On April 16, 2024 SCG Cell Therapy (SCG) and the Agency for Science, Technology and Research (A*STAR) reported the launch joint laboratories for cellular immunotherapies (Press release, SCG Cell Therapy, APR 16, 2024, View Source [SID1234642115]). This collaboration, at a combined funding of close to S$30 million supported under Singapore’s Research, Innovation and Enterprise 2025 Plan (RIE2025), aims to advance the development of induced pluripotent stem cell (iPSC) technology to produce novel cell therapies that meet Good Manufacturing Practice (GMP) standards. The collaboration will also establish a talent development programme to train the next generation of experts in this field, in accordance with current GMP and regulatory requirements.

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The research and application of new technologies are essential for addressing growing healthcare needs and maintaining long-term sustainability. However, turning laboratory innovations into practical clinical solutions poses significant challenges. These often involve developing manufacturing processes, validating analytical methods, and implementing automation and digitalisation to guarantee the stability and scalability of products.

The joint laboratories, established at SCG’s GMP facility and A*STAR’s research facility, leverage SCG’s and A*STAR’s proprietary technologies to develop scalable GMP-grade iPSC and therapeutic products. SCG contributes its specialised, automated cell therapy manufacturing technologies, while A*STAR brings its unique monoclonal antibody assets, iPSC banks, and expertise in process scaling and analytics.

This collaboration bridges the expertise between public sector research and development (R&D) and industry, consolidating resources from SCG Cell Therapy and A*STAR’s Bioprocessing Technology Institute (BTI) and Institute of Molecular and Cell Biology (IMCB) to advance innovative R&D towards GMP manufacturing. Additionally, it immerses researchers in the rigorously controlled GMP environment, facilitating the progression from research to clinical application.

"Cellular immunotherapies herald a new era of regenerative medicine, offering hope for patients with cancers and other serious illnesses. As a key player in T cell receptor (TCR) T cell therapeutics, SCG has developed in-house cGMP manufacturing capabilities to supply high-quality cell therapy products to patients. Through this first-of-its-kind joint collaboration with A*STAR, we bring together A*STAR’s advanced iPSC technology and bioprocessing capabilities with our expertise in GMP cell therapy manufacturing and clinical development, furthering our mission to provide affordable off-the-shelf cell therapy treatment options to patients", said Christy Ma, Chief Strategy Officer of SCG Cell Therapy.

"The discovery of iPSCs has revolutionised regenerative medicine, offering the potential for standardised, off-the-shelf cell therapies. Through this collaboration with SCG Cell Therapy, we aim to accelerate the translation of iPSC research into clinically viable therapies and strengthen Singapore’s position as a global leader in cell therapy innovation. By leveraging our complementary expertise and resources, the joint labs will not only advance iPSC technology for scalable, GMP-compliant cell therapy production but also serve as a platform for nurturing the next generation of talent in this transformative field," said Prof Koh Boon Tong, Executive Director, A*STAR’s BTI.

About iPSC

Induced pluripotent stem cells (also known as iPS cells or iPSCs) are a type of pluripotent stem cell that can be generated directly from adult cells. The iPSC technology was pioneered by Shinya Yamanaka’s lab in Kyoto, Japan, who showed in 2006 that the introduction of four specific genes encoding transcription factors could convert adult cells into pluripotent stem cells. He was awarded the 2012 Nobel Prize along with Sir John Gurdon "for the discovery that mature cells can be reprogrammed to become pluripotent". Pluripotent stem cells hold great promise in the field of regenerative medicine. Because they can propagate indefinitely, as well as give rise to every other cell type in the body (such as neurons, heart, pancreatic and liver cells), they represent a single source of cells that could be used to replace those lost to damage or disease.

On April 16, 2024 Kumquat Biosciences, a leader in translating breakthrough science into first-in-class therapeutics, reported a strategic and exclusive collaboration with Takeda to develop and commercialize a novel immuno-oncology small molecule inhibitor as a mono- and/or combination-therapy (Press release, Kumquat Biosciences, APR 16, 2024, View Source [SID1234642114]).

