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Oncology News (May 26 - June 1)

Coherus BioSciences - Positive Trial Data, May 26, 2024

Coherus BioSciences presented data on CHS-114 at the ASCO Annual Meeting, highlighting its safety and efficacy in heavily pretreated solid tumor patients. CHS-114, an afucosylated monoclonal antibody targeting CCR8, demonstrated no dose-limiting toxicities, exhibited selective depletion of peripheral CCR8+ regulatory T cells, and maintained depletion over the dosing interval, establishing proof of mechanism. Preclinical and preliminary clinical data suggest potential for combination therapy with the anti-PD-1 antibody, toripalimab-tpzi, and other immuno-oncology agents, indicating further evaluation.

Full Article: Coherus BioSciences presents preliminary results from phase I dose escalation study of its anti-chemokine receptor 8 (CCR8) antibody CHS-114 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting



Merus - Financial Status, May 27, 2024

Merus N.V. shares rose 36.2% after announcing promising mid-stage study results for petosemtamab, combined with Keytruda, in treating head and neck cancer. With a 60% response rate and manageable side effects, investors reacted positively. Merus plans to present more data at the 2024 ASCO Annual Meeting, reflecting strong investor optimism as the stock has surged 118.2% year to date.

Full Article: Merus N.V. surges 36% on head and neck cancer antibody data


AstraZeneca & Daiichi Sankyo - Positive Trial Data, May 27, 2024

AstraZeneca and Daiichi Sankyo report positive phase III trial results for datopotamab deruxtecan (Dato-DXd) in advanced nonsquamous non-small cell lung cancer, showing improved overall survival versus chemotherapy. Dato-DXd, discovered by Daiichi Sankyo, may replace conventional chemotherapy in late-line settings, with ongoing trials in first-line lung cancer. Daiichi's stock rose 3.4% in Tokyo, while AstraZeneca's closed down 0.9% on Friday, with respective 12-month changes of up 24% and 6.9%.

Full Article: In brief: AstraZeneca & Daiichi Sankyo hail positive survival data for Dato-DXd



Delcath Systems - Executive Changes, May 28, 2024

Delcath Systems, Inc. has appointed Dr. Bridget Martell to its Board of Directors effective May 23, 2024. Dr. Martell, who has extensive experience in biotechnology and oncology, currently serves as an independent director at Aligos Therapeutics and Achieve Life Sciences, and is a Biotechnology Operating Partner at Two Bear Capital. She holds degrees from Cornell, Boston University, and Chicago Medical School, and has been involved with Yale University. Dr. Martell looks forward to supporting Delcath's commercial and clinical development goals.

Full Article: Delcath Systems announces appointment of Bridget Martell, MA, MD, to Delcath's Board of Directors



Agios Pharmaceuticals - Acquisitions, May 28, 2024

Agios Pharmaceuticals will sell Royalty Pharma the rights to royalties on its brain cancer drug vorasidenib, receiving $905 million if the drug is approved. Royalty Pharma will get 15% royalties on up to $1 billion in annual U.S. sales and 12% on sales over $1 billion, while Agios retains 3% on sales above $1 billion. This deal helps Agios fund future drug launches and allows Royalty Pharma to benefit from expected substantial sales through 2038.

Full Article: Agios Pharmaceuticals to sell Royalty Pharma rights to royalties on brain cancer drug vorasidenib



Gilead Sciences - Partnerships, May 28, 2024

Gilead Sciences is investing $20 million in Cartography Biosciences to discover drugs for triple-negative breast cancer and non-small cell lung cancer using Cartography's genomics platform. Gilead will handle further development and commercialization of identified targets. Cartography receives $20 million upfront, preclinical milestone payments, and potential additional payments plus royalties. Founded in 2022, Cartography focuses on precise immunotherapies, with a lead program in colorectal cancer.

Full Article: Gilead pays $20M to join Cartography's next-gen cancer medicine expedition



Ikena Oncology - Company Downsizing, May 28, 2024

Ikena Oncology is cutting around 53% of its workforce and discontinuing its drug candidate IK-930, citing resource limitations and clinical data. The company is exploring strategic options like a merger or asset sale, and seeking a partner for IK-930's development. Ikena will proceed with IK-595, having cleared the first two cohorts of a Phase 1 study, with further developments expected later in 2024. As of March 31, 2024, Ikena held $157.3M in cash and equivalents, and it anticipates incurring $1.2M in restructuring costs for Q2 2024.

Full Article: Ikena to cut workforce by 53 percent, explore strategic options



Anaveon - Clinical Trial Updates, May 28, 2024

Anaveon announced FDA acceptance of its IND application for a Phase I/II study of ANV600, both as a monotherapy and in combination with Merck's KEYTRUDA®, to evaluate safety and efficacy in multiple cancers. ANV600 targets tumor-specific T cells to enhance their tumor-killing potential and is designed for use with PD-1 inhibitors. Anaveon retains worldwide rights to ANV600, with Merck providing KEYTRUDA for the trials.

