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Primmune Therapeutics Announces Enrollment Milestone in Phase 2 INFLECTION–003 Study of Polvitolimod HCl in Neoadjuvant Melanoma

On September 24, 2026 Primmune Therapeutics, a biotech company harnessing the power of the innate and adaptive immune system, reported the enrollment of the second patient in its Phase 2 INFLECTION-003 clinical study triggering the release of the second tranche of financing. The financing advances the development of Polvitolimod HCl (also known as PRTX007) as a curative therapy in the neoadjuvant and adjuvant settings for stage III melanoma.

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"Polvitolimod HCl is a novel oral TLR7/IRF7 agonist that induces robust systemic interferon responses and has demonstrated a favorable safety and tolerability profile in two Phase 1 studies" said Andrew Sharabi, MD, PhD, Chief Medical Officer of Primmune Therapeutics. "We have designed the Phase 2 INFLECTION-003 study to evaluate whether the combination of polvitolimod HCl and pembrolizumab before surgery will increase major pathologic response rates in patients with resectable stage III melanoma. We believe that priming the immune system with polvitolimod will enhance the clinical activity of pembrolizumab without a significant increase in toxicity, which would be a meaningful step forward for patients with this diagnosis."

INFLECTION-003 is a Phase 2, multi-center, single-arm study evaluating the safety, tolerability, and activity of neoadjuvant polvitolimod HCl in combination with pembrolizumab in participants with resectable stage III melanoma. Participants will receive oral polvitolimod HCl, a toll-like receptor 7 (TLR7) agonist prodrug, administered in combination with intravenous pembrolizumab for 9 weeks prior to surgical resection. The primary objective is to determine the major pathologic response (MPR) rate following neoadjuvant therapy. Secondary objectives include evaluation of safety, pathologic complete response (PCR) rate, event-free survival, overall survival, pharmacokinetics, and immune-related biomarkers. For more information, please visit ClinicalTrials.gov (NCT07565285).

"Polvitolimod HCl is the only oral TLR7/IRF7 specific agonist being developed for patients in the neoadjuvant solid tumor setting that we are aware of," said Charlie McDermott, Chief Executive Officer and Director of Primmune Therapeutics. "We believe there is a significant opportunity for safer and better tolerated immunotherapy combinations in early-stage solid tumor disease given the drug-related morbidity observed in clinical studies evaluating other immunotherapy combinations, such as nivolumab plus ipilimumab or pembrolizumab plus high-dose interferon."

About Polvitolimod HCl (PRTX007)

Polvitolimod HCl is a novel orally administered, systemically acting, toll-like receptor 7 (TLR7) agonist designed to functionally tune immune signaling toward an IRF7-driven poly-interferon response and away from the NF-B-mediated pro-inflammatory cytokine signaling that has limited the utility of systemically acting TLR7, TLR7/8, and TLR8 agonists. Polvitolimod HCl has been administered to 118 healthy human volunteers in two Phase 1 clinical studies (Study PRTX007-001 and Study PRTX007-002). In these studies, PRTX007 drove the desired systemic IRF7 poly-IFN response without undesired NF-B driven pro-inflammatory response. PRTX007 was generally well-tolerated in both Phase 1 studies with no serious adverse events reported.

(Press release, Primmune Therapeutics, SEP 24, 2026, View Source [SID1234671073])

Transgene Extends its myvac® Platform, Further Establishing its Position as a Key Player in the Rapidly Emerging Individualized Cancer Immunotherapy Field

On September 24, 2026 Transgene (Euronext Paris: TNG), a biotech company developing myvac, an individualized neoantigen therapeutic vaccines (INTV) platform designed to prevent cancer recurrence and a portfolio of virus-based candidates, reported its financial results for the six months ended June 30, 2026, and provides an update on the progress of its pipeline and its upcoming plans.

