On July 10, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has initiated a Phase I study in China of HMPL-415, an investigational novel selective allosteric inhibitor targeting Src homology-2 domain-containing protein tyrosine phosphatase-2 ("SHP2") (Press release, Hutchison China MediTech, JUL 10, 2023, View Source [SID1234633123]). The first patient received their first dose on July 6, 2023.

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The clinical trial is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-415 as a single agent in patients with advanced malignant solid tumors. This study is expected to enroll up to approximately 80 patients, including patients as part of the dose escalation stage, and further patients at the determined recommended Ph II dose (RP2D). The leading principal investigators are Dr. Tianshu Liu of Zhongshan Hospital Fudan University and Dr. Nong Yang of Hunan Cancer Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05886374.

About HMPL-415

HMPL-415 is a novel, highly potent and selective allosteric inhibitor targeting SHP2. SHP2 is a non-receptor protein tyrosine phosphatase ubiquitously expressed mainly in the cytoplasm of several tissues. SHP2 modulates diverse cell signaling events that control metabolism, cell growth, differentiation, cell migration, transcription and oncogenic transformation. It interacts with diverse molecules in the cell, and regulates key signaling events including RAS/ERK, PI3K/AKT, JAK/STAT and PD-1 pathways downstream of several receptor tyrosine kinases (RTKs) upon stimulation by growth factors and cytokines. Dysregulation of SHP2 expression or activity causes many developmental diseases, and hematological and solid tumors.1

HUTCHMED currently retains all rights to HMPL-415 worldwide.

On July 10, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and DualityBio, a next-generation ADC company, reported an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors (Press release, BeiGene, JUL 10, 2023, View Source [SID1234633122]).

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"With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our end-to-end ADC manufacturing capabilities."

"Duality is dedicated to becoming a leading next-generation ADC company, and the assets built upon our DITAC platform show encouraging efficacy and safety in preclinical as well as global clinical studies," said John Zhu, Ph.D., CEO at DualityBio. "We are excited to partner with BeiGene to accelerate the development of this asset. In combining the strengths of BeiGene and Duality, we believe more breakthrough ADC medicines will be brought to patients worldwide."

Under the terms of the agreement, DualityBio will receive an upfront payment, and will be eligible for a payment contingent upon BeiGene exercising its option and additional payments based upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.3 billion, in addition to tiered royalties. Upon exercising its option, BeiGene will hold global clinical, manufacturing, and commercial rights while DualityBio will perform all research activities through IND-enabling studies and support future IND filings by BeiGene.

On July 10, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, and DualityBio, a next-generation ADC company, reported an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors (Press release, BeiGene, JUL 10, 2023, View Source [SID1234633121]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors"

"With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our end-to-end ADC manufacturing capabilities."

"Duality is dedicated to becoming a leading next-generation ADC company, and the assets built upon our DITAC platform show encouraging efficacy and safety in preclinical as well as global clinical studies," said John Zhu, Ph.D., CEO at DualityBio. "We are excited to partner with BeiGene to accelerate the development of this asset. In combining the strengths of BeiGene and Duality, we believe more breakthrough ADC medicines will be brought to patients worldwide."

Under the terms of the agreement, DualityBio will receive an upfront payment, and will be eligible for a payment contingent upon BeiGene exercising its option and additional payments based upon the achievement of certain development, regulatory, and commercial milestones, totaling up to $1.3 billion, in addition to tiered royalties. Upon exercising its option, BeiGene will hold global clinical, manufacturing, and commercial rights while DualityBio will perform all research activities through IND-enabling studies and support future IND filings by BeiGene.

On July 9, 2023 RemeGen Co., Ltd. ("RemeGen" or "the Company") (HKG: 9995, SHA: 688331), a fully-integrated commercial-stage biotechnology company, reported a clinical research and supply agreement with Innovent Biologics ("Innovent") (HKEX: 01801) (Press release, RemeGen, JUL 9, 2023, https://www.prnewswire.com/news-releases/remegen-and-innovent-collaborate-on-clinical-trials-to-evaluate-the-potential-of-rc88-and-rc108-combined-with-pd-1-therapy-for-advanced-solid-tumors-301872574.html [SID1234633146]). This collaboration will focus on conducting clinical trials exploring combination therapies of the novel antibody-drug conjugates (ADCs), RC88 (targeting MSLN) and RC108 (targeting c-MET), along with the PD-1 inhibitor sintilimab injection (TYVYT).

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According to the agreement, Innovent will supply clinical drug supplies of sintilimab during the clinical trial collaboration, while RemeGen will conduct Phase I/IIa clinical studies in China. The trials will assess the safety, tolerability, and preliminary efficacy of RC88 or RC108 combined with sintilimab in Chinese cancer patients.

RemeGen’s independently developed ADC, RC88, targets mesothelin (MSLN) and was approved for Phase I clinical trials in China in November 2018. Preliminary results show that RC88 monotherapy exhibits anti-tumor activity against MSLN-expressing solid tumors and demonstrates manageable safety. The combined use of RC88 with immune checkpoint inhibitors (ICIs) such as PD-1/PD-L1 can induce immunogenic cell death (ICD), releasing a series of signaling molecules to further activate T cells, and enhancing the tumor immune response.

