On July 2, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, reported new clinical data from the ongoing STARt-001 Phase 1/2 trial of Invikafusp alfa during an oral session at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 (Press release, Marengo Therapeutics, JUL 2, 2025, View Source [SID1234654227]).

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Presentation Details

Title: Phase 1/2 clinical investigation of Invikafusp alfa, a first-in-class TCR-beta chain-targeted bispecific antibody, as monotherapy in patients with anti-PD(L)1-resistant, antigen-rich gastrointestinal (GI) cancers
Abstract Number: 479MO (Late-breaking)
Session Title: Mini Oral session – Innovation in GI cancers
Session Date and Time: Thursday, July 2, 2025, 4:15 PM – 5:35 PM CET (UTC+01:00)
Presenter: Elena Elez, M.D. Ph.D., Vall d’Hebron Institute of Oncology
Invikafusp alfa is Marengo’s first-in-class dual T cell agonist, designed with a bi-specific antibody format to selectively engage and activate the Vβ6 and Vβ10 subsets of T cells in vivo, promoting durable anti-tumor immunity. The updated clinical data continue to reinforce invikafusp alfa’s potential as a backbone immunotherapy for PD-1 resistant gastrointestinal (GI) cancers, with monotherapy clinical responses observed in both colorectal cancer (CRC) and gastric-esophageal junction (GEJ) cancer, including tumor types where checkpoint inhibitors have very limited monotherapy activity.

"We are thrilled to see high quality single agent clinical activity in multiple PD-1 resistant tumor types including MSS CRC, PD-L1 negative NSCLC and now, additional GI cancers including GEJ cancer," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics. "Invikafusp’s ability to drive meaningful responses in both PD-1-resistant/insensitive tumors, and across diverse tissue types, underscores the potential of our precision T cell activation platform to deliver real impact as a new class of IO backbone in immunotherapy-refractory tumors. These results further validate our commitment to advancing invikafusp as next gen IO especially in GI cancers."

"The activity we are observing with invikafusp in both CRC and GEJ tumors is highly compelling and highlights the clinical potential of a novel T cell agonist approach," said Aparna Parikh, M.D., GI Oncologist and Director of Colorectal Medical Oncology and the Center for Young Adult Colorectal Cancer at Massachusetts General Hospital Cancer Center and Harvard Medical School. "Having a new class of cancer immunotherapy with such a differentiated mechanism in GI tumors, especially in those not responsive to checkpoint inhibitors, is truly exciting for the GI cancer research field and cancer patients."

Updated Findings from the ESMO (Free ESMO Whitepaper) GI 2025 Clinical Plenary Presentation:

In 17 heavily pretreated PD-1 resistant TMB-H GI cancer patients, invikafusp alfa monotherapy demonstrated:
Disease control rate (DCR): 63%
Tumor Regression Rate of 53%
Overall response rate (ORR): 23%
Responses included:
Three CRC responders across major molecular subtypes (MSS RASwt, MSS RASmut, PD-1 resistant MSI-H)
One objective response in PD-1 resistant MSI-H GEJ
In PD-1 resistant TMB-H metastatic CRC specifically, ORR was 25% (3/12 patients)
Safety Profile:

No new safety signals observed in Phase 2a
Safety profile consistent with invikafusp alfa’s selective T cell activation mechanism
Adverse events were generally transient and manageable with supportive care
Invikafusp alfa (STAR0602) is a first-in-class, dual T cell agonist designed to selectively activate Vβ6 and Vβ10 T cell subsets in vivo, promoting durable anti-tumor immunity. Marengo is currently enrolling patients in the Phase 2a expansion cohorts of STARt-001 trial across multiple tumor types, including TMB-H metastatic CRC, and MSI-H or TMB-H solid tumors.

On July 2, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported a presentation and discussion on immunotherapies involving AIM’s drug Ampligen at the recent U.S.-Poland Science and Technology Symposium 2025, held June 17-20, 2025, across Silicon Valley, San Francisco and Stanford University (Press release, AIM ImmunoTech, JUL 2, 2025, View Source [SID1234654212]). Pawel Kalinski, MD, PhD, a world-renowned research oncologist, presented on the drug and participated in a discussion session titled Revolution in Healthcare.

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Dr. Kalinski has been a senior investigator for multiple oncology clinical studies involving Ampligen, which has been studied for conditions such as solid tumors, viral diseases and disorders of the immune system. In his presentation and panel discussion, Dr. Kalinski presented his work with Ampligen as evidence of the potential successes that private-public partnerships can produce if companies, institutions and governmental agencies work together via joint clinical trials in the development of new treatments and therapies. Specifically, Dr. Kalinski believes that there is great potential to expand within the United States as well as Poland and other Central and Eastern European Countries, through such initiatives as the Translational Research Cancer Centers Consortium, or Marie Sklodowska-Curie Symposia on Cancer Research and Care (5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care).