Full Article: Anaveon announces IND approval of ANV600-001 to expand Phase I/II clinical study



Avelos Therapeutics - Series B Investments, May 29, 2024

Avelos Therapeutics recently secured KRW 17 billion (approximately $12.3 million USD) in Series B funding, totaling KRW 30 billion (approximately $21.7 million USD). Founded in 2021, Avelos focuses on innovative treatments, notably AD1208, set to begin clinical trials later this year. With three other projects in the pipeline, including AVS1002, the company aims for global expansion and a KOSDAQ listing. CEO Young Whan Park and co-CEO Soongyu Choi express optimism for Avelos' future growth.

Full Article: Avelos Therapeutics announces KRW 17 billion Series B funding round, surpassing KRW 30 billion total raised



Ikena Oncology - Company Downsizing and Program Discontinue, May 29, 2024

Ikena Oncology has discontinued its IK-930 clinical program, a TEAD1-selective Hippo pathway inhibitor, due to a strategic review of clinical data, resources, and priorities. This decision includes a significant workforce reduction of approximately 53%. The company will continue to develop IK-595, a novel MEK-RAF molecular glue, and seek strategic options for IK-930, including potential partnerships. Despite initial promising data for IK-930, analysts express disappointment and emphasize the need for clear single-agent activity with IK-595 for future success. The company reported $157 million in cash as of March 31, 2024.

Full Article: Ikena Oncology discontinues IK-930 program and cuts workforce; analyst calls it disappointing



Monte Rosa Therapeutics - Executive Changes, May 30, 2024

Monte Rosa Therapeutics announced three leadership promotions: Sharon Townson, Ph.D., as Chief Scientific Officer; Phil Nickson, Ph.D., J.D., as Chief Business and Legal Officer; and Jennifer Champoux as Chief Operating Officer. CEO Markus Warmuth praised their roles in advancing pipeline programs and enhancing the QuEEN™ drug discovery engine. Sharon brings expertise from Kymera Therapeutics and Warp Drive Bio, Phil has over 15 years of life sciences legal experience, and Jennifer has diverse operations experience from H3 Biomedicine and Novartis Institutes for Biomedical Research.

Full Article: Monte Rosa Therapeutics announces leadership team promotions



Gilead Sciences - Fail Trial Results, May 30, 2024

Gilead Sciences' drug Trodelvy did not meet the primary goal of overall survival in a late-stage bladder cancer study, causing shares to drop 3.3%. The study reported higher deaths due to adverse events, particularly neutropenic complications, compared to chemotherapy. Gilead will analyze the data and consult with the FDA, but noted no changes to Trodelvy's safety profile for approved breast cancer uses. Continued approval for bladder cancer may depend on further trials.

Full Article: Gilead's Trodelvy fails to meet main goal in late-stage study



Eli Lilly - FDA Approval, May 30, 2024

The US FDA has given accelerated approval to Eli Lilly’s Retevmo (selpercatinib) for treating RET-altered pediatric cancers, making it the first in its class for children under 12. This approval includes various advanced or metastatic thyroid cancers and solid tumors with RET mutations. Based on the LIBRETTO-121 study, which showed a 48% response rate, this expands Retevmo's market lead over Blueprint Medicines’ Gavreto.

Full Article: Lilly's Retevmo cleared for RET-positive child cancers



Purple Biotech - Positive Trial Data, June 1, 2024

Purple Biotech announced positive interim results from its Phase 2 study of CM24 for second-line metastatic pancreatic ductal adenocarcinoma (PDAC) at the 2024 ASCO Annual Meeting. The study evaluates CM24, an anti-CEACAM1 antibody, combined with Bristol Myers Squibb’s nivolumab and standard chemotherapy, against standard chemotherapy alone. With 63 patients across 18 centers, the study aims to assess overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). Topline final data are expected by the end of 2024.

Full Article: Purple Biotech Ltd. Announces Positive Late-Breaking Interim Randomized Phase 2 Data at ASCO 2024



Molecular Partners - Positive Trial Data, June 1, 2024

Molecular Partners announced final data from its Phase 1 dose-escalation study of MP0317, a CD40 agonist, at the 2024 ASCO Annual Meeting. MP0317, designed to activate immune cells specifically within the tumor microenvironment by targeting fibroblast activation protein (FAP), showed promising results with reduced systemic toxicities. Acting Chief Medical Officer Philippe Legenne highlighted the potential of DARPins to provide effective, localized cancer therapies. The company plans to seek partners for further clinical evaluation of MP0317 in combination with other treatments.

Full Article: Molecular Partners presents positive data from Phase 1 study of MP0317

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