On December 2, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that its request for a Type C Meeting with the FDA has been accepted by the agency, and the meeting has been scheduled to occur this month.

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The meeting was requested to discuss the proposed accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer. The request is based on positive final results from the Company’s VERSATILE-002 trial, which showed promising median overall survival (mOS) and durable progression-free survival (PFS) in patients with CPS ≥ 1. The proposed amendment to the VERSATILE-003 Phase 3 trial would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with significant statistical power, potentially forming the basis for accelerated approval of PDS0101. mOS will remain as the primary endpoint for full approval as originally recommended by FDA.

"We believe the positive PFS data from VERSATILE-002 offers an important opportunity to shorten duration to a primary endpoint and potentially accelerate our path to regulatory submission, while still preserving mOS and safety assessment as the endpoint for full FDA approval," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are confident that the accelerated pathway we are seeking could expedite the availability of this promising treatment to patients in need, and we look forward to exploring this approach in greater detail with the FDA. We will provide further updates once we receive the FDA’s meeting minutes in January 2026."

(Press release, PDS Biotechnology, DEC 2, 2025, View Source [SID1234661052])

On December 2, 2025 Archeus Technologies, a company developing multiple differentiated radiopharmaceutical therapies for the treatment of patients with cancer, reported that it has dosed the first patient in its Phase 1 clinical trial of ART-101 in men with metastatic castration-resistant prostate cancer (mCRPC).

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ART-101 is a novel receptor-based targeting small molecule developed for the imaging and treatment of prostate cancer. The therapy was invented and developed by Reinier Hernandez, Ph.D., assistant professor of medical physics at the University of Wisconsin School of Medicine and Public Health and chief technology officer of Archeus Technologies, with substantial development support from the Wisconsin Alumni Research Foundation (WARF). ART-101 targets prostate-specific membrane antigen (PSMA), similar to several FDA-approved imaging and therapeutic agents. In preclinical studies, ART-101 has exhibited higher tumor uptake and retention, as well as lower normal tissue and salivary gland uptake, relative to current FDA-approved PSMA-targeting agents.

Through a collaboration agreement with WARF, the designated patent and licensing organization for the University of Wisconsin–Madison, Archeus is leading a first-in-human imaging study in mCRPC patients who are candidates to receive radioligand therapy with FDA-approved prostate cancer treatment Pluvicto (177Lu-PSMA-617). Participants will receive intravenous ART-101 – radiolabeled with the diagnostic isotope Indium-111 – to evaluate its safety, feasibility, biodistribution and kinetics, and tumor targeting.

"While current radioligand therapies provide a meaningful therapeutic benefit to patients with advanced prostate cancer, there are opportunities to even further enhance a patient’s quality of life and reduce even minimal side effects. This is especially important with upcoming alpha emitter-based therapies, where lower salivary gland uptake may help mitigate xerostomia," said Harshad Kulkarni, M.D., chief medical advisor at BAMF Health and principal investigator of the study. "As a vertically integrated comprehensive Theranostics center, BAMF Health was built to facilitate the next generation of theranostic agents. Our nationwide platform allows us to rapidly initiate and complete novel clinical trials like this, accelerating access to innovative options for patients."

"With significant development support, and promising preclinical data, ART-101 is an innovative therapeutic candidate with the potential to address key limitations of currently available radiopharmaceutical therapies for patients with prostate cancer," said Reinier Hernandez, Ph.D. "This clinical trial reflects Archeus’ foundational belief that precision imaging and dosimetry are essential to realizing the full potential of radiopharmaceutical therapy, as well as our commitment to advancing the broader portfolio and platform we are building."

(Press release, Archeus Technologies, DEC 2, 2025, View Source [SID1234661071])

On December 2, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER‑NSCLC‑02 (GDF‑15 Antibody‑MediaTed‑Human‑Effector‑T‑Cell Relocation) trial (NCT07246863). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab as a second-line treatment in patients with metastatic non-squamous non-small cell lung cancer (nsq NSCLC) who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.

