On October 21, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the addition of several key large cancer centers to its ongoing pivotal Phase 3 clinical study (ClinicalTrials.gov as NCT06072612 ), notably Dartmouth Cancer Center, Cedars-Sinai Medical Center, and Winship Cancer Institute of Emory University. BriaCell anticipates reporting top line data as early as H1-2026.

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The extensive national effort already includes the following noteworthy clinics: Mayo Clinic, Los Angeles Cancer Network, Smilow Cancer Hospital at Yale New Haven, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology Oncology Associates of Fredericksburg, Northwestern University, Manhattan Hematology/Oncology Associates, New York Cancer and Bood Specialists, and Texas Oncology-Baylor Charles A. Sammons Cancer Center.

BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice of treatment in a dvanced metastatic b reast c ancer (Bria-ABC).

"We are encouraged by the strong engagement from major academic and leading community cancer centers which underscores confidence in BriaCell’s novel technology," stated Dr. William V. Williams, BriaCell’s President & CEO. "We expect the addition of these clinical sites will further accelerate patient enrollment in BriaCell’s pivotal Phase 3 study of Bria-IMT regimen in MBC and support our mission to bring this therapy to patients with significant unmet medical needs."

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, OCT 23, 2025, View Source [SID1234656938])

On October 23, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, reported that three abstracts featuring its investigational intravenous Deciparticle everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), to be held December 9-12, 2025, at the Henry B. Gonzalez Convention Center, San Antonio, Texas. Sapu Nano is the developer of Deciparticle and is part of Sapu family of companies and a joint venture between Oncotelic (OTCQB:OTLC) and Dragon Oversea.

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Sapu003 is a novel Deciparticle formulation of everolimus for intravenous administration, designed to overcome the pharmacologic limitations of oral mTOR inhibitors (Afinitor), including poor bioavailability, dose-limiting toxicity, and restricted tumor penetration. Collectively, the accepted abstracts highlight the clinical rationale, molecular biomarkers, and pharmacokinetic justification supporting the ongoing Phase 1 trial of Sapu003 in hormone receptor-positive (HR )/HER2 metastatic breast cancer.

Presentation Details

Presentation Session:
Thursday, December 11, 2025 | 5:00 PM – 6:30 PM CST

Abstract Number Presentation Number Title
1834 PS4-04-04 High RICTOR / Low RPTOR Gene Expression Signature as a Predictive Biomarker for Intravenous Everolimus Nanoparticle (Sapu003): Rationale for the First in Human Trial
1702 PS4-04-21 Deciparticle Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing
1811 PS4-06-05 Sapu003: Everolimus for Injection – Pharmacokinetic Rationale for Phase I Evaluation in HR /HER2 Metastatic Breast Cancer

"These three accepted abstracts underscore the breadth and innovation of our Deciparticle nanomedicine platform," said Dr. Vuong Trieu, CEO of Sapu Nano. "Sapu003 represents the first intravenous everolimus formulation with the potential to deliver robust mTOR inhibition and direct tumor cytotoxicity. We are honored to share these findings with the global oncology community at SABCS."

The studies were conducted in collaboration with Southern Oncology Clinical Research Unit (SOCRU), Ingenu CRO, and Medicilon, and reflect a coordinated clinical-translational effort bridging molecular biomarker discovery, pharmacokinetic modeling, and scalable GMP manufacturing of Deciparticle everolimus.

(Press release, Oncotelic, OCT 23, 2025, View Source [SID1234656955])

On October 23, 2025 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported preclinical data related to the company’s cyclin D1 development program at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The data highlight the therapeutic potential of Circle Pharma’s first-in-class oral macrocyclic inhibitors to preserve retinoblastoma protein (Rb) tumor-suppressor activity by selectively blocking its interaction with cyclin D1, a key driver of cell cycle progression and proliferation in multiple hematological and solid tumor cancer types.

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"Cyclin D1 has long been recognized as a key driver in many cancers, but it has remained an elusive direct therapeutic target," said Marie Evangelista, Ph.D., senior vice president and head of cancer biology at Circle Pharma. "Using our MXMO platform, we have engineered orally bioavailable, cell-permeable macrocycles that selectively inhibit cyclin D1-Rb binding while sparing related isoforms such as cyclin D3—an approach aimed at reducing hematologic toxicities commonly observed with dual CDK4/6 inhibitors. These data mark a significant step forward in developing novel, macrocycle-based therapies for patients with cyclin D1-driven cancers."