"Since the beginning of the year, Transgene has delivered tangible progress and important results with the publication of the TG4050 Phase 1 data , the completion of enrolment in the Phase 2 trial in the same indication and the initiation of the Phase 1 trial of TG4070, the second INTV from our myvac platform introducing our proprietary AI-driven neoantigen selection and scalable cell-line manufacturing capabilities." commented Alessandro Riva, MD, Chairman and Chief Executive Officer of Transgene.
"These milestones strengthen the foundation of the continued advancement of our myvac platform, which will be key in our strategy to be Phase 3-ready in 2028, when we will obtain the topline results of the ongoing Phase 2 trial of TG4050 in resected head and neck cancer. At the same time, we are advancing our second INTV, TG4070, through Phase 1 development for non-small cell lung cancer.
"In parallel, we continue to leverage our expertise in MVA to develop TG-MVATM, a prophylactic vaccine against mpox and smallpox designed to address the growing global needs in biosecurity, pandemic preparedness and vaccine supply resilience. Supported by our financial visibility through early 2028, we are very well positioned to execute on our strategy and deliver the next wave of clinical and operational milestones for patients, partners and shareholders."

TG4050: Data continue to support potential role in preventing cancer recurrence in HNSCC

Phase 1 part: Robust clinical proof of principle, with 100% DFS sustained after more than 3 years of follow-up – now published in leading peer-reviewed journal Nature Communications

At the end of August 2026, the comprehensive and compelling clinical and translational results from the Phase 1 part of Transgene’s randomized Phase 1/2 trial (NCT04183166) evaluating TG4050 in resected HNSCC (see press release) were published in Nature Communications. The peer-reviewed publication confirmed the positive clinical and translational findings, TG4050’s favorable safety profile and the persistence of durable neoantigen-specific CD8+ T-cell responses one year after the end of treatment.

Latest follow-up data, announced alongside the publication, demonstrate sustained 100% DFS in patients treated with TG4050 after more than 3 years of follow-up (41 months median follow-up), whereas 3 of 16 patients in the control arm have relapsed.

Phase 2 part: patient randomization completed

In April 2026, Transgene announced the completion of patient randomization in the Phase 2 part of the Phase 1/2 trial for the adjuvant treatment of HNSCC (see press release).

The primary objective of the Phase 1/2 trial is to compare TG4050’s efficacy as a single agent versus watchful waiting in patients with resected locoregionally advanced HPV-negative head and neck cancer, with 2-year DFS as the primary endpoint.

The emergence of immune checkpoint inhibitor (ICI)-based perioperative treatment marks an important advance in the HNSCC treatment landscape. However, a significant unmet medical need remains, with approximately 35% of patients still experiencing disease recurrence within two years. TG4050 is designed to further improve outcomes in this population by inducing durable, patient-specific anti-tumor immune responses with the potential to reduce the risk of relapse.

Transgene expects to communicate topline results from TG4050’s Phase 1/2 trial by the end of Q1 2028. First immunological data are expected to be available in H2 2026, with the goal of presenting them at a scientific conference in H1 2027.

Preparing future clinical development and potential pivotal clinical trial in HNSCC

In April 2026, Transgene and NEC Bio B.V. announced the signing of a license agreement to advance the clinical development of TG4050 in head and neck cancer (see press release).
Under this agreement, Transgene secures access to NEC’s AI-based neoantigen prediction platform, to support TG4050’s further clinical development, commercialization and potential partnering. Transgene has paid a technology access fee of €2.5 million in Transgene shares as well as €1.0 million of the additional €2.5 million cash payment, the remainder of which will be paid out in several instalments through early 2028. Additional development and milestone payments will be paid to NEC based upon progress of the clinical development of TG4050 in head and neck cancer. NEC retains full ownership and operational control of its AI platform and will support Transgene in conducting further clinical activity.

In parallel, Transgene is optimizing its manufacturing processes and capabilities to prepare for a potential pivotal clinical trial in HNSCC, including a transition of TG4050 to cell-line based manufacturing.

