On January 21, 2025 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable efficacy results from the 12-month follow-up visit for the first patient and the two-month follow-up visit for the seventh patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides an enrollment update (Press release, Kiromic, JAN 21, 2025, View Source [SID1234649792]). 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 or locally-advanced non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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At the 12-month post-treatment follow-up visit, the first patient in Deltacel-01 had a 33.33% reduction in tumor volume compared with their pre-treatment tumor size, thereby achieving a partial response. This marks the second patient in the Deltacel-01 study with a partial response after our fourth patient. Additionally, the seventh patient had a 9.5% reduction in tumor size at their two-month follow-up visit. Both patients are being treated at the Beverly Hills Cancer Center (BHCC).

"The sustained, positive results we are seeing with the Deltacel-01 clinical trial are highly encouraging. Having a second patient achieve partial response with the first patient’s remarkable 33% tumor shrinkage at the 12-month follow-up highlights the therapeutic potential of our gamma-delta T cell therapy. The early response observed in the seventh patient further supports our confidence in this platform. We are expanding trial enrollment to expose more patients to the potential benefit of Deltacel while bolstering our clinical dataset," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

"The remarkable 33% tumor reduction seen in the first and fourth patient at our center along with the encouraging 9.5% reduction in the seventh patient, are truly exciting results from the Deltacel-01 clinical trial. These data, coupled with the patients’ reports of improved energy and better quality of life, reinforce the potential of Kiromic’s gamma delta T-cell therapy to deliver meaningful clinical benefit for patients with advanced lung cancer who have exhausted other treatment options," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at BHCC. "As a leading cancer center focused on providing access to the most innovative therapies, we are proud to partner with Kiromic and look forward to continuing to enroll patients and generate additional evidence supporting Deltacel’s promise as a transformative new treatment option."

The Eighth Patient Completes Treatment

The eighth patient successfully completed the Deltacel-01 treatment regimen and is tolerating therapy well. Initial efficacy results for this patient are expected in late February 2025. This patient was enrolled at the Clinical Research Advisors Koreatown, a satellite location of BHCC.

Kiromic also announces that the ninth patient in Deltacel-01 started treatment at Virginia Oncology Associates (Norfolk, VA). Additionally, the company expects to enroll the 10th and 11th patients into the trial by the end of January.

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 advanced NSCLC receive three intravenous infusions of Deltacel with six courses of low-dose, localized radiation over a 31-day period. The primary objective of Deltacel-01 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.

On January 21, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that the first patient has been dosed in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating potential first-in-class radioenhancer JNJ-1900 (NBTXR3) for the treatment of patients with Stage 3 unresectable non-small cell lung cancer receiving standard of care chemoradiation followed by consolidation durvalumab (NCT06667908) (Press release, Nanobiotix, JAN 21, 2025, View Source [SID1234649793]). CONVERGE is sponsored by Janssen Pharmaceutica NV, a Johnson & Johnson Company, under a global license agreement.

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"We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment," said Laurent Levy, Nanobiotix Chief Executive Officer and Chairman of the Executive Board. "With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve."

About NBTXR3 (JNJ-1900)

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson Company.

On January 21, 2025 Neogap Therapeutics AB, a Swedish biotechnology company developing personalised immunotherapy for cancer treatment, reported that the first two patients have been treated in the company’s Phase I/II clinical trial (Press release, Neogap Therapeutics, JAN 21, 2025, View Source;personalised-immunotherapy-trial,c4093680 [SID1234649794]). The trial investigates the safety and tolerability of a new, tailored treatment for advanced colorectal cancer, a disease with significant medical needs and limited treatment options.

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Colorectal cancer affects two million people worldwide annually and is the third most common cancer type. For patients with metastatic disease, survival prospects are limited, underscoring the need for new, effective treatments. Neogap’s immunotherapy, pTTL (personalised Tumour Trained Lymphocytes), is being developed to address these challenges by offering a personalised treatment based on the patient’s own immune cells.

