On May 5, 2025 AGC Biologics, your friendly CDMO expert, reported a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea (Press release, Novelty Nobility, MAY 5, 2025, View Source [SID1234652529]). Novelty Nobility will leverage AGC Biologics’ expertise and proprietary CHEF1 expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics’ Copenhagen, Denmark and Chiba, Japan facilities.

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Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively.

AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility’s first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March.

"We are very happy with the partnership with Novelty Nobility, where we will apply our CHEF1 platform to a novel bispecific antibody, helping support the advancement of this important candidate towards clinical trials," said Kasper Møller, Chief Technical Officer and Executive Vice President, AGC Biologics. "Our cell line development expertise in Copenhagen is strategically aligned with Novelty Nobility’s objectives, and we believe we can provide a strong foundation for their therapeutic development program."

"Chiba’s partnership with our Copenhagen team gives Novelty Nobility access to world-class cell line development experts while keeping their regional connection strong," noted Susumu Zen-in, Senior Vice President and General Manager, AGC Biologics Chiba. "When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. This approach is already helping us throughout the APAC region and creating wins for both Novelty Nobility and AGC Biologics."

AGC Biologics’ CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialization.

AGC Biologics offers a comprehensive suite of services for mammalian-based drug production, from cell line development to commercial manufacturing, enabling partners to accelerate their drug development timelines and bring life-changing therapies to patients. Visit www.agcbio.com/capabilities/mammalian to learn more.

On May 5, 2025 Immorta Bio Inc, a scientific longevity company dedicated to "Treating Diseases of Aging and Treating Aging as Disease", reported a talk called "Immunologically Mediated Senolysis" at the "Clinical Immunology Symposium" of the American Association of Immunologists Annual Meeting (Press release, Immorta Bio, MAY 5, 2025, View Source [SID1234652528]). Immorta Bio’s talk will be accompanied by presentations from Pfizer1 and University of Pittsburgh2. The talk will occur Monday, May 5 | 8:15 AM – 10:15 AM | Room 316C at the Hawai’i Convention Center.

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Immorta Bio is the first company to develop a "senolytic immunotherapy" for treatment of cancer and aging. This treatment comprises of training the immune system of patients to selectively kill "senescent cells" that promote aging and act as a shield to protect cancer against immune responses. By removing this defense mechanism, cancer becomes susceptible to immune attack.

The Company has shown that its lead senolytic immunotherapy product, SenoVax, is capable of destroying lung, breast, pancreatic and brain cancers, as well as melanoma3 in animal models.

"Having been chosen to present our work on using the immune system to fight cancer and aging in such an esteemed panel is truly an honor," said Dr. Thomas Ichim, President and Chief Scientific Officer of Immorta Bio.

T cell mediated mechanisms of how SenoVax enables its anticancer effects have previously been published in the peer-reviewed literature with collaborators at University of California San Diego, Georgetown University, Ceders Sainai, and Calidi Bio4. Additionally, the Company recently demonstrated that natural killer cell activation as a result of SenoVax therapy also plays a role in stimulation of cancer destruction5.

"We have founded Immorta Bio on the principle of ‘Scientific’ Longevity," said Dr. Boris Reznik, President and CEO of Immorta Bio. "There is no better validation of our science than to be chosen to give an oral presentation at such a prestigious and exclusive scientific gathering as AAI2025."

On May 5, 2025 Genezen, a leading viral vector Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies, Inc. (Optieum), a preclinical stage company dedicated to the discovery and development of innovative CAR-T cell therapies, reported a partnership for cGMP manufacturing of the lentiviral vector (LVV) construct used in the production of OPTF01, a novel CAR-T therapy for glioblastoma treatment (Press release, Genezen, MAY 5, 2025, View Source [SID1234652527]).

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Derived from Optieum’s proprietary Eumbody System, OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα), a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications.

Under this collaboration, Genezen will provide the technology transfer, process development, and cGMP manufacturing of the LVV construct used in the onward production of the OPTF01 CAR-T product. "Genezen is honored to support Optieum’s best-in-class CAR-T programs with our best-in-class LVV expertise to bring these critical therapies to life," said Steve Favaloro, Chairman and CEO of Genezen. "This collaboration with Optieum underscores our rich experience and the capabilities of both our people and state-of-the-art facilities to support customers on a global scale – now including a leading Japanese biotech."

Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Genezen’s team of experts ensures that critical materials for our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors."

OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation.

