Armenia Grants First Marketing Authorizations for Agenus’ BOT+BAL in Previously Treated MSS Metastatic Colorectal Cancer

On October 8, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that the Ministry of Health of the Republic of Armenia has granted marketing authorizations for Botvymo (botensilimab, BOT) and Evamplix (balstilimab, BAL), each approved for use in combination with the other for the treatment of adult patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases who have previously received available standard therapies. These are the first marketing authorizations for either medicine anywhere in the world. The approvals are expected to benefit patients in Armenia as well as patients who travel to Armenia for treatment under the care of Armenian oncologists.

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Botensilimab is a multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive antitumor immune responses, including in tumors that have historically responded poorly to conventional immunotherapy. Balstilimab is an anti-PD-1 antibody designed to sustain antitumor T-cell activity.

The approvals are effective as of October 2, 2026. They follow a rigorous review by Armenia’s regulatory authorities of the complete registration dossier, submitted in the international Common Technical Document format used under Eurasian Economic Union rules. The review covered product quality and manufacturing (chemistry, manufacturing and controls), nonclinical data, clinical efficacy and safety data, and the pharmacovigilance system and risk management plan. BOT and BAL were separately submitted and approved for use as a combination regimen. Under the approved product information, Botvymo is administered at 75 mg intravenously every 6 weeks for up to 4 doses, in combination with Evamplix at 240 mg intravenously every 2 weeks for up to 2 years or until disease progression or unacceptable toxicity.

Each marketing authorization is conditional and valid for one year and is renewable based on the clinical updates that Agenus will provide to the Armenian regulator each year.

"Armenia is the first country in the world to grant marketing approval for BOT+BAL," said Garo H. Armen, PhD, Chairman and Chief Executive Officer of Agenus. "The evidence behind this decision has been published in peer-reviewed journals and presented at major cancer conferences, and it has consistently pointed to clinical benefit for patients with metastatic colorectal cancer. We thank Armenia’s health authorities for the depth and care of their review. Patients who have exhausted standard treatments now have a new option, and we are proud to bring it to them."

Clinical Evidence Supporting the Approvals

The Armenian approvals were based on the totality of clinical evidence for BOT+BAL in MSS mCRC, including mature results from the fully enrolled MSS mCRC patient cohort from the Phase 1b C-800-01 study and data from the randomized Phase 2 C-800-25 study. Results from this clinical program have been published in peer-reviewed journals, including Nature Medicine and Clinical Cancer Research, and presented at major oncology congresses, including the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. The efficacy and safety data supporting the approvals are summarized in the approved product information for Botvymo and Evamplix.

Regional Opportunities

Following the Armenian approvals, Agenus will evaluate the potential to seek marketing authorizations for BOT+BAL in the MSS metastatic colorectal cancer setting in other Eurasian Economic Union member countries.

Access to BOT+BAL Outside Armenia

The Armenian marketing authorizations apply within the territory of Armenia.

In France, the national Autorisation d’Accès Compassionnel (AAC) program provides fully reimbursed, hospital-based access to BOT+BAL for eligible patients with MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. In a growing number of other countries, BOT+BAL is available through physician-initiated named-patient programs under local regulations. BAP Pharma serves as Agenus’ global partner for the French AAC pathway and named-patient access programs.

Physicians seeking information about authorized access pathways can visit the Patient Access section of our corporate website.

Important Safety Information

The approved product information for Botvymo and Evamplix includes warnings and precautions for immune-mediated adverse reactions, including colitis and diarrhea, hepatitis, pneumonitis, endocrinopathies, nephritis, myocarditis and pancreatitis, as well as infusion-related reactions. Healthcare professionals in Armenia should consult the approved product information before prescribing.

(Press release, Agenus, OCT 8, 2026, View Source [SID1234673287])

Lantern Pharma to Present at the ThinkEquity Conference in NYC on October 15th, 2026

On October 8, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical stage drug programs, reported that Lantern management will be presenting at the ThinkEquity Conference on Thursday, October 15, 2026, at 3:30 p.m. ET at the Mandarin Oriental in New York, NY.

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Webcast Link: https://event.summitcast.com/view/GXv6JAoMEphytK6ggozCk7/VS4pGMrvkgq2xwHrNQevWX
Conference Registration Link: View Source

Lantern Pharma management will be available for one-on-one meetings held throughout the conference.

