On September 19, 2023 (the "Effective Date"), BioXcel Therapeutics, Inc. (the "Company"), Krishnan Nandabalan, Ph.D., InveniAI LLC ("InveniAI") and Invea Therapeutics, Inc. ("Invea") and the other parties thereto entered into a non-compete agreement (the "Non-Compete Agreement") (Filing, 8-K, BioXcel, SEP 19, 2023, View Source [SID1234635377]). Pursuant to the Non-Compete Agreement, Dr. Nandabalan and InveniAI and Invea, each where Dr. Nandabalan serves as Chief Executive Officer and a member of the board, agreed not to compete with the Company and its controlled affiliates in the fields of neuroscience and immuno-oncology for a period of five years from the Effective Date and not to solicit employees of the Company or its controlled affiliates for a period of two years from the Effective Date.

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The foregoing description of the Non-Compete Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Non-Compete Agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated herein by reference.

On September 19, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that it will present initial data from Module 1 and 2 of its ongoing Phase 1 MYTHIC clinical trial in a plenary session at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 11-15, 2023 in Boston, MA (Press release, Repare Therapeutics, SEP 19, 2023, View Source [SID1234635267]). In addition to this presentation, the Company will present multiple posters at the conference highlighting preclinical and clinical developments, including data from Module 4 of its Phase 1/2 TRESR clinical trial.

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Module 1 and 2 of the Phase 1 MYTHIC clinical trial are evaluating lunresertib (RP-6306), a first-in-class, oral PKMYT1 inhibitor alone and in combination with camonsertib (RP-3500/RG6526), a potent and selective oral inhibitor of ATR, while Module 4 of the Phase 1/2 TRESR trial is evaluating camonsertib in combination with gemcitabine, both in molecularly selected advanced solid tumors. Repare entered into a worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib.

Details for the plenary and poster presentations are as follows:

Title: MYTHIC: First-in-human (FIH) biomarker-driven phase I trial of PKMYT1 inhibitor lunresertib (lunre) alone and with ATR inhibitor camonsertib (cam) in solid tumors with CCNE1 amplification or deleterious alterations in FBXW7 or PPP2R1A
Presenter: Dr. Timothy A. Yap, The University of Texas MD Anderson Cancer Center, Houston, TX
Abstract number: 35396
Poster number: B156
Session: Plenary Session 4: New Drugs on the Horizon
Session date and time: Friday, October 13 | 9:40 a.m. – 11:45 a.m. ET
Session location: Level 3, Ballroom AB

Title: Ataxia telangiectasia- and Rad3-related kinase inhibitor (ATRi) camonsertib in combination with low dose gemcitabine in patients with solid tumors with DNA damage response (DDR) aberrations: Preclinical and Phase 1b results
Presenter: Dr. Ezra Rosen, Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY
Poster number: B045
Session: Poster Session B
Session date and time: Friday, October 13 | 12:30 p.m. – 4:00 p.m. ET
Session location: Level 2, Exhibit Hall D

Title: Circulating tumor DNA (ctDNA) genomic and epigenomic profiling (GuardantINFINITY) for diagnosis of DNA damage repair (DDR) loss of function (LOF) and response monitoring in the TRESR and ATTACC trials
Presenter: Dr. Ezra Rosen, Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY
Poster number: A123
Session: Poster Session A
Session date and time: Thursday, October 12 | 12:30 p.m. – 4:00 p.m. ET
Session location: Level 2, Exhibit Hall D

Title: Retrospective baseline biomarker analyses in a first-in-human Phase 1 trial of the PKMYT1 inhibitor lunresertib (RP-6306) in pts with advanced solid tumors harboring CCNE1 amplification and/or deleterious alterations in FBXW7 or PPP2R1A.
Presenter: Elia Aguado-Fraile, Repare Therapeutics
Poster number: B169
Session: Poster Session B
Session date and time: Friday, October 13 | 12:30 p.m. – 4:00 p.m. ET
Session location: Level 2, Exhibit Hall D

