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INNATE PHARMA ANNOUNCES FDA CLEARANCE TO PROCEED WITH TELLOMAK 3, A CONFIRMATORY PHASE 3 TRIAL OF LACUTAMAB IN CTC

On November 10, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed.

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The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway.

"This important regulatory milestone with the FDA marks a key step forward for the lacutamab program," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders."

"We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3," said Sonia Quaratino, Chief Medical Officer of Innate Pharma. "The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time."

About lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin’s lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes.

Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome.

(Press release, Innate Pharma, NOV 10, 2025, View Source [SID1234659717])

IMUNON R&D Day Showcases Clinical Progress of Its Novel Immunotherapy, Phase 3 Trial and Significant Potential for Women with Ovarian Cancer

On November 10, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported an update on recent progress with its IMNN-001 development program for the treatment of newly diagnosed advanced ovarian cancer, including a review of positive data from the Company’s Phase 2 OVATION 2 Study and the minimal residual disease (MRD) study conducted in partnership with Break Through Cancer. The program will also include updates on trial activation and patient enrollment in the Company’s ongoing Phase 3 OVATION 3 pivotal trial.

"IMNN-001 represents a potential landmark breakthrough in the treatment of newly diagnosed ovarian cancer in combination with standard of care chemotherapy. Data thus far indicate that our novel immunotherapy has the potential to represent a major advance in treatment that can make a meaningful difference in the lives of thousands of women," said Stacy Lindborg, Ph.D., President and CEO of IMUNON. "No other frontline ovarian cancer treatment has shown improvement in overall survival, which of course is the ultimate goal. We are very encouraged to see results from our Ovation 2 Study demonstrate that IMNN-001 treatment plus chemotherapy is associated with a 13-month improvement in overall survival with a highly favorable benefit-risk profile. The results from this landmark trial strongly support the advancement of IMNN-001 into our Phase 3 trial. We are excited to share the latest updates in today’s event and to review what’s ahead for this program."

R&D Day Featured Speakers and Program Highlights:

Premal H. Thaker, M.D., Washington University School of Medicine, will discuss the significant continuing unmet needs in ovarian cancer, a devastating disease where patient outcomes and frontline standard of care treatment have not changed for about 30 years, and the promise IMNN-001 brings to these patients and clinicians. She will highlight the data from the Phase 2 OVATION 2 clinical trial, with results including:
Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.
Amir Jazaeri, M.D., University of Texas MD Anderson Cancer Center, will discuss safety, tolerability and translational insights from the Phase 2 MRD study of IMNN-001, including:
Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that clearly show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data further supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab and in the maintenance setting.
Giorgio Paulon, Ph.D., Berry Consultants, LLC, will review the Phase 2 and ongoing Phase 3 trial designs and the strength of evidence for IMNN-001 from a statistical perspective. He will highlight the well-precedented nature of the Phase 3 design with the FDA, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by FDA based on interim analyses of overall survival. This foundation, supported by conservative power assumptions drawn from Phase 2 data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

Douglas V. Faller, M.D., Ph.D., IMUNON, will share new data further demonstrating that IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis. He will share the rapid progress to-date on the Phase 3 trial of IMNN-001, including expansion to additional sites and enrollment exceeding the Company’s expectations, strong levels of support and interest from investigators and the scientific community, and key clinical and other milestones for the company moving forward.
A live webcast of the event and presentation materials will be available on the "Scientific Presentations" page of the IMUNON website at View Source

(Press release, IMUNON, NOV 10, 2025, View Source [SID1234659716])

Immunocore to present at upcoming investor conferences

On November 10, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate at the following conferences in November.

Guggenheim 2nd Annual Healthcare Innovation Conference
Fireside Chat: Tuesday, November 11, 2025, at 3:00 p.m. EST

Jefferies London Healthcare Conference
Fireside Chat: Wednesday, November 19, 2025, at 3:30 p.m. GMT

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.

