On November 29, 2023 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported two poster presentations at the upcoming 2023 San Antonio Breast Cancer Symposium (SABCS), taking place December 5-9, 2023 at the Henry B. González Convention Center in San Antonio, Texas (Press release, Cogent Biosciences, NOV 29, 2023, View Source [SID1234638040]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Details
The posters will be available on the ‘Posters and Publications’ page of Cogent’s website when they are presented.

Presentation ID: PO3-26-02
Title: Identification of a novel, brain penetrant, EGFR sparing, ErbB2 inhibitor with activity against oncogenic ErbB2 mutations
Session: Poster Session 3
Date: Thursday, December 7, 2023
Time: 12:00 PM – 2:00 PM CT (1:00 PM – 3:00 PM ET)

Presentation ID: PO3-26-01
Title: Preclinical in vitro and in vivo characterization of a novel, wild-type-sparing, PI3Kα H1047R mutant-selective inhibitor
Session: Poster Session 3
Date: Thursday, December 7, 2023
Time: 12:00 PM – 2:00 PM CT (1:00 PM – 3:00 PM ET)

On November 29, 2023 Celdara Medical and Critical Path Institute’s (C-Path) Translational Therapeutics Accelerator (TRxA) reported the signing of a Memorandum of Understanding (MOU) aimed at identifying and advancing promising new therapeutics in areas of high unmet medical need (Press release, Celdara Medical, NOV 29, 2023, View Source [SID1234638039]). Under the terms of this agreement, both organizations look to expand opportunities to provide financial support for the development of early-stage therapeutics by exchanging non-competitive information submitted in academic funding proposals.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Since its founding in 2008, Celdara Medical has built a robust pipeline of potential therapeutics for diseases with unmet needs, sourced from across the nation and globally. Many of these pipeline opportunities align with TRxA’s strategic objectives, as does the shared focus on and primacy of patient need and experience.

Launched in June 2022, TRxA is a global drug discovery and development accelerator focused on supporting academic scientists in defining optimal strategies for advancing new, cutting-edge small molecule therapeutics from the lab to patients. TRxA leverages C-Path’s expertise in translational and regulatory science to provide vital funding and drug development expertise to support its grantees in developing comprehensive data packages for potential drug candidates, a key to garnering interest from biotechnology and pharmaceutical companies to invest in clinical trials.

Dr. Jake Reder, Co-founder, and Chief Executive Officer of Celdara Medical, expressed his enthusiasm for the collaboration, stating, "At Celdara Medical, we advance therapies with the potential to make a meaningful difference in the lives of patients. This collaboration with TRxA will improve the efficiency of both organizations, expanding complementary access to our respective innovation pipelines."

Dr. Julie Coleman, Director at Celdara Medical, added, "This MOU reflects our shared commitment to breaking down barriers in drug development. By sharing resources and expertise with TRxA, we are poised to make significant strides in identifying important inventions and advancing treatments for patients with urgent medical needs."

Dr. Maaike Everts, Executive Director of C-Path’s TRxA, also shared her perspective on the collaboration, stating, "Drug discovery and development is a team sport; many types of expertise, funding models and organizations need to come together to mature an idea coming out of an academic institution into a therapy available to patients. I am very excited to work together with Celdara Medical to find the best environment and expertise needed to ensure our best and brightest ideas get nurtured into new medicines. The exchange of information under this MOU will be a great benefit to the scientists who approach us with their ideas for novel drugs."

The MOU between Celdara Medical and C-Path highlights the significance of collaboration and information sharing in delivering innovative therapies to patients. Together, the two organizations are committed to improving healthcare worldwide.

On November 29, 2023 Biolexis Therapeutics, Inc., a clinical stage AI-driven drug discovery company, reported the successful closure of a $10 million Series A funding round (Press release, Biolexis Therapeutics, NOV 29, 2023, View Source [SID1234638038]). The investment was led by Clarke Capital, a prominent institutional investor and alternative investment firm.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The new funding will advance Biolexis’ development pipeline which includes a range of promising metabolic drug candidates. These drugs have the potential to tackle various metabolic disorders that affect millions of people worldwide and are linked to significant health complications such as obesity and diabetes.

"This financial backing from Clarke Capital is a testament to the potential of our metabolic drug portfolio," said David Bearss, CEO of Biolexis. "Our science is on point and our team is ready to tackle the unmet needs within the metabolic disorder spectrum. With Clarke Capital’s support, we’re in a strong position to accelerate our drug development pipeline and move closer to bringing our solutions to patients."

