On December 9, 2025 CytoAgents, Inc., a clinical-stage biotechnology company developing CTO1681, a novel, steroid-sparing inhibitor of prostaglandin-mediated inflammation reported that data from two of its Investigational New Drug (IND) application enabling studies will be presented at the European Society for Medical Oncolgy (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, taking place December 10-12, 2025 in London, United Kingdom.

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!

CTO1681 is an orally administered immune modulator that targets inflammation in the tumor microenvironment and mitigates cell therapy induced toxicities frequently seen in lymphoma patients receiving CAR T-Cell Therapy. CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 in lymphoma patients receiving CAR T-Cell Therapy at risk for inflammatory driven toxicities.

At ESMO (Free ESMO Whitepaper), the company will present data from two non-clinical studies demonstrating that CTO1681 attenuates key cytokines known to drive Cytokine Release Syndrome (CRS) without compromising the CAR T-Cell mediated tumor killing in vitro and in vivo. These studies demonstrate that CTO1681 does not interfere with CD19 CAR T-Cell expansion and anti-tumor activity in vivo while reducing the inflammatory cytokines associated with CRS and ICANS.

"These data suggest CTO1681 could enable safer CAR T-Cell Therapy administration, support outpatient treatment paradigms and broaden patient access without compromising anti-tumor efficacy," said Teresa Whalen, Chief Executive Officer at CytoAgents. "We look forward to sharing these data at ESMO (Free ESMO Whitepaper) and to continuing our advancement of CTO1681."

Poster Presentation Details:

Title: CTO1681 Does Not Interfere with CAR T-Cell Anti-Tumor Efficacy In Vivo

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 109P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

Title: CTO1681 Attenuates CRS-Driving Cytokines Without Compromising CAR T-Cell-Mediated Tumor Killing In Vitro

Presenter: Michael Howell, PhD, Founder and President Mountaineer Biosciences, San Diego, CA, USA

Final Poster Number (FPN): 113P

Session Date and Time: Wednesday, December 10, 2025, 5:15 PM – 6:30 PM GMT

Location: Queen Elizabeth II Centre – Churchill Room

(Press release, CytoAgents, DEC 9, 2025, View Source [SID1234661333])

On December 9, 2025 Novastra Therapeutics ("Novastra"), a Boston-founded, clinical-stage biotechnology company developing next-generation immune reprogramming therapies for cancer, reported that its lead program, OAP-1 from its OmniAntigen XIRT platform, has entered a Phase 1b clinical study in patients with advanced solid tumors. First-in-human data show encouraging effects on how the immune system recognizes and attacks cancer in people with very advanced disease whose tumors have continued to grow despite multiple prior treatments, including chemotherapy, immunotherapy and, for some, radiation therapy. These "last-line" patients have very few remaining standard treatment options and are among the hardest cancer cases to treat.

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!

OAP-1 is a new type of personalized cancer treatment that focuses on "immune reprogramming." Instead of targeting just one or a few markers, OAP-1 uses a patient’s own tumor cells and coats them with a special ultra-thin nano-layer. This layer helps preserve the full "fingerprint" of the cancer while giving the immune system a strong and coordinated push to see the tumor as a threat again. The goal is to safely "retrain" the immune system to fight the patient’s cancer more effectively.

"Many people benefit from today’s cancer immunotherapies, but too often the cancer finds a way to escape and patients run out of options," said Junling Guo, PhD, Founder of Novastra Therapeutics. "Our next-generation OmniAntigen XIRT platform is designed for system-level immune reprogramming. We want to keep the full picture of each patient’s cancer and, at the same time, give the immune system a stronger, more organized second chance to respond."

OAP-1 is made using a same-day process that is designed to be performed near the patient. Tumor samples are collected, processed, and returned as a personalized dose within hours, without the need for gene editing or complex factory-style manufacturing. This approach aims to make personalized immunotherapy more practical and more accessible over time.

The ongoing Phase 1b clinical study is enrolling patients with advanced solid tumors whose cancer has continued to grow after treatment with PD-1/PD-L1 checkpoint inhibitor drugs, a common type of cancer immunotherapy. The main goals of this study are to evaluate safety and feasibility, and to understand how OAP-1 affects the immune system and tumor behavior over time.

So far, in the initial patients treated, OAP-1 has been well tolerated, with no unexpected safety concerns observed. Tests on blood and tissue samples show several highly encouraging cancer-related immune reprogramming effects, including a clear rise in a natural immune signal called interferon-alpha (IFN-α) which helps "wake up" the body’s defenses, followed by a substantial and sustained increase in specific "attacker" signals (interferon-gamma/IFN-γ). This pattern indicates stronger activation of immune cells that can recognize cancer and more T cells that appear to be targeting the patient’s own tumor. In line with these immune changes, early scan results in some patients suggest that their tumor growth has been brought under control, with signs that the tumors have stopped growing and, in some cases, may even be starting to shrink.

"The early clinical data on these immune reprogramming effects are very encouraging, especially in patients whose cancers have already stopped responding to standard immunotherapy," said Yunxiang He, PhD, Co-Founder of Novastra. "We believe that a next-generation, system-level immune reprogramming approach like OAP-1 could eventually serve as a flexible backbone that works together with existing checkpoint inhibitors and other cancer treatments."

About OmniAntigen XIRT

OmniAntigen XIRT (next-generation immune reprogramming therapy) is Novastra’s platform for rapidly turning patient-derived cells into same-day cancer immunotherapies. Each dose is designed to preserve a wide spectrum of tumor antigens – the unique "fingerprint" of a patient’s cancer – while adding a proprietary ultra-thin coating and immune-stimulating components that help "wake up" and reprogram the immune system at multiple levels. The platform is designed for closed-system, near-patient manufacturing in just a few hours, with the goal of making personalized immune reprogramming practical and scalable.