(Press release, Immunocore, NOV 10, 2025, View Source [SID1234659715])

Genmab Announces Proposed Private Offering of Senior Secured Notes and Senior Unsecured Notes and Syndication of New Senior Secured Term Loan Facility

On November 10, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that it and its wholly owned subsidiary Genmab Finance LLC ("Genmab Finance") intend to offer, subject to market and other conditions, $1.5 billion of senior secured notes due 2032 (the "Secured Notes") and $1.0 billion of senior unsecured notes due 2033 (the "Unsecured Notes," and together with the Secured Notes, the "Notes").

Genmab also launched the syndication of a new $2.0 billion senior secured term loan "B" facility, which term loan "B" facility is in addition to a $1.0 billion senior secured term loan "A" facility and $500 million senior secured revolving credit facility (collectively, the "New Credit Facilities") that Genmab previously syndicated to certain lenders as part of the financing for the pending acquisition (the "Acquisition") of Merus N.V. ("Merus").

Genmab intends to use the net proceeds from this offering of the Notes, together with borrowings under the New Credit Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition of Merus and related fees and expenses in connection with the Acquisition, the borrowings under the New Credit Facilities and the issuance of the Notes.

Prior to the Acquisition closing, the Notes and the related guarantees from Genmab subsidiaries will be secured solely by segregated securities accounts of Genmab in which the gross proceeds of the Notes will be held. Following the purchase of all Merus common shares tendered in the previously announced tender offer by Genmab, the Secured Notes will be secured by a first priority security interest in certain assets of Genmab and its subsidiaries that will guarantee the obligations under the New Credit Facilities, in accordance with certain customary practices in the relevant jurisdictions, and subject to certain thresholds, exceptions and permitted liens. The Secured Notes will be unconditionally guaranteed on a senior secured basis and the Unsecured Notes will be unconditionally guaranteed on a senior unsecured basis by certain subsidiaries of Genmab that will guarantee the obligations under the New Credit Facilities.

The indentures governing the Notes are expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of Genmab and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This announcement shall not constitute an offer to sell or a solicitation of an offer to purchase any securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, Genmab, NOV 10, 2025, View Source [SID1234659714])

Galecto Announces Acquisition of Damora Therapeutics

On November 10, 2025 Galecto, Inc. ("Galecto") reported the completion of the acquisition of Damora Therapeutics, Inc. ("Damora"), a privately held biotechnology company advancing a pipeline of antibody therapeutics aimed at transforming the treatment of mutant calreticulin- (mutCALR)-driven Myeloproliferative Neoplasms (MPNs), including Essential Thrombocythemia (ET) and Myelofibrosis (MF). The acquisition gives the combined company a pipeline covering a broad spectrum of hematological cancers and leverages the deep expertise of both teams, and positions Galecto to advance Damora’s complementary assets for people living with blood cancers, with the goal of developing safer, more effective, and more convenient disease-modifying therapies.

A concurrent private placement of Series C non-voting convertible preferred stock was led by Fairmount with participation from the following institutional investors: Viking Global Investors, Venrock Healthcare Capital Partners, Commodore Capital, Janus Henderson Investors, Wellington Management, RA Capital Management, TCGX, Forbion, BB Biotech, Blackstone Multi-Asset Investing, Perceptive Advisors, Vestal Point Capital, Balyasny Asset Management, Andreessen Horowitz (a16z Bio + Health), and a leading life sciences investment firm. The private placement resulted in gross proceeds to Galecto of approximately $284.9 million and is expected to fund operations into 2029, enabling advancement of Damora’s lead program, DMR-001, through key Phase 1 proof-of-concept data expected in 2027, as well as pipeline programs, DMR-002 and DMR-003, into Phase 1 studies.

MPNs are a group of rare, chronic blood cancers characterized by the abnormal production of blood cells in the bone marrow. MutCALRs drive uncontrolled proliferation and disease progression in 25% of ET and 35% of MF cases. There are approximately 42,000 patients in the United States living with mutCALR-driven MPNs.

