CG Pharmaceuticals, Inc. to Present at the 2024 ASCO Annual Meeting in Chicago on June 1st

On May 6, 2024 CG Pharmaceuticals, a late-stage clinical biopharmaceutical company specializing in metastatic pancreatic ductal adenocarcinoma (PDAC) maintenance therapy (NCT05249101), reported that it will feature one of its investigators, Dr. Christos Fountzilas from Roswell Park Comprehensive Cancer Center, at the ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago on June 1st, 1:30 – 4:30 PM CDT, during the Gastrointestinal Cancer session (TPS4206) (Press release, CG Pharmaceuticals, MAY 6, 2024, View Source [SID1234642703]). He will be presenting some of the findings from our completed Phase 1b and study design of the on-going Phase 2 clinical trial. Commencement of treatment for the first patient of Phase 2 began on January 9th, 2024, and the study will continue to recruit patients in approximately 25 institutions throughout the US.

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In the Phase 2 study, metastatic PDAC patients who show no evidence of disease progression after treatment with FOLFIRINOX, mFOLFIRINOX or NALIRIFOX will receive either the ivaltinostat/capecitabine combination therapy or capecitabine monotherapy after randomization. The primary endpoint is to evaluate ivaltinostat’s effect on improving progression free survival (PFS), while key secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

About Ivaltinostat:

Ivaltinostat is a potential first-in-class novel therapeutic candidate for pancreatic ductal adenocarcinoma that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies.

Eisbach Bio announces FDA clearance of IND application for EIS-12656, a first-in-class allosteric inhibitor of ALC1

On May 6, 2024 Eisbach Bio GmbH ("Eisbach" or the "Company"), a privately-held clinical-stage biotechnology company pioneering cancer medicines leveraging synthetic lethality, reported that United States Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application for EIS-12656, a small molecule inhibiting the chromatin helicase ALC1 (CHD1L) (Press release, Eisbach Bio, MAY 6, 2024, View Source [SID1234642702]). EIS-12656 targets ALC1 through allosteric mechanisms, suppressing the cancer-relevant genome reorganization induced by DNA damage. This leads to ALC1 chromatin trapping and cancer cell killing.

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EIS-12656 impacts tumors deficient in DNA repair pathways. It demonstrated substantial tumor growth inhibition in preclinical models, including in combination with standard-of-care therapies. Its allosteric mechanism of action should afford selectivity compared to related synthetic lethal targets, contributing to the exceptional safety observed in all relevant preclinical models.

"EIS-12656 selectively targets tumors with no apparent effects on normal tissues." said Adrian Schomburg, Ph.D., Founder and CEO of Eisbach. "Our clinical study will also explore combination therapies that were hindered by combinatorial toxicity in the past."

The discovery of EIS-12656 builds on the pioneering research of Eisbach founder Prof. Andreas Ladurner, whose team discovered that PARP effects in cancer cells are reliant on chromatin remodeling by ALC1. Eisbach built upon this knowledge and designed a first-in-class, once-daily small molecule therapy, directly targeting cancer genome reorganization induced by DNA damage at its source – the PARP-activated helicase ALC1.

About the Phase 1/2 Clinical Trial

The open label study of EIS-12656 will evaluate its safety, tolerability and efficacy in patients with genetically-defined advanced solid tumors. Led by Principal Investigator Timothy A. Yap, M.B.B.S., Ph.D., Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, the trial includes dose escalation of EIS-12656 monotherapy, followed by dose expansion modules and evaluation in patients progressing under PARP inhibitor treatment.

GIBF invests $10 Million in Nectin Therapeutics to Advance Novel Pipeline of First-in-Class Immunotherapies and Antibody Drug Conjugates

On May 6, 2024 Guangzhou-Israel Biotechnology Fund (GIBF) reported that it has invested $10 million in Nectin Therapeutics Ltd (Press release, Nectin Therapeutics, MAY 6, 2024, View Source [SID1234642701]). Nectin is a biotechnology company developing novel targeted immunotherapies that address resistance to approved immune oncology treatments. The funds will be used to continue the development of Nectin’s portfolio of novel immuno-oncology products, including the advancement of Nectin’s ongoing NTX1088 global Phase 1 clinical trial targeting PVR and the preclinical development of its anti-drug conjugate (ADC) portfolio.

