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Taiho Oncology and Cullinan Therapeutics Present Data on Zipalertinib in Patients with NSCLC with EGFR mutations and Active Brain Metastases at the ESMO Congress 2025

On October 12, 2025 Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., reported new data from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations and CNS involvement (Press release, Taiho, OCT 12, 2025, View Source [SID1234656562]). Data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, as a mini oral presentation on October 19 during the "NSCLC metastatic" session from 8:30 to 10 a.m. CEST.

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The mini oral presentation will highlight preliminary efficacy and safety data from the CNS involvement cohort of the ongoing parallel cohort Phase 2b REZILIENT2 trial of zipalertinib.1

Patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations represent a significant unmet medical need. An incidence of baseline brain metastases in EGFR ex20ins NSCLC patients ranging from 23% to 39% has been reported.² Patients with lung cancer with CNS involvement have a worse prognosis and require more aggressive therapy, including surgery and radiotherapy.

"Treatment options are limited for patients with NSCLC with EGFR mutations and active brain metastases," said Helena A. Yu, MD, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer. "We are pleased to see that in approximately one-third of patients exposed to zipalertinib, a decrease in CNS lesions was observed. These preliminary results suggest the potential for zipalertinib to treat these patients, warranting future investigation."

Authors will report results from the REZILIENT2 study of zipalertinib against active CNS metastases in patients with NSCLC harboring EGFR ex20ins or other uncommon mutations1:

Summary of Preliminary Efficacy – by Investigator

As of the February 2025 data cutoff, 32 patients were enrolled in the CNS involvement cohort of the ongoing parallel cohort Phase 2b REZILIENT2 trial and received zipalertinib 100 mg orally twice daily. Patients received a median of 2 prior lines of therapy, and of all patients enrolled, 21 patients had ex20ins mutations and 13 patients had other uncommon mutations.

As of the data cutoff, zipalertinib demonstrated:

In the Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) criteria evaluable population with measurable CNS disease (n=16, including 3 patients with leptomeningeal disease (LMD), intracranial objective response rate was 31.3% including 1 intracranial complete response.
In the same population, the intracranial disease control rate (iDCR) was 68.8% and the median intracranial duration of response (DOR) was 8.1 months.
Measured in 29 of the cohort’s patients, preliminary systemic objective response rate (ORR) was 27.6% and median DOR was 7.6 months.
Intracranial antitumor activity was found to be similar to its overall systemic anticancer activity in this cohort of patients.
Summary of Preliminary Safety and Tolerability

Administered at 100 mg orally twice daily, zipalertinib was found to be well tolerated, with no new safety signals observed.

Treatment-related adverse events of grade 3 or higher occurred in 8 patients (25%) and included anemia (n=3) and interstitial lung disease (n=2). There was one death due to interstitial lung disease.

About REZILIENT2
REZILIENT2 is a Phase 2b clinical trial (NCT05967689), evaluating the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring ex20ins mutations or other uncommon/single or compound EGFR mutations. Patients are enrolled into one of four cohorts: Cohort A ("prior ex20ins treatment"), Cohort B ("first-line"), Cohort C ("active brain metastases"), and Cohort D ("other uncommon EGFR mutations"). Cohort C includes patients harboring EFGR ex20ins or other uncommon/single or compound EGFR mutations and CNS involvement. In this cohort, patients may or may not have had prior treatment for advanced disease. Patients are treated with oral zipalertinib 100 mg twice daily. The primary endpoint is ORR and confirmed per investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and the secondary endpoints include DOR, DCR, PFS, OS, intracranial efficacy by RANO-BM criteria, PK and safety.

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with ex20ins mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001

On October 11, 2025 C-Ray Therapeutics (Chengdu) Co.,Ltd reported congratulations to its strategic partner, Biokin Pharmaceutical, on receiving implied approval from the National Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injection, the company’s first radiopharmaceutical and a Class 1 innovative biologic (Press release, C-Ray Therapeutics, OCT 11, 2025, View Source [SID1234656563]).

This milestone approval marks Biokin’s entry into the fast-growing Radiopharmaceutical Drug Conjugate (RDC) field and reinforces its leadership in large-molecule oncology therapies (ADC/GNC/ARC). The company’s flagship asset BL-B01D1 (a first-in-class EGFR×HER3 bispecific ADC) set a record-breaking global licensing deal of USD 8.4 billion, underscoring Biokin’s innovation strength and global vision.

As the core CRDMO partner for the [177Lu]-BL-ARC001 program, C-Ray Therapeutics (Chengdu) Co.,Ltd provided end-to-end services including radiolabeling process development, quality studies, and registration batch manufacturing. Leveraging China’s first fully automated GMP-grade radiopharmaceutical production line, C-Ray completed process development and quality studies in just five months, followed by registration batch production in only seven months. This digitalized, automated model not only eliminates traditional manual risks but also ensures efficiency, consistency, and product quality.

