On June 10, 2024 Hudson Therapeutics reported that Shaperon (KOSDAQ 378800, CEO Seung-Yong Seong), an innovative biopharmaceutical company specializing in immune therapeutics, has signed a Memorandum of Understanding (MOU) with Dong-A ST (KOSPI 170900, CEO Min-Young Kim) for the development of nanobody-based new drugs (Press release, Shaperon, JUN 10, 2024, View Source [SID1234644235]).

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A representative from Shaperon stated, "This MOU aims to leverage Shaperon’s nanobody development platform technology and Dong-A ST’s expertise in antibody commercialization to increase development speed and commercialization potential." Additionally, they stated, "We plan to select the most effective nanobodies in mouse models with human tumor transplants by the end of this year."

Since 2021, the two companies have collaborated on developing triple nanobody antibodies for cancer treatment. This involves using nanobodies to bring killer T cells and cancer cells into proximity by binding to targets on both cell types. Shaperon will advance nanobody development using its full-cycle platform, while Dong-A ST will leverage its antibody commercialization expertise for global biopharmaceutical development.

Nanobodies, about one-tenth the size of conventional antibodies, are gaining attention for next-generation immune checkpoint inhibitors due to their high stability, solubility, and production yield. Shaperon, the only domestic company with a full-cycle platform for nanobody production, development, and analysis from alpaca immunization, is developing a diverse pipeline targeting inflammation and cancer, including immune checkpoint dual antibodies and nanobody-based therapeutics.

Shaperon, the only domestic company with a full-cycle platform for nanobody production, development, and analysis from alpaca immunization, is developing a diverse pipeline targeting inflammation and cancer. This includes immune checkpoint dual antibodies and nanobodies for infectious diseases. Shaperon is also exploring nanobody-based protein therapeutics, such as antibody-drug conjugates (ADCs) and radiopharmaceutical therapies. Recently, they published preclinical results on influenza-targeting nanobodies and presented anti-cancer PDL1-CD47 dual nanobodies at the AACR (Free AACR Whitepaper), gaining recognition for their technological capabilities.

Janice Marie McCourt of Hudson Therapeutics in the US stated, "We have numerous global biotech companies that we met at BIO, Bio Europe, Bio Asia and the Pharm Summit conferences who are signing confidentiality agreements to license the current preclinical immune-oncology bispecific lead program, along with collaborating on Shaperon’s nanobody development platform to create bispecific and trispecific nanobody antibodies in orphan indications, immunology, inflammation, oncology and infectious disease targets that are first-in-class or best-in-class assets with significant commercial potential. We are so excited that the global R&D scientists and clinicians are excited to collaborate with us and create an impact focused on patients with significant unmet needs."

On June 10, 2024 J INTS BIO reported an update of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, during the 3rd of June poster session of the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held at McCormick Place in Chicago, USA, from May 31 to June 4 (Press release, J INTS BIO, JUN 10, 2024, View Source;jin-a02-showed-tumor-reductions-including-brain-metastasis-in-the-ongoing-first-in-human-dose-finding-phase-1-clinical-study-302168022.html [SID1234644234]).

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This latest study update of JIN-A02 reported another tumor Partial Response (PR) in a patient in Cohort 4 (100mg daily). The first tumor Partial Response (PR) recorded in this study, was a patient in the earlier Cohort at a lower dose of 50mg daily. In addition, the first instance of brain tumor activity was recorded in Cohort 4, with a 28.6% reduction of the brain metastasis.

To-date, Partial Response (PR) has been confirmed in two patients and Stable Diseases in three other, including the patient with reduction of brain metastasis in Cohort 4 and two patients from the lower Cohorts at a lower dose.

The final patient in Cohort 4 (100mg) is expected to complete the dose-limiting toxicity (DLT) assessment period soon and thus far, no DLT has been detected. In addition, no rash, diarrhea, or cardiac toxicity (side effects commonly associated with EGFR TKIs use), has been reported in this study despite the positive efficacy signals and clinical benefits already observed. The next Cohort at 150mg daily will begin end of June.

J INTS BIO said, "It is very meaningful to be able to share key clinical results in large-scale global conferences attended by global anticancer experts and research and development officials." and "JIN-A02 is expected to be a game changer to improve the life of patients with EGFR C797S positive NSCLC, for which there is currently no approved treatment," they added. According to the company, JIN-A02 is scheduled to enter phase 2 clinical trial by the end of this year.

On June 10, 2024 Aktis Oncology, a clinical biotechnology company discovering and developing novel classes of targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, reported that Matthew Roden, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the TD Cowen 2nd Annual Radiopharmaceutical Innovation Summit on Monday, June 17, 2024 at 9:20 a.m. ET (Press release, Aktis Oncology, JUN 10, 2024, View Source [SID1234644233]). The conference will be held virtually.

