Ipsen and Marengo Therapeutics announce second strategic partnership to advance precision T cell engagers from Marengo’s Tri-STAR platform

On June 6, 2024 Ipsen (Euronext: IPN; ADR: IPSEY) and Marengo Therapeutics Inc, a clinical-stage biotech company, reported the expansion of their ongoing oncology research partnership, to include TriSTAR, Marengo’s next-generation, precision T cell engager (TCE) technology (Press release, Ipsen, JUN 7, 2024, View Source [SID1234644184]). Traditional TCEs targeting ‘cold’ tumors have limited efficacy due to poor T cell quality and exhaustion. Marengo’s proprietary first-in-class TriSTAR TCEs have the potential to overcome these limitations, redirecting a new and expanded pool of highly activated memory Vβ T cells to the tumor. The teams will focus on exploring potential in ‘cold’ tumors which typically fail to trigger a strong immune response when treated with TCEs.

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"We take a science-first approach to expanding our pipeline and are delighted to continue our strong work with the teams at Marengo, who share our passion and drive to accelerate cancer innovations," said David Jenkins, SVP, Research and External Innovation at Ipsen. "Through Marengo’s next-generation TriSTAR platform we have the potential to unlock the power of the immune system, activating a wider pool of T cells to eradicate tumors that traditionally have a weak response to T-cell immunotherapies."

"We are excited to build on our existing research collaboration with Ipsen, which has already successfully delivered the first development candidate earlier this year," said Zhen Su, CEO of Marengo Therapeutics. "This new collaboration with Ipsen builds on our clinically validated TCR Vβ platform and our internal work with new TriSTAR T cell engagers that suggest best-in-class potential and the ultimate precision IO goal of delivering the right T cells to the right tumor. The TriSTAR platform significantly expands our portfolio to target difficult-to-treat ‘cold’ tumors, and we are thrilled to partner with the Ipsen oncology team to realize this ambition together."

Under the terms of the agreement, Ipsen will assume responsibility for all activities following development candidate nomination. Marengo will receive an upfront payment and potential payments up to a total of $1.2 billion if all milestones are met in addition to tiered sales royalty payments.

Calyx / Invicro Forges a Strategic Collaboration with BAMF Health to Accelerate Clinical Translation of Radioligand Therapies and Immuno-Oncology Agents

On June 7, 2024 Calyx / Invicro, a global leader in providing medical imaging solutions and development services to the clinical research community, reported a strategic partnership with BAMF Health, a world leader in molecular imaging and theranostics (Press release, Invicro, JUN 7, 2024, View Source;invicro-forges-a-strategic-collaboration-with-bamf-health-to-accelerate-clinical-translation-of-radioligand-therapies-and-immuno-oncology-agents-302167367.html [SID1234644201]). The partnership aims to accelerate the clinical translation of radioligand therapies (RLT) and immuno-oncology (IO) agents.

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This collaboration addresses challenges caused by fragmented service ecosystems, which have led to duplicative efforts, slow knowledge transfer, and prolonged development timelines. By combining Calyx / Invicro’s radiochemistry and imaging biomarker solutions with BAMF Health’s advanced radiopharmacy facility—which supports a range of alpha, beta, and gamma agents, and molecular imaging and therapy clinics—biotech and pharmaceutical companies now have an end-to-end resource for translating these advanced programs into clinical trials.

A catalyzing project for this partnership is an actinium-225 initiative, for which TerraPower is supplying actinium-225, and BAMF is leveraging its GE HealthCare StarGuide SPECT/CT and dosimetry expertise to enhance the study and application of actinium-225 in RLT.

This association represents a key moment in our industry, as contract research organizations, contract manufacturing organizations, and imaging clinics must collaborate more than ever to support these complicated and technically demanding RLT and IO programs. This collaboration and working relationship streamlines operations with easier contracting and communication, brings together knowledge across scientific, regulatory, and operational areas, and provides access to the latest technologies from early preclinical research to patient imaging.

"The success of Calyx / Invicro’s translational model in the CNS field, demonstrated at our London and New Haven clinics, shows the effectiveness of an integrated service approach. We believe our partnership with BAMF Health will bring the same level of innovation and acceleration to oncology," said Edward Hogan, COO of Calyx / Invicro.