"We are excited by the strong selectivity and anti-tumor activity we’re seeing across multiple cyclin D1-driven cancer models including mantle cell lymphoma and ER-positive breast cancer," said David J. Earp, J.D., Ph.D., president and chief executive officer of Circle Pharma. "Our approach has the potential to open a new class of therapeutics for patients, including for use in combination with other therapies, and we are on track to declare a development candidate for our cyclin D1 program by end of 2025."

Presentation Highlights:

In cyclin D1-dependent preclinical tumor models, Circle’s oral macrocyclic cyclin D1 RxL inhibitors:

Potently and selectively disrupt the cyclin D1–Rb interaction with >2,000-fold selectivity over cyclin D3–Rb binding, leading to phospho-Rb suppression and G1 cell cycle arrest in cyclin D1-dependant tumor cells.
Demonstrate robust anti-tumor activity in mantle cell lymphoma (MCL) and ER-positive breast cancer models, including enhanced efficacy in combination with CDK4-selective, CDK4/6-dual, and endocrine therapies.
Show a substantially improved in-vitro hematopoietic safety profile compared to dual CDK4/6 inhibition.
The poster presentation will be made available on the Circle Pharma website at View Source

About Circle Pharma’s Oral Cyclin D1 RxL Inhibitor Program

Cyclin D1 is a regulatory protein that plays a crucial role in cell cycle progression and is overexpressed in many solid tumors and hematologic malignancies. In these cancers, the cyclin D1/CDK4 complex drives cell proliferation by binding to the tumor suppressor retinoblastoma protein (Rb) and promoting its phosphorylation and inactivation. Using its MXMO platform, Circle Pharma has developed oral macrocyclic inhibitors that potently and selectively disrupt the cyclin D1-Rb interaction, demonstrating robust anti-tumor activity in cyclin D1-driven cancers.

(Press release, Circle Pharma, OCT 23, 2025, View Source [SID1234656939])

On October 23, 2025 Orion Corporation ("Orion") and Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates, reported that Orion has obtained an exclusive, focused commercial license to one of Abzena’s monoclonal antibodies (mAbs) that targets a cancer of high clinical unmet need. The antibody will strengthen Orion’s broad oncology-focused drug Research and Development pipeline.

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The antibody was designed and developed at Abzena’s Cambridge, UK, early phase R&D facility using their proprietary Composite Human Antibody (CHAb) technology as part of an integrated developability platform approach to select a superior lead candidate. Abzena’s scientists screened antibodies against a number of parameters including functionality, safety, and manufacturability to identify a lead candidate devoid of risks that could impact downstream development processes and ultimately affect the clinical outcome of the antibody. Leveraging the AbZelectPRO cell line development (CLD) platform a highly stable and productive manufacturing cell line for this antibody was generated for manufacture.

Campbell Bunce, Chief Scientific Officer of Abzena, said, "We are delighted to have partnered with Orion on the design and development of our CHAb-designed mAb to support their extensive oncology-focused Research and Development pipeline. Using our uniquely integrated developability approach along with our streamlined AbZelectPRO CLD platform, we were able to design a de-risked lead antibody that offers Orion’s program the best chances of success in the clinic."

Antti Haapalinna, Vice President, External Science and Partnering, R&D, Orion Corporation, said, "We are very satisfied with the excellent and transparent collaboration and the results it has delivered in our common antibody program."

Abzena has over 20 years of experience designing, developing, and manufacturing monoclonal antibody programs. The organization can support antibody programs at its Cambridge, UK, and San Diego, USA facilities, with downstream process development and GMP manufacturing activities taking place in the US up to 2,000 litre in scale.

(Press release, Orion, OCT 23, 2025, View Source [SID1234656956])

On October 23, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS) reported that the company will be webcasting its presentations at the following upcoming conferences:

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UBS Global Healthcare Conference in Palm Beach Gardens, FL on Monday, November 10, 2025, at 1:15 p.m. Eastern Time / 10:15 a.m. Pacific Time
Jefferies Global Healthcare Conference in London, England on Tuesday, November 18, 2025, at 10:30 a.m. Greenwich Mean Time / 5:30 a.m. Eastern Time
Baird Biotech Discovery Series takes place virtually on Wednesday, December 17, 2025, at 1:30 p.m. Eastern Time / 10:30 a.m. Pacific Time
The presentations will be accessible via webcast links on the Investor Events section of the Coherus website: View Source Replays of the presentations will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conferences, please reach out to your respective bank representative.

(Press release, Coherus Oncology, OCT 23, 2025, View Source [SID1234656940])