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Nectin is a clinical stage biotechnology company devoted to transforming the lives of cancer patients by leveraging unique insights into the nectin pathways to develop the next generation of immune oncology (IO) therapies. The company’s differentiated therapies have the potential to set new standards for efficacy and patient response rates across various difficult-to-treat cancers. Nectin’s technology addresses major escape mechanisms of current IO therapies through a diverse pipeline of novel monoclonal antibodies and antibody-drug-conjugates. It has a world-class scientific and management team with deep experience in oncology drug development and a successful track record in building biotechnology companies and developing innovative therapies. Nectin is a venture-backed, privately held company, funded by aMoon Fund, Peregrine Ventures, IBF, Integra Holdings, Myeloma Investment Fund (MIF), and Cancer Focus Fund.

NTX1088 is Nectin’s First-in-Class lead candidate – a highly potent monoclonal antibody directed against PVR (CD155), a transmembrane protein expressed on cancer cells and associated with resistance to PD1 and PDL1 immune checkpoint inhibitors. PVR blockade by NTX1088 is the first and only therapeutic approach aiming at restoring the antitumor immune activity of DNAM1 (CD226). DNAM1 is a cell surface glycoprotein, central to the function of T and NK cells, that is suppressed by PVR on tumor cells. Restoring the expression and activation of DNAM1 by blocking PVR results in increased antitumor activity from T and NK cells. PVR blockade by NTX1088 further stimulates an antitumor immune response by preventing the suppressing signaling of several immune checkpoint receptors, including TIGIT and CD96.

PVR is overexpressed in many solid tumors across different cancer indications, including lung, colorectal, liver, ovarian, breast, adrenal, pancreatic, uterine, head and neck, gastric and esophageal cancers. High PVR expression is associated with poor prognosis and with resistance to PD1 and PDL1 blockade, making PVR an attractive target for both monotherapy and in combination with PD1 blockers, as is currently being clinically evaluated in the combination of NTX1088 and KEYTRUDA (pembrolizumab).

"Nectin is working to usher in a new era of innovative immune-mediated cancer medicines and we are excited to back this important mission and team," said Professor Shlomo Noy, Managing Partner and Chief Medical Officer of GIBF. "We have been following the company closely as it continues to make meaningful progress across its portfolio as it develops transformational therapies that can improve the lives of many cancer patients and their treatment outcomes."

"We are grateful for the support from GIBF which reflects the rapid advancement of our anti-PVR clinical program as well as the progress in our development of several ADC candidates," said Fabian Tenenbaum, CEO of Nectin Therapeutics. "With this new investment we are looking forward to completing both the dose-escalation and dose-expansion trials for NTX1088 and continue our IND-enabling activities of our ADC assets. We value GIBF’s commitment to our mission of developing life-saving therapies and look forward to advancing innovative medicines to improve the lives of cancer patients."

AbbVie to Present at the Bank of America Securities Healthcare Conference

On May 6, 2024 AbbVie (NYSE: ABBV) reported that it will participate in the Bank of America Securities Healthcare Conference on Wednesday, May 15, 2024. Robert A. Michael, president and chief operating officer, Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, will present at 12:40 p.m. Central time (Press release, AbbVie, MAY 6, 2024, View Source [SID1234642700]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Vyriad Announces Oral Presentation at the 27th American Society of Gene & Cell Therapy Annual Meeting

On May 6, 2024 Vyriad, Inc., a clinical-stage biotechnology company developing the next generation of targeted genetic therapies, reported that its abstract, In Vivo Generation of αCD19-CAR T Cells Using a Novel LV-based Platform Successfully Clears Advanced NALM-6 Tumor without Noticeable Toxicity, has been selected for an oral presentation at the 27th American Society of Gene & Cell Therapy Annual Meeting to be held May 7-11, 2024, in Baltimore, Maryland (Press release, Vyriad, MAY 6, 2024, View Source;cell-therapy-annual-meeting-302137235.html [SID1234642699]). Vyriad’s presentation will discuss progress in developing its highly targeted, efficient, serum-stable and durable lentiviral vector technology to deliver genetic payloads directly and specifically to CD3+ T cells in vivo.

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Presentation Title: In Vivo Generation of αCD19-CAR T Cells Using a Novel LV-based Platform Successfully Clears Advanced NALM-6 Tumor without Noticeable Toxicity

Session Name: CAR T-cell Therapies

Presentation Date/Time: Thursday, May 9, at 5:15 p.m. EST

Presenting Speaker: Karina Krotova, Ph.D., Principal Scientist, Imanis Life Sciences

Full abstracts are available for online viewing via the ASGCT (Free ASGCT Whitepaper) Annual Meeting website at View Source