On September 10, 2025 Mednovo Group Co., Ltd. ("Mednovo") reported that the first patient has been successfully dosed in its Phase III clinical trial of Lutetium [177Lu] Oxodotreotide Injection, a Class 3 targeted radiotherapeutic drug (Press release, Mednovo, SEP 10, 2025, View Source [SID1234655935]).

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As the exclusive clinical supply and manufacturing partner, C-Ray Therapeutics delivered end-to-end support for this milestone, including technology transfer, clinical batch production, quality release, and logistics. Leveraging China’s first fully automated radiopharmaceutical production line built to global cGMP standards, C-Ray ensured the trial began on schedule. The company’s philosophy—high quality, cost efficiency, and first-time-right production—underpinned its execution.

Lutetium [177Lu] Oxodotreotide Injection targets somatostatin receptors and is primarily indicated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Entering Phase III represents a pivotal step for the program, requiring production processes and quality controls that meet near-commercial standards. C-Ray’s cGMP manufacturing capabilities and globally compliant quality system provided a solid foundation for reliable clinical supply.

Since the project was accepted by China’s Center for Drug Evaluation (CDE), C-Ray has worked closely with Mednovo’s clinical schedule, efficiently completing raw material release, technology transfer, production, testing, and nationwide logistics to ensure timely first-patient dosing.

Looking ahead, C-Ray will continue supporting Mednovo’s multi-center trial with its patented, internationally compliant cold-chain packaging for radiopharmaceuticals and its integrated land-air logistics network.

A Mednovo representative commented that C-Ray Therapeutics is a vital partner for their Lutetium [177Lu] Oxodotreotide Injection program. Their professional expertise, efficiency, and cGMP-compliant automated production line ensured the stable, high-quality supply of clinical materials for this Phase III trial. They look forward to advancing this program together.

To date, C-Ray has successfully supported more than 50 CRDMO (Contract Research, Development, and Manufacturing Organization) projects across the full lifecycle—from early-stage R&D to clinical and commercial supply. With a 28,000 m² cGMP-compliant R&D and manufacturing base and a global radionuclide supply chain, C-Ray continues to deliver high-quality, efficient, and fully compliant solutions for pharmaceutical partners worldwide.

On September 10, 2025 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, reported that it has concluded dosing in the first cohort of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC) (Press release, PanTher Therapeutics, SEP 10, 2025, View Source [SID1234655930]). The rapid completion of this middle-dose cohort reflects vigorous engagement of the clinical oncology community with this new approach to cancer treatment.

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The ongoing dose escalation and expansion study builds on findings from PanTher’s first-in-human trial that confirmed the safety of PTM-101 at 100 mg and reported promising tumor shrinkage. In the current U.S. Phase 1b trial, patients are being treated at escalating dose levels of 200 mg and 400 mg. Completion of the full cohort at the 200 mg dose level without evidence of toxicities further demonstrates PTM-101’s safety — even at a dose higher than what is typically used for IV infusion — and confirms its ability to be administered with well-established laparoscopic procedures. The Safety Committee has cleared advancement to the final anticipated cohort, and dosing at the 400 mg dose level has now begun, with the first patient treated.

"The swift execution of this first stage of our Phase 1b study underscores the momentum of our clinical strategy and the promise of PTM-101 as a new treatment paradigm for pancreatic cancer," said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. "We are encouraged by the good safety profile observed so far and excited by the strong engagement from our clinical investigators. Medical and surgical oncologists are eager for better treatment options for their patients and have found that PTM-101 fits seamlessly into their existing neoadjuvant clinical treatments, creating an opportunity to reach patients at a critical point early in their journey."

Intravenous chemotherapy is highly inefficient at permeating solid tumors and can cause debilitating side effects. PTM-101 is an investigational thin film formulation of the chemotherapy drug paclitaxel that is designed to overcome these limitations. It delivers a sustained (~6 weeks) high dose directly to the tumor site with little to no systemic exposure.