TG4070: Combining cutting-edge proprietary AI and scalable manufacturing to further expand the potential of the myvac platform across multiple solid tumor indications

Initiation of a randomized Phase 1 trial for TG4070 in NSCLC

In June 2026, Transgene announced the initiation of a randomized Phase 1 trial evaluating TG4070, a novel INTV fully designed and developed in-house (see press release). Transgene’s second INTV candidate, TG4070, reflects the important strategic expansion of the myvac platform. Like TG4050, it leverages Transgene’s clinically validated MVA viral vector, ensuring technological consistency of the myvac platform.

Patient screening is underway in this multicenter trial. The study is evaluating TG4070 in combination with nivolumab in patients with resected NSCLC following neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00). The combination is designed to leverage the complementary potential of individualized vaccination and immune checkpoint inhibition to enhance and sustain patient-specific anti-tumor immune responses. Prof. Nicolas Girard, MD, PhD (Institut Curie) is the Principal Investigator. A replay of Transgene’s KOL event to discuss this new indication and the associated clinical trial is available here.

SNIPERTM: Proprietary AI-based tool enabling high-precision neoantigen selection

Transgene has developed its proprietary in-house, AI-driven bioinformatics tool, SNIPERTM, to support the development of TG4070 and future myvac-derived candidates. Integrating multiple computational models, SNIPERTM is designed to identify and prioritize highly immunogenic neoantigens for each individual patient through a proprietary scoring framework.
In addition, VacDesignR, fully integrated into the myvac platform, is Transgene’s patented in-house computational design engine that optimizes genetic constructs for MVA vectors, significantly improving production reliability and vector quality.

Cell-line optimized manufacturing to support large scale production for myvac candidates

TG4070 is manufactured using a scalable and transposable cell-line based process designed to support broader deployment of INTV candidates while ensuring reliable vaccine supply. This optimized process enables more efficient and automated production, improved lead times and scalability. These manufacturing advances broaden the potential application of the myvac platform across additional indications and larger patient populations.

Together, these proprietary capabilities provide Transgene with an integrated in-house technology suite spanning neoantigen selection, vaccine design and scalable manufacturing to support INTV development from candidate design through clinical development.

Transgene extends its pipeline with TG-MVATM, a prophylactic vaccine candidate against mpox and smallpox

Leveraging the investment already made in the MVA cell-line platform used for myvac, Transgene is applying its deep viral-vector engineering expertise to Orthopoxvirus-related diseases, including mpox and smallpox.
TG-MVATM is a next generation vaccine candidate based on a non-replicating MVA backbone and an innovative cell line-based manufacturing process. It is designed to address key manufacturing and supply challenges, with the potential to diversify and expand vaccine availability to address public health needs and preparedness for future epidemics or bioterrorism threats.

On June 25, 2026, Transgene presented new preclinical data at the World Congress on Infectious Diseases (WCID) 2026, demonstrating the potential of TG-MVATM to provide robust protection against monkeypox virus (MPXV) (see presentation here).

Based on these positive results and ongoing discussions with Health Authorities and other key stakeholders on the next development steps, Transgene is preparing to advance TG-MVATM into clinical development to address future vaccine supply needs.

BT-001 oncolytic virus for intratumoral administration

The results obtained to date support the continued clinical development of BT-001 in solid tumors with the aim of improving responses to immunotherapy.
A Phase 1 clinical trial sponsored by an independent investigator at Copenhagen University Hospital has been approved by the Danish health authorities. Transgene and the University of Copenhagen are collaborating with the OV-PRIME-R trial to evaluate the combination of Transgene’s armed oncolytic virus BT-001 with an anti-PD1 in patients with localized rectal cancer with proficient mismatch repair status. Patient screening is expected to start in the coming months.