On May 5, 2025 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that the first patient has been dosed in the clinical study of peluntamig in combination with Roche’s anti-PD-L1 monoclonal antibody atezolizumab (TECENTRIQ ) (Press release, Phanes Therapeutics, MAY 5, 2025, View Source [SID1234652526]). The study is being conducted in a cohort of patients with extensive-stage small cell lung cancer (ES-SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinomas (EP-NECs).

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As previously announced, Phanes is conducting this study under a clinical supply agreement with Roche. Peluntamig is Phanes’ first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47. It was granted two orphan drug designations by the FDA for the treatment of SCLC and NEC, respectively, and two Fast Track designations for ES-SCLC with disease progression following platinum chemotherapy with or without a checkpoint inhibitor, and metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC), respectively.

The multi-center Phase I/II clinical trial of peluntamig (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of peluntamig in patients with advanced or refractory cancers expressing DLL3. A Phase I clinical trial of peluntamig is also ongoing in China (CTR20242720), and a Phase II clinical trial has been approved in China.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

On May 5, 2025 CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on anti-cancer therapies, reported that a poster presentation of preclinical data of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody), a key asset in CStone Pipeline 2.0, has been delivered at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, CStone Pharmaceauticals, MAY 5, 2025, View Source [SID1234652525]). CS2009 global phase I trial is ongoing in Australia with first patient dosed in this March and will soon be expanded to China and the US.

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PD-1, VEGFA, and CTLA-4 are clinically validated targets for immunotherapies, which can exert complementary, multi-dimensional anti-tumor effects through synergistic mechanisms. Blockade of PD-1 and CTLA-4 has demonstrated synergistic effects, extending overall survival benefits as well as progress-free survival benefits in many tumor types including NSCLC, which could be further strengthened by the blockade of VEGFA signaling. By integrating these three mechanisms of actions in one molecule, CS2009 holds great potential to deliver superior clinical benefits over PD-(L)1 antibodies or PD-(L)1/VEGF and PD-(L)1/CTLA4 bispecific antibodies.

CS2009 is a promising trispecific antibody targeting PD-1, VEGFA, and CTLA-4, which demonstrates broad clinical application prospects for solid tumors with the great potential to become the next-generation immune-oncology backbone to replace current anti-PD-(L)1-based therapies.

Key Highlights:

CS2009 exhibited enhanced affinity upon simultaneous PD-1/CTLA-4 engagement. CS2009 enhances anti-tumor efficacy by preferentially targeting PD-1/CTLA-4 double positive T cells in TME.
CS2009 exhibited an approximately 150-fold enhancement in checkpoint inhibitory activity on PD-1/CTLA-4 dual-reporter assay through crosslinking with VEGFA dimers. In PD-1 reporter assay, the CS2009/VEGFA combination demonstrated approximately 300-fold greater immune checkpoint activity compared to CS2009 alone. Mixed lymphocyte reaction (MLR) assays evaluating primary T cell activation revealed that crosslinking with VEGFA dimer significantly increases the activity of CS2009. These findings indicate enhanced activity of CS2009 in VEGFA-enriched TME and minimized peripheral overactivation-induced immune-related toxicity, thereby expanding its therapeutic window.
CS2009 demonstrated dose-dependent T-cell activation during GLP-toxicity study in cynomolgus monkeys.
CS2009 exhibited comparable pharmacokinetic (PK) profiles to those of monoclonal antibodies.
CS2009 demonstrates superb tolerability with the highest non-severely toxic dose (HNSTD)/ the no observed adverse effect level (NOAEL) identified as 100 mg/kg.
In summary, CS2009 is a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, with the potential to be first- or best-in-class for major tumor types. Its differentiated molecular design combines three clinically validated targets, preferentially invigorating exhausted tumor infiltrating lymphocytes (TILs) while demonstrating VEGF neutralization comparable to existing anti-VEGF antibodies. CS2009 covers a wide range of cancers, including but not limited to non-small cell lung cancer, hepatocellular carcinoma, gastric adenocarcinoma, endometrial cancer, ovarian cancer, renal cell carcinoma, and cervical cancer. Our results show that CS2009 exhibits superior anti-tumor activity compared to potential competitors, including PD-(L)1/CTLA-4 bispecific antibodies, PD-(L)1/VEGF bispecific antibodies, and PD-(L)1/CTLA-4 combination therapies.

Poster Information:

Title: CS2009: A first-in-class trispecific antibody targeting PD-1, CTLA-4, and VEGFA with potential to be a next-generation backbone therapy with combined checkpoint inhibition and anti-angiogenesis
Session Title: Overcoming Checkpoint Inhibition and Tumor Suppression
Abstract Number: 7299
Date & Time: Wednesday, April 30, 2025, 9:00 AM – 12:00 PM ET
Location: Poster Section 39, Board #14