On August 22, 2024 HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company reported its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place September 13-17 in Barcelona, Spain (Press release, HiFiBiO Therapeutics, AUG 22, 2024, View Source [SID1234646058]).

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The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069). These programs have shown promise both as monotherapy and in combination with anti-PD-1, demonstrating the capability to elicit a robust anti-cancer immune response, even in IO refractory tumors.

Harnessing its innovative Drug Intelligence Science (DIS) platform, HiFiBiO is at the forefront of advancing these therapies by specifically selecting tumor types, optimizing dosing regimens, and identifying predictive biomarkers to increase the probability of clinical success. The insights gained from these Phase 1 trials will play a critical role in guiding Phase 2 dosing strategies and patient selection criteria.

HiFiBiO’s novel immunotherapies and comprehensive translational strategy demonstrate the company’s deep commitment to innovative research and developing impactful therapies to address unmet medical needs. HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September.

Details on the poster presentations are as follows:

Title: Model-informed dose optimization of HFB200301, a TNFR2 agonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb tislelizumab (TIS), in patients (pts) with advanced solid tumors.
Presentation Number: 1011P
Session Date: Saturday, 14 September 2024
Speaker: Desamparados Roda Perez, MD, PhD, Hospital Clínico Universitario de Valencia

Title: Phase I dose escalation study of HFB200603, a best-in-class BTLA antagonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb Tislelizumab (TIS) in adult patients (pts) with advanced solid tumors.
Presentation Number: 1006P
Session Date: Saturday, 14 September 2024
Speaker: María de Miguel, MD, PhD, MBA, START Madrid – CIOCC HM Sanchinarro

The initial data from these abstracts will be available on the ESMO (Free ESMO Whitepaper) website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation.

On August 22, 2024 Bectas Therapeutics reported the company was awarded a $2.75M product development seed grant from the Cancer Prevention Research Institute of Texas (CPRIT) (Press release, Bectas Therapeutics, AUG 22, 2024, View Source [SID1234656652]).

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These funds will support the pre-clinical development of Bectas’ first-in-class precision antibody and patient selection biomarker that together are designed to overcome resistance to existing cancer treatments for over 200,000 patients per year.

Bectas received the top score amongst their cohort of applicants following rigorous diligence review of Bectas science, business and intellectual property, providing independent confirmation of the value we are creating for cancer patients and our investors.

On August 22, 2024 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported that a late-breaking abstract presenting the primary analysis of the IGNYTE clinical trial has been selected for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 being held September 13-17, 2024, in Barcelona (Press release, Replimune, AUG 22, 2024, View Source [SID1234646060]).

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Presentation Details:

Title: Primary efficacy, safety, and survival data from the registration-intended cohort of patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial with RP1 combined with nivolumab
Presentation Session Title: Mini Oral Session – Melanoma and other skin tumours
Presentation Number: LBA46
Date and Time: Sunday, September 15, 2024 at 3:45 – 3:50 p.m. CEST
Speakers: Caroline Robert, MD, PhD, Gustave Roussy Cancer Center

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On August 21, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported its unaudited financial results for the second quarter of 2024 (Press release, Nykode Therapeutics, AUG 21, 2024, View Source [SID1234646011]).

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The financial report can be accessed in the Investors section of the company’s website: View Source The company will host a webcast presentation at 4 p.m. CET / 10 a.m. ET.

A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website and on the following link: View Source;tp_key=dff7ea87a1

On August 21, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial (Press release, Bristol-Myers Squibb, AUG 21, 2024, View Source [SID1234646027]). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 21, 2025.

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"HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over the last decade, new treatment options are urgently needed," said Dana Walker, M.D., M.S.C.E., vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb. " Opdivo plus Yervoy showed superior survival benefit compared to other available treatment options, and we look forward to working with the FDA to advance our application to potentially bring a new first-line treatment option to patients."

The filing was based on the results from the Phase 3 CheckMate -9DW study in which the combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to investigator’s choice of lenvatinib or sorafenib. The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC, and these results support the combination becoming a potential new treatment option in the first-line setting. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. Results were presented at the 2024 American Society of Oncology (ASCO ) Annual Meeting .

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 CheckMate -9DW clinical trial.

About CheckMate -9DW

CheckMate -9DW is a Phase 3 randomized, open-label trial evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.

668 patients were randomized to receive Opdivo plus Yervoy ( Opdivo 1mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg for a maximum duration of 2 years) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the trial is overall survival and key secondary endpoints include objective response rate and time to symptom deterioration.

About Hepatocellular Carcinoma

Liver cancer is the third most frequent cause of cancer death worldwide. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 75%-85% of all liver cancers. HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.

Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation. While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.