Governance: Anne Stehlin joins Transgene as Chief Quality Officer; Katell Bidet Huang appointed Interim Chief Scientific Officer

Anne Stehlin, PharmD, recently joined Transgene as Chief Quality Officer and Responsible Pharmacist. Reporting to Chairman and CEO Alessandro Riva, she is a member of the Executive Committee.
Dr. Stehlin is a pharmaceutical executive with extensive experience in quality and manufacturing operations. Prior to joining Transgene, she held senior global quality leadership roles at Lonza, a leading biopharmaceutical CDMO. Before that, she served as Head of Global Quality Management and a member of the extended management team at Basilea Pharmaceutica.
Earlier in her career, she held multiple leadership roles at Novartis across technical operations and product quality, eventually serving as Global Head of Product Quality Lifecycle Management.
Dr. Stehlin holds a PharmD degree from the University of Strasbourg.

Katell Bidet Huang, PhD, head of Translational Medicine at Transgene, has been appointed Interim Chief Scientific Officer (CSO), succeeding Maurizio Ceppi who has left the Company. In this role, she joins Transgene’s Executive Committee and will ensure continuity of the Company’s scientific activities and maintain momentum across its research and development programs. She will serve in this position until a permanent Chief Scientific Officer is appointed.

Key Financial Elements & Financial Visibility

(in thousands of euros) June 30, 2026 June 30, 2025
Operating income 2,993 4,579
Research and development expenses (15,425) (17,910)
General and administrative expenses (4,122) (3,783)
Other expenses (186) 54
Operating expenses (19,733) (21,639)
Operating income/(loss) (16,740) (17,060)
Financial income/(loss) 1,071 (2,235)
Net income/(loss) (15,669) (19,295)

Operating income amounted to €3.0 million for the first six months of 2026 compared to €4.6 million for the same period in 2025. It mainly consisted of the Research Tax Credit, amounting to €2.5 million, compared with €4.4 million for the same period in 2025.

As of June 30, 2026, Transgene had €92.8 million in cash, cash equivalents and other current financial assets, compared to €111.9 million as of December 31, 2025.

Transgene’s cash burn3 amounted to €20.3 million in the first half of 2026 compared with €18.8 million for the same period in 2025.

Under current plans, the company has sufficient cash to ensure financial visibility until early 2028.

(Press release, Transgene, SEP 24, 2026, View Source [SID1234671072])

Scancell completes up to US$25 million in debt financing, providing optionality alongside equity investment to finance iSCIB1+ phase 3 development

On September 24, 2026 Scancell Holdings plc (AIM: SCLP) ("Scancell", or the "Company"), a late-stage clinical immuno-oncology company developing active immunotherapies designed to enhance anti-tumor immune responses in difficult-to-treat cancers, reported that, further to its announcement on 23 July 2026 regarding the planned merger with Neuphoria Therapeutics Inc. ("Neuphoria") and financing to conduct the registrational Phase 3 study for iSCIB1+ and a proposed listing on Nasdaq (the "Merger and Financing Announcement"), it has entered into a loan agreement (the "Loan Agreement") with certain funds and accounts managed by BlackRock (the "Lender"), for a loan facility of up to US$25,000,000 (the "Loan Facility").

The Loan Facility is available in four tranches. For the first three tranches, a portion of each is convertible into Ordinary Shares at the Lender’s option, totalling up to US $5,000,000.

The Company intends to draw down US$7,000,000 under the Loan Facility following, and conditional upon, shareholder approval of the Loan Facility at the EGM. Further tranches totalling US$8,000,000 are expected to be available following, and conditional upon, completion of the US Listing Transactions and the expected upcoming opening of the first clinical site for the Phase 3 study for iSCIB1+. These tranches are expected to be drawn following completion of the US Listing Transactions.

The remaining tranche may be drawn until 31 December 2027 subject to a minimum equity fundraising threshold.

Dr Phil L’Huillier, CEO of Scancell, said: "The debt facility is an important part of an equity and debt package in conjunction with the planned merger that allows Scancell to proceed at pace to initiate and execute the global registrational Phase 3 trial for its lead programme, iSCIB1+."

