iSCIB1+ MHRA CTA Approval for Ph3 trial

Scancell Holdings Plc

19 August 2026

 

19 August, 2026

Scancell Holdings plc

Scancell Receives UK MHRA Clinical Trial Authorization for the Phase 3 Registrational Trial of iSCIB1+ in Advanced Melanoma

Phase 3 registrational study of iSCIB1+ in advanced melanoma to enrol 550 patients across 90 global sites

The authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) approval follows the IND clearance from the U.S. Food and Drug Administration (FDA); additional regulatory submissions in the E.U., Canada and Australia are in progress

Commencement of global registrational Phase 3 trial is expected by the end of 2026 with initial progression-free survival (PFS) data expected in the second half of 2028.

Scancell Holdings plc (AIM: SCLP), a late-stage clinical immuno-oncology company developing active immunotherapies designed to enhance anti-tumor immune responses in difficult-to-treat cancers, announced today that the MHRA has granted a Clinical Trial Authorization (CTA) for the Phase 3 registrational trial of its lead ImmunoBody® iSCIB1+ in patients with advanced melanoma.

The Phase 3 randomized, double-blind, placebo-controlled registrational trial of iSCIB1+ in advanced melanoma has an adaptive trial design and aims to enroll 550 patients with stage III or IV unresectable melanoma, across approximately 90 global sites in the U.S., E.U., U.K., Canada, and Australia. Patients will be randomized 1:1 to receive either 8 mg iSCIB1+ plus ipilimumab and nivolumab or placebo plus ipilimumab and nivolumab. The primary endpoint of PFS is designed to support an accelerated approval with overall survival (OS) as the secondary endpoint, intended to support an application for full approval.  The Phase 3 design was informed by the Phase 2 SCOPE trial in which iSCIB1+ in combination with ipilimumab and nivolumab demonstrated sustained PFS of 77% at 22 months, and OS of 87.4% at 18 months.

Dr Phil L'Huillier, CEO of Scancell, said: "Our regulatory strategy continues to build momentum. The MHRA CTA for the Phase 3 trial of our lead asset iSCIB1+ in patients with advanced melanoma is an important milestone bringing us one step closer to delivering iSCIB1+ to patients in a global registrational trial setting."

The Phase 3 trial has received an IND clearance from the FDA in January 2026 and initiation activities will continue and are on track to commence by the end of 2026. Initial PFS data, which could support accelerated approval under our trial design, is targeted for the second half of 2028.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

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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. The Phase 2 SCOPE trial,  iSCIB1+ in combination with ipilimumab and nivolumab demonstrated a PFS of 77% at 22 months in the target HLA population in first-line advanced melanoma, with no increase in checkpoint inhibitor-related toxicities. 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+ 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+ 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.

Scancell (LSE:SCLP; www.scancell.co.uk) is a late-stage clinical biotechnology company developing targeted, off-the-shelf, active immunotherapies, generated by the ImmunoBody® and Moditope® platforms, designed to stimulate durable anti-tumor responses. The lead product, iSCIB1+, is a DNA ImmunoBody® that has demonstrated a favorable safety profile and clinically meaningful activity both as a monotherapy, in a Phase 1 trial, and in combination with checkpoint therapies in a Phase 2 trial in patients with melanoma. Modi-1 is a Moditope peptide currently being evaluated in a Phase 2 study in head & neck and renal cancers. In addition, Scancell is advancing a pipeline of high affinity GlyMab® antibodies targeting tumor specific glycans, two of which have been licensed for further development to Genmab A/S, an international biotechnology company and global leader in the antibody therapeutics space.

