On July 17, 2024 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported a clinical trial collaboration and supply agreement with MSD International Business GmbH, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, to evaluate its second FcγRIIB-blocking antibody BI-1607 in combination with ipilimumab, and KEYTRUDA (pembrolizumab) in a Phase 2 study in patients with metastatic melanoma (Press release, BioInvent, JUL 17, 2024, https://www.bioinvent.com/en/press/bioinvent-announces-new-clinical-trial-collaboration-and-supply-agreement-msd-evaluate-bi-0 [SID1234649281]).

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Under the terms of the supply agreement, MSD will provide its anti-PD-1 therapy KEYTRUDA to be used in combination with BI-1607 and the CTLA-4 antibody ipilimumab. The open-label Phase 2 study will incorporate several dosing levels of BI-1607 and lower dosing levels of ipilimumab in patients with unresectable or metastatic melanoma.

"This clinical trial collaboration and supply agreement with MSD allows us to build on the promising Phase 1 and preclinical data by expanding our BI-1607 program with a Phase 2 study in a new triplet combination," said Martin Welschof, CEO of BioInvent. "While anti-PD-1 therapy and/or anti-CTLA-4 therapy is the standard of care in metastatic melanoma, many patients cannot tolerate the treatment due to ipilimumab’s toxicity. Our preclinical studies indicate that a triple combination regimen including BI-1607 could allow the use of lower doses of ipilimumab, potentially achieving increased tolerability and higher efficacy. In our recent Phase 1 study, BI-1607 was safe and well-tolerated and showed early signs of clinical activity when administered in combination with trastuzumab. We look forward to broadening the clinical evaluation of this promising antibody in a combination that has the potential to make a major impact on cancer care."

BI-1607 is an engineered antibody that can be viewed as a platform to enhance efficacy and overcome resistance to existing cancer treatments, such as targeted monoclonal antibodies and immune checkpoint inhibitors. In December 2023, BioInvent presented first clinical data from the Phase 1 dose escalation study evaluating BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. The data demonstrated the treatment was well tolerated and no serious adverse events related to BI-1607 were observed. Stable disease was observed in 6/11 evaluable patients. Previously in 2021, BioInvent announced proof-of-concept data showing the ability of BI-1607 to overcome resistance to CTLA-4-based therapy. BioInvent is currently running 6 clinical programs testing the use of five proprietary antibodies across different cancer indications and has multiple data readouts anticipated in the next six months.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merk & Co., Inc., Rahway, NJ, USA.

On July 17, 2024 Faeth Therapeutics (Faeth), a clinical-stage biotechnology company, reported that Oliver Maddocks, Co-Founder and Chief Scientific Officer, and Debbie Chirnomas, M.D., Chief Medical Officer, will present today at the Raymond James Biotech Private Company Showcase (Press release, Faeth Therapeutics, JUL 17, 2024, View Source [SID1234644945]). Oliver and Debbie will discuss Faeth’s lead PIKTOR program development plans and participate in a Q&A following the presentation.

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Faeth’s lead program, FTH-001/003 or "PIKTOR," features the combination of serabelisib, a PI3Kɑ inhibitor, and sapanisertib, an mTORC 1/2 inhibitor. This combination effectively targets and shuts down the PI3K pathway, one of the most frequently mutated pathways in cancer. PIKTOR has demonstrated impressive outcomes in a Phase 1b trial across endometrial, ovarian, and breast cancers in conjunction with paclitaxel. Additionally, Faeth’s second clinical initiative involves FTH-002, a specially designed amino acid sachet administered alongside an amino acid-restricted diet and radio/chemotherapy.

Faeth boasts a strong clinical and preclinical pipeline, fueled by its MetabOS discovery platform. This platform utilizes AI, machine learning, and carefully selected data sets to pinpoint targets tailored to specific tumor genotypes.

Established by luminary oncology researchers including Drs. Lew Cantley, Siddhartha Mukherjee, and Karen Vousden, Faeth is dedicated to developing therapies that target cancer metabolism. While the significance of metabolism in cancer growth is recognized, it is still largely underutilized in treatment, with only a handful of therapies available. Faeth employs a unique strategy that combines an in-depth understanding of cancer metabolism, functional genomics, and computational biology to create effective, less toxic treatments.

On July 17, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that an abstract featuring results from the NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) has been selected for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place in Barcelona, Spain, September 13-17, 2024 (Press release, TME Pharma, JUL 17, 2024, View Source [SID1234644944]).

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The oral presentation will provide further analysis of the dual inhibition of NOX-A12 and bevacizumab in glioblastoma in the expansion arm of the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO (Free ESMO Whitepaper) Congress website. 00:05 a.m. CEST on Monday, September 09, 2024. It will be available concurrently on the TME Pharma website.