The Phase 3 trial received IND clearance from the FDA in January 2026. Following Scancell’s recent UK Financing, Phase 3 initiation activities are underway and the Company is on track to commence the trial by the end of 2026. Initial progression free survival ("PFS") data, which could support accelerated approval under our trial design, is targeted for the second half of 2028.

Further terms of the Loan Facility

Amounts advanced under the Loan Facility are repayable, following an 18 month interest only period, in 24 equal monthly instalments of principal and interest, or in 18 equal monthly instalments of principal and interest commencing after 24 months if the Company has raised cumulative equity funding of at least US$100,000,000 (inclusive of the proceeds of the UK Placing and the Retail Offer). The Loan Facility must be repaid in full on a change of control of the Company.

Interest on the Term Loan Facilities accrues at 10.50% per annum from the date of advance and is payable in cash on the first day of each month (an "Interest Payment Date"). Interest on the Convertible Facilities accrues at a rate of 10.95% per annum and is capitalised and added to the principal amount of the relevant tranche on each Interest Payment Date.

The Lender may convert all or part of the outstanding principal of the Convertible Facilities (including capitalised interest) into Ordinary Shares at a 30% premium to the equity fundraising price announced on 23 July 2026 (subject to adjustment for the Share Consolidation).

The Company may elect to prepay the Loan Facility in full, subject to payment of a prepayment fee.

The Loan Agreement contains customary representations, warranties, covenants and events of default for a facility of this type and size (including a requirement to hold certain minimum amounts of cash subject to security in favour of the Lender). The Company’s obligations are guaranteed by its wholly owned subsidiary, Scancell Limited, and secured over substantially all assets of the Company and Scancell Limited.

Warrants

In connection with the Loan Facility, the Company will grant warrants to subscribe for Ordinary Shares ("Warrants") pro rata to drawdowns under the Loan Facility to Kreos Capital VIII Aggregator SCSp, an affiliate of the Lender (the "Warrantholder").

The number of Ordinary Shares issued to the Warrantholder ("Warrant Shares") will be determined at the point of exercise of the Warrants and will be equal to 4.5% of each drawdown amount divided by the Subscription Price.

The "Subscription Price" will be the lowest price paid per share in the Financing (subject to adjustment for the Share Consolidation), or if the Private Placement does not complete, [the lower of (a) the lowest price paid in any future equity financing round by the Company and (b)] the 30-day VWAP per Ordinary Share following an announcement that the Private Placement will not complete. The number of Warrant Shares and/or the Subscription Price are subject to customary adjustments. The Warrants are exercisable at any time up to the earlier of (i) 10 years from the date of the Loan Facility or (ii) a sale of the Company.

Shareholder Approval

Drawdowns under the Loan Facility and the issue of the Warrants are conditional upon shareholder approval at the EGM, [which the Company expects to hold in October 2026]. Further details of the Loan Facility and the EGM will be contained in the Circular and Notice of General Meeting, which will be announced and distributed to shareholders in due course.

Capitalised terms used but not otherwise defined in this announcement have the same meaning as defined in the Merger and Financing Announcement.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR) as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018.

The person responsible for arranging for the release of this announcement on behalf of Scancell is Phillip L’Huillier, Chief Executive Officer.

About iSCIB1+
iSCIB1+ is a DNA ImmunoBody in development for the treatment of melanoma. Administered by needle-free intramuscular injection, iSCIB1+ encodes an antibody targeting the melanoma-associated antigens gp100 and TRP-2, priming high-avidity T cells to generate a robust and durable anti-tumor response. In the Phase 2 SCOPE trial in first-line advanced melanoma, iSCIB1+ in combination with ipilimumab and nivolumab demonstrated a PFS of 77% at 22 months in the target HLA population, with no increase in checkpoint inhibitor-related toxicities. iSCIB1+ has demonstrated a favorable safety profile and clinically meaningful activity as a monotherapy in Phase 1 and in combination with checkpoint inhibitors in the Phase 2 SCOPE trial in advanced melanoma.

