completed post-doctoral studies as a Damon Runyon-Walter Winchell Cancer Research fellow at Rockefeller University.
Odyssey’s board of directors includes:

Gary D. Glick, Ph.D., President and CEO, Odyssey Therapeutics
Carl L. Gordon, Ph.D., CFA, Managing Partner, OrbiMed Advisors
Jill Carroll, Partner, SR One Capital Management
Charles Baum, M.D., Ph.D., President, Founder, and Head of R&D, Mirati Therapeutics
Valerie Odegard, Ph.D., President and CSO, Silverback Therapeutics

On December 7, 2021 ATP (Apple Tree Partners), a leader in life sciences venture capital, reported the launch of Adendra Therapeutics Ltd. ("Adendra"), a company that will discover and develop treatments for cancers and autoimmune diseases by applying new insights into regulation of adaptive immune responses by dendritic cells (Press release, ATP, DEC 7, 2021, View Source [SID1234596533]). Adendra is funded with a $53 (£40) million Series A investment from ATP and founded by ATP as a spin-out of breakthrough biology conducted at the Francis Crick Institute in London in the lab of immunologist Caetano Reis e Sousa, D.Phil., whose research on ways in which dendritic cells orchestrate immune responses to cell death has been published in leading scientific journals.

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Adendra’s proprietary technology is based on the work of Professor Caetano Reis e Sousa’s Immunobiology Laboratory at The Francis Crick Institute in collaboration with Raj Mehta, Ph.D., an Entrepreneur-in-Residence (EIR) at ATP who has previously founded and led companies including GammaDelta Therapeutics (recently acquired by Takeda) and Revitope Oncology. Adendra aims to design and develop novel immunotherapies focused on modulation of dendritic and other immune cells to augment immunological control of cancer or curtail T cell-driven autoimmunity.

"We are delighted to partner with Caetano and the Francis Crick Institute to form Adendra, to translate their pioneering work in dendritic cell biology into novel therapeutics," said Dr. Mehta, ATP EIR and Adendra co-founder and Chief Executive Officer. "Building on the leading scientific knowledge and expertise coming from Caetano’s lab and applying ATP’s capabilities in therapeutics development and life sciences strategy and operations, Adendra is uniquely positioned to improve the current treatment paradigm in cancer and other diseases."

"I am delighted to have the backing of ATP to enable the clinical translation of research in the field of innate immune recognition of dead cells and am excited about the prospect of offering meaningful clinical benefit to patients suffering from cancer or autoimmune diseases," said Professor Reis e Sousa, Adendra co-founder and Senior Group Leader and Assistant Research Director at the Francis Crick Institute.

Adendra will use proceeds from the financing to generate developmental candidates for new molecular and biological therapeutics against solid cancers and T cell-based autoimmune disorders. Beyond these areas of focus, Adendra welcomes approaches from potential research partners interested in accessing the company’s specialized capabilities and tools to address other urgent unmet medical needs.

"Adendra exemplifies ATP’s model of creating and building companies through ongoing partnership with leading scientific experts to develop first- and best-in-class therapies," said Seth Harrison, M.D., ATP founder and managing partner. "We are pleased to launch ATP’s first UK-based enterprise, we anticipate more transformational ventures emerging from our scientific collaborations in the UK and Europe, and we look forward to establishing Adendra at the forefront of the next leading wave of immune-oncology and immunotherapy companies."

In conjunction with the Series A, Professor Reis e Sousa and Drs. Mehta and Harrison have joined the Adendra Board of Directors, along with Raj Chopra, M.D., Ph.D., ATP’s Head of Oncology who is also a venture partner at the firm. Donna Hackett, Head of Commercial Translation at the Francis Crick Institute, is a Board Observer

On December 6, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported the presentation of interim clinical data from the company’s ongoing Phase 1/2 study of BDC-1001, the company’s lead immune-stimulating antibody conjugate (ISAC) in a poster session at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021, being held virtually from Dec. 6-11, 2021 (Press release, Bolt Biotherapeutics, DEC 6, 2021, View Source [SID1234618691]). The lead author for the poster is Manish Sharma, M.D., START Midwest, with contributions from Ecaterina Dumbrava, M.D., MD Anderson Cancer Center, and other colleagues from the U.S. and South Korea.

