On May 20, 2024 BioCity Biopharma reported that the preliminary Phase I data of BC3195 (CDH3 ADC) as a monotherapy for advanced solid tumors, and the data from two clinical studies of SC0245 (ATR inhibitor) will be exhibited at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 (Press release, Biocity Biopharmaceutics, MAY 20, 2024, View Source [SID1234644485]). The ASCO (Free ASCO Whitepaper) Annual Meeting will be held in Chicago, USA, from May 31 to June 4, 2024.

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Detailed information is as below:

（1）Abstract Title:

BC3195, a novel ADC targeting CDH3: Preliminary results of a first-in-human phase I study in patients with advanced solid malignancies.

Abstract #：e15008

Session Type：

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

lt will be published on meetings.asco.org/abstracts-presentations at 5:00 PM EDT on May 23,2024.

（2）Abstract Title:

An open-label, single-arm, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the ATR inhibitor SC0245 in advanced solid malignancies.

Session Type：

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Abstract #：e15126

lt will be published on meetings.asco.org/abstracts-presentations at 5:00 PM EDT on May 23,2024.

（3）Abstract Title:

An open-label, multicenter, phase Ib/II study of the ATR inhibitor SC0245 in combination with irinotecan in patients with relapsed and refractory extensive stage small cell lung cancer (ES-SCLC).

Session Type:

Poster Session—Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session date and time:

June 3，2024，from 1:30 p.m.~4:30 p.m. (Central Daylight Time)

Poster Bd #：364

About BC3195

BC3195 is currently the only ADC targeting CDH3/P-Cadherin in clinical development globally. In preclinical studies, BC3195 binds to cell surface CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%.

BC3195 is in parallel clinical development in both China and the US. Prof. Yilong Wu from Guangdong Provincial People’s Hospital and Prof. Bob Li from MSK Cancer Center are leading the studies in these territories, respectively.

About SC0245

SC0245 is the first small molecule ATR Kinase inhibitor that entered clinical development stage in China and ranked in the top tier globally.

SC0245 exhibited strong ATR kinase inhibition potency in preclinical studies. In multiple animal models, SC0245 demonstrated favorable safety, tolerability, and pharmacokinetic profiles. SC0245 also exhibited strong antitumor activity as a single agent or in combination with other therapeutics in these models.

In a phase I clinical study led by Prof. Lin Shen at Beijing Cancer Hospital, SC0245 demonstrated favorable safety and tolerability profiles, and a high disease control rate.

SC0245 is now in a phase Ib/II clinical study in combination with irinotecan for the treatment of small cell lung cancer. This study is led by Prof. Shun Lu, oncology department director at Shanghai Chest Hospital.

On May 20, 2024 ERS Genomics Limited (‘ERS’), the CRISPR licensing Company, and IRBM, a leader in the field of drug discovery, reported a non-exclusive CRISPR/Cas9 license agreement (Press release, IRBM, MAY 20, 2024, View Source [SID1234643476]). The agreement grants IRBM access to ERS’ CRISPR/Cas9 patent portfolio.

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IRBM is a drug discovery CRO with expertise ranging from target validation and hit finding to preclinical candidate nomination across various therapeutic areas, including oncology, infectious diseases, and neuroscience. The company has contributed to the discovery and development of four marketed therapeutics for HIV, HCV, ovarian cancer, and cutaneous T-cell lymphoma.

Carlo Toniatti, MD, PhD, CSO, IRBM, said: "We are committed to delivering high quality drugs by leveraging our broad range of expertise and capabilities across the entire preclinical drug discovery continuum. With the integration of CRISPR/Cas9 gene editing technology we are increasing our capability to identify and validate potential drug targets, to generate more predictive pre-clinical models and to elucidate the mechanisms of action of novel therapeutics."

John E Milad, CEO, ERS Genomics, commented: "We are committed to supporting cutting-edge research and expanding the horizons of medical innovation by providing companies such as IRBM with the ability to take advantage of CRISPR/Cas9 technology. We look forward to seeing the innovative ways in which our gene editing technology will be utilised in various stages of drug discovery, providing candidates for a wide range of therapeutic areas."

ERS Genomics provides licensing to CRISPR/Cas9 technology for companies interested in pursuing its use in their commercial programs. Comprising 100+ patents globally, ERS’ portfolio encompasses CRISPR/Cas9 usage in all cells, including eukaryotic and prokaryotic cells such as mammalian cells, bacteria, archaea, yeasts, algae, and insects. ERS Genomics licenses these patents via its direct license from Emmanuelle Charpentier and now has nearly 150 licenses in place worldwide.

Financial details of the agreement are not disclosed.

On May 20, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported upcoming presentations at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, Illinois from May 31st to June 4th (Press release, GeneCentric Therapeutics, MAY 20, 2024, View Source [SID1234643475]). Presentations include new clinical validation results for a novel signature identifying patients with head and neck squamous cell carcinoma (HNSCC) that may benefit from treatment beyond typical surgical resection. The results are from GeneCentric’s ongoing collaboration with Neil Hayes, MD, MPH, at the University of Tennessee Health Science Center’s Center for Cancer Research, and Jose P. Zevallos, MD, MPH, at the University of Pittsburgh School of Medicine, to discover and develop new prognostic and/or predictive signatures to aid in the treatment selection for patients with HNSCC. In addition, GeneCentric will present updated findings from its development of a novel RNA-based immune checkpoint inhibition predictive response signature (ICI-PRS) that optimizes the selection of patients with a primary diagnosis of urothelial cancer who are potential candidates for anti-PD-(L)1 inhibition treatment.