iSCIB1+ has been granted Fast Track Designation for the treatment of advanced melanoma from the FDA. The registrational Phase 3 trial of iSCIB1+ in patients with advanced melanoma has received an IND clearance from the FDA and CTA from the UK MHRA and is expected to begin in the second half of 2026. A Phase 2 trial of iSCIB1+ in patients with neo/adjuvant melanoma is planned for the first half of 2027.

iSCIB1+ is an investigational medicinal product. It has not been approved by the MHRA, the FDA or any other regulatory authority for the treatment of melanoma or any other indication, and its safety and efficacy have not been established.

(Press release, Scancell, SEP 24, 2026, View Source [SID1234671071])

Medicenna Announces Oral Presentation of New Bizaxofusp Results in Recurrent Glioblastoma at the 2026 Society for Neuro-Oncology Annual Meeting

On September 24, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, reported that an abstract evaluating survival outcomes with bizaxofusp (formerly MDNA55) in unresectable, IDH-wildtype recurrent glioblastoma (rGBM) has been selected for an oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO 2026), taking place November 12-15, 2026, in Philadelphia.

The oral presentation will be delivered by Dr. Nicholas A. Butowski, MD, Professor of Neurological Surgery and Director of Translational Research, Neuro-Oncology at the University of California, San Francisco.

"Selection for an oral presentation at SNO highlights the interest of the neuro-oncology community in the continued clinical development of bizaxofusp for patients with recurrent glioblastoma," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna. "We look forward to presenting this survival analysis in the intended Phase 3 population and continue engaging with leading clinicians, researchers and potential pharma partners during SNO 2026."

Details of the oral presentation are as follows:

Presentation Type: Oral Presentation
Title: Survival outcomes with bizaxofusp (MDNA55) in unresectable IDH-wildtype recurrent glioblastoma (rGBM) using a propensity score-weighted external control arm (ECA) in the intended Phase 3 population
Session: Clinical Trials Oral Abstracts Session I
Presenter: Nicholas A. Butowski, MD, University of California, San Francisco
Date and Time: Friday, November 13, 2026, 10:36 a.m. ET
Group Q&A: Friday, November 13, 2026, 10:43 a.m. ET
Location: Room 118 ABC, First Floor, Pennsylvania Convention Center, Philadelphia

About Bizaxofusp
Bizaxofusp (formerly MDNA55) is Medicenna’s IL-4 Empowered Superkine that has been evaluated in more than 130 patients across five clinical trials, including a Phase 2b study in recurrent glioblastoma. Bizaxofusp is designed to selectively target the interleukin-4 receptor (IL-4R), which is overexpressed by glioblastoma cells and cells in the tumor microenvironment, and is administered directly into the tumor using convection-enhanced delivery. Bizaxofusp has received Fast Track designation from the U.S. Food and Drug Administration and Orphan Drug designation in the United States and Europe.

(Press release, Medicenna Therapeutics, SEP 24, 2026, View Source [SID1234671070])

Nuvectis Announces NXP200 Granted Breakthrough Therapy Designation in China for BRAF V600-Mutant, Recurrent or Progressive, High-Grade Glioma

On September 24, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported that NXP200 (HSK42360), an oral, brain-penetrant, paradox-breaker BRAF inhibitor, has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE).

NXP200 is a paradox-breaking BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation that is seen with first-generation BRAF inhibitors. To date, NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients as well as in patients previously treated with BRAF inhibitors, against primary central nervous system (CNS) tumors and other tumor types including non-small cell lung, colorectal and papillary thyroid cancers.

In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco Pharmaceutical Group.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We congratulate our partner Haisco for achieving this significant regulatory milestone, which is further testament to its tremendous strategic and operational capabilities. The CDE’s granting of Breakthrough Therapy Designation underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma. In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026."

(Press release, Nuvectis Pharma, SEP 24, 2026, View Source [SID1234671069])