On October 31, 2025 Mycenax Biotech Inc. (TWO:4726), a leading biologics CDMO based in Taiwan, reported the signing of a License Agreement with Japan-based RIN Institute Inc., granting Mycenax rights to apply RIN’s proprietary Val-Leu-Lys (VLK) linker technology in CDMO services worldwide.

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RIN’s VLK linker has demonstrated superior anti-tumor efficacy and high serum stability, enabling the development of advanced ADCs. Specifically, the VLK linker facilitates cytotoxicity through two mechanisms: action within the tumor microenvironment and enhanced ADC internalization. The agreement strengthens Mycenax’s capability to deliver differentiated ADC solutions for global pharmaceutical partners.

"We are thrilled to finalize this agreement with RIN Institute, marking an important milestone in our mission to provide innovative and competitive ADC solutions," said Pei-Jiun Chen, CEO and President of Mycenax. "This collaboration further enhances our technical capabilities and reinforces our commitment to advancing next-generation ADC therapeutics."

The partnership builds upon the Letter of Intent (LOI) signed on April 7, 2025, which laid the foundation for closer cooperation between the two companies in advancing ADC innovation.

(Press release, Mycenax, OCT 31, 2025, View Source [SID1234659213])

On October 31, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it has entered into a securities purchase agreement with a new long-term fundamental investor for the purchase and sale of 5,000,000 shares of common stock at a purchase price of $0.80 per share, in a registered direct offering, for gross proceeds of approximately $4 million, before deducting placement agent commissions and other offering expenses. The offering is expected to close on or about November 3, 2025, subject to the satisfaction of customary closing conditions.

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The Company expects to use the net proceeds from the offering for the advancement of their clinical trials, working capital and general corporate purposes. Upon closing of the offering, the Company expects it will have cash runway until the end of the first quarter of 2027.

A.G.P./Alliance Global Partners is acting as the sole placement connection with the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 280681) which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The offering is being made only by means of a prospectus which is part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Additionally, when available, electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.

(Press release, Intensity Therapeutics, OCT 31, 2025, View Source [SID1234659212])

On October 31, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology and inflammation & immunology (I&I), reported that it will present a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting, taking place November 5–9, 2025, in National Harbor, Maryland.

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The presentation will include initial Phase 2 monotherapy results from the ongoing STARt-001 trial, which is evaluating Invikafusp alfa in tissue-agnostic, tumor mutational burden-high (TMB-H) advanced cancers. The findings underscore Invikafusp alfa’s potential to selectively activate unique T cell subsets, leading to reinvigoration of anti-tumor immunity across a broad range of solid tumors.

Presentation Details:

Title: Initial monotherapy clinical activity of invikafusp alfa, a first-in-class TCR β-chain-targeted bifunctional antibody, in tissue-agnostic, TMB-H patients from STARt-001, a Phase 1/2 trial
Conference: SITC (Free SITC Whitepaper) Annual Meeting 2025
Abstract Number: LBA1316
Session Title: Clinical Oral Abstract Session 1
Session Date and Time: Friday, November 7, 2025, 11:30 AM ET
Presenter: Aurélien Marabelle, MD, PhD (Gustave Roussy Cancer Center, France)
Marengo will also present data from its TriSTAR T cell engager platform in addition to four preclinical analyses in collaboration with the National Cancer Institute (NCI) exploring rational combinations of Invikafusp alfa with standard-of-care modalities.

(Press release, Marengo Therapeutics, OCT 31, 2025, View Source [SID1234659211])

On October 31, 2025 Alpha Fusion Inc. (Headquarters: Chiyoda-ku, Tokyo; CEO: Sunao Fujioka; hereinafter "Alpha Fusion") reported the initiation of a company-sponsored Phase I clinical trial (jRCT2031250472) of the alpha-emitting radiopharmaceutical af-001, which contains [211At]NaAt as its active pharmaceutical ingredient, in patients with differentiated thyroid cancer (papillary and follicular carcinoma).

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This clinical trial is designed based on the results of an investigator-initiated Phase I study conducted at The University of Osaka, and consists of Part Ia and Part Ib.

In Part Ia, the maximum tolerated dose (MTD) of a single intravenous administration of af-001 will be determined in patients with differentiated thyroid cancer who are refractory to or intolerant of standard therapies. Part Ib will evaluate the efficacy and safety of multiple intravenous administrations of af-001 to determine the recommended dose for Phase II trials in patients with differentiated thyroid cancer who have not received prior radioactive iodine (RAI) therapy (RAI-naïve).

Part Ia of the study will be conducted at the National Cancer Center Hospital East (Principal Investigator: Dr. Makoto Tahara, Chief, Department of Head and Neck Medical Oncology), and Part Ib will be conducted at multiple sites in Japan.

The clinical development of af-001 will proceed with the goal of obtaining regulatory approval for use in patients with RAI-naïve differentiated thyroid cancer (papillary and follicular carcinoma). If clinical efficacy and safety are indicated in this patient population, af-001 is expected to contribute as a next-generation radiopharmaceutical and as a novel therapeutic option for differentiated thyroid cancer.

af-001 is manufactured under GMP for investigational products in collaboration with the Kobe City Medical Center General Hospital (Director: Dr. Yasuki Kihara; Chuo-ku, Kobe City, Hyogo), and promptly delivered to the National Cancer Center Hospital East after production.