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Details of the ASCO (Free ASCO Whitepaper) presentations are as follows:

Title: Clinical validation of a mesenchymal gene expression signature for prognosis and treatment decision making in early-stage oral cavity squamous cell carcinoma.
Session: Head and Neck Cancer
Date: June 2, 2024, 9:00am – 12:00pm CDT
Abstract/Poster Number: 6091/407

Title: Prediction of immune checkpoint inhibitor (ICI) response in patients with urothelial cancer (UC) by a novel RNA-based ICI response signature (ICI-PRS).
Session: Publication Only: Genitourinary Cancer — Kidney and Bladder
Abstract: e16502

The poster and abstracts will be accessible under the News & Events section of the Company’s website following the conference.

On May 20, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the completion of its purchase of antibodies and related assets from Atreca, Inc (Press release, Immunome, MAY 20, 2024, View Source [SID1234643474]). Under the terms of the agreement, Immunome paid Atreca $5.5 million upfront, and Atreca will be eligible for up to $7.0 million in clinical development milestones. Immunome received the rights to 28 antibodies as well as certain materials.

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"Novel and underexplored targets are central to Immunome’s pipeline strategy," said Jack Higgins, PhD, Chief Scientific Officer. "The antibodies acquired from Atreca add to our ADC toolbox, complementing our existing discovery programs pursuing undisclosed targets."

Added Clay Siegall, PhD, President and Chief Executive Officer, "Immunome intends to further expand its ADC portfolio through cost-effective business development, rigorous discovery efforts, and disciplined development. We believe this purchase accelerates our efforts to bring innovative therapies to cancer patients."

On May 20, 2024 Xcell Biosciences Inc. (Xcellbio), an innovative technology company focused on cell and gene therapy manufacturing applications, and AmplifyBio, a rapidly growing contract development and manufacturing organization, reported the launch of a partnership designed to streamline and improve the manufacturing process for engineered T-cell receptor (TCR) therapies targeting solid tumors (Press release, AmplifyBio, MAY 20, 2024, View Source [SID1234643473]). Preliminary results of this work will be presented at the annual meeting of the International Society for Cell & Gene Therapy (ISCT 2024), taking place May 29 – June 1 in Vancouver, British Columbia.

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"We are focused on enabling the development of a broad range of advanced therapies and believe there are significant opportunities for improving upon therapies that work effectively for solid tumors, from concept to commercialization," said J. Kelly Ganjei, President and CEO of AmplifyBio. "There is a pressing need for more effective and potent therapies, and we believe that working with the Xcellbio team and their unique AVATAR Foundry platform will allow us to make significant progress in that journey, and the results from this work will help create a better sandbox for our clients."

Across the cell and gene therapy field, scientists are looking for ways to boost the fitness and potency of T cells to turn them into more effective therapies for solid cancers, enabling therapeutic options to patients that are not available today. "Current cell therapies have been highly effective for liquid tumors, but little progress has been made for the vast majority of patients with solid tumors. With low oxygen levels, low pH, and other hostile factors, the microenvironment within solid tumors makes it very difficult for T cells to kill cancer cells," said James Lim, co-founder and Chief Scientific Officer of Xcellbio. "Our joint development work with AmplifyBio will demonstrate how the AVATAR Foundry will improve the manufacturability and potency of engineered TCRs by significantly reducing manufacturing times and utilizing non-viral workflows to produce scalable and cost-effective therapies."

Xcellbio previously developed the AVATAR incubator system for cell and gene therapy research and development. Its AVATAR Foundry platform is a cGMP cell therapy manufacturing platform that delivers novel capabilities for improving the potency of cell and gene therapies. In this partnership, scientists from AmplifyBio will work with the Xcellbio team to develop novel cell therapy manufacturing methods based on the AVATAR Foundry platform. The efforts will focus on identifying key elements for successful manufacture of TCR therapies, such as product characterization matrix, correlation to metabolic profile, and potency. An IND filing is expected next year to target human papillomavirus-positive (HPV+) tumors using an engineered TCR therapy.

Brian Feth, co-founder and CEO at Xcellbio, commented: "We are pleased to team up with AmplifyBio, which has a strong track record in supporting the discovery, development, and manufacture of candidate therapies. We’re excited to work together to demonstrate that T cells grown in the AVATAR system can achieve higher potency and greater tumor-killing activity compared to T cells grown in traditional incubators. This has tremendous potential to one day make a difference for patient care."

Scientists from AmplifyBio and Xcellbio will present their joint poster, "Adapting T Cells for the Tumor Microenvironment (TME) During Manufacturing for Improved Anti-Tumor Potency," at ISCT 2024 (poster #933). It will include data about how T cells were metabolically conditioned in the AVATAR system to improve their fitness and potency.

To learn more about the beta access program for the AVATAR Foundry platform, please visit View Source