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 20, 2025 GSK plc (LSE/NYSE: GSK) reported the European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy (carboplatin and paclitaxel) for first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy (Press release, GlaxoSmithKline, JAN 20, 2025, View Source [SID1234649774]). This approval broadens the previous indication for Jemperli plus chemotherapy in the European Union (EU) to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours, which represent approximately 75% of patients diagnosed with endometrial cancer and who have limited treatment options.

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Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit. We’re proud Jemperli continues to redefine the treatment landscape for patients."

Dr Mansoor Raza Mirza, Chief Oncologist, Copenhagen University Hospital, Denmark, and RUBY principal investigator said: "Clinicians have been waiting for years for an immuno-oncology-based option that can meaningfully improve overall survival outcomes for patients with MMRp/MSS primary advanced or recurrent endometrial cancer. The expanded approval represents a significant advance that delivers on this hope, now for patients with both dMMR/MSI-H and MMRp/MSS tumours."

The European Commission’s approval to expand the use of Jemperli plus chemotherapy is based on results from Part 1 of the RUBY phase III trial. RUBY Part 1 is the only clinical trial in this setting to show a clinically meaningful and statistically significant overall survival (OS) benefit in the full population of patients with primary advanced or recurrent endometrial cancer, demonstrating a 31% reduction in risk of death (HR: 0.69; 95% CI: 0.54–0.89) compared to chemotherapy alone.

At the 2.5-year landmark, the chance of being alive was 61% (95% CI: 54-67) for patients in the Jemperli plus chemotherapy group (245 patients) compared to 49% (95% CI: 43-55) in the chemotherapy group (249 patients). In addition, a 16.4-month improvement in median OS was observed with Jemperli plus chemotherapy versus chemotherapy alone (44.6 months [95% CI: 32.6–NR] vs. 28.2 months [95% CI: 22.1–35.6], respectively). The median duration of follow-up was more than three years.1 The safety and tolerability analysis from RUBY Part 1 showed a safety profile for Jemperli plus carboplatin-paclitaxel that was generally consistent with the known safety profiles of the individual agents. The most common treatment-emergent adverse reactions (≥ 10%) in patients receiving Jemperli plus chemotherapy were rash, rash maculopapular, hypothyroidism, pyrexia, alanine aminotransferase increased, aspartate aminotransferase increased and dry skin.

OS data were presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer on 16 March 2024, and were published in Annals of Oncology on 9 June 2024. The label for Jemperli plus chemotherapy in the US was expanded to all adult patients with primary advanced or recurrent endometrial cancer in August 2024.

About endometrial cancer 
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries,2 with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.3 Incidence rates are expected to rise by approximately 40% between 2020 and 2040.4 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year.5 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.6 Among patients with primary advanced or recurrent endometrial cancer, approximately 75% have MMRp/MSS tumours.7

About RUBY  
RUBY is a two-part global, randomised, double-blind, multicentre phase III trial of 785 patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus carboplatin-paclitaxel plus placebo followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo.   

In Part 1, the dual-primary endpoints are investigator-assessed progression-free survival (PFS) based on the Response Evaluation Criteria in Solid Tumours v1.1 and OS. The statistical analysis plan included pre-specified analyses of PFS in the mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) and overall populations and OS in the overall population. Pre-specified exploratory analyses of PFS and OS in the MMRp/MSS population and OS in the dMMR/MSI-H populations were also performed. RUBY Part 1 included a broad population, including histologies often excluded from clinical trials and had approximately 10% of patients with carcinosarcoma and 20% with serous carcinoma. 

In Part 2, the primary endpoint is investigator-assessed PFS in the overall population, followed by PFS in the MMRp/MSS population, and OS in the overall population is a key secondary endpoint. Additional secondary endpoints in Part 1 and Part 2 include PFS per blinded independent central review, PFS2, overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability.  

RUBY is part of an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT), a research network of the European Society of Gynaecological Oncology (ESGO) that consists of 22 trial groups from 31 European countries that perform cooperative clinical trials, and the GOG Foundation, a non-profit organisation dedicated to transforming the standard of care in gynaecologic oncology.

About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes.

In the US, Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This includes patients with MMRp/MSS and dMMR/MSI-H tumours. Jemperli is also approved as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Additionally, Jemperli is indicated in the US for patients with dMMR recurrent or advanced solid tumours, as determined by a US FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication in solid tumours may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 
 
Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli and cobolimab (GSK4069889), a TIM-3 antagonist. 

Important Information for Jemperli in the EU
Indication
Jemperli is indicated:

in combination with carboplatin and paclitaxel, for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy;
as monotherapy for treating adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
Refer to the Jemperli EMA Reference Information for a full list of adverse events and the complete important safety information in the EU.

On January 20, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that KJ-C2320, an allogeneic CAR T-cell therapy targeting CD38, has administered the first dose to a patient in an investigator-initiated trial (IIT) (Press release, Carsgen Therapeutics, JAN 20, 2025, View Source [SID1234649775]).

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KJ-C2320 is developed based on CARsgen’s THANK-uCAR platform. An investigator-initiated trial is ongoing in China to evaluate KJ-C2320 for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).

About THANK-uCAR

THANK (Target to Hinder the Attack of NK cells)-uCAR is CARsgen’s proprietary technology to generate allogeneic CAR-T cells with improved expansion and persistence by modifying donor-derived T cells. To minimize graft versus host disease (GvHD) and host versus graft response (HvGR) from allogeneic T cells, we disrupt the genomic loci encoding TCR and beta-2 microglobulin (B2M) to eliminate surface expression of the TCR or the human leukocyte antigen class I (HLA-I), an approach that has been validated by previous research. However, natural killer (NK) cells can attack T cells without HLA-I expression, which then limits the expansion and persistence of the allogeneic CAR-T cells. To protect the allogeneic CAR-T cells from the patient’s NK cells’ attacks, we arm these TCR-/B2M-T cells with a CAR that recognizes NKG2A to hinder the NKG2A-positive NK cell rejection of the CAR T cells and therefore allow the THANK-uCAR-T cells to resist the attack by NK cells. Clinical studies have demonstrated that the BCMA CAR-T therapy developed on the THANK-uCAR platform can expand in patients achieving complete response to levels comparable to autologous CAR-T, showing preliminary evidence of controllable safety and promising efficacy.