Title: Preclinical development of PKMYT1 and ATR inhibitor combinations
Presenter: Michael Zimmerman, Repare Therapeutics
Poster number: B057
Session: Poster Session B
Session date and time: Friday, October 13 | 12:30 p.m. – 4:00 p.m. ET
Session location: Level 2, Exhibit Hall D

Title: Preclinical development of PKMYT1 and WEE1 inhibitor combinations
Presenter: David Gallo, Repare Therapeutics
Poster number: A023
Session: Poster Session A
Session date and time: Thursday, October 12 | 12:30 p.m. – 4:00 p.m. ET
Session location: Level 2, Exhibit Hall D

On September 19, 2023 Magnet Biomedicine, a biotechnology company advancing molecular glue discovery with rational selection and design, reported a $50 million Series A financing co-led by founding and initial investor, Newpath Partners, and ARCH Venture Partners (Press release, Magnet Biomedicine, SEP 19, 2023, View Source [SID1234635262]). Magnet is reimagining what is achievable with molecular glues by looking beyond known protein–protein interactions and analyzing the broad protein landscape to pair target proteins with rationally selected presenter proteins to drive therapeutic effects.

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The financing will support Magnet’s differentiated approach to the discovery and development of TrueGlues—compounds that induce cooperative protein–protein interactions. The investment will further enable advancement of its diverse portfolio of programs spanning several indications, including cardiovascular disease, oncology, and immune disorders.

A Rational Approach to Molecular Glues
Magnet was founded by world-leading molecular glue researcher Stuart Schreiber, Ph.D., 2017 Nobel Laureate Michael Rosbash, Ph.D., chemoproteomics pioneer Benjamin Cravatt, Ph.D., human geneticist Richa Saxena, Ph.D., and chemical biologist David Spiegel, M.D., Ph.D. The company is led by President and Chief Scientific Officer, Brian Safina, Ph.D.

"Molecular glues offer expansive potential to transform human medicine. Recent advancements, however, have been narrowly focused on tangential approaches such as degradation, leaving much of the potential of true molecular glues untapped," said Stuart Schreiber, Ph.D., Scientific Co-founder of Magnet. "Technological advancement and innovation in proteomics, high-throughput screening, and bioinformatics are fueling renewed interest in molecular glues—bringing opportunities for rational selection and design of clinically impactful molecular glues within our scientific reach."

Magnet’s TrueGlue discovery platform combines state-of-the-art screening technologies using proprietary and diverse chemical libraries and human-biology-driven target selection to identify TrueGlues. These small molecules harness approaches beyond protein degradation and offer notable benefits such as restricting drug effects to disease-relevant tissues to avoid toxicities, inducing biological synergy on defined targets, mimicking monoclonal antibodies, and targeting historically undruggable proteins. Magnet is initially progressing TrueGlues to address diseases strongly supported by human biology, with clinically and genetically validated targets and clear opportunities to improve treatment options for patients.

"Our TrueGlue discovery platform enables us to take a broad view of the protein landscape to develop a new class of molecular glues capable of facilitating novel protein–protein interactions with the potential to drive clinically meaningful therapeutic responses in patients," said Brian Safina, Ph.D., President and Chief Scientific Officer of Magnet. "We are grateful for the support from ARCH and Newpath as we progress this novel approach."

"Magnet is advancing a unique approach to molecular glue discovery that offers opportunities to expand the scope of addressable protein targets," said Thomas Cahill, M.D., Ph.D., Founder and Managing Partner at Newpath Partners. "Their scientific leadership is driving forward a new way of creating novel medicines to reach patients across a vast range of indications."

