On July 3, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of a novel B7-H3 targeted ADC ICP-B794 (Press release, InnoCare Pharma, JUL 3, 2025, View Source [SID1234654240]).

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ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others.

Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "ICP-B794 is developed from the Company’s proprietary ADC platform. The platform is designed to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology."

With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like TRK inhibitor zurletrectinib (ICP-723), positions the Company to establish a strong presence in the field of solid tumor treatment.

On July 3, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso’s first bispecific ADC to enter clinical trials (Press release, Akeso Biopharma, JUL 3, 2025, View Source [SID1234654239]).

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AK146D1 has recently received approval from the U.S. FDA, Australia’s TGA, and China’s NMPA to begin clinical trials.

Currently, Akeso’s globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space.

Building on this, ADC therapeutics have become a key component of Akeso’s "IO+ADC" 2.0 strategy, reshaping the global treatment landscape and setting new standards for cancer care.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said:
"Leveraging our extensive experience in the development of multispecific antibody drugs, the advancement of innovative bispecific ADCs like AK146D1 enables the company to unlock the global clinical potential of its innovative product portfolio, expanding opportunities for the ongoing evolution of cancer therapies."

"Our globally first-in-class bispecific antibodies cadonilimab and ivonescimab have been successfully approved in China and have shown groundbreaking clinical value across various cancer treatments. This has established a strong global advantage for the company in the IO 2.0 space. Additionally, the efficient development of ADCs, particularly a series of innovative bispecific ADCs, will further strengthen our leadership in the ADC 2.0 field. As a result, after the evolution of IO + chemotherapy, IO + ADC, and IO 2.0 + ADC, Akeso has once again created a global competitive edge in "IO+ADC" 2.0. We are excited about the potential of these next-generation treatments to benefit patients worldwide."

Trop2 and Nectin4 are highly expressed in various tumor types but exhibit relatively low expression in normal tissues, making them ideal targets for ADC therapy. By targeting both Trop2 and Nectin4, AK146D1 aims to provide a broader therapeutic window and potentially overcome resistance seen with single-target ADCs, thus improving treatment efficacy.

While there are approved monoclonal ADCs targeting Trop2 and Nectin4, AK146D1 is the first bispecific ADC targeting both markers. Preclinical studies of AK146D1 have shown promising results, demonstrating strong anti-tumor activity and favorable safety profiles in tumors expressing Trop2 or Nectin4. The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, and Akeso is excited about the potential benefits it could offer to clinicians and patients worldwide.

On July 3, 2025 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported the pricing of an underwritten public offering of 14,285,715 shares of its common stock and accompanying Series A warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock and Series B warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock, at a combined public offering price of $1.75 per share of common stock and accompanying Series A and Series B warrants (Press release, Inovio, JUL 3, 2025, View Source [SID1234654235]). All of the securities in the offering are being sold by INOVIO. The offering is expected to close on or about July 7, 2025, subject to the satisfaction of customary closing conditions. INOVIO also granted the underwriters an option for a period of 30 days to purchase up to 2,142,857 additional shares of the Company’s common stock and Series A warrants to purchase up to 2,142,857 additional shares of its common stock and Series B warrants to purchase up to 2,142,857 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by INOVIO, excluding any exercise of the underwriters’ option to purchase additional securities and assuming no exercise of the accompanying Series A and Series B warrants, are expected to be approximately $25 million.

Piper Sandler & Co. is acting as sole active book-running manager for the offering. Oppenheimer & Co. Inc. is also acting as a passive bookrunner for the offering.

A shelf registration statement relating to the shares of common stock and accompanying Series A and Series B warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected] and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected].

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

On July 3, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that on July 2, 2025 the Company granted (i) non-qualified stock options to one newly-hired non-executive employee to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $1.12, which was the closing price per share of the Company’s common stock as reported by NASDAQ on July 2, 2025, the options grant date, and (ii) restricted stock units (RSUs) representing 37,900 shares of its common stock to two newly-hired non-executive employees (Press release, Fate Therapeutics, JUL 3, 2025, View Source [SID1234654234]). The grants were approved by the Compensation Committee of the Company’s Board of Directors and granted under the Company’s Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date. The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.

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On July 2, 2025 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco") and Instil Bio, Inc. (Nasdaq: TIL, "Instil"), reported the clearance of an Investigational New Drug (IND) application for IMM2510/AXN-2510 by the U.S. Food and Drug Administration (Press release, ImmuneOnco Biopharma, JUL 2, 2025, View Source [SID1234655711]).

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Instil expects to initiate a Phase 1b/2 trial of IMM2510/AXN-2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of IMM2510/AXN-2510 in patients with solid tumors. Additionally, Instil continues to anticipate data from the ongoing phase 2 study of IMM2510/AXN-2510 in combination with chemotherapy in front-line NSCLC in China to be shared in the second half of 2025 by ImmuneOnco.

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are pleased to announce that IMM2510/AXN-2510, a product of our collaboration with Instil Bio, has received clearance to proceed to the Phase 1b/2 clinical trial in the United States. This represents a significant step forward in our joint efforts.We are also looking forward to the disclosure of preliminary safety and efficacy data from the Phase 2 clinical trial of IMM2510 in combination with chemotherapy for the first-line treatment of non-small cell lung cancer in the second half of 2025. These results will provide further validation of its clinical efficacy. We are dedicated to continuing the advancement of this project with the aim of delivering more effective therapeutic options to patients worldwide."

Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil said: "We are pleased to announce the clearance of the IMM2510/AXN-2510 IND by the FDA. Evaluating IMM2510/AXN-2510 in a global population will be a critical milestone in the clinical development of IMM2510/AXN-2510."