GeneQuantum Healthcare (Suzhou) Co. Ltd.

From September 7 to September 10, 2024, the World Congress on Lung Cancer (WCLC) was held in San Diego, USA. WCLC is one of the most influential academic events in the field of lung cancer, where top experts and scholars from all over the world share and discuss the latest cutting-edge developments. On September 10, local time, GeneQuantum released the latest data of the first human study (FIH) of a novel HER2-ADC GQ1005 in HER2-expressing or HER2- mutated advanced solid tumors in the form of an oral report at the conference. As of the data cut-off on May 10th, 188 patients were enrolled, including 50 patients with NSCLC. The median age of the whole population is 55 years old, and 54.8% of patients have received third-line or above treatments in the past, and the median drug exposure were 84 days. The median age of the NSCLC subgroup is 58 years old, and 52% of patients have received at least second-line treatments in the past, and the median drug exposure exposure were 85 days. GQ1005 has excellent safety and tolerance: Lower rates of gastrointestinal toxicity, hepatotoxicity and hematotoxicity than benchmark in whole population and NSCLC. ≥G3 TRAEs were less than 20% (17.6% and 14.0% in whole population and NSCLC, respectively). The most common ≥G3 TRAEs (incidence ≥2%) in whole population are lymphocyte count decreased (4.3%) and anemia (3.7%). The most common ≥G3 TRAEs (incidence ≥2%) in NSCLC are vomiting (4%), nausea (4%), anemia (2%), decreased appetite (2%), platelet count decreased (2%), fatigue (2%), and lymphocyte count decreased (2%). Lower incidence of ILD in whole population and NSCLC. Most of them were grade 1-2 and recovered. GQ1005 shows promising antitumor activity： Among the whole population, the objective response rate (ORR) of 154 assessable patients was 40.9%, and the disease control rate (DCR) was 83.8%. In NSCLC, the ORR of 40 evaluable patients was 32.5% and the DCR was 92.5%. The median follow-up time was 4.5 months and 5.49 months in whole population and NSCLC, respectively. The median progression-free survival (mPFS) was 7.23 months, and the median duration of response (mDoR) was 8.8 months in whole population and NSCLC The 12-month OS rate all beyond 70% in both targeted population, 72.6% and 73.4% respectively. Dr. Shi Yan, Chief Medical Officer of GeneQuantum, said:“We are very happy to share the latest research data of GQ1005 in the form of an oral report at the WCLC conference. GQ1005 is a new generation of HER2 ADC independently developed by GeneQuantum, which has shown encouraging safety and clinical benefits in a variety of advanced solid tumors expressed by HER2. Although the number of NSCLC in the current study is small and the follow-up time is still short, it has also shown positive efficacy signals and excellent safety characteristics, which is enough to stimulate interest in further exploration. We will continue to promote the research and exploration of GQ1005 in a variety of solid tumors with HER2 expression/mutation, and bring new treatment options to more patients.” About GQ1005 GQ1005 is an innovative anti-HER2 antibody-drug conjugate (ADC) developed by GeneQuantum. The antibody is an engineered trastuzumab targeting HER2, and the payload is a topoisomerase I inhibitor, DXd. GQ1005 was produced using a unique immobilized enzyme-based site-specific conjugation platform, leading to higher homogeneity and purity. This ADC features a highly stable linker and has a bystander killing effect. Preclinical studies have shown that GQ1005 exhibits similar antitumor efficacy to Enhertu and better stability than Enhertu, with a notable absence of toxicity, suggesting a superior therapeutic profile. At present, GQ1005 has been approved to carry out phase III clinical trials for the treatment of HER2-positive non-surgical resection/metastatic breast cancer. About GeneQuantum Healthcare GeneQuantum, headquartered in China, is a global leader in the ADC field, distinguished for its advancement of enzymatic site-specific conjugation technologies. GQ’s pioneering technologies, iLDC and iGDC, serve as the foundation of a comprehensive ADC drug development platform, spanning from the initial design to seamless commercial production. The technology offered by GQ provides numerous advantages, such as exceptional product homogeneity, elevated process quality, enhanced metabolic stability, and low commercialization costs. GQ remains steadfast in its commitment to delivering vital technical support, expediting global ADC drug development. For more information, please visitwww.genequantum.com.