Additional Information

In connection with the proposed business combination (Business Combination) between Neuphoria Therapeutics Inc. (Neuphoria) and Scancell, Scancell and  Neuphoria intend to file with the U.S. Securities and Exchange Commission (SEC) a Registration Statement on Form F-4 (Registration Statement) containing a preliminary proxy statement of Neuphoria and a preliminary prospectus of Scancell, and after the Registration Statement is declared effective, Neuphoria will mail a definitive proxy statement/prospectus related to the proposed Business Combination to its stockholders. This communication does not contain all the information that should be considered concerning the proposed Business Combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed Business Combination. Neuphoria's stockholders and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and the amendments thereto and the definitive proxy statement/prospectus and other documents filed in connection with the proposed Business Combination, as these materials will contain important information about Scancell, Neuphoria and the proposed Business Combination. When available, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to stockholders of Neuphoria as of a record date to be established for voting on the proposed Business Combination. Stockholders of Neuphoria will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC's website at www.sec.gov, or by directing a written request to: Neuphoria Therapeutics Inc, 100 Summit Dr, Burlington, Massachusetts 01803.

Participants in the Solicitation

Neuphoria and its directors and executive officers may be deemed participants in the solicitation of proxies from Neuphoria's stockholders with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests in Neuphoria is contained in Neuphoria's proxy statement on Schedule 14A for the 2025 Annual Meeting, which was filed with the SEC on October 30, 2025 and is available free of charge at the SEC's web site at www.sec.gov, or by directing a written request to Neuphoria Therapeutics Inc, 100 Summit Dr, Burlington, Massachusetts 01803. Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed Business Combination when available.

Scancell and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Neuphoria in connection with the proposed Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed Business Combination will be included in the proxy statement/prospectus for the proposed Business Combination when available.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may", "will", "believe", "expect", "plan", "anticipate", "aim", "continue", "target" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements.

These statements include, but are not limited to, statements regarding: expectations regarding clinical benefits and availability of Scancell's product candidates, including iSCIB1+ in advanced melanoma; expectations regarding the design, progress, timing, enrolment, randomization, scope, expansion, and results of Scancell's existing and planned clinical trials, including Scancell's Phase 3 registrational trial of iSCIB1+ in advanced melanoma and Phase 2 monotherapy trial of iSCIB1+ in patients with neo/adjuvant melanoma; the expected submission of clinical trial applications or investigational new drug applications; the timing and sufficiency of clinical trial outcomes to support potential approval of any of Scancell's product candidates; the potential regulatory approval; and the timing, ability to close and anticipated benefits of the proposed Business Combination. Any forward-looking statements are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond Scancell's control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions, including as a result of health epidemics or pandemics, war in Ukraine, the conflict in the Middle East, or global geopolitical tension, on Scancell's business, financial position, strategy and anticipated milestones, including Scancell's ability to conduct ongoing and planned clinical trials; Scancell's ability to obtain a clinical supply of current or future product candidates; Scancell's ability to obtain regulatory approval of its product candidates; Scancell's ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Scancell's need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Scancell's ability to obtain, maintain and enforce intellectual property protection for any of its product candidates it is developing; the success of Scancell's current and future collaborations, partnerships or licensing arrangements; the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations or agreements with respect to the Business Combination; the outcome of any legal proceedings that may be instituted against Neuphoria, Scancell, the combined company or others following this announcement of the Business Combination and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the stockholders of Neuphoria, to obtain financing to complete the Business Combination or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Scancell as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain key relationships and retain its management and key employees; costs related to the Business Combination; changes in applicable laws or regulations; and other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in Neuphoria's Annual Report on Form 10-K for the fiscal year ended June 30, 2025 or in other documents filed by Neuphoria with the SEC. There may be additional risks that neither Scancell nor Neuphoria presently know or that Scancell and Neuphoria currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Neither Scancell nor Neuphoria undertakes any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Scancell and Neuphoria disclaim any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Scancell, Neuphoria or any of their respective directors, officers, employees, affiliates, agents, advisors or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication.

No Offer

This communication is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities pursuant to the proposed transaction or otherwise, nor shall there be any sale of any such 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 such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

For more information please contact:

Scancell Holdings plc	[phone]
Phil L'Huillier, CEO
Panmure Liberum (Nominated Adviser and Joint Broker)	[phone]
Emma Earl, Will Goode, Mark Rogers
WG Partners LLP (Joint Broker) David Wilson, Claes Spang	[phone]
Investor and media relations Mandeep Sehmi	[phone] [e-mail]

 

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