On October 21, 2024 NUCLIDIUM reported that the first patient has been successfully imaged in a phase 1 clinical trial evaluating the company’s radiotracer candidate as a safe and accurate diagnostic and disease-staging imaging agent in prostate cancer patients (Press release, NUCLIDIUM, OCT 21, 2024, View Source [SID1234647286]). 61Cu-NuriProTM (61Cu-NODAGA-PSMA I&T) is the diagnostic component of NUCLIDIUM’s NuriProTM program, binding specifically to Prostate Specific Membrane Antigen (PSMA). PSMA has evolved as an established biomarker for the diagnosis, staging, and treatment of patients suffering from certain types of prostate cancer.[i],[ii],[iii],[iv] 61Cu-NuriPro is the first candidate from the company’s innovative copper-based radiopharmaceutical pipeline to enter the clinic. Its theranostic counterpart, 67Cu-NuriProTM (67Cu-NODAGA-PSMA I&T), for the treatment of patients with certain types of prostate cancer, is currently completing its preclinical program. A phase 1 clinical study is planned to start in 2025.

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The investigator-initiated, non-randomized phase 1 trial is being conducted at Hoag Memorial Hospital Presbyterian in Newport Beach, California. It will evaluate the safety and effectiveness of the NuriProTM diagnostic candidate for imaging prostate cancer, compared to an 18F-based, FDA-approved PSMA-targeting radiotracer. The 61Cu-based candidate can potentially provide key benefits compared to other established radiotracers. With a 3.3-hour half-life, compared to the 1-to-2-hour half-life of most molecular imaging agents, it allows for a far greater distribution range following production. The company’s candidate can be easily manufactured at room temperature, enabling on-demand preparation and a simplified and easy-to-apply workflow with reduced need for laboratory equipment. It further enables delayed imaging, allowing for the detection of even the smallest metastases. Upon successful completion of the trial, NUCLIDIUM will advance the NuriProTM program into a Phase 1/2 theranostic clinical trial, evaluating both the 61Cu-based imaging agent alongside the 67Cu-based therapeutic candidate.

61Cu-NuriPro can be easily manufactured at room temperature, enabling on-demand preparation and a simplified as well as easy-to-apply workflow with reduced need for laboratory equipment. The diagnostic tracers are manufactured by PharmaLogic Holdings in Los Angeles, CA, and delivered to Hoag in a ready-to-inject form. NUCLIDIUM and PharmaLogic entered into a collaboration agreement in 2023, under which NUCLIDIUM provides PharmaLogic with scientific know-how, proprietary technology, and raw material enabling PharmaLogic to safely and accurately produce high-quality 61Cu-radionuclides and radiopharmaceuticals.

On October 21, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, reported that its Founded Entity, Seaport Therapeutics, ("Seaport") a biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, reported the closing of an oversubscribed $225 million Series B financing round (Press release, PureTech Health, OCT 21, 2024, View Source [SID1234647287]). The syndicate was led by General Atlantic, a leading global growth investor, with participation from funds and accounts advised by T. Rowe Price Associates, Inc., Foresite Capital, Invus, Goldman Sachs Alternatives, CPP Investments, and other new investors. Founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder PureTech also participated. Following the Series B financing, PureTech will hold equity ownership in Seaport of 36.7% on a diluted basis.

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The financing brings the total capital raised by Seaport to $325 million since the Company’s launch in April 2024. Seaport will use the proceeds to advance its clinical-stage pipeline of first and best-in-class medicines through important clinical milestones as well as further advance the capabilities of the Glyph technology platform, which has demonstrated clinical proof-of-concept. The programs in Seaport’s pipeline use the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations.

Commenting on today’s announcement, Bharatt Chowrira, PhD, JD, Chief Executive Officer of PureTech and a member of the Seaport Board of Directors, said:

"We’re very pleased with Seaport’s $225 million Series B financing. Led by a syndicate of top-tier investors, this milestone highlights the significant progress we’re making across our portfolio. The strong support from this stellar investor group not only reinforces the value generated by our unique R&D engine but also underscores our commitment to advancing transformative therapies for patients. As we look ahead to the upcoming data readout for our internal LYT-100 (deupirfenidone) program, we’re excited to continue driving innovation across our portfolio with the goal of delivering impactful treatments that address significant medical needs."

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).