On December 4, 2025 OTR Therapeutics, a biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies, emerged from stealth and reported the successful completion of a $100 million Series A financing closed in June 2025. The round was backed by True Light Capital, a wholly-owned subsidiary of Temasek, LAV, Pfizer Ventures, and Sirona Capital.

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Founded in March 2025, OTR Therapeutics is establishing a novel, scalable, and capital-efficient model that synergizes internal R&D with strategic curation of high-potential external innovation. This integrated approach enables the company to focus on scientific rigor and operational agility, leveraging its deep regional insights and the development efficiency of the local ecosystem to accelerate innovative therapies to patients worldwide.

The proceeds of the financing will advance OTR’s pipeline of differentiated programs that target significant treatment gaps in immunology & inflammation, oncology, and other disease areas. The funds will also expand OTR’s R&D hub capability, which emphasizes both scientific excellence and strategic partnership agility to foster expedited development of high-impact therapies.

In line with its strategy, OTR also announced the acquisition of a preclinical program with best-in-class potential for neurological diseases with high unmet needs. This acquisition is part of the company’s strategic and ongoing efforts to identify and advance promising early-stage assets into global clinical development, alongside its internal proprietary discovery programs to address a broader range of critical patient needs.

"The rapidly evolving global pharmaceutical R&D landscape demands greater novelty, speed and efficiency," said Dr. Zhui Chen, Founder and CEO of OTR Therapeutics. "At OTR, we aim to build a next-generation biotech model that delivers unprecedented R&D and capital efficiency. It enables us to stay agile while remaining rigorously focused on propelling novel, differentiated drug candidates through global clinical translation in a disciplined and efficient manner. We are grateful for the strong support from our investors and their confidence in our vision and capability to deliver transformative therapies for patients."

Co-founded by Zhui Chen, Ph.D., Shannon Chuai, Ph.D., and Yuan Shi, Ph.D., OTR Therapeutics is led by a team of seasoned drug hunters and entrepreneurs in the biotech and pharmaceutical industries with a proven track record of delivering breakthrough innovation, operational excellence, and financial success.

Yi Shi, Managing Director, LAV: "We believe the biopharma industry is shifting towards more capital-efficient and specialized R&D models. OTR Therapeutics is at the forefront of this evolution, demonstrating how a focused, integrated framework can expedite the journey of translating early-stage innovation into global clinical development."

Michael Baran, Partner, Pfizer Ventures: "Pfizer Ventures identifies and invests in emerging companies who are developing innovative medicines and technologies that have the potential to shape the future of our industry. To this end, we’re pleased to be able to support OTR Therapeutics as it scales its R&D capabilities and builds a portfolio of potentially transformative therapies."

(Press release, OTR Therapeutics, DEC 4, 2025, View Source [SID1234661146])

On December 4, 2025 AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic CAR-T cell therapies, reported that the FDA and the European Medicines Agency (EMA) have cleared the company’s IND and approved the Clinical Trial Application (CTA), respectively, for QUADvance (AVC-203-01), a Phase II/II trial of AVC-203 for the treatment of relapsed/refractory B-cell malignancies.

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AVC-203 is a CRISPR-engineered allogeneic CAR-T candidate designed to target and eliminate cells expressing receptors CD19 and/or CD20, which are known to be expressed in nearly all B-cell malignancies.

"We are excited to build on the early success and promising activity and safety of our ongoing clinical program of allogeneic CAR-T in AML (NCT05949125) by now advancing into B Cell Lymphoma with what we believe to be the most scientifically compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell’s President & CEO. "To date, attempts at solving the key scalability and cost issues of autologous CAR-T therapy by engineering cells from unrelated donors have fallen short. Nevertheless, the obvious benefits of such an approach, including consistency and potency of an actual drug product – something in vivo approaches cannot provide – remain as compelling as ever. AvenCell remains focused on ensuring that any patient who can benefit from CAR-T therapy can receive it, through the massive scaling of supply and dramatic reductions in cost of goods, with a product that is as good or better than best-in-class autologous CAR-Ts."

About AVC-203

AVC-203 is a CRISPR-engineered allogeneic CAR-T therapy incorporating four key innovations:

Dual antigen targeting: AVC-203 CAR-T cells contain a receptor that simultaneously targets CD19 and CD20.

Immune evasion: CRISPR/Cas9 engineering enables donor cells to avoid both Graft-versus-Host Disease (GvHD) and rejection by the patient’s immune system.

Improved T-cell fitness and off-the-shelf availability: Allogeneic manufacturing from healthy donors leverages better T-cell fitness and eliminates patient-specific production, enabling immediate treatment

Switchable targeting: A RevCAR receptor dimerized to the CD19/CD20 CAR enables flexible targeting of additional tumor antigens through bi- or tri-specific bridging proteins, allowing future target expansion beyond CD19/CD20.
Trial Designs and Objectives

The phase I/II study will be conducted at multiple sites in the US and Europe and will evaluate the safety, tolerability, efficacy, and pharmacokinetics of AVC-203 in adults with relapsed or refractory B-cell malignancies. The phase Ia dose escalation study is expected to be followed by a phase Ib dose expansion study and a Phase II pivotal trial.