The clinical trial is being conducted in Sweden at Karolinska University Hospital and Danderyd’s Hospital in Stockholm, as well as Västmanland Hospital in Västerås. The trial targets patients with stage IV metastatic colorectal cancer. Patients are being continuously recruited nationwide, and a total of 12–16 patients will receive the treatment. The primary aim is to evaluate safety and tolerability while collecting data on treatment response.

"We are delighted to have treated the first patients – this is a significant milestone in our clinical trial and our mission to develop curative treatments for critically ill cancer patients. We have an outstanding trial team and look forward to the upcoming results," says Samuel Svensson, CEO of Neogap Therapeutics.

About Neogap’s immunotherapy, pTTL
pTTL (personalised Tumour Trained Lymphocytes) is a cell-based immunotherapy that enhances the patient’s own T cells to fight cancer. The therapy combines sophisticated DNA sequencing with T-cell expansion to deliver a precision treatment for solid tumours. It is powered by Neogap’s patented technologies, PIOR and EpiTCer. The goal is to provide patients with a tailored and innovative therapy that meets their specific needs.

The clinical trial is conducted in collaboration with the following units:

Phase 1 unit, Center for Clinical Cancer Studies, Theme Cancer, Karolinska University Hospital Solna, Stockholm, Sweden
Medical Unit Cell therapy and Allogeneic stem cell transplantation (ME CAST), Theme Cancer, Karolinska University Hospital Huddinge, Stockholm, Sweden
Medical Unit Pelvic cancer – Colorectal cancer, Theme Cancer, Karolinska University Hospital Solna, Stockholm, Sweden
Department of Surgery, Västmanlands Hospital, Västerås, Sweden
Department of Surgery and Urology, Danderyd’s Hospital, Stockholm, Sweden

On January 21, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma (Press release, Replimune, JAN 21, 2025, View Source [SID1234649796]). The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold an advisory committee meeting in relation to this application, and at this time have not identified any potential review issues. The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is currently underway with over 100 sites planned globally.

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"There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen," said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. "The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application."

The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. Recently, Replimune received Breakthrough Therapy designation for RP1 in combination with nivolumab for the treatment of advanced melanoma, based on the safety and clinical activity observed in the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial.

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. For more information, please visit View Source

About Melanoma
Melanoma is the fifth most common cancer, with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024.i Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Options are limited after immune checkpoint blockade therapy, with no standard of care available to patients.

About RP1
RP1 (vusolimogene oderparepvec) 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 January 21, 2025 TRACER and VAR2 Pharma reported the first patient enrolled in the VARTUTRACE study, a Phase 0 first-in-human imaging trial (NCT06645808) (Press release, Var2 Pharmaceuticals, JAN 21, 2025, View Source [SID1234649798]). The patient, suffering from lung carcinoma received the Investigational Medicinal Product (IMP), a zirconium-89-labeled single-chain variable fragment (scFv), Vartumab, on Dec 17, 2024. The patient successfully completed all study visits.

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The obtained data provides valuable insight into using the onco-fetal Chondroitin Sulfate (ofCS) binding Vartumab to selectively target tumors (Nat Commun. 2024 Aug 30;15(1):7553). The study will in total include 16 patients with various solid cancer types for each of the two Vartumab antibodies. Allowing the research team to evaluate the biodistribution and tumor accumulation of both Vartumabs prior to clinical testing of Vartumab-based Antibody Drug Conjugates (ADC).

"The enrollment of the first patient is always a big milestone in clinical research. Our team is very happy with the first patient-in and we’re excited to gather more data on the Vartumabs." – Noortje van Dijk, project manager at TRACER.

"I am thrilled to see our new pan-cancer antibodies moving forward in this first clinical study, paving the way for efficacy studies and hopefully one day a novel treatment for the many cancer patients with limited or exhausted clinical options" – Ali Salanti, CEO at VAR2 Pharma.