On October 21, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that the first patient has been dosed in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Revolution Medicines, OCT 21, 2024, View Source [SID1234647288]).

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RASolute 302 is a global, randomized, open-label Phase 3 study designed to evaluate the safety and efficacy of RMC-6236 monotherapy for patients with metastatic pancreatic cancer compared with standard of care chemotherapy. The trial is anticipated to enroll approximately 460 patients worldwide who had received one prior line of therapy with a 5-fluorouracil (5-FU)-based or gemcitabine-based regimen. The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation. The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov.

"Treating the first patient in RASolute 302 is a significant milestone for Revolution Medicines as we seek to revolutionize treatment for patients with RAS-addicted cancers," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "RMC-6236 is designed to directly inhibit RAS(ON) signaling, which is the primary oncogenic driver of pancreatic cancer. Supported by the encouraging initial PFS and OS observations and safety profile reported from the Phase 1 RMC-6236 monotherapy trial, the randomized RASolute 302 trial will formally assess the potential for this bold investigational drug to make a meaningful difference for people living with metastatic PDAC, one of the most difficult-to-treat cancers."

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.

About RMC-6236
RMC-6236 is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. RMC-6236 suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so across oncogenic RAS mutations G12X, G13X and Q61X, in major cancers including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

On October 21, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company dedicated to developing cancer therapies and transforming the cost, pace, and timeline of oncology drug discovery and development, reported that they will be participating in and hosting two webinars that are open to the public during October (Press release, Lantern Pharma, OCT 21, 2024, View Source [SID1234647290]).

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Lantern expects to discuss in detail how big data and AI are being leveraged to advance the development of multiple indications for drug-candidates LP-184 and LP-284 during the "Leveraging Artificial Intelligence to Develop Therapies for Brain and Childhood Cancers". Lantern will also discuss how their algorithm for blood-brain-barrier (BBB) penetrability played a critical role in supporting the development of LP-184 across multiple CNS cancer indications, including GBM. This webinar will be hosted by Tribe Public and feature Panna Sharma, Lantern’s President and CEO. Both LP-184 and LP-284 are currently enrolling patients in Phase 1 trials.

Webinar Wednesday will focus on Lantern’s AI-focused collaboration with Actuate Therapeutics, a clinical-stage biopharmaceutical company that went public in August 2024. Andrew Mazar, Ph.D., Chief Operating Officer of Actuate, and Lantern’s computational biologist Joseph McDermott, Ph.D., will discuss the multi-year research and development collaboration that accelerated the development of Actuate’s lead drug candidate, Elraglusib.

Links to Register for October Webinars

Tribe Public Webinar on October 28, 2024 – https://bit.ly/3BVgPb5
Lantern Pharma Webinar Wednesday on October 30, 2024 – https://bit.ly/3YsL2XN

On October 22, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the strengthening of a previously announced co-development agreement with Orano Med, a clinical-stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), where both companies will develop and market 212Pb-based Radio-DARPin Therapeutics for the treatment of cancer (Press release, Molecular Partners, OCT 21, 2024, https://investors.molecularpartners.com/news-releases/news-release-details/molecular-partners-and-orano-med-strengthen-agreement-co-develop [SID1234647291]).

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This revision builds on the original agreement signed in January 2024, under which both companies agreed to co-develop Radio-DARPin Therapeutics. For the first program, MP0712, a DLL3-targeting Radio-DARPin, Molecular Partners holds the commercialization rights. The amended agreement now targets four programs, with each company holding the commercialization rights to two of these programs. Both companies anticipate initiating first-in-human studies for MP0712, pending regulatory clearance, in 2025. Molecular Partners will hold the second program’s commercialization rights, and Orano Med will have the rights to develop and commercialize programs three and four.