Title: Dual inhibition of postradiogenic angio-vasculogenesis in glioblastoma: Results of the phase 1/2 GLORIA trial
Presenter: Dr. Frank A. Giordano, Chair of the Department of Radiation Oncology, University Medical Center Mannheim, Germany
Session: Mini oral session: CNS tumors
Time and Date: 08.30-8.35 a.m. CEST, Sunday, September 15, 2024

On July 17, 2024 Anagenex, a pioneering drug discovery company pairing large-scale data generation with proprietary artificial intelligence (AI) to discover the next generation of small molecule medicines, reported the company has nominated PRMT5 and MAT2A as its first two preclinical programs (Press release, Anagenex, JUL 17, 2024, View Source [SID1234644943]). PRMT5 is an essential gene required for cell survival. Inhibition of the metabolic protein MAT2A leads to PRMT5 inhibition. Both of these proteins are viewed as potential cancer therapeutic targets.

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Anagenex has built a platform that pairs large-scale data generation enabled by artificial intelligence (AI) to find and develop hits to multiple targets simultaneously, exploring entire pathways to identify the most promising compounds to modify disease biology.

Anagenex prioritizes targets with clear human validation. Targets with a human biomarker are four times more likely to be approved, however hundreds remain un-drugged because these often belong to novel target classes or challenging mechanisms. Synthetic lethal oncology, a situation in which loss of function of two genes together result in cell death, while loss of either gene alone does not, is a particularly fruitful area for targets because they often come with an associated human biomarker and massive unmet medical need persists.

Anagenex’s first programs addressing PRMT5 and MAT2A fit this validated human target hypothesis. PRMT5 is a pan-essential gene and MAT2A inhibition leads to inhibition of PRMT5. Both leverage MTAP deletion, a gene that is lost in 15% of all solid tumors, providing a unique mechanism to target therapies exclusively to tumors. While competitive programs are showing value in the clinic, Anagenex’s unique platform has been able to identify highly novel compounds for these targets which it believes will help patients by increasing selectivity and brain penetrance.

"Today none of the programs in the clinic have been able to unlock the majority of patients who might be eligible for PRMT5 and MAT2A inhibitors," said Ryan Kruger, Chief Scientific Officer of Anagenex. "PRMT5 needs to be hit extremely effectively but hitting PRMT5 in normal tissue creates dose-limiting side-effects. MTAP loss provides us with a magic bullet to inhibit PRMT5 only in tumor cells either through the inhibition of MAT2A or through inhibition of PRMT5 directly."

The most effective PRMT5 compounds in the clinic are 74-fold selective for tumors over regular cells, but preclinical and clinical data suggests that at least 250-fold selectivity is needed to provide treatment benefit to most patients. Brain penetrance is also important because 40% of patients in the primary indication, Non-Small Cell Lung Carcinoma (NSCLC), experience progression to brain metastases that are often fatal.

Anagenex has developed a series of scaffolds with extreme selectivity, and preliminary work is demonstrating that some of those are brain penetrant. Anagenex is targeting to nominate one of these programs as a development candidate in 2H 2025.

"Essentially all of the competitive compounds targeting PRMT5 and MAT2A are exploring the same scaffolds," stated Kruger. "Simply rehashing chemistry others have explored won’t generate the breakthroughs patients need. Fortunately, our platform has discovered several scaffolds that are completely unrelated to those currently being clinically evaluated, giving us a fresh endeavor to help patients in a whole range of cancers."

In parallel to the announcement of the targets within Anagenex’s synthetic lethal oncology portfolio, the Company is planning to expand into immunology in 2024, leveraging its unique discovery platform to solve the most challenging immune disorders. This follows Anagenex’s initiation of a partnership with Nimbus Therapeutics across a variety of targets, which was previously announced in late-2023.

"Our platform is uniquely suited to finding chemical matter for any target, fulfilling our mission to find a molecule for every malady," said Nicolas Tilmans, Anagenex CEO. "The true power of our platform is in the scalability, and its capability to screen many targets in parallel, then investigate them with up to 100 million target-focused compounds. This scale of early-stage compound investigation ensures that we will generate multiple compounds that will make it to the clinic."

On July 17, 2024 Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, reported that it will deliver an oral presentation at The Promise of Interleukin-2 Therapy meeting taking place in Paris from September 4th to 7th, 2024 (Press release, Egle Therapeutics, JUL 17, 2024, View Source [SID1234644942]).

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The presentation, entitled "EGL-003, a novel IL-2 mutein to selectively expand and activate regulatory T cells and improve therapeutic efficacy in autoimmune disease", will show evidence that EGL-003, a non-targeted Fc-fused IL-2 agonist mutein, selectively binds to regulatory T cells (Treg) and induces Treg IL-2 signaling.

The resulting increase of Treg frequencies was observed in vitro and in different mouse models. Accordingly, EGL-003 significantly improved clinical, macroscopic, and histological parameters in a DSS-induced colitis mouse model with expansion of tissue-resident Tregs.

EGL-003 is the first drug candidate being developed for treatment of autoimmune diseases in Egle’s pipeline and has advanced into IND-enabling studies.

Session Title: IL-2 and Treg cell therapies; Session Date and Time: Friday September 6th, 2024 2:00 PM – 3:30 PM; Location: Poster Section 4; Poster Board Number: 23 Published Abstract Number: 4079