NuFund Venture Group Invests in Resolute Science to Advance First-in-Class Cancer Therapeutics Platform for Solid Tumors

On February 5, 2025 NuFund Venture Group reported investment in Resolute Science, a preclinical-stage biotechnology company developing a pan-cancer platform targeting tumor-associated macrophages to deliver cytotoxic and radiotherapeutic payloads deep into solid tumors (Press release, Resolute Science, FEB 5, 2025, View Source [SID1234656391]). The funding will support IND-enabling studies for Resolute’s lead asset, RS-5, a MAC-TAC (Macrophage-Targeted Conjugate) carrying an MMAE payload showing profound single-agent anti-cancer efficacy.

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SAN DIEGO, Feb. 5, 2025 /PRNewswire-PRWeb/ — NuFund, a leading venture group, is thrilled to announce its investment in Resolute Science, Inc., a preclinical-stage biotechnology company developing a novel class of pan-cancer therapeutics for the treatment of aggressive and hard-to-treat solid tumors.

Resolute Science is advancing a pipeline of first-in-class synthetic drug conjugates to deliver targeted cytotoxic and radiotherapeutics deep into tumors. The modular design of its MAC-TAC (Macrophage Targeted Conjugate) platform enables the rapid development of drug candidates carrying a variety of payloads. Resolute’s approach has the potential to overcome the resistance mechanisms associated with cancer-cell targeting therapeutics, delivering more effective and well-tolerated treatments to patients who have run out of options.

Solid tumors have two main cell populations: cancer cells and tumor-associated macrophages (TAMs). TAMs are stable, abundant, non-dividing, and often comprise 30% to 50% of a solid tumor’s mass. By targeting TAMs to receive, process, and distribute payloads throughout the tumor, Resolute aims to improve drug penetration into tumors, reduce off-target toxicity, and deliver greater and more durable anti-cancer efficacy compared to existing treatment options.

"Resolute has developed a potentially breakthrough approach for cancer therapy by targeting a receptor expressed by tumor-associated macrophages to deliver payloads into tumors," explains John Montana, NuFund member and Deal Lead. "Early preclinical data is impressive, and NuFund is proud to help support the company’s drive through the IND-enabling stage and ultimately position them for clinical studies in cancer patients."

As part of the investment, NuFund’s John Montana will join Resolute Science as a board observer. Additionally, James Mackay, a NuFund member and existing Senior Business Advisor to Resolute, will join Resolute’s Board of Directors. While Mackay’s board appointment is independent of this transaction, his deep industry expertise and continued involvement with Resolute further strengthen the company’s leadership as it advances its programs toward the clinic.

"We are grateful for NuFund’s support as we work to translate our therapeutics into the clinic, said Dr. Faith H. Barnett, Founder and CEO of Resolute Science. "NuFund’s financial backing and confidence in Resolute will help us bring new therapies to cancer patients, particularly those with limited or no treatment options. I’m also excited to welcome James to our board. He has been an incredible asset to our company"

This investment will support Resolute Science in advancing its lead asset, RS-5, a MAC-TAC carrying an MMAE payload, through IND-enabling studies and submission. RS-5 has demonstrated potent single-agent anti-cancer efficacy in 16 preclinical studies across multiple tumor models while being well tolerated.

2024 Annual Report

On February 5, 2025 Boston Scientific reported its financial annual report of the year 2024 (Presentation, Boston Scientific, FEB 5, 2025, View Source [SID1234652112]).

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Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

On February 5, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification (Press release, Pasithea Therapeutics, FEB 5, 2025, View Source [SID1234650055]). This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice.

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"As we are observing substantial exposure levels of PAS-004, we remain encouraged by the safety profile PAS-004 continues to exhibit," stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "With the differentiated profile of PAS-004, we believe it is possible that this highly specific macrocyclic MEK inhibitor with a half life of greater than 60 hours may change the treatment paradigm for patients with NF1 and inoperable plexiform neurofibromas. We are looking forward to presenting updated pharmakokinetic (PK) and pharmacodynamic (PD) data during Q1 2025."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

On February 5, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year (Press release, PDS Biotechnology, FEB 5, 2025, View Source [SID1234650056]).

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PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

"The integral elements for trial initiation are ready, including alignment with the FDA," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC."

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

"HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU," said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. "Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC."

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

Protara Therapeutics to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference

On February 5, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025, at 12:40 pm ET (Press release, Protara Therapeutics, FEB 5, 2025, View Source [SID1234650057]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.