On June 6, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, reported the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma (Press release, Replimune, JUN 6, 2024, View Source [SID1234644176]). The results by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO (Free ASCO Whitepaper) 2024, with all responses lasting greater than 6 months from baseline.

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"The overall strength of the IGNYTE data and safety profile further highlights the potential of RP1 in a difficult treatment setting with limited options for patients," said Sushil Patel, Ph.D., CEO of Replimune. "Based on these compelling results and recent FDA interactions, we are increasingly confident in our path forward. We have shared the results with the agency and plan to request a pre-BLA meeting, in advance of our intended BLA submission. With these data in hand, we are preparing for a commercial launch next year."

The anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients who received RP1 plus nivolumab after confirmed progression while being treated with at least 8 weeks of prior anti-PD1 therapy (+/- anti-CTLA-4). The primary analysis by independent central review was triggered once all patients had been followed for at least 12 months.

The topline results show the overall response rate was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. Responses from baseline were highly durable, with all responses lasting more than 6 months and median duration of response exceeding 35 months. The Company plans to submit the full primary analysis data from the anti-PD1 failed melanoma cohort including key secondary endpoint data and subgroups for presentation at an upcoming medical congress.

RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 constitutional-type side effects, observed. Treatment-related adverse events associated with RP1 in combination with nivolumab were predominantly Grade 1-2 constitutional type events (> 5% of patients), including fatigue, chills, pyrexia, nausea, influenza-like illness, injection-site pain, diarrhea, vomiting, headache, pruritis, asthenia, arthralgia, myalgia, decreased appetite, and rash, with a low incidence of Grade 3-5 events. Grade 4 events were one each of lipase increased, alanine aminotransferase increased, blood bilirubin increased, cytokine release syndrome, myocarditis, hepatic cytosis and splenic rupture. There were no Grade 5 events.

Conference Call Details
Replimune will host a conference call and webcast today at 8:00 a.m. ET. Listeners can register for the conference call via this link. Analysts wishing to participate in the question-and-answer session should use this link. The webcast and slides of the presentation can be accessed in the Investors section of the Company’s website at www.replimune.com. A replay of the webcast will be available on the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

On June 6, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate atirmociclib, Pfizer’s investigative selective-CDK4 inhibitor, in combination with RLY-2608 and fulvestrant in patients with PI3Kα-mutated, HR+, HER2- metastatic breast cancer (Press release, Relay Therapeutics, JUN 6, 2024, View Source [SID1234644175]).

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"We are very enthusiastic to evaluate Pfizer’s novel investigative selective-CDK4 inhibitor atirmociclib in combination with RLY-2608, the first mutant selective PI3Kα inhibitor," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "We believe that combining these two selective agents – atirmociclib and RLY-2608 – will avoid key off-target toxicity that comes from hitting CDK6 and wild-type PI3Kα, which has historically significantly limited use of non-selective agents. The breast cancer treatment landscape continues to evolve quickly, and we are pleased that the safety profile RLY-2608 has demonstrated to-date makes it well-positioned to be part of the next generation of therapies."

Under the terms of the agreement, Pfizer will provide atirmociclib for use in the study and Relay will be responsible for conducting the study. The RLY-2608 + atirmociclib + fulvestrant triplet combination is planned to begin by the end of 2024.

About RLY-2608

RLY-2608 is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers, with oncogenic mutations detected in about 14% of patients with solid tumors. RLY-2608 has the potential, if approved, to address more than 250,000 patients per year in the United States, one of the largest patient populations for a precision oncology medicine.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of RLY-2608, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of RLY-2608. RLY-2608 is currently being evaluated in a first-in-human trial designed to treat patients with advanced solid tumors with a PIK3CA (PI3Kα) mutation. For more information on RLY-2608, please visit here.

On June 6, 2024 Novavax presented its corporate presentation (Presentation, Novavax, JUN 6, 2024, View Source [SID1234644174]).

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On June 6, 2024 Lava Therapeutics presented its corporate presentation (Presentation, Lava Therapeutics, JUN 6, 2024, View Source [SID1234644173]).

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On June 6, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 6, 2024, View Source [SID1234644172]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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Scans taken six months post-treatment showed the patient’s tumor size had decreased by 13% compared with the pre-treatment size, and no new tumor lesions were detected, which translates into a six-month progression-free survival. In addition, no dose-limiting toxicities were reported, reinforcing the safety profile of Deltacel observed in previous follow-up visits. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"We are delighted to report that Patient 1 in the Deltacel-01 clinical trial has achieved six-month progress-free survival, and that they continue to do well with no side effects. This is an important clinical milestone that underscores the potential of Deltacel in treating advanced cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Notably, we observed a 13% decrease in tumor size. These results are encouraging and support our belief in the potential of Deltacel to provide an effective new treatment for patients with advanced cancers. We are committed to advancing this trial and bringing hope to those with limited treatment options."

Kiromic continues to expect to report long-term follow-up results for the other two subjects in the first cohort and the first subject in the second cohort by the end of June.

Additionally, the fifth patient in Deltacel-01 began treatment in May, is currently doing well without any signs of toxicity and is expected to have their first efficacy assessment in July. The sixth patient is currently undergoing pre-enrollment screening and is projected to start treatment in mid-June.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.