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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]).

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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.

Akari Therapeutics Files Two NewPatents for Immuno-Oncology Mode of Action for Novel ADC Platform Utilizing Spliceosome Modulating Payload PH1

On October 9, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported that it has filed two new provisional patent applications with the United States Patent and Trademark Office (USPTO). The first application includes claims protecting Akari’s novel immuno-oncology payload, PH1 (a novel Thailanstatin analog), and its spliceosome modulatory mechanism of action, which is expected to provide a therapeutic benefit by activating the host immune system in the fight against cancer. The second patent filing includes claims for a combination therapy of PH1 pipeline ADCs with other immuno-oncology drugs that alleviate checkpoint inhibition and have demonstrated synergy with immune checkpoint inhibitors (ICIs) in preclinical models. These new patent applications are part of a growing patent portfolio strategy designed to further extend Akari’s proprietary position with respect to the Company’s novel PH1 payload. These filings also build upon Akari’s recent provisional patent filing in late September covering the use of Akari’s ADC platform to target cancer by modulating alternative splicing drivers within cancer cells.

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, "The filing of these two patent applications furthers our strategy to establish a framework for building a new class of immuno-oncology ADC therapies and build on the tremendous success of checkpoint inhibitors. We believe the data within our patent applications enable the potential of our PH1 payload to build novel first-in-class immune-oncology ADCs and continue to demonstrate Akari’s advances in our understanding of spliceosome modulation as a strategy to attack cancer. In particular, these two patent applications include data that highlight the unique immuno-oncology action that the PH1 payload can potentially unlock to drive differentiated clinical outcomes and remissions for cancer patients in the future."

"We look forward to sharing more details at the upcoming presentation at the Society for Immunotherapy Cancer (SITC) (Free SITC Whitepaper) Congress as an oral presentation on November 9th to highlight the progress of our exciting research on Akari’s spliceosome modulating payload PH1. These specific provisional patent applications are designed to protect our disclosures at the SITC (Free SITC Whitepaper) conference and increase the scope of our intellectual property estate, which we anticipate will enable long term value creation for Akari and potential partners we elect to work with on our ADC portfolio," concluded Mr. Gaslightwala.

To build on the Company’s current patent estate around the PH1 spliceosome modulating payload, these patent filings include data that highlights the immuno-oncology properties of Akari’s proprietary ADCs as a single agent, as well as a synergistic gain-of-function effects from the synergy created when Akari’s proprietary ADCs are combined with certain checkpoint inhibitors, as compared to either single agent-ADC or immune checkpoint inhibitor therapy.

Checkpoint inhibitors have seen historic success across several cancer types but have only benefited roughly 20-30% of patients as measured by response rates in approved cancer types. Akari’s data underscore the potential for creating a new ADC paradigm for targeting cancer via spliceosome modulation and unlocking the potential of a combination checkpoint inhibitor-PH1 ADC regimen in new and exciting ways.

The Company continues to expand its current ADC pipeline to encompass multiple targets, such as AKTX-101 (Trop2 ADC with PH1 payload), as well as future programs (AKTX-102, undisclosed target with PH1 payload).

(Press release, Akari Therapeutics, OCT 9, 2025, View Source [SID1234656890])