On January 09, 2023 Kronos Bio, Inc., a company dedicated to transforming the lives of those affected by cancer, reported that it has entered into a discovery collaboration in the field of oncology with Genentech, a member of the Roche Group, focused on discovering and developing small-molecule drugs that modulate transcription factor targets selected by Genentech (Press release, Genentech, JAN 9, 2023, View Source [SID1234629876]).

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The partnership will allow Genentech to leverage Kronos Bio’s expertise to identify protein-protein interactions, genetic dependencies and gene expression signatures to better understand and target the oncogenic activity of transcription factors in cancer types of interest. Under the collaboration, researchers at the two companies will collaborate using Kronos Bio’s proprietary drug discovery platform, including the small molecule microarray (SMM) for hit finding, to build upon research conducted to date by Genentech.

"This, our first collaboration, brings together expertise from both companies with the goal of answering fundamental scientific questions about the biology of cancer that we hope will one day lead to the advancement of new clinical candidates," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We are pleased to be able to leverage our unique platform to collaborate with Genentech to further Kronos Bio’s understanding of transcription-driven oncogenesis and ability to identify novel targets involved."

Kronos Bio will lead discovery and research activities to a defined preclinical point when Genentech will have the exclusive right to pursue further preclinical and clinical development and commercialization. Under the terms of the agreement, Kronos Bio will receive an upfront payment of $20 million and be eligible for additional payments, which could total up to $554 million, based on reaching certain milestones, including discovery, preclinical, clinical and commercial milestones, as well as tiered royalties on any potential products that are commercialized as a result of the collaboration.

"We are excited about the possibilities that this collaboration with Kronos Bio brings to further our understanding of complex scientific networks with the goal of bringing highly effective medicines to patients," said James Sabry, Global Head of Roche Pharma Partnering.

About Kronos Bio’s Discovery Engine
Kronos Bio is focused on targeting the activity of oncogenic transcription factors that have a well-defined and central role in driving particular types of cancer. The company leverages its expertise to map transcription regulatory networks, enabling the identification of protein-protein interactions, genetic dependencies and gene expression signatures of specific oncogenic transcription factors in cancers of interest. Utilizing these transcription regulatory network maps, the company relies on a number of tools, including its proprietary Small Molecule Microarray (SMM) to screen for new drug starting points.

On January 9, 2023 AmMax Bio, Inc. ("AmMax"), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, and Evopoint Biosciences Co., Ltd ("Evopoint"), a leading biopharmaceutical company applying its cutting-edge platform technologies to discover and develop innovative medicines, reported that AmMax has entered into an exclusive option with Evopoint for a worldwide license, excluding Greater China, for the development and commercialization of a novel ADC for treating solid tumors (Press release, AmMax Bio, JAN 9, 2023, View Source [SID1234626210]).

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With its proprietary linker-payload system and monoclonal antibody, this technology has demonstrated robust antitumor activity in multiple preclinical models which presents significant opportunities to treat many different types of cancer. The animal efficacy and toxicity studies also support a significantly widened therapeutic index (TI) that is expected to provide a much-improved efficacy and safety profile.

"AmMax’s mission is to develop and commercialize oncology therapeutics that have the potential to become the new standard of care," said Larry Hsu, Ph.D., Chairman & Chief Executive Officer of AmMax, "Today’s agreement with Evopoint underscores this commitment by adding a potentially best-in-class ADC program to our portfolio. We are excited to partner with Evopoint and, upon exercising the option, to move this highly differentiated drug candidate into patient studies in the second half of 2023."

"We are very pleased to enter into this agreement with AmMax," said Jason Meijie Le, Chief Executive Officer of Evopoint Biosciences. "Evopoint is dedicated to develop and deliver innovative medicines to physicians and patients. We are very impressed with AmMax’s therapeutic area expertise and proven track record in drug development and commercialization. We look forward to partnering with AmMax to advance this transformative product worldwide. This collaboration evidences the superiority of our product pipeline."

Under the exclusive option agreement, the parties have pre-negotiated licensing terms and will work together to complete the upcoming IND filing and design subsequent dose-escalating clinical studies.

On January 9, 2023 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board, will present recent progress and 2023 corporate milestones at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023 from 11:15 – 11:55 am ET, and that Biomea management will hold 1×1 meetings during the conference January 9 – 11 (Press release, Biomea Fusion, JAN 9, 2023, View Source [SID1234626199]).