"The continued progress and strengthening of our collaboration with our partner Orano Med is a strong testament not only to the DARPin platform, but also to the strong teamwork between our companies. Behind DLL3, slated to go into clinical development in 2025, we are building a strong portfolio of candidates," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Molecular Partners expects no immediate impact on its financial forecast for the fiscal year 2024 from the expansion of the co-development agreement and maintains its funding guidance into 2027. Cash and cash equivalents (including short-term time deposits) as of September 30, 2024, are currently estimated at approximately CHF 140 million (unaudited).

On October 21, 2024 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer drugs, reported that the patent (WO/2024/208354) for the company’s independently developed antibody-drug conjugate (ADC) CS5006 was published on October 10, 2024 (Press release, CStone Pharmaceauticals, OCT 21, 2024, View Source [SID1234656226]).

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CS5006 is a first-in-class antibody-drug conjugate (ADC) with a novel target: integrin β4 (ITGB4). ITGB4 is a transmembrane protein that exclusively binds to integrin α6 (ITGA6) to form a heterodimer (α6β4), with laminin as its extracellular ligand. ITGB4 is considered a biomarker for various tumors, with elevated expression correlating with aggressiveness and poor prognosis. Using our in-house bioinformatics platform, combined with cutting-edge AI algorithms and comprehensive comparisons with published literature, we have identified ITGB4 as highly expressed in multiple indications, including non-small cell lung cancer, colorectal cancer, esophageal squamous cell carcinoma, and head and neck squamous cell carcinoma, making it an ideal candidate for targeted therapy.

During the development of CS5006, CStone Pharmaceuticals combined candidate monoclonal antibodies with clinically validated linkers and drug payloads, including GGFG-DXd and VC-MMAE, as model ADC molecules to support the project’s proof-of-concept studies. In vitro results demonstrated that both CS5006-GGFG-DXd and CS5006-VC-MMAE ADCs, upon internalization into tumor cells, efficiently released cytotoxins, rapidly killing tumor cells. In vivo results further validated the potent anti-tumor activity and expected tolerability of these two ADCs, providing strong data support for their next clinical development steps. Currently, CS5006 utilizes a proprietary linker and is nearing completion of preclinical candidate molecule (PCC) screening. An Investigational New Drug (IND) application is expected to be submitted in 2025.

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said, "The publication of the CS5006 patent not only demonstrates our innovative achievements in the ADC field, but also highlights CStone’s comprehensive capabilities from R&D to commercialization. We are excited about the clinical potential of CS5006 and other innovative ADC programs and hope they will bring groundbreaking treatment options to cancer patients worldwide."

CStone Pharmaceuticals is also actively developing next-generation linkers with proprietary intellectual property rights to enhance the hydrophilicity and tumor selectivity of currently used linkers, such as the GGFG tetrapeptide linker and the VA/C dipeptide linker. These novel linkers will maximize the safety and efficacy of ADCs, significantly increase the flexibility of linker adaptation for targets and antibody molecules, and support multiple ADC programs in CStone’s pipeline 2.0, including CS5005 targeting SSTR2, CS5006 targeting ITGB4, and CS5007 targeting EGFR/HER3.

On October 21, 2024 3B Pharmaceuticals GmbH (3BP), a privately-held German biotechnology company focused on research and development of radiopharmaceutical precision therapies for cancer patients, reported it has signed an option and asset purchase agreement with Novartis Pharma AG (Novartis) for its prostatespecific membrane antigen (PSMA) program (Press release, 3B Pharmaceuticals, OCT 21, 2024, View Source [SID1234647277]).

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3BP’s program includes a novel PSMA-binding molecule that may be a potential nextgeneration radioligand therapy (RLT) for prostate cancer and is currently being studied in two investigator-initiated trials.

"This agreement with Novartis marks a pivotal moment for 3BP," said Ulrich Reineke, Managing Director of 3B Pharmaceuticals. "If the option for the asset purchase is exercised, we are confident that Novartis, with its strong commitment and expertise in radioligand therapies, will drive the continued clinical development of our lead PSMA-targeted molecule and advance it to help prostate cancer patients worldwide."

Financial details of the agreement have not been disclosed.