On October 15, 2025 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream")(Tokyo: 4587), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, "PDRadiopharma"), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), reported that a registrational Phase 2 clinical trial (jRCT: 2031250225) has been initiated in Japan for 64Cu-PSMA-I&T, a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 64Cu-PSMA-I&T in Japan. Both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T are considered potential products for diagnosing and treating PSMA-expressing prostate cancer. There is demand in Japan for PSMA PET diagnosis, as many urologists wish to use this imaging modality in clinical practice. In collaboration with Curium, we aim to address this need and utilize radiopharmaceuticals to provide new medical treatments for patients."

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Global Clinical Trial Progress

For 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.
For 64Cu-PSMA-I&T, trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

(Press release, PeptiDream, OCT 15, 2025, View Source [SID1234656689])

On October 15, 2025 OSE Immunotherapeutics reported its consolidated financial results for the first half of 2025.

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(Press release, OSE Immunotherapeutics, OCT 15, 2025, View Source [SID1234661838])

On October 15, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported that, as part of its previously announced $375 million capital return program, it has entered into share purchase agreements (the "Purchase Agreements") to repurchase all of the shares of the Company’s common stock beneficially owned by each of ADAR1 Capital Management ("ADAR1") and Pontifax Venture Capital ("Pontifax") at a purchase price of $17.75 per share in cash. The aggregate purchase price for the repurchase is approximately $181 million, which is expected to be funded from the Company’s existing cash and cash equivalents. The transactions are expected to close on October 15, 2025. In connection with the Purchase Agreements, Mr. Ran Nussbaum and Mr. Tomer Kariv have tendered their resignations to the Board of Directors, effective immediately.

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In connection with its entry into the Purchase Agreements, Keros also reported that it plans to distribute 25% of any net cash proceeds it receives on or before December 31, 2028 from its global license agreement with Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") to Keros stockholders.

Following the closing of the transactions with ADAR1 and Pontifax, the Company intends to commence a tender offer for up to $194 million in value of shares of the Company’s common stock, subject to market conditions, at a purchase price of $17.75 per share in cash. The Company presently intends to commence the tender offer by the end of October 2025. The Company expects to fund the tender offer from its existing cash and cash equivalents.

"We are pleased to have reached these agreements with ADAR1 and Pontifax, and look forward to completing our capital return program in the near term. The capital return program – which includes an additional commitment to distribute future near-term Takeda proceeds – reflects our confidence in the outlook for Keros and the prospects for our key clinical program, KER-065," said Jean-Jacques Bienaimé, Chair of the Board of Directors. "With a more focused and streamlined organization, supported by a strong financial position, we are moving forward fully focused on the execution of our clinical strategy. We continue to target a first quarter 2026 start of the Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy ("DMD"), subject to positive regulatory interaction, and believe Keros is well-positioned to deliver meaningful value to both patients and stockholders."

"Our engagement with the management team and Board has delivered results for all stockholders, including a commitment by Keros to return a portion of the Takeda licensing revenue directly to investors," said Daniel Schneeberger, Founder and Chief Investment Officer at ADAR1 Capital Management. "We appreciate the collaborative dialogue we have had with the Company and believe today’s announcement is a thoughtful and positive step toward enhancing long-term stockholder value."

The negotiation and approval of the repurchase transactions with ADAR1 and Pontifax were overseen by a Capital Return Committee of Keros’ Board of Directors, composed entirely of independent and disinterested directors. The Committee recommended that the full Board approve the repurchase transactions and the subsequent tender offer, which the Board approved.

The Purchase Agreements include certain customary standstill, voting and other provisions. Details of the Purchase Agreements will be filed on a Form 8-K with the U.S. Securities and Exchange Commission (the "SEC").

Goldman Sachs & Co. LLC is serving as Keros’ financial advisor, and Cooley LLP is serving as legal counsel.

(Press release, Keros Therapeutics, OCT 15, 2025, sec.gov/Archives/edgar/data/1664710/000110465925099512/tm2528773d1_ex99-1.htm [SID1234656674])

On October 15, 2025 Tubulis reported the successful closing of a €308 million (USD 361 million) financing. The round was led by Venrock Healthcare Capital Partners with participation from additional new investors Wellington Management and Ascenta Capital. Existing investors who supported the Series C include Nextech Invest, EQT Life Sciences, Frazier Life Sciences, Andera Partners, Deep Track Capital, Bayern Kapital, Fund+, High-Tech Gründerfonds (HTGF), OCCIDENT, and Seventure Partners.

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The proceeds from the Series C financing will be used to expand the clinical development of TUB-040, Tubulis’ lead antibody-drug conjugate (ADC) candidate, into earlier lines of therapy and additional tumor indications. TUB-040 targets NaPi2b, an antigen that is overexpressed in ovarian cancer and lung adenocarcinomas. TUB-040 is currently being evaluated in a Phase I/IIa study (NAPISTAR1-01, NCT06303505) in patients with platinum-resistant ovarian cancer (PROC) as well as relapsed or refractory non-small cell lung cancer and was granted Fast Track designation by the U.S. FDA in June 2024. The capital will also advance Tubulis’ pipeline, including the clinical-stage ADC candidate TUB-030, several preclinical programs, and expand its proprietary ADC platform technologies to bring ADCs into novel applications.

"This landmark financing round reflects the deep conviction these global healthcare investors have in Tubulis and the disruptive potential of our ADC platforms," said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. "With TUB-040 progressing in the clinic and first data to be shared in a late-breaking oral presentation at ESMO (Free ESMO Whitepaper), we are ready to expand into earlier treatment lines, while continuing to innovate across our pipeline and technology platforms. The new funding empowers us to execute on our vision of creating truly differentiated antibody-drug conjugates that are tailored to the biology of solid tumors and can deliver superior therapeutic value to patients."

"Tubulis has distinguished itself in the ADC field with a forward-looking vision consistently backed by strong scientific data," said Nimish Shah, Partner at Venrock Healthcare Capital Partners. "The company is now positioned to translate an exceptional preclinical foundation into meaningful clinical results, with several important readouts on the horizon. As Tubulis continues to expand its pipeline and build momentum, I’m excited to partner with the leadership team and Board to advance a new generation of ADC medicines for patients."

In conjunction with the financing, Dr. Lorence Kim, Co-founder and Managing Partner at Ascenta Capital and Patrick Heron, Managing Partner at Frazier Life Sciences, will join Tubulis’ Supervisory Board. An overview of all Supervisory Board members and their biographies can be found here.

"This milestone financing is a testament to the scientific strength and executional track-record of the Tubulis team," added Dr. Christian Grøndahl, Chair of the Supervisory Board of Tubulis. "The company has built a unique ADC platform and is now working on demonstrating its clinical impact. With the backing of experienced biotech investors, Tubulis is on a path towards solidifying its position as a global leader in the ADC landscape."

(Press release, Tubulis, OCT 15, 2025, View Source [SID1234656690])

On October 15, 2025 PharmaMar Group (MSE: PHM) reported it has received a milestone payment of $50 million from Jazz Pharmaceuticals plc (Nasdaq:JAZZ) related to the full approval granted on October 2nd of this year from the U.S Food and Drug Administration (FDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

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In December 2019, PharmaMar entered into an exclusive license agreement with Jazz Pharmaceuticals for lurbinectedin in the United States.

(Press release, PharmaMar, OCT 15, 2025, View Source [SID1234656675])