OAP-1, the first clinical candidate from the OmniAntigen XIRT platform, is currently being evaluated in a Phase 1b clinical trial in advanced solid tumors with prior exposure to checkpoint inhibitor therapy.

(Press release, Novastra Therapeutics, DEC 9, 2025, View Source [SID1234673478])

On December 9, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the Japan Patent Office has issued Patent No. 7783866 for PDS0101 granting broad composition of matter and methods of use claims. The new patent expands previously granted patents in Japan, and adds to the Company’s robust intellectual property estate, which includes previously granted patents in the United States, China, Australia, and Hong Kong. The Company has additional patent applications pending in several other countries. Together with anticipated biologics exclusivity in the United States, the Company has patent and market protections for PDS0101 into the 2040s.

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 incidence of HPV16-related cancers is rapidly increasing in the US and Europe and also increasing globally.* PDS0101 is currently being studied in the Company’s Phase 3 trial for PDS0101 + pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer.

"The issuance of an additional patent for PDS0101 in Japan further strengthens our global IP portfolio and reinforces the robust intellectual property position supporting our growth. This marks an important step in protecting the value of our innovative immunotherapies as we advance our pipeline worldwide." said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotechnology.

The Company intends to continue to advance broad intellectual property protections for PDS0101 and its other investigational agents in development.

(Press release, PDS Biotechnology, DEC 9, 2025, View Source [SID1234661318])

On December 9, 2025 Artera, a developer of multimodal AI-based prognostic and predictive cancer tests, reported the commercial launch of the ArteraAI Prostate Test (Post‑RP) for patients experiencing biochemical recurrence (BCR) following radical prostatectomy.

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 test builds on the established ArteraAI platform and delivers prognostic results and insights into short-term ADT benefit to optimize decision-making in the salvage therapy setting, where additional treatment is given if cancer returns after surgery.

After radical prostatectomy, PSA should be undetectable. A rising PSA after surgery can indicate biochemical recurrence, suggesting residual cancer cells may remain. With an estimated 20% to 40% of patients affected, the test now delivers personalized, AI-driven data to this previously underserved population, expanding access to advanced precision medicine.

"The launch of the ArteraAI Prostate Test (Post-RP) is a significant milestone in Artera’s continued growth," said Andre Esteva, CEO of Artera. "This expansion broadens our portfolio, extends our reach to an underserved patient population, and strengthens our partnerships across the healthcare ecosystem. As demand for responsible AI in oncology accelerates, we remain focused on scaling access, delivering measurable value to clinicians, and ensuring our technology reaches the patients who need it most."

This test is based on the robust data presented at the 2024 AUA Annual Meeting, which showed that ArteraAI’s MMAI-based prostate biomarker can accurately estimate the risk of metastasis and help predict which men may benefit from intensified salvage therapy, including hormone therapy plus radiation.

"There is a continued need to optimize treatment for men with post-prostatectomy BCR, especially in understanding which patients benefit from ADT when undergoing salvage radiation," said Todd Morgan, urological surgeon and Chief of Urologic Oncology at Michigan Medicine. "This test has substantial promise for helping individualize these treatment decisions."

As with all Artera products, the ArteraAI Prostate Test (Post‑RP) integrates seamlessly into standard pathology workflows, enabling rapid turnaround and broad accessibility. The test relies on the digitized image of the surgical specimen, preserving the resected tissue while delivering actionable insights to guide personalized treatment decisions.

The launch of the ArteraAI Prostate Test (Post-RP) reinforces Artera’s mission to advance the frontier of precision oncology, offering a timely, cost-effective tool that complements clinical assessments for patients with recurrent prostate cancer.

The ArteraAI Prostate Test (Post‑RP) is now available for commercial ordering nationwide. For more information, visit artera.ai.

(Press release, Artera, DEC 9, 2025, View Source [SID1234661334])

On December 9, 2025 Pulse Biosciences, Inc. (Nasdaq: PLSE)(the "Company" or "Pulse Biosciences"), a company leveraging its novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported a research collaboration with The University of Texas MD Anderson Cancer Center to examine the use of the Company’s nPulse Vybrance Percutaneous Electrode System for treatment of thyroid cancers. The Investigational Device Exemption (IDE) submitted for this first-in-human clinical feasibility study has been approved by the FDA.

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!

Under the agreement, MD Anderson researchers led by Victoria Banuchi, M.D., Associate Professor of Head & Neck Surgery, will conduct a clinical study to assess the safety and effectiveness of using nPulse technology to treat papillary thyroid microcarcinoma, a common cancer affecting hundreds of thousands of US patients. The trial is planned to commence early in 2026. The study will be conducted at two sites and is planned to enroll 30 subjects. Under an existing material transfer agreement, preclinical studies with MD Anderson researchers are ongoing to assess the effect of nsPFA energy on anaplastic thyroid carcinoma. With a five-year survival rate of less than 5%, anaplastic thyroid carcinoma is one of the deadliest types of cancer.

"We believe the nonthermal mechanism of action of nsPFA, which limits scarring, fibrosis, and damage to critical surrounding structures, positions our nPulse technology as potentially the ideal treatment for benign and malignant thyroid tumors. We look forward to carrying this collaborative work forward to evaluate how our game-changing technology may benefit these patients," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences.

About the Company’s nPulse Vybrance Percutaneous Electrode System

The Company’s nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nPulse Console. The novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications.

(Press release, Pulse Biosciences, DEC 9, 2025, View Source [SID1234661319])