The Series A funding marks a significant milestone for Biolexis but also marks Clarke’s return to partner with Drs. Bearss and Vankayalapati, having been a major investor in their first company, Montigen Pharmaceuticals, a decade and a half ago before it was sold to a publicly traded company. The reteaming will allow the company to expand its operations and accelerate the clinical development of its key drug candidates. With the prevalence of metabolic diseases on the rise and current treatments in limited supply, the need for new and effective treatment options is more urgent than ever.

"At Clarke Capital, we’re committed to investing in companies poised to make a significant impact on healthcare," said James Clarke, CEO of Clarke Capital. "Biolexis’ impressive approach to addressing metabolic disorders and other treatment-resistant conditions has the potential to change lives. We are overjoyed to support their mission and look forward to seeing the results of their groundbreaking work."

To date, Drs. Bearss and Vankayalapati have filed more than 20 Investigational New Drugs (INDs) and have secured more than 100 patents. Using its unique AI-driven MolecuLern process, Biolexis has 40 active programs in discovery and 10 pipeline programs in the IND-enabling stages of development. The process, which targets any class of protein to identify novel chemical entities (NCEs) with drug-like characteristics and real wet-lab data validation, reduces the discovery and development timeline from years to months.

On November 29, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that it will host an Investor Event at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego and via webcast at 8:00 PM PST on December 10, 2023 (Press release, BeiGene, NOV 29, 2023, View Source [SID1234638037]). This event will cover BeiGene’s R&D progress and broad hematology portfolio, with invited speakers presenting key data from the ASH (Free ASH Whitepaper) 2023.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source Archived replays will be available for 90 days following the event.

On November 29, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported positive new data for tabelecleucel (tab-cel or EBVALLO) in patients with relapsed or refractory (r/r) or treatment-naïve Epstein-Barr virus-positive post-transplant lymphoproliferative disease involving the central nervous system (CNS) (EBV+ CNS PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT) (Press release, Atara Biotherapeutics, NOV 29, 2023, View Source [SID1234638036]). These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The clinical experience from this combined analysis of four single-arm, open-label studies, including the multicohort Phase 2 EBVision trial (NCT04554914, n=4) expands on previous data from two single-center, Phase 2 studies (NCT00002663, n=10; NCT01498484, n=2), and multicenter, expanded-access protocol (NCT02822495, n=2).

"EBV+ CNS PTLD is a rare but extremely serious disease, and patients often face a poor prognosis that underscores the urgent medical need," said AJ Joshi, M.D., Executive Vice President, Chief Medical Officer at Atara. "We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting. Tab-cel shows a strong objective response rate in these high-risk patients with a favorable safety profile for patients with EBV-driven diseases."

In this pooled analysis, a total of 18 patients, including one previously untreated patient, with EBV+ CNS PTLD received cycles of three weekly infusions of tab-cel at ~2×106 cells/kg. Key endpoints were objective response rate (ORR), overall survival (OS), and safety parameters. Patients received a median (range) of 1 (0 to 5) lines of prior therapy.

An ORR of 77.8% (14/18) was observed in all patients (95% CI: 52.4, 93.6), with a best overall response of Complete Response (CR; 38.9%; n=7) or Partial Response (PR; 38.9%; n=7). The median time to response (TTR) in all patients was 1.8 months (range: 0.7–6.4).

The estimated one-year overall survival (OS) rate was 70.6% (95% CI: 43.0, 86.6) for all patients. The one-year OS rate for responders was 85.7% versus 0% for non-responders.

Tab-cel was well-tolerated. No reports of serious treatment-emergent adverse events, including neurotoxicity, organ rejection, graft versus host disease, or tumor flare reaction of any grade, were identified related to tab-cel.

Detailed results on baseline demographics, disease characteristics, best overall response, OS, and additional safety data including tab-cel exposure details, will be presented on December 7 in the Proffered Paper Session 2.

Oral Presentation Details:
Title: Clinical Experience of Tabelecleucel in Epstein-Barr Virus-Positive Post-transplant Lymphoproliferative Disease (EBV+ PTLD) Involving the Central Nervous System
Presenting Author: John Patton, M.D., Ph.D., James Comprehensive Cancer Center, The Ohio State University, Columbus, OH
Date & Time: December 7, 2023, at 2:15 – 3:45 p.m. CET / 5:15 – 6:45 a.m. PST
Presentation Number: 49O
Session: Proffered Paper Session 2
Location: Palexpo Congress Centre, Room B