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A live webcast of the presentation will be available on the Investors & Media page of Biomea’s website at:

View Source

"2022 was a year of strong execution and fundamental infrastructure build as we transitioned to a clinical-stage company and expanded our pipeline. We enter 2023 with three clinical trials studying BMF-219 across 8 cancer indications covering both blood cancers and solid tumors as well as in Type 2 diabetes, the 7th leading cause of death in the United States," stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. "We anticipate advancing BMF-500 into the clinic during the first half of 2023, subsequent to FDA clearance of an IND, which will increase our clinical pipeline to 4 clinical trials covering 10 indications. COVALENT-111, our Phase I/II study in Type 2 diabetes is now due to report initial safety and efficacy from the first two cohorts of the Phase II portion by the end of Q1."

Mr. Butler further commented, "we continue to activate sites and enroll patients in our Phase I/Ib (COVALENT-101) study of BMF-219 in patients with several liquid tumor types, and plan to report initial clinical data from this study in the first half of 2023. In addition, we anticipate initiating dosing imminently in our Phase I/Ib (COVALENT-102) study of BMF-219 in patients with KRAS-mutated solid tumors. In 2023, we will continue the patient-centric urgency and disciplined execution that are now well-established hallmarks of Team Biomea."

RECENT & ANTICIPATED MILESTONES

ONCOLOGY

COVALENT-101 (BMF-219)

Presented robust anti-tumor activity of covalent menin small molecule inhibitor, BMF-219, as a single agent and mechanistic evidence for novel inhibition of the menin protein in preclinical models of diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). BMF-219 displayed single agent potency, surpassing greater than 90% cell killing at clinically relevant exposures in DLBCL, MM and CLL cell lines and patient-derived samples.

BMF-219 is the first investigational menin inhibitor in clinical development to show potential as a therapeutic agent in hematologic malignancies outside of MLLr and NPM1 mutated acute myeloid leukemia/acute lymphoblastic leukemia (AML/ALL) patients, specifically in subsets of DLBCL, MM and CLL patients.

Biomea continued site activation and patient enrollment for the dosing of BMF-219 across four liquid tumor cohorts in the COVALENT-101 study, including patients with AML/ALL, DLBCL, MM and CLL.

Next Anticipated Milestone:

On track to present initial clinical data of AML/ALL patients (including those with MLL rearrangement and NPM1 mutation) dosed in the COVALENT-101 study in the first half of 2023.

COVALENT-102 (BMF-219)

Presented strong and highly specific pan-KRAS anti-cancer activity of BMF-219 as a single agent across KRAS G12C, G12D, G12V and G13D mutant cell lines including in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and the most prevalent type of pancreatic cancer, PDAC.

BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the treatment of solid tumors. A targeted pan-KRAS inhibitor could have the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.

Biomea received FDA clearance of its IND in the fourth quarter of 2022 and has since initiated a Phase I/Ib clinical trial of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation.

Next Anticipated Milestone:

On track to dose first patient in COVALENT-102 study in January 2023.

COVALENT-103 (BMF-500)

Presented data showing multi-fold higher potency and increased cytotoxicity of Biomea’s covalent FLT3 small-molecule inhibitor BMF-500 compared to the commercially available reversible, non-covalent FLT3 inhibitor gilteritinib, and complete, sustained tumor regression in mouse models of FLT3-ITD AML with maintenance of effect after cessation of therapy.

Next Anticipated Milestone:

On track to file IND for BMF-500 in the first half of 2023 to initiate COVALENT-103 study of the covalent FLT3 inhibitor in patients with acute leukemia.

DIABETES

COVALENT-111 (BMF-219)

Presented preclinical data highlighting the ability of BMF-219 in a Type 2 diabetes rat model to restore normal HOMA-B, a measure of pancreatic beta cell function, following only 4-weeks of treatment and to significantly lower HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively.

BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the improvement of glycemic control and insulin sensitivity in Type 2 diabetes patients.

Biomea completed the healthy volunteer portion of the Phase I/II COVALENT-111 study of BMF-219 in Canada. BMF-219 was well tolerated with an encouraging pharmacokinetic and pharmacodynamic profile in healthy volunteers and with no safety signals detected.

Biomea received FDA clearance in December 2022 to expand the Phase II portion of COVALENT-111 to sites in the U.S. and in January 2023 announced dosing of the first U.S. patient with Type 2 diabetes. The company continues to enroll Type 2 diabetes patients in the Phase II portion of the study in Canada as well.

Next Anticipated Milestones:

On track to present initial clinical data from the first two cohorts of the Phase II portion of the study by the end of Q1 2023, and to present details of the healthy volunteer (Phase I) portion of the study at a scientific medical meeting in 2023.

FUSIONTM SYSTEM DISCOVERY PLATFORM

Developed two covalently binding small molecules (BMF-219 and BMF-500), each within 18 months from target identification to IND candidate, leveraging the proprietary FUSIONTM System Discovery Platform and showing excellent preclinical profiles.