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Under the terms of the agreement, Kumquat granted Takeda an exclusive, global, and royalty bearing license to develop and commercialize a selected small molecule inhibitor. Subject to Kumquat’s option, Takeda will assume and fund all development and commercialization activities beyond the phase 1 trial activities led by Kumquat. Kumquat will receive up to $130 million in near-term payments and potentially more than $1.2 billion if all future clinical, regulatory, and commercial milestones are achieved during the term of the agreement plus tiered royalties on potential net sales of any commercial products resulting from this license.

"The advancement of this immuno-oncology small molecule program speaks to our ability to thrive on the challenges of drugging tough therapeutic targets of great potential," said Yi Liu, Chief Executive Officer of Kumquat. "We are proud of our persistent and innovative breakthrough, and we are thrilled to collaborate with Takeda, who shares our vision and strategy for realizing the benefit of small molecule-based transformative I/O treatments. This collaboration empowers this I/O program to advance to the clinic quickly and holds potential to benefit a broad population of cancer patients."

"We are excited to collaborate with Kumquat, an accomplished team with deep insights into this challenging target and therapeutic space," said P.K. Morrow, the Head of the Oncology Therapeutic Area Unit at Takeda. "This collaboration aligns with our mission to advance a cutting-edge pipeline focused on maximizing the benefit of the immune system to address the continued unmet needs of cancer patients. We look forward to working with Kumquat to accelerate the development of this exciting asset."

On April 16, 2024 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported that it will present preliminary data from its Phase 1 study of BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy, in refractory patients with either non-small cell lung cancer (NSCLC), melanoma or renal cell carcinoma (RCC), who previously progressed on immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Biomica, APR 16, 2024, View Source [SID1234642113]). The conference will take place at McCormick Place in Chicago, Illinois, and will also be available virtually from May 31 to June 4, 2024.

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Presentation Details:

Title: Preliminary results from a First-in-Human (FIH), open-label Phase 1 study with BMC128, a rationally designed live bacterial consortium, in combination with nivolumab.
Session Type: Poster Session
Abstract Number: 8631
Date and Time: June 3, 2024, 1:30 PM – 4:30 PM (CDT)

Dr. Elran Haber, CEO of Biomica, stated: "We look forward to presenting our preliminary data at ASCO (Free ASCO Whitepaper), and to provide initial safety and efficacy results from our ongoing Phase 1 POC trial evaluating BMC-128 in combination with nivolumab in refractory patients. These results mark significant progress, laying the groundwork for the next phase in our clinical development process".

Additional information about the trial, can be found at: View Source (ClinicalTrials.gov Identifier: NCT05354102).

About BMC128:
BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI tech-engine.
Developed as a Live Bacterial Product (LBP), BMC128 is an LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.
Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

On April 16, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported the preclinical research findings of three potential novel drug candidates in poster format at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held from April 5 to 10, 2024 (Press release, Mabwell Biotech, APR 16, 2024, View Source [SID1234642111]).

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Poster Presentation

1. Disrupting IL-11/IL-11R signaling by an efficacious anti-IL-11 antibody 9MW3811 enhances T cell tumor infiltration and synergizes with anti-PD-1 therapies in vivo

Synopsis No.: 2365

The reported 9MW3811 is a high-affinity humanized neutralizing antibody against IL-11 independently developed by Mabwell, and has IND applications approved in China, the United States, and Australia, and its phase I clinical trials are ongoing in Australia and China.

As an important inflammation factor, IL-11 plays a significant role in the development and progression of fibrosis and tumor. Studies have shown that high expression of IL-11 is associated with the prognosis of various tumors such as lung cancer, hepatic cancer, and colorectal cancer. IL-11 not only promotes the growth of tumor cells through the STAT3 pathway but also has a significant impact on immune cells in the tumor microenvironment. 9MW3811 effectively blocks the formation of the IL-11/IL-11Ra/gp130 ternary complex by binding to IL-11, thereby inhibiting the activation of downstream signaling pathways. 9MW3811 has shown good anti-tumor therapeutic effects in multiple preclinical pharmacodynamic models, especially when used in combination with anti-PD-1 antibodies, it significantly promotes lymphocytic infiltration of CD8+ T cells, improves the T cell exhaustion caused by anti-PD-1 antibodies, upregulates the secretion of cytotoxic cytokines, thus exhibiting better combined anti-tumor effects.