BAMF Health’s Director of Clinical Trials, Dan Rogers, added, "Combining our strengths with Calyx / Invicro allows us to tackle the unique challenges of developing radioligand and immuno-oncology therapies. This collaboration is set to enhance and speed up the development process, towards our mission of making precision medicine available and affordable to everyone."

Through this partnership, Calyx / Invicro and BAMF Health aim to tackle key hurdles in the clinical translation of radioligand and immuno-oncology treatments. Their combined efforts highlight a commitment to advancing these therapies, redefining oncology care standards, and ensuring faster access to promising treatments for patients.

MAIA Biotechnology’s Telomere Targeting Functionality is Shown Viable by FDA’s Approval of a Telomerase Inhibitor Agent Therapy

On June 7, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage company developing telomere-targeting immunotherapies for cancer, reported the validation of clinical and regulatory pathways for viable therapies leveraging the cell’s telomeric functions as evidenced by the U.S. Food and Drug Administration (FDA) approval of imetelstat, a treatment for low- to intermediate-risk hematologic malignancies (myelodysplastic syndromes) from Geron Corporation (Press release, MAIA Biotechnology, JUN 7, 2024, View Source [SID1234644202]).

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"MAIA is one of the earliest pioneers of telomere targeting as a therapeutic strategy, and we share in the enthusiasm for the FDA approval of imetelstat for rare blood cancers originating in bone marrow. We have found that telomere targeting as a mechanism of action plays a key role in treating certain cancers, and we are studying this science in our Phase 2 trial of THIO in high-risk non-small cell lung cancer (NSCLC)," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "Our most recent clinical data shows THIO’s exceptional efficacy in checkpoint inhibitor and chemo-resistant patients in NSCLC. We salute Geron for validating the pathway," concluded Dr. Vitoc.

Telomerase is present in over 85% of human cancers and contributes significantly to the proliferation and reproductive immortality of cancer cells. MAIA’s lead candidate is THIO, a telomere targeting agent in clinical development (Phase 2 THIO-101) to evaluate its activity in NSCLC. THIO is recognized by telomerase and incorporated into telomeres in cancer cells. Once incorporated, THIO compromises the telomere structure and function, leading to ‘uncapping’ of the chromosome ends and thus resulting in rapid tumor cell death.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China

On June 7, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China (Press release, Hutchison China MediTech, JUN 7, 2024, View Source [SID1234644193]). The first patient received their first dose on May 31, 2024.

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This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological malignancies. The study is divided into two phases, a dose escalation phase and a dose expansion phase. The study is expected to enroll at least 60 patients. The lead principal investigators are Dr. Jianxiang Wang and Dr. Hui Wei of Chinese Academy of Medical Sciences Blood Diseases Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT06387082.

About HMPL-506 and Menin

HMPL-506 is a novel, investigational, selective small molecule inhibitor for oral administration targeting the menin protein. The menin protein is a scaffold protein that controls gene expression and cell signaling. Mixed-lineage leukemia ("MLL", also known as KMT2A) rearrangement and nucleophosmin 1 ("NPM1") mutation play key roles in acute myeloid leukemia ("AML"). MLL-rearranged AML accounts for approximately 5% of adult AML and NPM1-mutant AML accounts for approximately 30% of AML.[1],[2],[3] Current research has demonstrated that the inhibition of menin-MLL interaction is a feasible therapeutic strategy in MLL-rearranged and/or NPM1-mutant AML.[4],[5],[6],[7] Currently there is no menin inhibitor approved worldwide. HUTCHMED currently retains all rights to HMPL-506 worldwide.

According to the National Cancer Institute (NCІ), there will be approximately 20,380 new cases of AML in the U.S. in 2023 and the five-year relative survival rate is 31.7%.[8] There were an estimated 19,700 new cases of AML in China in 2018 and is estimated to reach 24,200 in China in 2030.

Replimune to Present at the Goldman Sachs 45th Annual Global Healthcare Conference

On June 7, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that Sushil Patel, Chief Executive Officer of Replimune, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:00 PM ET (Press release, Replimune, JUN 7, 2024, View Source [SID1234644194]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.