Replimune Presents Major Evaluation Information from IGNYTE Medical Trial of RP1 Mixed with Nivolumab in Anti-PD1 Failed Melanoma at European Society for Medical Oncology (ESMO) Congress 2024

Information from the IGNYTE major evaluation exhibits clinically significant exercise throughout all subgroups, together with those that had obtained prior anti-PD1 and anti-CTLA-4 or had major resistance to anti-PD1

Injected and non-injected lesions responded with comparable frequency, depth, period and kinetics

WOBURN, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: NASDAQ:), a medical stage biotechnology firm pioneering the event of novel oncolytic immunotherapies, at this time introduced that information from the first evaluation of the IGNYTE medical trial of RP1 mixed with nivolumab had been offered by Caroline Robert, M.D., Ph.D. of Gustave Roussy as a late breaking summary throughout an oral session on the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona.

We’re excited to share the total IGNYTE major evaluation information which clearly exhibits clinically significant and sturdy systemic anti-tumor exercise throughout the enrolled inhabitants, with responses in each injected and non-injected tumors, together with visceral lesions, mentioned Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. These optimistic information will type the idea of our upcoming BLA submission for RP1 in anti-PD1 failed melanoma within the 2H 2024,  which is a crucial step ahead as we proceed to progress RP1 plus nivolumab as a possible new possibility in a setting with solely restricted  remedies at present obtainable.

The anti-PD1 failed melanoma cohort from the IGNYTE medical trial included 140 sufferers who obtained RP1 plus nivolumab after confirmed development whereas being handled for a minimum of 8 weeks with anti-PD1 based mostly remedy (+/- anti-CTLA-4). The first evaluation by blinded impartial central overview was triggered as soon as all sufferers had been adopted for a minimum of 12 months. Due to necessities that sufferers should have confirmed progressive illness on a direct anti-PD1-based remedy, which is the present first line customary of care, a lot of the sufferers enrolled had 1 (45.7%) or 2 (18.6%) traces of prior therapies.

Outcomes from the IGNYTE medical trial offered at ESMO present:

• The general response fee (ORR) was 33.6% by modified RECIST (mRECIST) 1.1 standards, the first endpoint as outlined within the protocol, and 32.9% by RECIST 1.1 standards, a further sensitivity evaluation requested by the FDA.
• The whole response fee by mRECIST was 15%.
• In sufferers who had prior anti-PD1 and anti-CTLA-4, the ORR was 27.7% and for individuals who had major resistance to anti-PD1, the ORR was 35.9% by mRECIST.
• Median period of response from response initiation was 21.6 months and media period of response from therapy initiation was 27.6 months. On the time of the evaluation, 85% of responses had been ongoing greater than a yr from beginning therapy.
• Whereas median total survival has not been reached, one-, two- and three-year survival charges had been 75.3%, 63.3% and 54.8% respectively.

RP1  mixed with nivolumab continues to be well-tolerated. Remedy-related adversarial occasions related to  RP1  together with nivolumab had been predominantly Grade 1-2 constitutional kind occasions (> 5% of sufferers), together with fatigue, chills, pyrexia, nausea, influenza-like sickness, injection-site ache, diarrhea, vomiting, headache, pruritis, asthenia, arthralgia, myalgia, decreased urge for food, and rash, with a low incidence (12.8% of sufferers) of Grade 3-4 occasions, which had been predominantly Grade 3. Grade 4 occasions had been one every of lipase elevated, cytokine launch syndrome, myocarditis, hepatic cytolysis and splenic rupture. There have been no Grade 5 occasions.

The presentation is obtainable on the Firm web site below Occasions and Displays.

About  RP1
RP1  (vusolimogene oderparepvec) is Replimune’s lead product candidate and relies on a proprietary pressure of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, meant to maximise tumor killing efficiency, the immunogenicity of tumor cell dying, and the activation of a systemic anti-tumor immune response.

About  Replimune  
Replimune Group, Inc., headquartered in  Woburn, MA, was based in 2015 with the mission to remodel most cancers therapy by pioneering the event of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform relies on a potent HSV-1 spine meant to maximise immunogenic cell dying and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a novel twin native and systemic exercise consisting of direct selective virus-mediated killing of the tumor ensuing within the launch of tumor derived antigens and altering of the tumor microenvironment to ignite a robust and sturdy systemic response. The RPx product candidates are anticipated to be synergistic with most established and experimental most cancers therapy modalities, resulting in the flexibility to be developed alone or mixed with quite a lot of different therapy choices. For extra info, please go to  www.replimune.com.

Ahead Wanting Statements
This press launch incorporates ahead wanting statements throughout the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Trade Act of 1934, as amended, together with statements relating to the design and development of our medical trials, the timing and sufficiency of our medical trial outcomes to assist potential approval of any of our product candidates, our objectives to develop and commercialize our product candidates, affected person enrollments in our present and deliberate medical trials and the timing thereof, and different statements recognized by phrases equivalent to may, expects, intends, could, plans, potential, ought to, will, would, or comparable expressions and the negatives of these phrases. Ahead-looking statements should not guarantees or ensures of future efficiency, and are topic to quite a lot of dangers and uncertainties, lots of that are past our management, and which may trigger precise outcomes to vary materially from these contemplated in such forward-looking statements. These components embrace dangers associated to our restricted working historical past, our capacity to generate optimistic medical trial outcomes for our product candidates, the prices and timing of working our in-house manufacturing facility, the timing and scope of regulatory approvals, the provision of mixture therapies wanted to conduct our medical trials, adjustments in legal guidelines and rules to which we’re topic, aggressive pressures, our capacity to determine further product candidates, political and international macro components together with the affect of the coronavirus as a worldwide pandemic and associated public well being points and the Russian-Ukrainian and Israel-Hamas political and army conflicts, and different dangers as could also be detailed sometimes in our Annual Experiences on Type 10-Okay and Quarterly Experiences on Type 10-Q and different studies we file with the  Securities and Trade Fee. Our precise outcomes may differ materially from the outcomes described in or implied by such forward-looking statements. Ahead-looking statements communicate solely as of the date hereof, and, besides as required by legislation, we undertake no obligation to replace or revise these forward-looking statements.

Investor Inquiries
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ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com

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Replimune
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media@replimune.com

Source: Replimune Group Inc