Regarding the initiation of this study, Sunao Fujioka, CEO of Alpha Fusion Inc., commented as follows:

"Based on the achievements of the investigator-initiated Phase I study in patients refractory or intolerant to standard therapies, we expect to maximize the potential of af-001 by confirming its safety and efficacy in RAI-naïve patients. Alpha Fusion is fully committed to advancing the clinical development of af-001, with the ultimate goal of providing outpatient alpha-emitting radiopharmaceutical therapy to more patients with thyroid cancer. In addition, we are pursuing multiple research and development pipelines utilizing At-211, aiming to create innovative radiopharmaceuticals for various types of cancer."

Background

RAI therapy is the standard treatment for differentiated thyroid cancer. However, in cases involving multiple metastases or insufficient therapeutic response despite clear iodine uptake, repeated RAI treatments may be required.

Moreover, due to radiation protection requirements in Japan, RAI therapy must be administered in shielded rooms, leading to hospitalization that imposes psychological stress on patients and financial burdens on hospitals. A survey in Japan reported an average waiting time of approximately 3.7 months, and 23% of facilities having a wait time exceeding six months (Survey Report on the Utilization of RI Therapy Rooms for Thyroid Cancer, 2022).

Given these challenges, there is a growing demand for patient-centric radiopharmaceuticals that can achieve potent tumor-reducing effects in an outpatient setting.

About At-211 (af-001)

af-001 is a radiopharmaceutical containing astatine-211 (At-211) as its active pharmaceutical ingredient. It is selectively taken up by differentiated thyroid cancer cells through the sodium/iodide symporter (NIS) and exerts a cytotoxic effect by emitting alpha particles.

At-211 emits alpha particles with higher energy than beta particles, inducing double-strand DNA breaks in cancer cell nuclei and leading to tumor regression.
Because alpha particles have a very limited range (approximately several tens of micrometers), af-001 can deliver strong therapeutic effects while minimizing damage to surrounding normal tissues. Consequently, substituting RAI with the limited-range alpha emitter af-001 may enable outpatient-based treatment.

With these unique characteristics, af-001 is being developed as a next-generation radiopharmaceutical and a novel treatment for differentiated thyroid cancer, offering both efficacy and safety.

Results of the Investigator-Initiated Clinical Trial and Positioning of the Company-Sponsored Trial

Prior to this company-sponsored trial, an investigator-initiated Phase I clinical trial (Alpha-T1 Trial) of [211At]NaAt, identical in composition to af-001, was conducted at The University of Osaka under the supervision of Dr. Tadashi Watabe, Principal Investigator (NCT05275946).

The study indicated the safety and tolerability of [211At]NaAt in patients with differentiated thyroid cancer refractory or intolerant to standard therapies. Additionally, the study reported a ≥50% reduction in thyroglobulin concentration (a tumor marker) and cases of disappearance of 131I uptake on imaging.

The present company-sponsored trial aims to evaluate the efficacy and safety of af-001 (identical in pharmaceutical ingredient to TAH-1005, [211At]NaAt) in RAI-naïve patients, with the objective of determining the recommended dose for subsequent Phase II studies.

(Press release, Alpha Fusion, OCT 31, 2025, View Source [SID1234659210])

On October 31, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that it has entered into a royalty-based financing agreement with HealthCare Royalty ("HCRx"), providing up to $71 million in non-dilutive capital and establishing the financial foundation for self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growth.

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"This non-dilutive financing reflects our commitment to preserving long-term shareholder value, while strategically aligning capital to unlock the full potential of our nanotherapeutics platforms. Importantly, this funding provides the resources to advance the company through critical potential milestones that will lead to self-sustainability and durable value creation," said Bart van Rhijn, Chief Financial and Business Officer at Nanobiotix.

Key Terms of the Royalty Financing Agreement

At the closing of the agreement, Nanobiotix will receive an upfront payment of $50 million and expects to receive an additional $21 million one year post closing subject to reaching certain conditions
Assuming $71 million is funded, success-based1 remuneration to HCRx includes:
Repayment from a defined portion of royalties on the first $1 billion of net sales and a portion of certain regulatory and commercial milestone payments, subject to a cap of approximately $124 million (1.75x Multiple on Invested Capital ("MOIC")) if repayment is completed by end of 2030, increasing to approximately $178 million (2.50x MOIC) if repayment occurs thereafter (the Return Cap figures assume $71 million is funded)
Following achievement of the Return Cap, a royalty-only tail period will commence, which entitles HCRx to a predefined, reduced share of royalties not to exceed $14.9 million per year; the tail period will expire 10 years following the first commercial sale of JNJ-1900 (NBTXR3) in the US
Payment and repayment obligations under both this royalty financing agreement with HCRx and the existing royalty agreement with the European Investment Bank (EIB) will be furnished through the transfer of receivables from the JNJ-1900 (NBTXR3) license agreement to a French law trust
"We are excited to partner with Nanobiotix at this pivotal stage of its growth" said Clarke Futch, Chairman and Chief Executive Officer at HCRx. "The differentiated nature of their physics-based approach and the compelling clinical profile of JNJ-1900 (NBTXR3) align with our mission of supporting innovative therapies that address areas of significant unmet need. This investment underscores our confidence in this first-of-its-kind approach to cancer treatment, which has the potential to redefine standards of care and establish an entirely new class of therapy."

TD Cowen acted as sole financial advisor to Nanobiotix.

Assuming the drawdown of the second tranche one year post closing, this financing extends Nanobiotix cash runway into early 2028 subject to closing of the agreement. This extension of cash runway does not include potential milestone payments from the JNJ-1900 (NBTXR3) licensing agreement. The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

(Press release, Nanobiotix, OCT 31, 2025, View Source [SID1234659207])