Magnet Leadership, Board & Co-founders
Magnet is led by industry veterans with deep expertise spanning the biotech and pharma sectors:

Brian Safina, Ph.D., President and Chief Scientific Officer
Bret Williams, Ph.D., Vice President of Biology
Matthew Hayward, Ph.D., Vice President of Drug Discovery
Jennifer Franklin, Vice President of Administration & Operations
The company’s platform and approach are born from pioneering research from renowned scientific co-founders:

Stuart Schreiber, Ph.D., Broad Institute, Harvard University
Michael Rosbash, Ph.D., Brandeis University, Nobel Laureate (2017)
Benjamin Cravatt, Ph.D., The Scripps Research Institute
Richa Saxena, Ph.D., Massachusetts General Hospital, Broad Institute
David Spiegel, M.D., Ph.D., Yale University
Magnet’s Board of Directors includes:

Thomas Cahill, M.D., Ph.D., Founder and Managing Partner at Newpath Partners
Kristina Burow, Managing Director at ARCH Venture Partners
"With a stellar team and industry-leading foundational science from leaders in the molecular glue landscape, Magnet is poised to drive new innovation and bring forth a robust portfolio of novel molecular glue medicines with the potential to transform the way we address human disease," said Kristina Burow, Managing Director at ARCH Venture Partners.

On September 19, 2023 Boundless Bio, a clinical stage, next-generation precision oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported a clinical trial collaboration and supply agreement with Eli Lilly and Company for supply of their CDK4/6 inhibitor Verzenio (abemaciclib) for use in combination with BBI-355 in a clinical trial of patients with locally advanced or metastatic solid tumors with oncogene amplifications (Press release, Boundless Bio, SEP 19, 2023, View Source [SID1234635266]). BBI-355 is an orally administered, novel, selective small molecule inhibitor of CHK1 and represents what Boundless Bio believes is the first ecDNA-directed therapy (ecDTx) in development for oncogene amplified cancers.

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"We are pleased to enter this supply agreement with Lilly to evaluate the combination of BBI-355 and abemaciclib in patients with ecDNA-driven solid tumors harboring CDK4 or CDK6 amplifications in our ongoing POTENTIATE trial," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "To date, CDK4/6 inhibitors have only been approved in HR+/HER2- breast cancer. Based on preclinical data, we believe BBI-355 has the potential to disable the underlying ecDNA driving oncogene amplification and unlock synergistic anti-tumor activity when combined with abemaciclib, potentially providing an important new treatment option for patients with CDK4 or CDK6 amplified solid tumors."

Under the terms of the agreement, Lilly will provide abemaciclib clinical drug supply at no cost for Boundless Bio’s ongoing Phase 1/2 clinical trial (POTENTIATE), which will assess BBI-355 in combination with certain selected targeted therapies, including abemaciclib, in patients with specific oncogene amplified solid tumors.

About the POTENTIATE Trial

BBI-355 is being evaluated in a first-in-human Phase 1/2 clinical trial ("POTENTIATE": Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) in patients with locally advanced or metastatic solid tumors with oncogene amplifications, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.

The open-label, non-randomized, 3-part trial involves: BBI-355 single agent dose escalation and expansion in cancer patients with oncogene amplification, dose escalation of BBI-355 in combination with certain selected targeted therapies in cancer patients with specific oncogene amplifications, and dose expansion of BBI-355 in combination with certain selected targeted therapies in cancer patients with specific oncogene amplification on ecDNA. BBI-355 is administered orally every other day. In part 3 of the trial, an ecDNA diagnostic clinical trial assay (CTA), which we call ECHO (ecDNA Harboring Oncogenes), will be implemented to determine the presence of oncogenes amplified on ecDNA in patient tumor samples. ECHO is a proprietary bioinformatic diagnostic algorithm designed by Boundless Bio and developed into a CTA in collaboration with SOPHiA GENETICS to detect oncogenes amplified on ecDNA from tumor biopsy samples using routine clinical NGS assays.

