On June 3, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer reported that the first patient has been enrolled in the Phase II part of the randomized Phase I/II clinical trial of the individualized therapeutic cancer vaccine, TG4050, in the adjuvant treatment of head and neck cancer (Press release, Transgene, JUN 3, 2024, View Source [SID1234644069]). Patient screening and enrollment are active, with the aim of enrolling 80 patients internationally in the overall Phase I/II trial.

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TG4050 is based on Transgene’s myvac viral vector platform and NEC’s cutting-edge AI capabilities for the identification and prediction of the most immunogenic neoantigens for each patient. The therapeutic vaccine, TG4050, is being jointly developed by Transgene and NEC in head and neck cancer.

TG4050 advancing to Phase II part based on Phase I data showing immunogenicity and first signs of clinical benefit.

The promising TG4050 Phase I data presented at AACR (Free AACR Whitepaper) 2024 (see press release distributed on April 9, 2024, here) showed strong immunogenicity, persistent cellular immune response as well as signs of clinical benefit for patients. At the time of the analysis, only patients in the control arm had relapsed, while all patients who received TG4050 were disease-free. Based on these promising data, Transgene and its partner NEC have decided to move forward with an extension of the randomized trial consisting of a Phase II part. This Phase II part will continue investigating single-agent TG4050 in patients with newly diagnosed, locoregionally advanced, HPV-negative, squamous cell carcinoma of the head and neck (SCCHN) in the adjuvant setting following completion of surgery and chemoradiotherapy.

Although some advancements in the treatment of SCCHN have been made, there remains a significant medical need for these patients, including in the adjuvant setting. With the current standard of care, 30% to 40% of patients are expected to relapse within 24 months following surgery and adjuvant therapy. Despite completed Phase III trials, immune checkpoint inhibitors have yet to demonstrate significant benefits for these patients.

TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene commented, "The inclusion of the first patient in the Phase II part of our Phase I/II trial marks a further milestone for Transgene. In the ongoing trial, TG4050 is targeting patients with head and neck cancer at high-risk of relapse, with the aim of extending disease-free survival. The Phase I data we have generated indicate that TG4050 enables the induction of specific cellular immune responses that persist up to 7 months post treatment initiation, with all treated patients remaining disease-free after a median follow-up of 18.6 months. We are encouraged by these promising clinical outcomes and look forward to generating data from the Phase II part of the trial. Personalized cancer vaccines are an extremely exciting development and, if successful, could also be utilized to treat other forms of cancer to improve and extend the lives of patients."

This international, multicenter, open label, two-arm trial is currently screening patients in France at IUCT-Oncopole (Toulouse) and Institut Curie (Paris). Additional sites in France, Europe and the US will be added in the coming months. Overall, the Phase I/II trial will randomize approximately 80 patients. The inclusion of the last patient in the Phase II part of the study is expected in Q4 2025.

TG4050 is designed based on each patient’s tumor

TG4050 is an individualized immunotherapy derived from Transgene’s myvac platform, combining Transgene’s biotechnology known-how and expertise with NEC’s artificial intelligence (AI) capabilities. Cancer vaccines of this type are individually designed to stimulate and educate the patient’s immune system to fight against their own cancer. This viral-based immunotherapy integrates about thirty tumor neoantigen, identified and selected from tumor sequencing to generate the most effective immune response.

On June 3, 2024 Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for a broad range of immunological diseases and cancer, reported that clinical data for its lead drug candidate, ELA026, will be presented as one of six selected abstracts in a late-breaking oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (Press release, Electra Therapeutics, JUN 3, 2024, View Source [SID1234644004]). The conference is being held in Madrid, Spain and live-streamed on June 13-16, 2024.

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The oral presentation will describe clinical data from a Phase 1b study of ELA026 for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH), a rare, life-threatening hyperinflammatory disease for which there is currently no approved treatment. ELA026 is a monoclonal antibody that targets signal regulatory protein (SIRP)-α/β1/γ, enabling precise depletion of pathologic immune cells. The abstract is published on the EHA (Free EHA Whitepaper) website here.

Details of the oral presentation are as follows:

Title: ELA026 Targeting of SIRP(+) Immune Cells Results in a High Response Rate and Improved 2-Month Survival of Treatment-Naïve Malignancy-Associated Hemophagocytic Lymphohistiocytosis in a Phase 1 Study
Presenter: Abhishek Maiti, MD, Assistant Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center
Session Name: Late-Breaking Oral Session
Session Date & Time: Sunday, June 16, 2024, 9:45 – 11:15 a.m. Central European Summer Time
Location: Madrid Recinto Ferial Hall Picasso, and livestreamed on the EHA (Free EHA Whitepaper) Congress platform
Abstract Code: LB3442

About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare, life-threatening inflammatory disease for which there is no approved treatment. It can be triggered by cancer (malignancy-associated HLH, or mHLH), infection, autoimmune disease, or immunotherapy. sHLH is associated with a systemic inflammatory response for which patients require immediate intervention. Without treatment, patients may experience multiple organ failure and death. sHLH has a high mortality rate during the first months of diagnosis, with mHLH patients having the poorest outcomes.