B-cell malignancies

B-cell malignancies — including non-Hodgkin lymphomas, multiple myeloma, and B-cell acute lymphoblastic leukemia (B-ALL) — account for the majority of blood cancers. Approximately 120,000 and 150,000 new cases are diagnosed annually in the United States and Europe, respectively.

(Press release, AvenCell Therapeutics, DEC 4, 2025, View Source;302632517.html [SID1234661145])

On December 4, 2025 PreciseDx, the leading innovator behind PreciseBreast, a novel AI digital pathology test, reported the upcoming presentation of three abstracts that further validate the test’s ability to assess risk of recurrence in early-stage breast cancer. Ongoing studies aim to demonstrate PreciseBreast’s ability to predict treatment benefit.

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Three abstracts will be presented during the annual San Antonio Breast Cancer Symposium (SABCS) taking place December 9-12, 2025, in San Antonio, TX. These presentations underscore the growing momentum and clinical success of PreciseBreast which utilizes our proprietary AI platform to combine AI-enabled image feature data with key clinical factors to deliver a PreciseBreastⓇ Score that accurately stratifies patients by recurrence risk.

SABCS-accepted abstracts presented by PreciseDx

PS113-13: Clinical validation of an Artificial Intelligence digital pathology-based prognostic test to predict risk of recurrence using biopsy specimens from patients with invasive breast cancer

Author/Presented by: Michael J. Donovan, PhD, MD
Poster Presentation: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM
PS4-12-28: A novel approach for phenotyping triple negative breast cancer using an Artificial Intelligence digital pathology-based prognostic test to assess recurrence risk and response to therapy

Author/Presented by: Nicholas Stanzione MD, David Geffen School of Medicine, UCLA
Poster Presentation: Thursday, December 11, 2025, 5:00 PM – 6:30 PM
SABCS-accepted abstract presented by Lankenau Medical Center/Main Line Health

PS3-06-02: Prospective Evaluation of "PreciseBreast" AI Tool in Early-Stage Invasive Breast Cancer Risk Stratification

Author/Presented by: Lankenau Medical Center, Main Line Health, Talar Telvizian, MD
Poster Presentation: Thursday, December 11, 2025, 12:30 PM – 2:00 PM
"These results build on our prior publications validating PreciseBreast’s clinical and analytical accuracy in early-stage invasive breast cancer by demonstrating the ability to use the patient’s biopsy specimen to risk stratify as well as advancing our understanding of patients with triple negative breast cancer," shared Eric Converse, CEO of PreciseDx. "We’re particularly excited about the independent, real-world experience at Lankenau Medical Center using PreciseBreast in patients with HR+, HER2- early breast cancer and continuing our collaboration with NSABP to further evaluate PreciseBreast’s ability to predict chemotherapy benefit in this population."

(Press release, PreciseDx, DEC 4, 2025, View Source [SID1234661144])

On December 4, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, today announces two presentations at the upcoming 2025 San Antonio Breast Cancer Symposium (SABCS), in San Antonio, TX on December 9-12, 2025.

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Presentations:

Title:

Accelerating an Anthracycline-Free Future: A New Drug in Clinical Testing Offers Patients Hope for Safer, More Effective Breast Cancer Therapy Combinations

Date:

Thursday, December 11, 2025

Time:

5 p.m. – 6:30 p.m. CT

Abstract/Poster:

#801 Poster PS4-10-15

Presenting author:

Lewis Bender, M.S. M.A. M.B.A., Intensity Therapeutics

Title:

Intratumoral Injections of INT230-6 Prior to Neoadjuvant Immuno-chemotherapy in Early-Stage Triple Negative Breast Cancer: Early observations from INVINCIBLE-4-SAKK 66/22 (NCT06358573), a Phase II Randomized Clinical Trial

Date:

Friday, December 12, 2025

Time:

12 p.m. – 1:30pm CT

Abstract/Poster:

#1589 PS5-01-04

Presenting author:

Andreas Müller, M.D., Swiss Cancer Institute

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On December 4, 2025 J & D Pharmaceuticals LLC reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s investigational therapy for the treatment of Hepatocellular Carcinoma (HCC) a rare and life-threatening disorder that is estimated to occur in approximately 73,000 individuals in the United States in 2025.

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HCC is a devastating disorder that has a very poor prognosis. With FDA approved medications the amount of time extended in patient with HCC is only 2.5 months. There is a need for a safer and more effective medication for HCC.

"Receiving Orphan Drug Designation is yet another significant milestone for J & D Pharmaceuticals," said Lenard Lichtenberger, PhD, Chief Scientific Officer. "This designation adds to the two previous orphan drug designations we received and continues to underscore the urgent need for innovative therapies for HCC patients and strengthens our commitment to developing solutions that we expect to transform the lives of those affected by this debilitating condition not just by adding years to their lives but life to those years."

The FDA’s Orphan Drug Designation program provides incentives to encourage the development of treatments for rare diseases, including tax credits for qualified clinical testing, exemption from certain FDA fees, and the potential for seven years of market exclusivity upon regulatory approval.

J & D Pharmaceuticals plans to advance its HCC program into clinical development and will continue working closely with the FDA and the HCC community to accelerate progress toward delivering a novel treatment option to patients in need.

(Press release, J & D Pharmaceuticals, DEC 4, 2025, View Source;d-pharmaceuticals-llc-receives-orphan-drug-designation-for-treatment-of-hepatocellular-carcinoma-hcc-302632020.html [SID1234661142])