About BBI-355

BBI-355 is an orally administered, novel, selective checkpoint kinase 1 (CHK1) inhibitor and, what we believe, is the first ecDNA-directed therapy (ecDTx) being investigated to treat patients with oncogene amplified cancer. CHK1 is a master regulator of the cellular response to DNA replication stress (RS), which frequently arises from oncogene amplification on ecDNA. By disrupting proper CHK1 function in oncogene amplified cancer cells, we believe BBI-355 facilitates catastrophic RS, and preferentially kills cancer cells relative to healthy cells. CHK1 was identified as an ecDNA essential target via Boundless Bio’s proprietary Spyglass research platform.

On September 19, 2023 BostonGene reported an agreement with Hokkaido University Hospital to drive the discovery, validation and implementation of a groundbreaking stratification protocol for HER2-positive breast cancer patients (Press release, BostonGene, SEP 19, 2023, https://www.businesswire.com/news/home/20230918064199/en/BostonGene-and-Hokkaido-University-Hospital-Collaborate-to-Develop-Novel-HER2-Protocols-for-Breast-Cancer [SID1234635265]).

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Located in Sapporo, Japan, Hokkaido University Hospital stands as one of the most prominent medical institutions in the country. Affiliated with Hokkaido University School of Medicine, the hospital offers both high-quality patient care and cutting-edge medical research with an international perspective. As an academic hospital, it is also committed to the mentorship and development of upcoming medical professionals through expansive training programs.

Conventional HER2-targeted antibodies, such as trastuzumab and pertuzumab, fall short in treating patients with HER2-low breast cancer. However, recent clinical trials have demonstrated that trastuzumab-deruxtecan, an antibody-drug conjugate targeting HER2, benefits these patients. Additional data are required to elucidate the best approach for identifying HER2-low patients likely to benefit from the novel therapy. A growing interest lies in the RNA-based method, which can simultaneously investigate the tumor microenvironment and HER2 expression levels. This collaboration aims to demonstrate the benefits of the methodology that interrogate the impacts of the tumor immune ecosystem on HER2-targeted therapy. In this study, BostonGene will apply its genomics pipeline to reveal key tumor drivers, including immune microenvironment properties and genomic biomarkers of response to diverse therapies. In addition, the BostonGene-developed unique and robust machine learning algorithm named Kassandra will digitally reconstruct the tissue tumor microenvironment and cellular composition to identify distinct cell populations. The joint research will be led by Professors Ichiro Kinoshita, MD, PhD at the Division of Clinical Cancer Genomics/Department of Medical Oncology and Masato Takahashi, MD, PhD at the Department of Breast Surgery, Hokkaido University Hospital.

"We are excited to enter into this partnership with BostonGene to fully understand the molecular profiles of our patients. BostonGene’s comprehensive solutions have the potential to deliver breakthrough discoveries and help us identify novel treatment approaches," said Ichiro Kinoshita, MD, PhD.

"Breast cancer ranks as the primary cause of cancer in women across the country. Enhancing treatment outcomes remains a critical focus. Through the findings of this research, we aim to advance technologies that offer more precise medical care and minimize the recurrence of breast cancer in as many patients as possible," said Masato Takahashi, MD, PhD.

"We’re honored to partner with Hokkaido University providing our AI-based molecular and immune profiling to uncover treatable targets to personalize therapy for breast cancer patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "This collaboration supports our mission to equip doctors in finding the most effective treatment options for their patients."

BostonGene, NEC Corporation and Japan Industrial Partners recently announced the formation of BostonGene Japan Inc., a Tokyo-based joint venture to advance personalized medicine and dramatically improve patient outcomes. The company will utilize BostonGene’s high-complexity molecular technology and advanced biocomputational algorithms to accelerate the development and validation of novel precision medicine approaches.

BostonGene will participate in the 82nd Annual Meeting of the Japanese Cancer Association (JCA) at Pacific Convention Plaza Yokohama from September 21 to September 23. Please contact Erin O’Reilly to learn more or to schedule a meeting.