On June 3, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in solid tumors without lymphodepletion at the 6th Annual Allogeneic Cell Therapies Summit to be held in Boston, MA, from June 10-12, 2024 (Press release, NKGEN Biotech, JUN 3, 2024, View Sourcenkgen-biotech-to-present-updated-phase-1-data-on-snk02-allogeneic-nk-cell-therapy-in-solid-tumors-at-the-6th-annual-allogeneic-cell-therapies-summit-2024/" target="_blank" title="View Sourcenkgen-biotech-to-present-updated-phase-1-data-on-snk02-allogeneic-nk-cell-therapy-in-solid-tumors-at-the-6th-annual-allogeneic-cell-therapies-summit-2024/" rel="nofollow">View Source [SID1234644021]).

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Presentation Details:

Title: Protecting Patients by Removing Need for Lymphodepletion to Better Preserve Immune Function

Conference Track: Clinical Track

Date and Time: Wednesday, June 12, 2024, 12:00 pm ET

Dr. Song’s presentation will detail the Company’s novel allogeneic blood-derived NK cell therapy ("SNK02") commercial manufacturing and cryopreservation process, as well provide an update on their initial Phase 1 results using SNK02 to treat patients with advanced refractory solid tumors. Furthermore, Dr. Song will explore the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function, and potentially enhancing treatment efficacy. The presentation will also include a discussion on an unexpected discovery from the SNK02 Phase 1 trial, hinting at its possible applicability as a treatment for patients beyond cancer.

A copy of the presentation will be available on the Scientific Publications page of the Company’s website at View Source once the presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK02 on advanced solid tumors, which may not be included in this conference presentation, can also be found on the Scientific Publications page.

About SNK02

SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic NK cell immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.

On June 3, 2024 RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, reported the results of the first-in-human, single-arm, open-label, multi-center Phase I/II study evaluating RC88 in patients with MSLN-expressing advanced solid tumors on June 3, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2024) held in Chicago from May 31-June 4, 2024 (Press release, RemeGen, JUN 3, 2024, View Source [SID1234644037]). The first author, Professor Liu Yutao, from the Chinese Academy of Medical Sciences Cancer Hospital, presented RemeGen’s poster session (Poster #422) of this study that focused on efficacy and safety in patients with ovarian cancer, non-squamous non-small cell lung cancer, and cervical cancer.

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RC88 is a novel, first-in-class, antibody-drug conjugate (ADC) developed by RemeGen that targets mesothelin (MSLN) with a monomethyl auristatin E (MMAE) payload. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to MMAE which acts as a microtubule inhibitor. RC88 has a high affinity for MSLN and can specifically bind to MSLN overexpressing tissues. In this study, RC88 has demonstrated a terminating effect on tumor cells with various levels of MSLN expression. RC88 has demonstrated anti-tumor activity and a manageable RC88 monotherapy safety profile in MSLN-positive advanced solid tumors. Preclinical studies showed that RC88 can selectively deliver a potent cytotoxic payload to MSLN-expressing cells through internalization, thus inducing G2/M arrest and apoptosis.

Patients with MSLN-expressing advanced malignant solid tumors that had failed standard therapies were enrolled in this study. For the Phase II study, the primary endpoint was overall response rate (ORR) per RECIST v1.1 criteria-based endpoints, with secondary endpoints including disease control rate (DCR), progression-free survival (PFS), and safety.

As of February 21, 2024, 170 patients with advanced solid tumor were enrolled. The dose escalation phase was completed, and 2.0 mg/kg and 2.5 mg/kg Q3W doses were expanded into Phase II.

In the ovarian cancer (OC) cohort, 54 patients were enrolled, all with 2+ or 3+ MSLN expression. Of these, 40 (74.1%) had an ECOG score of 1; 33 (61.1%) had received prior bevacizumab treatment, and 28 (51.9%) had prior PARP inhibitor (PARPi) exposure. As of March 22, 2024, a total of 31 patients in the 2.0mg/kg group who had received two to four lines of prior therapies were efficacy-evaluable. Among them, the ORR and confirmed ORR (cORR) were 45.2% (14/31, 95%CI 27.3, 64.0) and 41.9% (13/31, 95%CI 24.5, 60.9), respectively. The median DoR was 8.02 months (95%CI 2.83, 8.54).