C-Ray also made significant breakthroughs in cold-chain logistics, addressing long-distance, multi-center transport challenges for radiopharmaceuticals.

"C-Ray Therapeutics (Chengdu) Co.,Ltd has been an indispensable partner in the [177Lu]-BL-ARC001 program," said a Biokin executive. "Their expertise, execution speed, and customer-first mindset have accelerated our timeline while ensuring top-quality results. C-Ray’s automated GMP production line and innovative logistics solutions overcame critical challenges in this field, and we look forward to continuing our partnership in advancing this important therapy."

Moving forward, C-Ray Therapeutics (Chengdu) Co.,Ltd will continue supporting Biokin with clinical supply and distribution through its automated production line and China’s first international-standard radiopharmaceutical cold-chain system, ensuring smooth multi-center clinical research.

Biokin joins other leading Chinese pharma companies, including Kelun, Hengrui, Yunnan Baiyao, and Fosun, in expanding from ADCs and bispecifics into RDCs, pushing China’s radiopharmaceutical industry toward a new era of integrated diagnosis and therapy.

As a key integrator in this wave, C-Ray Therapeutics (Chengdu) Co.,Ltd has delivered over 50 CRDMO projects (35 CRO and 15 CDMO programs) covering the full lifecycle of radiopharmaceuticals—from early research and IND filing to clinical and commercial supply. With a strong isotope supply chain, including 14 projects involving Ac-225, C-Ray is committed to enabling partners to lead the global RDC race and bringing precision medicine to more patients.

Xenetic Biosciences, Inc. Announces Pricing of $4.5 Million Underwritten Offering of Common Stock

On October 10, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported the pricing of an underwritten offering of 735,000 shares of common stock at a price to the public of $6.12 per share, for gross proceeds of approximately $4.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses (Press release, Xenetic Biosciences, OCT 10, 2025, View Source [SID1234656556]). All shares of common stock are being offered by Xenetic. The offering is expected to close on or about October 14, 2025, subject to the satisfaction of customary closing conditions.

Canaccord Genuity is acting as the sole bookrunner for the offering.

Xenetic intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-282756) that was declared effective by the Securities and Exchange Commission ("SEC") on November 1, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and a final prospectus supplement with the final terms of the offering will be filed with the SEC and will be available for free on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Canaccord Genuity LLC, Attention: Syndication Department, One Post Office Square, Suite 3000, Boston, Massachusetts 02109, or by telephone at (617) 371-3900, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

Pelareorep Corporate presentation

On October 10, 2025 Oncolytics biotech presented its corporate presentation (Presentation, Oncolytics Biotech, OCT 10, 2025, View Source [SID1234656555]).

Bristol Myers Squibb Strengthens and Diversifies Cell Therapy Portfolio with Acquisition of Orbital Therapeutics

On October 10, 2025 Bristol Myers Squibb (NYSE: BMY, "BMS") and Orbital Therapeutics ("Orbital") reported a definitive agreement under which BMS will acquire Orbital, a privately held biotechnology company pioneering a new generation of RNA medicines that reprogram the immune system in vivo, enabling treatments that provide the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease (Press release, Bristol-Myers Squibb, OCT 10, 2025, View Source [SID1234656554]).

"In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases," said Robert Plenge, MD, PhD, executive vice president, Chief Research Officer, BMS. "This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options."

The acquisition includes Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, OTX-201, which comprises an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression delivered via targeted lipid nanoparticles (LNPs). This in vivo approach, in which the patient’s own body serves as the manufacturer of CAR T-cells, has the potential to offer a reduced treatment burden and improved accessibility compared to ex vivo CAR T-cell therapies. Additionally, BMS will acquire Orbital’s proprietary RNA platform, which integrates circular and linear RNA engineering, advanced LNP delivery, and AI-driven design to enable durable, programmable RNA therapies tailored to the distinct biology of a broad spectrum of diseases.

"With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, BMS. "As a leader in cell therapy, we are uniquely positioned to evaluate multiple different platform approaches to induce immune reset in autoimmune diseases and continue to optimize in vivo technology in clinical development."

"This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine," said Ron Philip, Chief Executive Officer, Orbital Therapeutics. "Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX-201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today’s complex therapies."

Under the terms of the agreement, BMS will pay $1.5 billion in cash at closing to acquire Orbital, which is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and until then, BMS and Orbital will continue to operate as separate and independent companies. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction.

Advisors
Covington & Burling LLP is serving as legal counsel to Bristol Myers Squibb. Centerview Partners LLC is serving as exclusive financial advisor to Orbital Therapeutics, and Goodwin Proctor LLP is serving as legal counsel.