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PanTher Completes First Cohort in Pancreatic Cancer Phase 1b Trial Ahead of Expectations

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.

Aktis Oncology to Participate in Upcoming September Investor Conferences

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]):

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.

Citius Oncology Announces Closing of $9.0 Million Registered Direct Offering and Concurrent Private Placement

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.

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.

Hoth Therapeutics Secures Key European Regulatory Milestone with EMA Submission for Phase II Trial of HT-001 in Cancer Patients Suffering from EGFRi-Induced Skin Toxicities

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]).

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.

Revolution Medicines Shares New Clinical Results Supporting Initiation of RASolute 303, a Global Phase 3 Registrational Trial of Daraxonrasib in First Line Metastatic Pancreatic Ductal Adenocarcinoma

On September 10, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported key clinical updates from its daraxonrasib Phase 1 clinical trials (Press release, Revolution Medicines, SEP 10, 2025, View Source [SID1234655926]). The data, to be presented during an investor webcast today at 5:00 p.m. Eastern Time (ET), will focus on new daraxonrasib data in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), including long-term follow-up data in second line patients and initial monotherapy and chemotherapy-combination data in first line patients.

"Patients living with pancreatic cancer have an urgent need for more effective and durable treatment options, and we are pursuing a bold vision to establish new global standards of care across treatment lines for this devastating disease," said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Daraxonrasib’s pioneering mechanism of action covering RAS cancer driver mutations broadly, and highly encouraging new clinical findings released today, together provide strong evidence of its potential to serve these patients. The promising clinical profile observed in investigational studies to date in both previously treated and treatment-naïve patients with pancreatic cancer compels initiation of our planned registrational study evaluating daraxonrasib as monotherapy and in combination with chemotherapy in the first line metastatic setting."

Daraxonrasib Monotherapy: Long-term Follow-Up in 2L Metastatic PDAC
As of a June 30, 2025 cutoff date, patients with second line and beyond (2L+) metastatic PDAC treated with daraxonrasib 300 mg daily (QD) were evaluated for long-term follow-up on key safety and efficacy endpoints.

Safety: In 2L+ patients with RAS mutant PDAC (n=83), daraxonrasib 300 mg QD was generally well tolerated with a safety profile consistent with previously reported data. No new safety signals were identified.
Efficacy: Daraxonrasib at 300 mg QD demonstrated compelling antitumor activity and durability, with the following results for patients with second line (2L) RAS mutant PDAC with a RAS G12X mutation (n=26) or any RAS mutation (n=38), respectively:
The confirmed objective response rate (ORR) per RECIST v1.1 was 35% and 29%.
The disease control rate (DCR) was 92% and 95%.
The median progression-free survival (PFS) was 8.5 months (95% confidence interval (CI), 6.7 – 10.5) and 8.1 months (95% CI, 5.9 – 10.1).
The median overall survival (OS) was 13.1 (95% CI, 10.9 – NE) and 15.6 months (95% CI, 10.9 – NE).
Median follow-up was 16.7 months.
RASolute 302, the ongoing Phase 3 registrational trial of daraxonrasib monotherapy as a 2L treatment for metastatic PDAC, remains on track to complete global enrollment this year to enable an expected data readout in 2026.
Daraxonrasib Monotherapy: Initial Results in 1L Metastatic PDAC
As of a July 28, 2025 cutoff date, patients with treatment-naïve RAS-mutant PDAC treated with daraxonrasib 300 mg QD monotherapy were evaluated on key safety and antitumor activity endpoints.

Safety: In patients treated in this cohort (n=40), the safety profile observed for daraxonrasib monotherapy as a first line (1L) treatment was generally consistent with the reported safety findings for daraxonrasib in the 2L setting. The mean dose intensity was 85%.
Efficacy: In patients who met the definition of 1L metastatic PDAC and had sufficient follow-up (n=38), the ORR was 47% and the DCR was 89%, with a median follow-up of 9.3 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
Daraxonrasib plus Gemcitabine nab-Paclitaxel (GnP) Combination: Initial Results in 1L Metastatic PDAC

The combination of daraxonrasib plus chemotherapy is designed to sustain continuous suppression of RAS signaling by maintaining sufficient dose intensity for daraxonrasib, to leverage the antitumor contribution of chemotherapy and to achieve a safety profile that is competitive against standard chemotherapy.

For the combination, the company selected daraxonrasib 200 mg QD plus the standard dose of GnP given on a Days 1 and 15 schedule.

As of a July 28, 2025 data cutoff date, patients with 1L metastatic PDAC treated with the combination of daraxonrasib plus GnP were evaluated on key safety and antitumor activity endpoints.

Safety: In patients with RAS mutations (n=40), daraxonrasib plus GnP was generally well tolerated. The safety profile observed for the combination regimen was consistent with the sum of the known safety findings of each respective agent, and no new safety signals emerged. The mean dose intensity was 81%.
Efficacy: In patients who had sufficient follow-up (n=31), the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
These encouraging clinical results support the company’s plans to initiate RASolute 303, a global, randomized Phase 3 trial in patients with 1L metastatic PDAC, in the fourth quarter of 2025. The three-arm trial will evaluate daraxonrasib monotherapy and the combination of daraxonrasib plus GnP, each compared to a control arm with GnP treatment.

Investor Webcast

Revolution Medicines management will host an investor webcast today, September 10, at 5:00 p.m. ET (2:00 p.m. PT) to discuss these updates. To participate in the live webcast, participants may register at View Source A live webcast of the call will be available on the website at View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.

The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately 92% of all pancreatic cancer cases2. Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations3. Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%4.

About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).