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The company reported data from 57 subjects participating in an ongoing Phase 1/2 study of BDC-1001, across 16 different types of HER2-expressing solid tumors. BDC-1001 demonstrated a favorable safety and tolerability profile at all evaluated doses and schedules, showing early signs of clinical activity with corresponding biomarker changes in the tumor microenvironment of post-treatment tumor biopsies. BDC-1001 is an immune-stimulating antibody conjugate (ISAC) comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to an innovative TLR7/8 agonist.

"The favorable safety profile and early indications of clinical disease control in the BDC-1001 study are encouraging," said Dr. Sharma, Associate Director of Clinical Research at START Midwest. "There is a clear need for well tolerated, durable treatments in the fight against cancer and I’m excited to see if BDC-1001 can deliver on that potential as we explore higher drug exposure levels."

The poster presentation at ESMO (Free ESMO Whitepaper) I-O reported new safety, pharmacokinetic/pharmacodynamic, and efficacy results for the ongoing Phase 1 dose-escalation portion of the BDC-1001 monotherapy trial. Fifty-seven subjects have been treated at increasing dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks, and data from these subjects demonstrate that:

BDC-1001 continues to have a favorable safety and tolerability profile with mild (grade 1/grade 2) infusion related reactions in some patients and no dose-limiting toxicities at dose levels up to 20 mg/kg every three weeks and 12 mg/kg every two weeks. There was no indication of cytokine release syndrome (CRS), and a maximum tolerated dose (MTD) has not been reached.
Early signs of clinical activity are noted in 13 of 40 tumor evaluable subjects with one durable partial response maintained through 52 weeks and multiple subjects achieving stable disease for >12 weeks.
The pharmacokinetic (PK) data demonstrate increasing peak drug levels with increasing dose, and linearity of PK above the 5 mg/kg dose level. Clinical PK modeling predicts that target exposure levels can be achieved with weekly dosing.
Plasma and tissue biomarker results show increase in multiple biomarkers indicative of myeloid cell and TLR 7/8 activation that is consistent with BDC-1001’s mechanism of action. Increasing drug exposure correlates with increases in plasma cytokines and corresponding biomarker changes in the tumor microenvironment of multiple post-treatment tumor biopsies, with intriguing signs of clinical disease control.
These encouraging data point to the need for increased drug exposure to optimize clinical benefit. The favorable safety profile of BDC-1001 allows for continued enrollment in the dose escalation portion of the study, and the Company’s refined PK model based on data from more than 50 patients predicts that weekly administration will provide BDC-1001 exposures at or above the target exposure threshold. The data also support initiation of the combination therapy study with nivolumab (PD-1 inhibitor).

"Bolt Biotherapeutics is committed to agile clinical development based on data. In this Phase 1/2 study of BDC-1001, we have gained tremendous insight into the ability of this novel candidate to mobilize the patient’s immune system in targeting the tumor and its microenvironment. The increases in myeloid cell infiltration and repolarization of macrophages we’ve seen in multiple post-treatment biopsies are provocative and consistent with our proposed mechanism of action," said Edith Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. "We look forward to exploring weekly dosing as we get closer to determining the recommended Phase 2 dose for BDC-1001 as monotherapy, and to initiating combination therapy with a checkpoint inhibitor."

Presentation Details
Title: Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors
Lead author: Manish R. Sharma, M.D.
Presentation Number: 164P
Timing: On-demand access beginning Dec. 6 at 12:00 p.m. CET.

The poster presentation will be available on the ESMO (Free ESMO Whitepaper) I-O conference website and on Bolt’s website.

Conference Call and Webcast Details

Bolt Biotherapeutics management will host a conference call for the investment community, in conjunction with the now virtual ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, to discuss emerging clinical data and insights from the ongoing Phase 1/2 study today, Monday, December 6, 2021, at 8:00 a.m. ET/5 a.m. PT.

The conference call can be accessed by dialing +1 (833) 665-0609 within the U.S. or Canada or by dialing +1 (929) 517-0400 from international locations. The passcode for the call is 2633068. A live webcast, including slides, will be available on the Events & Presentations page of Bolt Biotherapeutic’s website at www.boltbio.com. An archived replay can be accessed for 30 days following the webcast.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.