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The trial will assess multiple treatment strategies combining visugromab with an anti-PD-1 antibody and the chemotherapy docetaxel, including a chemo-free regimen. Standard-of-care chemotherapy alone will serve as the control arm. The trial consists of a safety run-in followed by a randomized phase evaluating visugromab in the different combination regimen settings.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and resistance to anti-PD-(L)1 therapies. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory NSCLC patients, demonstrating deep and durable responses, with a median duration of response of 32.2 months and a favorable safety profile. In addition to its ability to restore immune activation, visugromab also showed potential to alleviate cancer cachexia, a severe condition limiting treatment tolerability and responsible for 20-40% of cancer deaths.1

"The decision to evaluate visugromab in second-line nsq NSCLC, in addition to the first-line setting, was driven by the strength of our Phase 1/2a data in heavily pretreated patients, where we observed deep and durable responses well beyond those typically seen with other therapies in this setting," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "By neutralizing GDF-15, a key driver of immune suppression, visugromab may overcome resistance, restore responsiveness to immunotherapy and extend the benefit of anti-PD-1 agents. Its additional potential to mitigate cancer cachexia and support tolerance to chemotherapies and other anti-cancer regimens offers a distinct advantage in this difficult-to-treat population."

"We are expanding visugromab’s development into key settings where immune resistance severely limits treatment options," said Scott Clarke, Chief Executive Officer at CatalYm. "Second-line nsq NSCLC is a particularly challenging indication with limited benefit from current standard-of-care. This trial builds on the compelling rationale for GDF-15 neutralization and is part of our late-stage development program to deliver visugromab’s potential to patients in urgent need of better solutions."

The randomized, multi-arm Phase 2b GDFATHER-NSCLC-02 trial will enroll approximately 131 patients across multiple sites in the US, EU and Switzerland. Following the safety run-in, patients will be randomized into one of four treatment arms:

Visugromab + anti-PD-1 inhibitor + chemotherapy
Visugromab + anti-PD-1 inhibitor (chemo-free)
Visugromab (at lower dose) + anti-PD-1 inhibitor + chemotherapy
Chemotherapy alone (control)
The primary endpoint of the study is objective response rate (ORR) defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), participant weight course over time and safety-related measures.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US2. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma3. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy4, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, DEC 2, 2025, View Source [SID1234661072])

On December 2, 2025 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies reported that that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together "TZLS-501") via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to drive value for shareholders. Tiziana shareholders at the record date will retain value from TZLS-501 through the distribution in specie of shares in the new TZLS-501 listed entity.

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The Company recently announced that it would advance development of TZLS-501, a dual-action IL-6R monoclonal antibody targeting both membrane-bound and soluble forms of IL-6R. This decision was based in part on heightened industry interest in the IL-6 pathway—underscored by Novartis’ recent $1.4 billion acquisition of Tourmaline Bio for its IL-6 inhibitor pacibekitug. The Company considers TZLS-501 as having the potential to be a standalone business. Accordingly, the Company intends to proceed with steps for a publicly listed immunology-focused spin-out company, centered on the IL-6 market. The record date for this proposed transaction will be announced in the coming weeks and the transaction will formally be put to shareholders of Tiziana for approval. TZLS-501 will remain an asset of Tiziana Life Sciences until such time as shareholders formally approve proposals for the spin-out entity.

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: "The recent Novartis acquisition of Tourmaline Bio for $1.4 billion highlights the tremendous value and strategic importance of IL-6 pathway therapeutics in addressing systemic inflammation and related diseases. Building on our September announcement to advance TZLS-501, we believe now is the ideal time to position this promising asset as a standalone entity. TZLS-501’s unique dual mechanism—blocking IL-6R signaling while reducing circulating IL-6 cytokines—offers significant potential as a monotherapy or in combination with other agents. This spin-out will unlock dedicated resources for its development, while allowing us to maintain focus on intranasal foralumab as our lead program."