"From a surgical perspective, PTM-101 has been straightforward to place and has integrated seamlessly into minimally invasive staging laparoscopy and mediport placement. I favor a robotic-assisted approach, which allows for enhanced handling of the delicate tissue around the pancreas," said principal investigator Danielle DePeralta, M.D., surgical director of the Pancreas Multidisciplinary Program at the Northwell Health Cancer Institute, Lake Success, NY. "Importantly, patch placement is incorporated into procedures that the patient would otherwise need prior to initiating standard systemic chemotherapy. My hope is that targeted local treatment with the patch, paired with standard chemotherapy, will make more patients with isolated pancreatic tumors candidates for surgical removal with the goal of long-term survival and cure. Because of the proximity of pancreatic tumors to major blood vessels, even minimal tumor shrinkage can make a big difference."

The dose escalation and dose expansion Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in subjects with borderline resectable or locally advanced PDAC. Dosing of patients has taken place at three clinical sites in the United States, with The University of Texas MD Anderson Cancer Center in Houston, Texas, recently joining the list of sites participating in the trial.

PTM-101 is the lead product candidate within PanTher’s pipeline of implantable medicines designed to directly address hard-to-treat solid tumors. PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types.

About PTM-101

PanTher’s most advanced investigational product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-term, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066.

On September 10, 2025 Aktis Oncology, Inc., a clinical-stage oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, reported that Matthew Roden, PhD, President and Chief Executive Officer, and other members of the Aktis Oncology leadership team, will participate in the following September investor conferences (Press release, Aktis Oncology, SEP 10, 2025, View Source [SID1234655929]):

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Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit

Date:

Thursday, September 11, 2025

Location:

New York, N.Y.

Bank of America Healthcare Trailblazers Private Company Conference

Date:

Wednesday, September 17, 2025

Location:

Everett, Mass.

On September 10, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, reported the closing of its previously announced registered direct offering and concurrent private placement of an aggregate of 5,142,858 shares of common stock and unregistered warrants to purchase up to an aggregate of 5,142,858 shares of common stock (Press release, Citius Oncology, SEP 10, 2025, View Source [SID1234655928]). The combined effective offering price for each share of common stock and accompanying warrant was $1.75. The warrants have an exercise price of $1.84 per share, will be exercisable six months from the date of issuance, and will expire on the five and one-half year anniversary from the date of issuance.

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The gross proceeds to the Company from the registered direct offering and concurrent private placement were approximately $9.0 million before deducting placement agent fees and other offering expenses payable by the Company.

Maxim Group LLC acted as the sole placement agent in connection with the offering.

The shares of common stock described above were offered pursuant to a registration statement on Form S-3 (File No. 333-289979), which was filed with the U.S. Securities and Exchange Commission ("SEC") on September 2, 2025, and was declared effective by the SEC on September 4, 2025. The offering of shares of common stock was made only by means of a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement relating to the shares of common stock has been filed with the SEC. Electronic copies of the prospectus relating to this offering, may also be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York 10022, Attention: Syndicate Department, by telephone at (212) 895-3745 or by email at [email protected]. The warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities 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 September 10, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, reported it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi) (Press release, Hoth Therapeutics, SEP 10, 2025, View Source [SID1234655927]).

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The submission marks a major regulatory inflection point for Hoth, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments. Pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple U.S. sites.

CEO Commentary

"We are very pleased with the timely CTA submission to the EMA, a pivotal step in advancing our international development of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Skin toxicities from EGFRi therapies remain an urgent, unmet medical need, and with no FDA or EMA-approved treatment available, advancing HT-001 in Europe represents a powerful opportunity to improve patient quality of life and drive meaningful value creation for shareholders."

Next Catalysts on Horizon

EMA Decision Expected in Coming Months covering initial sites across three EU countries.
Broader EU Expansion underway, with additional sites targeted to accelerate patient enrollment.
U.S. Phase 2a Trial Progressing – evaluating efficacy, safety, and tolerability of HT-001.