Damora is the sixth company launched based on assets developed by Paragon Therapeutics. DMR-001 is a potentially best-in-class anti-mutCALR monoclonal antibody demonstrated to have enhanced activity in Type 1 and Type 2 mutCALR-driven preclinical models, with approximately 10-fold greater potency against Type 2 mutCALR-driven cell proliferation, as compared to internal data generated using a reference molecule in clinical development, supporting its potential to address the full spectrum of mutCALR mutations in both ET and MF. DMR-001 is engineered with validated half-life extension technology to enable infrequent low-volume, subcutaneous dosing. An IND submission for DMR-001, with anticipated first-in-human administration via subcutaneous administration, is expected to occur in mid-2026.

"The acquisition of Damora marks a pivotal milestone for Galecto as we evolve our focus toward advancing Damora’s highly differentiated mutCALR portfolio, which addresses significant unmet need across the full spectrum of blood cancers driven by mutCALR," said Dr. Hans Schambye, President and CEO of Galecto. "This pipeline, led by DMR-001, is designed to overcome the limitations of current candidates in early clinical development and has the potential to establish a new standard of care in the treatment of ET and MF. With a strong balance sheet, we believe we are well-positioned to drive these programs rapidly into the clinic and ultimately deliver meaningful benefit to patients."

"The immediate access to public capital markets and the strengthened financial position achieved through this acquisition and concurrent private placement provides momentum to accelerate the development of our highly specialized portfolio," added Peter Harwin, incoming Galecto Board Member and Managing Member at Fairmount. "Our team is eager to leverage Galecto’s infrastructure to rapidly transition DMR-001 from IND-enabling studies to first-in-human trials by mid-2026, ensuring these assets, focused on superior efficacy and convenience, reach patients as quickly as possible."

In addition, Galecto is excited to combine these newly acquired complementary pipeline assets with its investigational candidate GB3226, a dual ENL-YEATS and FLT3 inhibitor for multiple genetic subsets of acute myeloid leukemia (AML). As previously disclosed, GB3226 will be featured in two poster presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6 – 9, 2025, in Orlando, Florida. Galecto also announced that it received constructive feedback from the U.S. Food and Drug Administration (FDA) in response to its pre-Investigational New Drug (pre-IND) submission and plans to submit an IND application in the first quarter of 2026 to enable future clinical evaluation of GB3226 in AML.

Management & Organization

In conjunction with the transaction, Galecto Board Members will include:

•
Carl Goldfischer, MD (current Chair)

•
Jayson Dalls, MD (current)

•
Amit Munshi (current)

•
Hans Schambye, MD, PhD (current)

•
Peter Harwin, Managing Member, Fairmount

•
Chris Cain, PhD, Director of Research, Fairmount

•
Julianne Bruno, Growth Partner, Fairmount

About the Acquisition and Financing Transaction

The acquisition was approved by the Board of Directors of Galecto and the Board of Directors and stockholders of Damora. The closings of the transactions are not subject to the approval of Galecto’s stockholders. On an as-converted basis and after accounting for these transactions (and without giving effect to any beneficial ownership limitations), the total number of shares of Galecto common stock will be 61,998,882.

Lucid Capital Markets is serving as financial advisor to the Board of Directors of Galecto. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., is serving as legal counsel to Galecto. Wedbush PacGrow is serving as financial advisor to Damora. Jefferies, Leerink Partners, UBS, and LifeSci are serving as the placement agents to Damora, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Damora.

Webcast Details

The company will host a webcast on November 10, at 8:00 a.m. ET to discuss the transaction as well as Damora’s approach and pipeline assets. To access the call, please dial 1-646-357-8766 (International) or 1-888-880-3330 (toll-free). To access the live webcast, please go to View Source A replay of the webcast presentation will be temporarily archived on the Investors section of Galecto’s website following the presentation.

(Press release, Galecto Biotech, NOV 10, 2025, View Source [SID1234659713])