(Press release, Lantern Pharma, OCT 8, 2026, View Source [SID1234673286])

IMUNON to Participate in Upcoming Investor Conferences

On October 8, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, reported that Stacy Lindborg, Ph.D., President and Chief Executive Officer, will participate in the following October 2026 investor conferences.

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Maxim Growth Summit 2026
Date: October 12 – 14, 2026
Location: Hard Rock Hotel, New York, NY
Presentation: Oncology Panel, October 14, 2026, at 9:00 a.m. ET

For more information and a complete agenda of the Maxim Growth Summit, please visit View Source

2026 ThinkEquity Conference
Date: October 15, 2026
Location: Mandarin Oriental Hotel, New York, NY
Presentation: 1:30 p.m. ET in the Boardroom

For more information and a complete agenda of the ThinkEquity Conference, please visit View Source

The Company will host 1×1 meetings throughout the conferences. For more information or to schedule a meeting, please contact Maxim Group or ThinkEquity conference representatives or email [email protected].

(Press release, IMUNON, OCT 8, 2026, View Source [SID1234673285])

Northwest Biotherapeutics and the UK National Health Service Blood and Transplant Announce Collaboration to Support DCVax®-L Production

On October 8, 2026 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, and the UK National Health Service Blood and Transplant ("NHSBT") reported that they have entered into a collaboration, as the culmination of months of joint efforts by the parties, to support production of the Company’s experimental cancer vaccine DCVax-L.

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The NHSBT announcement can be found at View Source and states as follows: NHS Blood and Transplant’s specialist therapeutic apheresis and cell processing capabilities are supporting the production of DCVax-L, with plans to expand the model to additional locations across England.

NHS Blood and Transplant’s Therapeutic Apheresis Services (TAS) and Cellular and Molecular Therapies (CMT) teams are supporting the UK production of DCVax-L – a treatment for Glioblastoma multiforme (GBM), an aggressive form of primary brain cancer, as well as all solid tumours.

Working in collaboration with Northwest Biotherapeutics and Advent Bioservices, NHSBT’s specialist teams are supporting key stages of the manufacturing: TAS is carrying out leukapheresis procedures to collect the immune cell starting material needed for the DCVax-L treatment, forming part of the personalised manufacturing process for an individual patient. Leukapheresis is an established procedure in which blood is collected and separated so that specific white blood cells can be obtained, while the remaining blood components are returned to the patient.

CMT is providing specialist cell processing and handling of cellular material to support the onward pathway.

The collaboration between NHSBT and Northwest Biotherapeutics brings together this clinical and operational expertise with the work of NWBio and Advent Bioservices in developing DCVax-L in the UK.

The collaboration initially involves Leeds and Oxford. Building on this work, NHSBT, NWBio and Advent Bioservices are exploring the phased expansion of the model to additional NHSBT locations across England.

Ms. Linda Powers, CEO of Northwest Biotherapeutics, said:
"NHSBT’s impressive expertise and facilities for advanced therapies are at the forefront of the field. We are very excited about collaborating with them on our DCVax-L personalised immune therapies for cancer. We believe NHSBT’s capabilities can significantly enhance the scale-up and accessibility of DCVax-L."

Dr James Griffin, Medical Director at NHSBT, said:

"The collaboration forms part of ongoing work between NHSBT, NWBio and Advent Bioservices to strengthen the infrastructure supporting the production of DCVax-L in the UK. We aim to help make cutting edge advanced therapies more accessible. Alongside the planned expansion of the existing therapeutic apheresis and cell processing model, the organisations are also exploring opportunities for broader collaboration involving NHSBT’s specialist laboratory and advanced therapies capabilities."

(Press release, Northwest Biotherapeutics, OCT 8, 2026, View Source [SID1234673284])

Medicus Pharma Highlights Three Years of Progress and Outlines Potential Path to Long Term Value

On October 8, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, reported a shareholder update celebrating its third anniversary, highlighting three years of progress, focused on execution and capital efficient drug development. The Company has advanced its transformation into a precision oncology-led biotechnology company, with a portfolio of select novel assets, anchored by CD228V, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, SkinJect for basal cell carcinomas in patients with Gorlin syndrome and Teverelix for development opportunities in urology and women’s health.

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This transformation, outlined in our recent strategic update, reflects progress in clinical advancement, strategic acquisitions, and investment in the people and capabilities needed to execute. From a company centered on SkinJect, we have built a portfolio with multiple potential paths to clinical and commercial value.