There can be no certainty that the transaction will proceed and any listing will be subject to meeting the required listing criteria.

About TZLS-501

TZLS-501, a fully human mAb, was licensed from Novimmune, SA, (Geneva, CH) in 2017. IL-6 is a cytokine that binds to its receptor subunit IL-6Rα on the cell membrane, and is a major determinant in priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases. TZLS-501 acts via a dual mechanism by inhibiting IL-6R signaling and depleting circulating levels of IL-6.

On December 2, 2025 CorriXR Therapeutics, an oncology-focused biotherapeutics company pioneering a ground-breaking gene editing platform technology, InhaTarget Therapeutics, a company dedicated to the early development and clinical validation of innovative treatments of pulmonary diseases by inhalation, and Merxin Ltd, a designer and supplier of inhaler devices, reported to have entered a strategic collaboration to develop a pioneering inhaled genetic therapy targeting lung cancer.

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The partnership draws upon CorriXR’s proprietary CRISPR-based gene editing platform targeting NRF2, InhaTarget’s proprietary formulation platform and strong experience in pulmonary drug development, and Merxin Ltd’s advanced inhalation device technology. Through their combined expertise, they aim to create a patient-friendly inhaled therapy that delivers targeted treatment directly to lung tumors, maximizing efficacy, minimizing systemic side effects, and offering new hope for patients facing one of the world’s deadliest cancers.

Innovative Therapeutic Approach

CorriXR’s patented non-viral gene editing platform disables the transcription factor NRF2, a master regulator of cellular stress responses and known driver of tumor treatment resistance. As reported in a recent paper published in Molecular Therapy Oncology, preclinical data in lung cancer models have demonstrated that disabling NRF2 can meaningfully resensitize tumor response to chemotherapy with minimal off-target effects.

The collaboration seeks to demonstrate effective delivery of the CorriXR compound via InhaTarget’s proprietary lipid-nanoparticle (LNP) formulation platform, which enables encapsulation of active ingredients for inhalation delivery. Merxin Ltd will contribute their customized and patented inhaler device technology for drug delivery to the lungs. Initial studies will be conducted in cell culture and in a lung carcinoma mouse model, with results expected in mid-2026.

Addressing Unmet Medical Needs

Lung cancer continues to be one of the leading causes of cancer-related deaths globally. The study will focus on treatment of squamous cell lung carcinoma (LUSC), a common and aggressive form of non-small cell lung cancer (NSCLC) that comprises 25 – 30% of worldwide cases. With over 380,000 new cases of LUSC diagnosed globally each year and a five-year survival rate below 15%, the need for new therapies is urgent. Chemotherapy plus immunotherapy (IO) or IO alone is the current standard for first-line treatment of LUSC but still typically results in progression after 8 months or less. Many patients develop treatment resistance, leaving limited options beyond dose escalation, which increases toxicity and intolerance and typically worsens quality of life.

Leadership Perspectives

Dr. Eric B. Kmiec, founder and CEO of CorriXR Therapeutics, stated, "This partnership represents a significant step forward in our mission to harness the power of CRISPR-based gene editing for the benefit of patients with cancer by slowing the growth of solid tumors and improving effectiveness of existing treatments. We are excited by the potential of this collaboration to target lung cancer using a non-invasive inhaled delivery approach, which would greatly improve the quality of life for patients."

Dr. Frédéric De Coninck, co-founder and CEO of InhaTarget Therapeutics, commented, "Combining our pulmonary drug delivery LNP platform with CorriXR’s groundbreaking science and Merxin’s device technology has the potential to reshape the landscape of lung cancer treatment. We are eager to advance work on this novel combination."

Dr. Philippe Rogueda, CBO and founder of Merxin Ltd., remarked, "Our advanced inhaler technology is designed to ensure non-invasive, precise, consistent delivery of novel therapeutics. We are excited to contribute to this vital effort and help bring innovative solutions to patients with lung cancer."

(Press release, CorriXR Therapeutics, DEC 2, 2025, View Source [SID1234661073])