On March 19, 2025 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company’s innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer (Press release, Shanghai Henlius Biotech, MAR 19, 2025, View Source [SID1234651270]).

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According to the U.S. FDA, the drug or biological product receives an ODD will be eligible for certain development incentives, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent, aiming to accelerate the development process so that patients can benefit from the products as soon as possible. Receiving an Orphan Drug Designation for HLX22 recognizes its potential to treat patients with gastric cancer and marks another milestone for HLX22, following the initiation of its multicenter phase 3 clinical trials in multiple countries and regions worldwide, and signifies a crucial step forward in its global presence.

Until now, gastric cancer still constitutes a major global health problem. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally[1]. Gastric cancer is often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6%[2,3]. Despite significant advancements in targeted therapies, such as anti-HER2 agents, and immune checkpoint inhibitors (anti-PD-1/PD-L1 mAbs) for gastric cancer treatment in recent years[4], the disease’s high molecular heterogeneity leads to markedly varied responses to chemotherapy, targeted therapy, and immunotherapy across different subtypes[5]. This underscores the urgent unmet clinical needs in the overall management of gastric cancer.

HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe) demonstrate that the addition of HLX22 to trastuzumab plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[6-8]，expected to redefine the first-line standard treatment for advanced gastric cancer. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC have been approved in China, the U.S, Japan and Australia, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally.

Looking forward, Henlius will adhere to patient-centricity, accelerating the multi-regional clinical trials of HLX22 to deliver this innovative therapy to patients worldwide. Meanwhile, the company will continue to delve into the oncology field, driving the development of more innovative therapeautics to provide high-quality and affordable treatment options.

On March 19, 2025 Akebia Therapeutics, Inc. ("Akebia") (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported the pricing of its underwritten public offering (the "Offering") of 25,000,000 shares of its common stock at a public offering price of $2.00 per share (Press release, Akebia, MAR 19, 2025, View Source [SID1234651269]). All shares are being offered by Akebia. The gross proceeds to Akebia from the Offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be $50.0 million. In addition, Akebia has granted the underwriters a 30-day option to purchase up to 3,750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on March 21, 2025, subject to the satisfaction of customary closing conditions.

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Leerink Partners and Piper Sandler & Co. are acting as joint bookrunning managers for the Offering. BTIG, LLC is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the Offering.

The shares are being offered by Akebia pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on September 3, 2024 and declared effective by the SEC on September 12, 2024.

The Offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the Offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the Offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800)-808-7525, ext. 6105, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800)-747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell, or a 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 any such state or jurisdiction.

On March 19, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 Phase III trial (Press release, Immutep, MAR 19, 2025, View Source [SID1234651268]). The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.

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The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, "We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date."

Details for the poster presentation:
Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number: 131TiP
Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time: 26 March 2025, 13:50 CET

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alpha (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On March 19, 2025 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Company’s Management will be attending and presenting at the Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer 2025 Conference being held March 27th-29th, 2025 at The Roosevelt New Orleans Hotel in New Orleans, LA (Press release, Theriva Biologics, MAR 19, 2025, View Source [SID1234651267]).

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A company presentation will take place during the conference’s Innovation track on Friday, March 28th at 9:00am. NeauxCancer conference’s Innovation track spotlights the most promising emerging biotech and healthcare companies advancing detection, treatment, and cures across critical oncology areas.

Theriva’s management team will be available for one-on-one meetings during the conference, interested investors should contact Theriva’s investor relations representative as below.

On March 19, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported that it will host a KOL call that will feature Dr. Ehab Atallah, Professor of Medicine at the Medical College of Wisconsin and principal investigator of the Actimab-A + CLAG-M combination trial in patients with relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Actinium Pharmaceuticals, MAR 19, 2025, View Source [SID1234651266]). Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium’s cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium will provide a pipeline update to highlight 3 separate potential multi-billion-dollar blockbuster market opportunities for its targeted radiotherapies including the following:

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Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including AML and myelodysplastic syndromes (MDS) across multiple treatment settings
Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)
Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes
To register for the KOL Call & Pipeline Update please use the following link:

View Source

Sandesh Seth, Actinium’s Chairman and CEO, said, "We have made significant progress across our pipeline in the first quarter of 2025 achieving several important milestones. We are excited to highlight the large multi-billion-dollar market opportunities for Actimab-A in myeloid malignancies and now solid tumors, as well as cell and gene therapy conditioning with Iomab-ACT. With cash runway into 2027, we are in an excellent position to advance our programs, and we are excited to deliver validating data in the second half of 2025."