In the non-squamous non-small cell lung cancer (NSCLC) cohort, 16 EGFR/ALK wild-type (WT) patients were efficacy-evaluable. The ORR and cORR were 31.3% (5/16) and 25% (4/16), respectively. Among the above patients with MSLN high expression (PS2#≥50), the ORR, cORR, median PFS and median DoR were 41.7% (5/12), 33.3% (4/12), 6.87 months and 9.13 months, respectively.

In the cervical cancer (CC) cohort, 18 patients who had progressed on previous systemic therapies were enrolled. The ORR and cORR were 33.3% (6/18) and 27.8% (5/18), respectively. Among the 12 patients that received ≥ 2 lines of therapies, the ORR and cORR were 41.7% (5/12) and 33.3% (4/12), respectively.

"Currently, chemotherapy is the standard of care for OC with an ORR rate of 12%. The promising results of 41.9% ORR from this study underscore the potential of RC88 to significantly improve outcomes for patients with MSLN-expressing advanced solid tumors," said Dr. Fang Jianmin, CEO of RemeGen. "We are committed to advancing our innovative therapies to address these huge unmet medical needs and enhance patient care."

On June 3, 2024 InvoX Pharma Limited ("invoX"), a research-driven global biopharmaceutical company with an advancing pipeline of innovative products, reported updated findings from its ongoing phase 1 study of FS222, an investigational CD137/PD-L1 bispecific antibody, in patients with advanced solid tumours (Press release, InvoX Pharma, JUN 3, 2024, View Source [SID1234644053]). These data demonstrated encouraging anti-tumour activity in multiple tumour types with a manageable safety profile. These preliminary findings were presented today at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago as an oral presentation during the Development Therapeutics – Immunology Session.

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FS222 is a novel tetravalent bispecific antibody, using invoX’s proprietary Fcab platform technology, that drives PD-L1 dependent CD137 agonism. The data presented today are from 100 subjects in the ongoing first-in-human (FIH) dose-escalation phase 1 clinical trial of FS222 (NCT04740424) in patients with advanced solid tumours. The study is designed to evaluate safety and identify the maximum tolerated dose, with secondary objectives related to anti-tumour activity, pharmacokinetics, and pharmacodynamics.

As a monotherapy dosed once every 4 weeks, FS222 increased T cell proliferation and intratumoural CD8+ T cell infiltration across a wide range of doses. The rate of treatment-related adverse events (TRAEs) was generally dose dependent. Overall, TRAEs were consistent with the intended dual mechanism of action of CD137 agonism and PD-L1-blockade and were generally manageable and reversible. Grade ≥ 3 TRAEs occurred in 36/100 subjects, with the most common including increases in aspartate aminotransferase and alanine aminotransferase, thrombocytopenia, neutropenia and febrile neutropenia.

In the study, FS222 demonstrated encouraging anti-tumour activity in multiple tumour types. Responses (as defined by RECIST1.1 criteria) were observed in cutaneous melanoma (n=9), ovarian cancer (n=2), non-small cell lung cancer (NSCLC) (n=2), and one each for mucosal melanoma, triple negative breast cancer (TNBC), mesothelioma and MSS colorectal cancer. The rate of disease control (defined as the rate of complete responses, partial responses and stable disease combined) was 45.0% for all patients in the study.

In 19 patients with metastatic/advanced cutaneous melanoma previously treated with a PD-1 antibody the overall response rate (defined as the rate of complete responses and partial responses combined) was 47.4% and the disease control rate was 68.4%.

Elena Garralda, MD, MSc, Director of Early Drug Development at Vall d’Hebron University Hospital, said: "While there have been great advances in immuno-oncology research, existing treatments continue to face challenges with response rates and duration of response, especially in treatment-resistant cancer. The opportunity to target multiple complementary immune mechanisms with a single agent is very exciting and has significant potential to address an unmet need for patients. These results for FS222 are really encouraging and should be studied further, as they show a promising anti-tumour effect with a manageable safety profile."

Ben Toogood, Chief Executive Officer at invoX, said: "We are encouraged by these results and are impressed by the preliminary anti-tumour activity observed with FS222, especially in melanoma patients previously treated with a PD-1 antibody. There is an urgent need for innovative immuno-oncology treatments for patients with treatment-resistant cancers. We see significant potential for FS222 in this area and will continue to investigate FS222 further, with the aim of providing benefit to patients in the future."

Ben added: "These data also provide important validation of our antibody platform. We are excited about the potential to utilise our proprietary CD137-agonist domain from our Fcab platform in additional bispecific antibodies targeting multiple tumour types and patient populations."

Enrollment in this phase 1 study of FS222 is ongoing and the study is exploring additional FS222 dose optimization.