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On June 10, 2024 Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, reported the publication in Nature Reviews Immunology of a manuscript co-authored with the National Institutes of Health titled "Chimeric antigen receptor T cell therapy for autoimmune disease"1 (Press release, Kyverna Therapeutics, JUN 10, 2024, View Source [SID1234644232]).

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With more than 30 ongoing sponsored clinical trials and a growing number of published clinical evidence suggesting the potential of CAR T-cell therapy approaches for autoimmune diseases, the manuscript highlights key considerations on optimal target cell population, CAR construct design, acceptable toxicities, and potential for lasting immune reset.

"It is quite exciting to see how the learnings from the development of innovative CAR T-cell approaches for the treatment of cancer patients are now being applied to the treatment of patients with autoimmune diseases," said James Kochenderfer, M.D., senior investigator, clinician, and translational researcher in the Surgery Branch of the National Cancer Institute, National Health Institutes of Health in Bethesda, MD. "I look forward to seeing further progress in this emerging field ultimately leading towards a potential breakthrough in patient treatment."

"We are very proud of our scientific collaboration with widely recognized opinion leaders in CAR T-cell therapy," said Peter Maag, Ph.D., chief executive officer of Kyverna. "By rapidly advancing an evidence-based science we may bring potentially long-lasting, treatment-free therapeutic options to many patients in need."

About KYV-101
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine2.

KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology.

With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.

On June 10, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) has approved a global registrational Phase III study of the company’s novel drug candidate olverembatinib (HQP1351), in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had failed prior systemic treatment (Press release, Ascentage Pharma, JUN 10, 2024, View Source [SID1234644231]). This approval marks a major milestone in Ascentage Pharma’s clinical development in solid tumors.

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This global, multicenter, single-arm, open-label, pivotal registrational Phase III study is designed to evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST. The CDE has agreed that results from the study can be used to support a future New Drug Application (NDA) for olverembatinib in SDH-GIST.

GIST is the most common type of soft tissue sarcoma that arises in the gastrointestinal track, with a global incidence of 1-1.5/100,000 per year.1 KIT and PDGFRA are key genetic drivers of GIST, and 85% – 90% of all patients with GIST harbor KIT or PDGFRA mutations. The introduction of tyrosine kinase inhibitors (TKIs) has improved the prognosis of patients with this subset of GIST. However, 85% of pediatric patients and 10%-15% of adult patients with GIST do not harbor KIT or PDGFRA mutations, thus belong to a subtype dubbed wild-type GIST. Depending on whether the SDH expression is lost in the patient, wide-type GIST can be further categorized into SDH-deficient and non-SDH-deficient GISTs.2-3

SDH-deficient GIST has unique clinical and pathological characteristics. According to existing literatures, SDH-deficient GIST has a median age of diagnosis of 21 years and is more common in women. SDH-deficient GIST, primarily arises in the gastric area with a high propensity to metastasize, is characterized in immunohistochemistry essays by the loss of SDHB protein expression. Patients with early-stage localized SDH-deficient GIST can be treated with surgeries, although most patients eventually relapse. At present, there is no standard treatment option for relapsed and advanced SDH-deficient GISTs. Imatinib is generally considered ineffective for the condition and other TKIs have also failed to demonstrate satisfactory efficacy2-5, offering a five-year event-free survival (EFS) rate of just 24%.4 Being commonly diagnosed at young ages, patients with SDH-deficient GIST endure significant impact on their quality of life and survival, therefore have urgent unmet medical needs for new treatment options.

Olverembatinib is an orally-available novel third-generation TKI developed by Ascentage Pharma. The drug has been granted a Breakthrough Therapy Designation by the China CDE for the treatment of patients with SDH-deficient GIST who had received first-line treatment. As a multi-targeted TKI, olverembatinib has shown excellent efficacy and manageable safety in patients with SDH-deficient GIST. Since 2022, the clinical study evaluating olverembatinib in SDH-deficient GIST has been selected for presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for three consecutive years, including an oral report at the 60th ASCO (Free ASCO Whitepaper) Annual Meeting just took place this month. According to the latest results, olverembatinib has achieved a clinical benefit rate (CBR) of 92.3% in patients with SDH-deficient GIST.

Olverembatinib is the first China-approved third-generation BCR-ABL inhibitor. To date, the drug has been approved for two indications in China, including adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs. Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

"In earlier studies, olverembatinib has already shown encouraging efficacy and favorable safety in patients with SDH-deficient GIST," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We are excited by the approval for this global registrational Phase III study because it could potentially lead to a clinical breakthrough for another indication that currently lacks approved treatment options while marking a major milestone for Ascentage Pharma’s clinical development in solid tumors. Remaining steadfastly committed to the mission of addressing unmet clinical needs in China and around the world, we will expeditiously advance this clinical development program for the benefit of more patients."