Next Anticipated Milestone:

On track to announce a third development candidate from the FUSION platform in the first half of 2023.

On January 9, 2023 GreenLight Biosciences Holdings, PBC (Nasdaq:GRNA), and EpiVax Therapeutics Inc, reported that they have signed an exclusive collaboration agreement to jointly develop and commercialize personalized mRNA-based vaccine candidates for cancers (Press release, EpiVax, JAN 9, 2023, View Source [SID1234626177]).

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GreenLight Biosciences is a public benefit corporation striving to bring effective and safe RNA-based solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet. Epivax Theraeutics Inc. is a biotechnology company with extensive experience in immune-engineering more effective vaccines that recently completed an end-to-end computational pipeline for the design of precision cancer immunotherapies, Ancer.

Under this collaboration, the companies will design and develop new personalized mRNA cancer vaccine candidates using GreenLight and EpiVax Therapeutics technology platforms. EpiVax Therapeutics has developed a proprietary computational tool for precision immunotherapy, Ancer, an end-to-end, automated platform that integrates multiple advanced algorithms into a single pipeline to rapidly design custom therapies for individual cancer patients using each patient’s own tumor genome sequence as the starting point for the vaccine design. The Ancer algorithms include two extensively validated tools, EpiMatrix and JanusMatrix, which, when used together, identify the most immunogenic CD8 and CD4 neoepitopes while excluding potentially tolerogenic epitopes that may reduce vaccine efficacy. EpiVax Therapeutics was the first personalized vaccine company to use computational tools to identify tolerogenic epitopes in neoantigens and to exclude these from cancer vaccine designs. EpiVax Therapeutics’ pipeline currently includes vaccine design capacity for bladder cancers and other solid tumors.

GreenLight’s mRNA design, formulation and manufacturing expertise is currently applied to research and develop mRNA vaccine candidates, including a collaboration with the NIH to develop a next generation Covid vaccine, and a multi-target license agreement with Serum Institute of India, which includes developing a shingles vaccine candidate. GreenLight has also completed two commercial-scale engineering runs manufacturing mRNA at scale, in partnership with Samsung Biologics. This includes production of drug substance and lipid nanoparticle formulation to produce bulk drug product in a single facility, producing 650g of mRNA.

Together, GreenLight and EpiVax Therapeutics will leverage their respective expertise and jointly develop and commercialize potential novel personalized mRNA-based vaccine candidates for a wide range of oncology indications.

"We are delighted to partner with EpiVax Therapeutics, to expedite development of personalized cancer vaccine candidates using GreenLight’s RNA platform," said Andrey Zarur, CEO of GreenLight. "We are excited to combine our mRNA design and manufacturing expertise with EpiVax Therapeutics’ neoantigen discovery platform and oncology expertise to build towards a future of accessible and timely oncology vaccines."

EpiVax Therapeutics CEO, Nicole Ruggiero, added, "I am excited by what lies ahead. We have found the ideal partner for our personalized vaccine program in GreenLight Biosciences. Combining our advanced Ancer pipeline for personalized cancer vaccine design with GreenLight’s expertise in mRNA production is a win-win for the companies and for cancer patients."

On January 9, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has entered into a non-exclusive license agreement with Cabaletta Bio, Inc (Nasdaq: CABA). The agreement allows Cabaletta to incorporate Autolus’ proprietary RQR8 safety switch1 into a cell therapy program for the treatment of autoimmune disease, with an option for Cabaletta to incorporate the safety switch in up to four additional cell therapy programs (Press release, Autolus, JAN 9, 2023, View Source [SID1234626158]).

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"We are delighted to partner with Cabaletta and to expand the use of our safety switches in autoimmune disease," said Dr. Martin Pule, Chief Scientific Officer of Autolus. "Safety switches are critical to the future of our field of advanced cell therapies. They allow us to develop approaches that are designed to significantly improve patient outcomes, whilst at the same time potentially reducing the risk of adverse side effects from the treatment."

Under the terms of the agreement, Autolus will receive an upfront payment for non-exclusive access to the RQR8 safety switch for use in Cabaletta’s CD19-CAR T cell therapy program for the treatment of autoimmune disease, with the potential for near term option exercise fees and development and regulatory milestone payments. In addition, Autolus is entitled to receive royalties on net sales of all Cabaletta cell therapy products that incorporate the RQR8 safety switch.

This agreement demonstrates how Autolus is able to generate value from its technologies and pipeline and follows similar deals with Bristol Myers Squibb and Moderna.