TOLREMO therapeutics Completes USD 39 Million Series A Financing Round with Strategic Investment from Pierre Fabre Invest

On September 20, 2023 TOLREMO therapeutics AG (TOLREMO) reported that it has completed its Series A financing, bringing the total amount raised to USD 39 million (CHF 34.1 million) (Press release, TOLREMO, SEP 20, 2023, View Source [SID1234635268]). BioMedPartners AG led the round with participation from a new investor, Pierre Fabre Invest, as well as existing investors. TOLREMO’s mission is to stop non-genetic cancer drug resistance as it emerges by dismantling cancer’s earliest defenses to targeted therapies, thus surmounting a universal challenge for current and future targeted treatments.

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TOLREMO’s lead candidate, TT125-802, is an orally available small molecule CBP/p300 bromodomain inhibitor that blocks critical transcriptional resistance pathways responsible for cancer’s early escape mechanisms to targeted therapies. The proceeds of the Series A round will support the initiation of a Phase 1 monotherapy dose escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, and early signs of efficacy, including biological activity of TT125-802, in a range of solid tumor indications. Stepwise, TOLREMO will then advance to evaluating TT125-802 in combination with targeted therapies such as KRAS, EGFR or AR inhibitors in specific advanced solid tumor indications.

"Cancer drug resistance is a major impediment to the long-term survival of patients and is most often addressed in the later stages of treatment when genetic mutations have already rendered the cancer permanently impervious to therapy. At TOLREMO, we have developed TT125-802 to specifically block early, non-genetic resistance pathways to targeted treatments. In combination with therapeutic agents, such as KRAS, EGFR, AR inhibitors, or other targeted therapies, TT125-802 has the potential to prevent therapy evasion and significantly improve treatment durability," said Stefanie Flückiger-Mangual, PhD, co-founder and Chief Executive Officer of TOLREMO. "We value the continued commitment from our current investors and warmly welcome Pierre Fabre Laboratories, the second largest private French pharmaceutical group, into our syndicate of investors through their dedicated investment body. With this strong support, we aim to advance the development of TT125-802 to bring long-term benefits to cancer patients."

In conjunction with the financing, Julie M. Cherrington, PhD, an experienced life science executive with a track record of successfully bringing drugs into the clinic through to commercialization, has been appointed as Chair of the Board of Directors. In addition, Francesco Hofmann, PhD, Head of R&D for Medical Care at Pierre Fabre Laboratories, joined TOLREMO’s Scientific Advisory Board. Dr. Hofmann has extensive experience in accelerating the delivery of new therapeutics, having facilitated the clinical development of more than twelve novel cancer drugs.

"TOLREMO has a very distinct scientific approach to providing rational combination therapies that preemptively address the problem of drug resistance in cancer treatment. TT125-802 inhibits transcriptional changes, which are central for resistance development to a multitude of targeted cancer therapies. This new investment is very consistent with our renewed strategy to focus our R&D portfolio on targeted therapies," commented Francesco Hofmann, Head of R&D for Medical Care at Pierre Fabre Laboratories and new member of TOLREMO’s Scientific Advisory Board.

"I am truly impressed with TOLREMO’s achievements in discovering and advancing a highly differentiated new treatment approach originating from the analysis of non-genetic cancer resistance phenotypes," said Julie Cherrington, the new Chair of the TOLREMO Board of Directors. "I look forward to supporting the team at this critical juncture as the company advances its lead program into clinical development."

Julie M. Cherrington is a seasoned biotech industry leader and holds board roles across several firms, including Mirati Therapeutics Inc, Syncona, Sardona Therapeutics, KisoJi Biotechnology, MycRx, and Actym Therapeutics, where she is also the Chair. In addition, she is a Venture Partner at Brandon Capital Partners. Dr. Cherrington has a proven track record as a company leader in her roles as CEO and R&D head at numerous companies. Furthermore, her earlier career contributions at SUGEN and Gilead Sciences were instrumental to the development of multiple FDA-approved drugs. Dr. Cherrington completed a postdoctoral fellowship at the University of California, San Francisco, and received her PhD training in microbiology and immunology from the University of Minnesota and Stanford University. She also holds a B.S. in biology and M.S. in microbiology from the University of California, Davis.

Novartis statement on collaboration and license agreement for tislelizumab with BeiGene, Ltd.

On September 19, 2023 Novartis reported that since the company entered the agreement in January 2021, the PD-1 inhibitor landscape has changed considerably (Press release, Novartis, SEP 19, 2023, https://www.novartis.com/news/novartis-statement-collaboration-and-license-agreement-tislelizumab-beigene-ltd [SID1234636350]). As a result of this, we have reassessed our strategy in this category and decided to terminate this agreement.

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With the termination of the agreement, BeiGene, Ltd. will re-assume all development and commercialization rights for tislelizumab, and Novartis will manufacture tislelizumab. Novartis and BeiGene are committed to working together to develop a transition plan to enable tislelizumab regulatory submissions to continue as planned and ensure smooth transition of activities. Additionally, BeiGene will provide Novartis with ongoing clinical supply of tislelizumab to support its clinical trials.

This decision will provide Novartis with greater flexibility for development of its unique, potentially transformational pipeline assets, notably in markets where there are already approved PD-1 therapies in desired indications that can support development of our novel IO combination programs.

Entry into a Material Definitive Agreement

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.

Repare Therapeutics to Present Preliminary Phase 1 MYTHIC Module 1 and 2 Data at 35th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

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

Magnet Biomedicine Emerges from Stealth with $50 Million to Advance Rational Approach to Molecular Glues with TrueGlue™ Discovery Platform

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.