Our progress has occurred alongside stock-price volatility and pullback. We must make a concerted effort to explain more clearly, when we can, how the investments made to date position Medicus and support that explanation with measurable results.

Building the Foundation for Potential Long-Term Value

Our strategy is to identify promising therapeutic assets with existing scientific and clinical foundations and concentrate incremental investment on milestones that can strengthen their development prospects and partnering value.

Over these three years, we have assembled a board and management team and established the clinical, regulatory, financial, and governance capabilities needed to advance our programs. Commencing in October 2023, our progression from the TSX Venture Exchange to Nasdaq in November 2024, broadened our access to public capital markets. Approximately $90 million raised through equity and debt financing supported clinical development, strategic acquisitions, and organizational operations, while retaining resources for ongoing requirements.

That investment has given Medicus a broader portfolio and the capacity to pursue more complex development opportunities. Its ultimate return will depend on the clinical evidence we generate, the partnerships we secure, and the discipline with which we manage future spending.

CD228V and the Opportunity in Targeted Cancer Therapy

Antibody-drug conjugates, or ADCs, combine an antibody that recognizes a target on cancer cells with a potent cancer-killing payload. Their promise lies in directing treatment toward tumor cells, although the balance between antitumor activity and toxicity depends on the target, molecular design, and clinical setting.

CD228V brings together a less crowded solid-tumor target, second-generation molecular engineering, and an existing clinical and manufacturing foundation. It targets melanotransferrin, also known as CD228, a cell-surface protein associated with melanoma and expressed across several other solid tumors. Its expression and potential for internalization make it an attractive target for delivering an ADC payload.

Our initial priority is melanoma, particularly relapsed, refractory, or immunotherapy-resistant disease, where additional treatment options are needed. We intend to integrate biomarker work into development to better understand which patients may benefit.

We believe CD228V also has potential beyond melanoma, including in CD228-expressing lung, head and neck, and esophageal cancers. CD228V is early in development, and neither its efficacy nor an improved safety profile has been established; no approved therapy has yet validated CD228 as a treatment target.

We believe the combination of target biology, molecular design, and development readiness gives CD228V a compelling place in our portfolio. Our goal is to translate that foundation into evidence that can support further development and attract partners with complementary capabilities.

SkinJect and a Focused Gorlin Syndrome Strategy

We completed the SKNJCT-003 Phase 2 study, evaluated its findings, and identified the 200-microgram dose for further development. The FDA subsequently authorized initiation of SKNJCT-005, our planned registrational study in patients with Gorlin syndrome, an autosomal dominant rare disease.

Patients with Gorlin syndrome face a lifetime burden of recurrent basal cell carcinomas and repeated procedures. We believe this population provides a focused setting in which to evaluate SkinJect as a localized treatment option.

The completed work has informed dose selection and defined the next study, providing a clearer basis for allocating resources and evaluating potential partnerships. Additional clinical evidence and regulatory review remain necessary.

Teverelix and Partner Ready Development Opportunities

The acquisition of Antev in August 2025 expanded our portfolio into urology and women’s health through Teverelix, an investigational, next generation, GnRH antagonist. We subsequently strengthened its underlying economics by reducing the royalty rate and refined its priorities to acute urinary retention relapse prevention and symptomatic endometriosis, alongside a partnership-led strategy in advanced prostate cancer patients with high cardiovascular risk profile.

Our recent submission of an optimized registrational protocol for advanced prostate cancer is intended to incorporate previously FDA-cleared dose-optimization work into a proposed integrated development program. Subject to FDA review, this approach is designed to give potential partners a clearer plan for advancing the asset.

The Next Phase of Execution

Our priorities are to advance selected clinical and regulatory milestones, align organizational costs with those priorities, and pursue licensing, co-development, and other strategic opportunities. Partnerships could contribute non-dilutive development funding and expertise while reducing the capital Medicus would otherwise need to provide. Their timing, terms, and completion remain uncertain.

For our shareholders, we continue to strive to help make the connection between our portfolio and potential value more tangible. We are committed to explain the significance of each milestone, the resources required to reach it, and the decisions it enables. The measure of our progress should be stronger clinical evidence, clearer development pathways, and transactions that support continued advancement.

We remain confident in the purpose of our work and committed to responsible capital allocation. We have built a company with a broader scientific opportunity than when we began. Our mission is to demonstrate what that opportunity can deliver for patients and shareholders.

(Press release, Medicus Pharma, OCT 8, 2026, View Source [SID1234673283])