2. 2MW4991, a novel ADCC-enhanced integrin αvβ8 blocker, exhibits high anti-tumor potency and was well tolerated in cynomolgus monkeys

Synopsis No.: 6349

The reported 2MW4991 is a high-specificity and high-affinity ADCC-enhanced antibody targeting integrin αvβ8. Integrin αvβ8 is an important activator of TGF-β, and specifically regulates the activity of TGF-β in immune cells. Studies have found that integrin αvβ8 is highly expressed in various tumors, and blocking αvβ8 can completely inhibit the release of TGF-β. 2MW4991 can completely block the release of TGF-β mediated by αvβ8, showing strong anti-tumor activity in various pharmacodynamic models such as CT26 and EMT6, and significantly promotes immune cell infiltration in tumors, greatly increasing the sensitivity of immune-excluded tumors to PD1 inhibitors. 2MW4991 has a significant synergistic effect when used in combination with PD1. The studies conducted in non-primate models have shown that 2MW4991 has good safety and metabolic profiles.

3. 2MW4691, a novel CCR8/CTLA-4 bispecific antibody, displays potent anti-tumor efficacy by specifically depleting tumor-infiltrating Tregs and blocking CTLA-4 signaling on CD8+ T cells

Synopsis No.: 6350

The reported 2MW4691 is an ADCC-enhanced bispecific antibody targeting CCR8/CTLA-4. Targeting CTLA-4 has a strong anti-tumor effect, but its clinical application is limited due to strong side effects. CCR8 is a specific marker of tumor-infiltrating Tregs, and is almost not expressed in other immune cells and peripheral Tregs. Single-cell sequencing analysis of Treg cells infiltrating various tumors found that CCR8 is expressed in a small subset of Treg cells infiltrating tumors, and CTLA-4 is widely expressed in Treg cells and CD8+ T cells. 2MW4691 retains high affinity targeting CCR8 and attenuated CTLA-4-binding and -blocking activity, specifically eliminating Treg cells infiltrating tumors. Due to the lower CTLA-4 expression in the peripheral tissues, 2MW4691 only blocks the immunosuppression mediated by CTLA-4 signaling on peripheral CD8+ T cells. 2MW4691 demonstrates strong anti-tumor activity in preclinical CCR8 single transgenic animal models, CTLA-4 single transgenic animal models, and double transgenic animal models, and has shown good metabolic activity and safety in primate animals.

On April 16, 2024 Volastra Therapeutics, a clinical-stage biotechnology company, reported it has dosed the first patient in its Phase Ib clinical trial evaluating sovilnesib in patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC) (Press release, Volastra Therapeutics, APR 16, 2024, View Source [SID1234642109]). This trial (NCT06084416) is a randomized dose optimization study of once-daily oral sovilnesib at different dose levels to establish the recommended Phase 2 dose.

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Sovilnesib was granted Fast Track designation in this indication by the U.S. Food and Drug Administration (FDA) based on its initial clinical data as well as the high unmet need in this population. Volastra in-licensed sovilnesib (formerly AMG-650) from Amgen in February 2023. The company is also progressing its internally developed KIF18A inhibitor, VLS-1488, in an ongoing Phase 1 clinical trial (NCT05902988).

"Advancing our two chemically differentiated KIF18A inhibitors in parallel Phase 1 clinical trials presents the rare opportunity to efficiently gather comparative clinical data," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "We believe our strategy will allow us to select the first, and potentially best-in-class, medicine for patients to advance to late-stage development for treatment of platinum-resistant or refractory HGSOC."

In the U.S. alone, there are more than 20,000 new cases of ovarian cancer each year, over 75% of which are advanced. The majority of these patients will see disease progression on platinum-based therapy.

"Patients with advanced HGSOC have poor treatment response rates after disease progression on platinum-based chemotherapy, and as a result have a significant need for new treatment options," Dr. Joyce Liu M.D., MPH, Associate Chief and Director of Clinical Research in the Division of Gynecologic Oncology at Dana Farber Cancer Institute and a principal investigator on the trial commented. "We are excited to participate in this trial evaluating a unique treatment approach in hopes of advancing new options for patients."

In addition to clinical development of novel therapeutics, Volastra is deploying multiple unique biomarker approaches to measure chromosomal instability and other predictors of response to KIF18A inhibitors through partnerships with companies including Microsoft, Tailor Bio, and Function Oncology.