On April 6, 2023 Evopoint Biosciences Co., Ltd.("Evopoint"), a biopharmaceutical company focused on discovering and developing innovative and transformative medicines, reported a collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate Evopoint’s XNW5004, a selective EZH2 inhibitor, in combination with KEYTRUDA(pembrolizumab), MSD’s anti-PD-1 therapy, in a Phase Ib/II study in Chinese patients with advanced solid tumors (Press release, Evopoint, APR 6, 2023, View Source [SID1234629874]).

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XNW5004 is a rationally designed, highly selective and potent EZH2 inhibitor with potentially best-in-class efficacy and safety profile demonstrated in a Phase I trial in patients with lymphoma. The combination trial is an open label, single-arm Phase Ib/II study designed to establish the RP2D dose of XNW5004 in combination with KEYTRUDA and to evaluate the safety and efficacy of XNW5004 in combination with KEYTRUDA for patients with advanced solid tumors.

"We are extremely pleased to collaborate with MSD, a well-established world leader and pioneer in the field of cancer immunology," said Jing Qiang, Chairmen of Evopoint. "Our promising drug candidate, XNW5004, has demonstrated a potential additive benefit when given in combination with anti-PD-1 therapy in animal models. Based on the mechanism of action of EZH2 in tumor cells and tumor microenvironment, the observations in our preclinical studies, and the excellent efficacy and safety profile of XNW5004 exhibited in the Phase I study, we are very optimistic that XNW5004 in combination with KEYTRUDA may significantly improve the clinical outcome in patients with advanced solid tumors, potentially providing meaningful clinical benefits to those patients for improving their lives."

Under the terms of the agreement, Evopoint will sponsor the Phase Ib/II trial and MSD will supply KEYTRUDA. Evopoint maintains the global rights to XNW5004.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About XNW5004

XNW5004 is a rationally designed, highly selective and potent small molecule inhibitor of EZH2 with the potential of being the best-in-class EZH2 inhibitor. Studies have revealed that EZH2 play important roles in the pathological processes including tumorigenesis, tumor progression and tumor immunogenicity. Targeting EZH2 has been proven a relatively effective treatment strategy in liquid tumors.

In preclinical studies, XNW5004 has demonstrated excellent anti-tumor activity and safety in various liquid tumor and solid tumor models, either as single agent or in combination with other therapies including immune checkpoint inhibitors. In a recently completed Phase I trial, XNW5004 exhibited excellent single-agent efficacy and safety in lymphoma, and the potential to be best-in-class selective EZH2 inhibitor. Interim results of the Phase 1 study were presented at the ASH (Free ASH Whitepaper) meeting in December, 2022.

On April 6, 2023 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported that its Chief Scientific Officer, Loïc Vincent, Ph.D., reported that it will present data from the Company’s oncogenic driver program targeting KRAS G12D, at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida, taking place April 14th – 19th (Press release, Affini-T Therapeutics, APR 6, 2023, View Source [SID1234629873]).

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Oral presentation details are as follows:

Session MS.CL07.01 – Immunotherapy: Sunday, April 16th from 3:52 pm – 4:07 pm ET: Preclinical development of safe and effective T cell receptors specific for mutant KRAS G12D peptide

On April 6, 2023 Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and abcam (NASDAQ: ABCM), a global life science company working together with researchers to advance science and enable faster breakthroughs, reported an agreement to co-market abcam primary antibodies specifically validated for use on Lunaphore’s COMET platform (Press release, Abcam, APR 6, 2023, View Source [SID1234629872]).

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The agreement will enable researchers to use abcam’s antibodies without conjugation directly on the COMET platform, with unparalleled scalability and reproducibility. By using validated primary antibodies together with the capabilities of COMET, researchers can accelerate assay development processes and achieve reliable results. The partnership also aims to address the reproducibility crisis in life sciences by providing trusted tools for multiplex immunofluorescence analysis.

Lunaphore recently expanded its offerings to become the first universal, end-to-end solution for spatial biology research. Lunaphore’s COMET is the only high-throughput, hyperplex platform ensuring scalability and reproducibility without the need to conjugate primary antibodies. It has a wide range of research applications across multiple disciplines and drug development stages, provides walk-away automation, and allows for the generation of highly robust and reproducible hyperplex data with full tissue preservation that answers the growing needs of translational research.

"This collaboration underscores the importance we place on using antibodies from trusted and proven vendors like abcam. We understand how important it is to the research community to use antibodies that they already know and rely on and be able to directly transfer and use them for multiplexing," said Déborah Heintze, Chief Marketing Officer at Lunaphore. "We are very proud to see how customers can already optimize and run new panels in days. Proposing validated abcam antibodies on COMET will help streamline and scale the researchers’ multiplexing capabilities even more."

"We’re excited to be partnering with Lunaphore to offer the life science community a library of primary antibodies validated for use with Lunaphore’s automated platform for hyperplex immunofluorescence analysis," said Courtney Nicholson, Vice President Business Development at abcam. "Spatial biology is truly revolutionizing our understanding of human health and disease, and we are pleased to be working together with Lunaphore to support researchers with the tools they need to further advance this promising new field."