Similarly, RC108, another ADC independently developed by RemeGen targeting c-MET, was approved for Phase I clinical trials in November 2020. The ongoing trials indicate the potential of RC108 monotherapy against c-MET-expressing solid tumors, with manageable safety. Preclinical research suggests that RC108 induces tumor-specific adaptive immunity and increases T cell infiltration in the tumor microenvironment, while PD-1 monoclonal antibodies activate T cells, enhancing the anti-tumor immune response. Therefore, it is expected that the combination therapy of RC108 and TYVYT can enhance both the presentation of tumor antigens by dendritic cells and the killing of tumor cells by T cells, resulting in enhanced tumor suppression.

TYVYT, a PD-1 inhibitor developed collaboratively by Innovent and Eli Lilly and Company (NYSE: LLY), has been approved for seven indications, six of which have been included in China’s National Reimbursement Drug List (NRDL). It is the only PD-1 inhibitor to include first-line treatment for the five major high-incidence solid tumors (non-squamous non-small cell lung cancer, squamous non-small cell lung cancer, liver cancer, gastric cancer, esophageal cancer), and also the first and only immunotherapy drug in the field of gastric cancer to be included in the NRDL.

"The alliance with Innovent is a critical step forward in the research and commercialization strategy of combination therapies with RC88 and RC108," said Su Na, Senior Vice President of RemeGen. "By combining these therapies with sintilimab, we offer innovative treatment plans that target two pathways. These mechanisms are complementary, potentially helping to overcome or delay treatment resistance and provide an effective solution to unmet clinical needs."

"We are thrilled to join forces with RemeGen to unlock the potential of combining sintilimab injection with novel ADCs," added Dr. Zhou Hui, Senior Vice President of Innovent. "Preclinical studies have suggested that combining ADCs with an anti-PD-1 monoclonal antibody may improve patient outcomes and overcome drug resistance. As immunotherapy advanced into the next era of development, we hope to strengthen the leading position of sintilimab as a backbone immunotherapy as well as investigate the new opportunities of combination therapies, and provide better treatment options for more cancer patients."

On July 8, 2023 Tyligand Bioscience reported the completion of a multimillion-dollar Series A+ financing (Press release, Tyligand Bioscience, JUL 8, 2023, View Source [SID1234644985]). This round was led by Ming Ventures, with participation from Taikun Fund, Suzhou Harvicapital, Shengdi Investment, and Calor Capital as co-investors. Existing shareholders CMS Capital and BOHE Angel Fund also increased their stake. The capital raised will primarily be used to accelerate the advancement of multiple projects in Tyligand’s innovation pipeline, including clinical trials in both US and China.

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Tyligand Bioscience is dedicated to discovering and developing highly differentiated small molecule therapies to provide more effective treatment options for drug resistant tumors include lung, pancreatic, and triple-negative breast cancers. The founding team has a strong track record in the field of small molecule drug discovery and development, and has a wealth of management and operational experience in multinational pharmaceutical companies as well as emerging biotechs. The company focuses on addressing unmet clinical needs with structurally intriguing small molecules and their conjugates, with several candidates having entered into clinical stage development. TSN084, a multi-kinase inhibitor targeting CDK8/19 and other kinases closely associated with tumor proliferation and immune suppression, is currently undergoing Phase I clinical trials in both US and China and has recently received FDA orphan drug designation for treating AML. With the prevailing trend in the kinase field moving towards highly selective inhibitors against a single target, the excellent tolerability and ability of TSN084 to launch a multi-targeted attack provide possibilities to address drug resistance and immune evasion. TSN222 is a global 1st dual-acting tumor immune agonist (DATIA) with differentiated design from traditional immune agonists. Preclinical data indicated that TNS222 was capable of sequentially activating the innate immune system and selectively killing tumors, thereby leading the establishment of durable adaptive immune memory and controlling the proliferation of distal tumors. This compound has also received approval for clinical trials in both US and China. Additionally, Tyligand has demonstrated the effectiveness of DATIA series of molecules as payloads for antibody-drug conjugates, and has attracted multiple collaborators.

Dr. Tony Zhang, founder and CEO of Tyligand, stated, "We are extremely grateful for the support from Ming Ventures and co-investors. This round of support not only serves as an encouragement to the Tyligand team but also as a recognition of the differentiated pipeline built from the Tyligand’s on unique molecule design platform. We will continue to push forward the pipeline with utmost efficiency and creativity, making medicines with greater clinical value for the waiting doctors and patients."

Ming Venture stated, "We are honored to lead this round of financing for Tyligand Bioscience. Innovative drugs are a key investment focus for Ming Venture, and we continue to have a positive outlook on the oncology area. This field has significant umet clinical needs and growing market potential, and every progress can genuinely help alleviate patients’ suffering. Core members of Tyligand’s team have years of extensive R&D management experience and are a trustworthy team. The company has a clear strategic vison, strong execution, and great capital utilization efficiency, having completed the preclinical development of three products in record time. The unique approach of dual-function immune agonism by small molecules offers key advantages in immunoncology field, and we look forward to benefiting global cancer patients with these innovative products as soon as possible."