On April 9, 2024 FivepHusion, an advanced clinical-stage biotechnology company, reported Human Regulatory Ethics Committee (HREC) approval for the next clinical trial of Deflexifol, an optimised all-in-one formulation of the chemotherapeutic agent 5-fluorouracil (5-FU) and its biomodulator leucovorin (LV), for the treatment of solid tumours (Press release, FivepHusion, APR 9, 2024, View Source [SID1234641929]).

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Bellberry Ltd, Australia’s leading independent organisation providing scientific and ethical review of human research projects, has approved the clinical trial protocol and patient consent documentation for the Deflexifol "FP101B" trial. HREC approval is a mandatory requirement prior to clinical trial initiation.

FP101B is a planned multi-centre phase 1b dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Deflexifol in combination with oxaliplatin and bevacizumab as a first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC). The trial design is based on US FDA advice and will be the fourth clinical study investigating Deflexifol as a treatment for solid tumours, and the first to study Deflexifol in combination with other standard of care drugs as a first-line treatment. FP101B will be conducted by FivepHusion strategic partner Syneos Health, a leading fully integrated global biopharmaceutical solutions organisation. The goal of the FP101B trial is to confirm the optimal dose of Deflexifol to be investigated in a planned global phase III registration study designed to confirm the superiority of Deflexifol over standard of care 5-FU/LV "backbone" therapy in unresectable mCRC.

This ethics approval follows strong enthusiasm from oncologists to a poster presentation describing the rationale and design of FP101B, presented at the November, 2023 Australasian Gastro-Intestinal Trials Group (AGITG) Annual Scientific Meeting in Christchurch, New Zealand. Deflexifol is an optimised co-formulation of 5-FU and LV that requires no change in clinical practice whilst offering superior safety and efficacy for cancer patients.

Dr Christian Toouli, CEO & Managing Director, commented, "There is a significant unmet medical need to optimise standard of care 5-FU/LV therapy for solid tumour treatment. This HREC approval endorses the feedback we have received from oncologists and the US FDA on the appropriateness of investigating Deflexifol as an optimised replacement of 5-FU/LV in the standard of care for the 1st line treatment of mCRC. We intend to initiate this trial as soon as possible."

On April 9, 2024 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that members of the management team will participate in a fireside chat at the Stifel 2024 Virtual Targeted Oncology Forum on Tuesday, April 16, 2024 at 11:30 AM ET (Press release, Deciphera Pharmaceuticals, APR 9, 2024, View Source [SID1234641928]).

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A live webcast of the fireside chat will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On April 9, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program (Press release, Cogent Biosciences, APR 9, 2024, View Source [SID1234641927]). The data are being presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting taking place in San Diego, California.

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"We’re excited with the progress we’ve made on our ErbB2 program and look forward to sharing our differentiated profile at this year’s AACR (Free AACR Whitepaper) meeting," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "These data further demonstrate Cogent’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need. Based on these results, we expect to initiate IND-enabling studies for our potent, selective, CNS-penetrant ErbB2 program in mid-2024."

AACR Poster Details

Title: Characterization of a Novel Mutant Selective, EGFR Sparing, ErbB2 Inhibitor with Activity Across Activating Mutations in Systemic and CNS Tumors
Session Category: Chemistry
Session Title: Drug Design and in Silico Screening
Session Date and Time: Tuesday, Apr 9, 2024 9:00 AM – 12:30 PM PT (12:00 PM – 3:30 PM ET)
Location: Poster Section 20
Poster Board Number: 15
Published Abstract Number: 4486

The poster can be accessed on the ‘Posters and Publications’ page of Cogent’s website.

Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification. The poster presented today describes CGT4255’s exceptional stability in human whole blood and liver cytosol fractions and high oral bioavailability and low clearance across preclinical species. In addition, CGT4255 demonstrated 80% brain penetrance in mice and was well-tolerated at 10x concentration, resulting in mouse tumor regression, suggesting potential best-in class properties.

On April 9, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the presentation of a poster during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5 through 10 in San Diego, which focused on a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures (TLS), being developed as a novel therapeutic strategy for solid tumors from Candel’s enLIGHTEN Discovery Platform (Press release, Candel Therapeutics, APR 9, 2024, View Source [SID1234641925]).

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TLSs are ectopic lymphocyte aggregation structures found in the tumor microenvironment and their induction could potentially improve anti-tumor immunity. The presentation describes the development of an investigational TLS-inducing multimodal therapeutic using the enLIGHTEN Discovery Platform. The enLIGHTEN Advanced Analytics suite was applied to immune checkpoint inhibitor-treated patient datasets, and the predicted payload components included factors regulating the development of TLS. Delivery of two unique in silico predicted payload combinations, using an enLIGHTEN programmable vector, resulted in TLS induction, monotherapy anti-tumoral activity, and enhanced responses in combination with anti-PD-1 antibody therapy in mouse models of solid tumors.

"The recent observation that the presence of TLS in tumors is an important prognostic factor associated with an improved response to immunotherapy has fueled drug development efforts in this area. However, TLS assembly is complicated and requires a series of events, including antigen presentation, stromal cell activation, and immune cell activation and aggregation, which are difficult to obtain with a single therapeutic," said Francesca Barone, MD, PhD, Chief Scientific Officer at Candel. "The enLIGHTEN Discovery Platform enables the generation of multimodal agents through the integration of artificial intelligence-driven payload combinations into programmable vectors. This makes it possible to create a single asset that may induce TLS formation and enhance anti-tumor immunity."

"The delivery of the second immunotherapy candidate based on the enLIGHTEN Discovery Platform, on an accelerated timeline, further validates the ability of this innovative platform to create new therapeutic candidates at a fast pace," added Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Our platform is flexible and scalable, which makes it suitable for strategic partnerships, for example to create synergy with CAR-T cell therapy or other immunotherapies, potentially resulting in improved survival rates."

Further detail from Candel’s AACR (Free AACR Whitepaper) full poster presentation is available on the Candel website at: www.candeltx.com/media.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting and the 2023 International Oncolytic Virus Conference, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer.

On April 9, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in a fireside chat at the Stifel 2024 Targeted Oncology Forum taking place virtually from April 16 – April 17, 2024 (Press release, C4 Therapeutics, APR 9, 2024, View Source [SID1234641924]).

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Fireside Chat Details:
Event: Stifel 2024 Targeted Oncology Forum
Date/Time: Tuesday, April 16, 2024 from 10:30 am ET – 10:55 am ET

A live webcast will be available on the Investors section of the company’s website at www.c4therapeutics.com. An archived replay of the webcast will be available for approximately 30 days following the live event.