Lunaphore and abcam will present novel data together in a poster at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, highlighting shared research:

Automated multiplex immunofluorescence enables single cell analysis of tumor stroma
Poster #: 4616, Section 4
Date and time: April 18, 1:30 pm – 5:00 pm EST
Speaker: Dr. François Rivest, Application Development Team Leader, Lunaphore

About COMET

COMET is the only fully automated, high-throughput, hyperplex platform ensuring scalability and reproducibility without the need to conjugate primary antibodies. COMET provides walk-away automation, integrating staining, imaging, and image preprocessing steps to obtain standard hyperplex images. COMET generates highly robust and reproducible data with full tissue preservation, allowing researchers to perform downstream modalities such as H&E or transcriptomics using the same slide. Its superior tissue profiling capabilities facilitate the analysis of 40 different spatial markers in each automated run on a tissue slide. In contrast to other spatial biology solutions, COMET works with off-the-shelf, label-free primary antibodies, making panel design much more flexible and faster than any other hyperplex solution. COMET works with regular glass slides from standard histology workflows; it is validated for human and mouse samples and is compatible with any other animal sample. The platform can be used for a wide range of research applications, allowing for a dramatic improvement in the understanding of disease pathology. Orders of the new COMET version can be placed and will be available for shipment in the upcoming months. To learn more about the COMET platform, please visit: View Source

On April 6, 2023 Alpha Cancer Technologies Inc. (ACT), a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunomodulation therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, reported the publication of pre-clinical study results in Cancer Cell International highlighting the company’s recombinant human AFP (ACT-101) conjugate with maytansine in mouse xenograft models of colorectal cancer (Press release, Alpha Cancer Technologies, APR 6, 2023, View Source [SID1234629871]). Results from the study demonstrate the exceptional safety profile and potent anti-tumor activity of multiple ACT-101 conjugates through the successful targeting of the alpha fetoprotein receptor uniquely located on cancerous cells and myeloid-derived suppressor cells (MDSCs).

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The AFP receptor has been found on the surface of cancer cells and MDSCs exclusively, making it an attractive target for the delivery of toxins selectively to tumor cells and MDSCs. Human AFP acts as a shuttle protein, transporting a variety of molecules including targeted anti-cancer agents inside the cell via the AFP receptor. ACT-101 is a recombinantly produced non-glycosylated form of human AFP, which will carry and deliver maytansine and other chemotherapy payloads to tumor cells via the AFP receptor. The selection of maytansine was based on its prior efficacy in clinical studies when incorporated into ADCs.

The AFP receptor has emerged as a novel target for cancer therapeutics given the expression of AFP on most cancers and MDSCs, and lack of presence on normal tissues. Studies were performed to investigate the use of ACT-101 conjugated with maytansine for targeted toxin delivery to cancer. Four structurally different ACT-101-maytansinoid conjugates containing cleavable glutathione sensitive linkers were initially investigated in a mouse xenograft model of colorectal cancer (COLO-205). Reduction in tumor volume was seen for all four conjugates compared to control (p < 0.05). The anti-tumor effects of the conjugate selected for further development, ACT-903, persisted after treatment discontinuation, with tumors becoming undetectable in 9 of 10 mice, and all 10 mice surviving through Day 60 with no obvious signs of toxicity. A follow-up study performed in the same model compared the effects of single intravenous doses of ACT-903 (10–50 mg/kg) to control groups receiving vehicle or ACT-101. A significant reduction of tumor burden compared to control was achieved in the 40 and 50 mg/kg dose groups. Survival was also significantly prolonged in the 40 mg/kg and 50 mg/kg cohorts. Free maytansine blood levels at 4 hours were 0.008% of the dose, indicating stability in circulation as was expected based on in vitro plasma stability studies. No obvious signs of toxicity were seen in any of the treated groups. The observed efficacy and excellent tolerability of ACT-903 in these xenograft models support advancing the development of ACT-903 into clinical studies.

"Based on the evidence we continue to observe in our pre-clinical studies, we believe ACT-903 has the potential to address the limitations of current-generation antibody drug conjugates through a targeted delivery exclusively to cancer and immune suppressor cells, allowing for greater efficacy with minimal toxicity," said Dr. Igor Sherman, CEO of ACT. "Given the broad range of cancer cells expressing the AFP receptor, we believe our technology offers a potential pan-cancer opportunity and we look forward to continuing the development of this program to bring it to cancer patients in the shortest possible time."

The manuscript, titled "High anti-tumor activity of a novel alpha-fetoprotein-maytansinoid conjugate targeting alpha-fetoprotein receptors in colorectal cancer xenograft model," was published in Cancer Cell International on April 5, 2023 and the full manuscript can be accessed here.

On April 6, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported the grant of stock options to purchase 17,000 shares of its common stock to one new employee (Press release, Verastem, APR 6, 2023, View Source [SID1234629870]). The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employee’s acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $0.39 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on April 3, 2023. The stock options that were granted to the one new employee will vest at a rate of twenty-five percent (25%) on the one-year anniversary of the employee’s date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.

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