This year’s conference theme was "Opportunities in Singularity." The conference was organized by the US-Poland Science and Technology Symposium in partnership with Taube philanthropies, the Consulate General of the Republic of Poland in Los Angeles, leading Polish universities, the Council of Polish Engineers in North America and Top 500 Innovators alumni.

AIM CEO Thomas K. Equels stated: "We can advance cancer research rapidly if we work together. This combined determination can pair innovative therapies with the critical funding needed to turn promising ideas into successful actions. In fact, putting this concept into practice will be one of my main goals at the upcoming Marie Sklodowska-Curie Symposia on Cancer Research & Care in Warsaw, Poland in September, where I will be working to establish government- and industry-funded clinical partnerships and potential licensing agreements in Europe, with an emphasis on Poland."

On July 2, 2025 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported the closing of its underwritten public offering of $115 million of shares of its common stock (Press release, Nektar Therapeutics, JUL 2, 2025, View Source [SID1234654228]). Nektar sold 4,893,618 shares of common stock in the offering, which includes 638,298 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The shares of common stock were sold at a public offering price of $23.50 per share. The gross proceeds to Nektar from the offering were approximately $115 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Nektar intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, clinical development and manufacturing costs to support the advancement of its drug candidates, as well as other general corporate purposes.

Jefferies and Piper Sandler acted as joint bookrunning managers for the offering. BTIG, LLC also acted as bookrunner for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (No. 333-286222) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 28, 2025 and declared effective on April 1, 2025. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 that state or jurisdiction.

On July 2, 2025 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "Company"), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the closing of its previously announced underwritten public offering for gross proceeds of approximately $6.9 million prior to deducting underwriting commissions and offering expenses (Press release, Cellectar Biosciences, JUL 2, 2025, View Source [SID1234654213]). The offering includes participation from healthcare dedicated funds and executive management.

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The offering is composed of (i) 1,045,000 Class A Units (which includes 180,000 Class A Units issued pursuant to the Underwriter’s exercise of the over-allotment option in full) with each Class A Unit consisting of (a) one share of common stock and (b) one common warrant to purchase one share of common stock (the "Common Warrants"), and (ii) 335,000 Class B Units with each Class B Unit consisting of (a) one pre-funded common stock purchase warrant to purchase one share of common stock ("Pre-funded Warrants") and (b) one Common Warrant. The price per Class A Unit is $5.00 and the price per Class B Unit is $4.99999 (collectively, the "Offering"). The Common Warrants have an exercise price of $5.25 per share, are exercisable upon issuance, and have a term expiring five years from issuance.

Ladenburg Thalmann & Co. Inc. acted as sole bookrunning manager in connection with this Offering.

The gross proceeds from the Offering to the Company, before deducting underwriting discounts and commissions and other Offering expenses and excluding any proceeds that may be received upon the exercise of the Common Warrants were approximately $6.9 million. The Company currently intends to use the net proceeds of the Offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer.

The securities described above were sold pursuant to a registration statement on Form S-1 (File No. 333-288333), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 1, 2025. A prospectus relating to the securities was filed with the SEC on July 1, 2025 and is available on the SEC’s website at View Source Electronic copies of the final prospectus, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On July 2, 2025 Modella AI, a leader in artificial intelligence for life sciences, reported a multi-year agreement with AstraZeneca (Press release, AstraZeneca, JUL 2, 2025, View Source [SID1234654229]). Under the agreement, Modella AI will provide access to its state-of-the-art multi-modal AI foundation models to AstraZeneca. This agreement aims to harness Modella AI’s advanced foundation models, capable of rich feature extraction from diverse data types, to accelerate clinical development across AstraZeneca’s global oncology portfolio.

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"Foundation models are transforming precision medicine. They are the backbone of AI-powered biomedical discovery and mark the first step toward fully autonomous AI agents," said Jill Stefanelli, CEO of Modella AI. "Our state-of-the-art multimodal foundation models provide powerful features from different data types for downstream tasks. When integrated with AstraZeneca’s research engine, they will have the potential to accelerate data driven development and enable the development of new AI agents that can automate complex R&D workflows."

AstraZeneca will leverage Modella AI’s platform to enhance its oncology R&D capabilities, with the goal of enhancing clinical development, biomarker discovery, and improving patient outcomes. Both companies will collaborate closely to integrate the models into AstraZeneca’s research pipeline, enabling data-driven discovery at increased scale and speed.

"At AstraZeneca, AI is integrated across every aspect of clinical development," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "Through the use of foundation models, combined with our unique datasets and AI expertise, we are confident in our strategy to accelerate development and increase the probabilities of success in our oncology clinical trials."