-BHV-1510 is a novel trophoblast cell surface antigen-2 (Trop-2) directed antibody drug conjugate (ADC) that has demonstrated a highly differentiated preclinical monotherapy efficacy profile, the potential for broader therapeutic margin than other Trop-2 ADCs currently in development, and synergistic affects when combined with anti-PD1 therapy -Biohaven also entered into a clinical supply agreement with Regeneron to study the combination of BHV-1510 with Regeneron's anti-PD-1 Libtayo® (cemiplimab-rwlc) in the Phase 1/2 clinical trial -Malignancies of epithelial tissue account for the vast majority of all cancers and the advanced or metastatic forms of these carcinomas represent an urgent unmet medical need NEW HAVEN, Conn., May 29, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, announced the first patient has been dosed in a first-in-human Phase 1/2 study of BHV-1510, a highly differentiated Trophoblast Cell Surface Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the lead ADC program to advance into clinical trials in Biohaven's growing oncology pipeline. Continue Reading Figure 1 Figure 2 Figure 3 The Phase 1/2 study of BHV-1510 is a multicenter, open-label study in subjects with select advanced or metastatic epithelial cell tumors. The trial consists of a dose-escalation phase, followed by a multicohort expansion phase. Additional information can be found at (NCT06384807). "We are extremely proud to advance our first oncology clinical program with a potentially best in class ADC," said Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven. "With the initiation of this monotherapy study, we are one step closer to providing differentiated and superior treatment options to people living with cancer. We are also excited to work with Regeneron and efficiently explore BHV-1510 in combination with its PD-1 inhibitor Libtayo® across a range of tumors." BHV-1510 is a next-generation, fully optimized ADC that consists of a Trop-2 directed antibody conjugated to a proprietary best-in-class Topoisomerase 1 (TopoIx) payload at a homogeneous drug-antibody ratio (DAR) of 4. BHV-1510 incorporates a unique site-specific conjugation methodology and highly stable and irreversible linker chemistry designed by GeneQuantum Healthcare Co. (Suzhou) Ltd. Preclinically BHV-1510 has shown superior cellular cytotoxicity, bystander killing, and immunogenic cell death resulting in improved efficacy as monotherapy, and synergistic efficacy in combination with anti-PD-1 therapy. In IND-enabling studies, BHV-1510 also showed a broader therapeutic margin relative to more advanced Trop-2 ADCs, including a lack of lung toxicity, that may translate to an improved clinical efficacy and safety profile. Shiraj Sen M.D., Ph.D., Director of NEXT Oncology-Dallas, commented, "Antibody drug conjugates have shown promising efficacy in solid tumors, but their clinical potential is currently limited by their safety margin. BHV-1510 has compelling and differentiated preclinical data, with the potential to translate to better safety and efficacy in several tumors including those with significant unmet need. We are excited to be working with the Biohaven team on this important clinical trial for patients with advanced epithelial tumors." Biohaven entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) under which Biohaven will sponsor and fund the planned clinical trial and Regeneron will provide Libtayo. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1). Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven stated, "Biohaven's ADC technology and portfolio has the potential to differentiate from current ADCs in the market that use older payloads or maleimide linkers. The advancement of our lead ADC program, BHV-1510, into clinic as both monotherapy and in combination with Regeneron's anti-PD-1 represents an important first opportunity to show the breadth and differentiation of Biohaven's extensive ADC pipeline. Coupled with our deep in-house expertise in oncology clinical development, ADC chemistry, and complex manufacturing, we believe our diverse and growing ADC portfolio positions Biohaven for future leadership in oncology." Biohaven is developing a broad portfolio of highly differentiated ADCs with the potential to broaden therapeutic margin, increase time on treatment, and improve efficacy. Biohaven's proprietary MATE™ platform technology focuses on novel, single-step conjugation chemistry, with the potential to be superior to the current industry standard maleimide and lipophilic click chemistry. About Biohaven Biohaven is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA (spinocerebellar ataxia); myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer. For more information, visit . Forward-looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first in class therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MATE™ is a trademark of Biohaven Therapeutics Ltd. Libtayo® is a registered trademark of Regeneron Pharmaceuticals, Inc. Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741 Media Contact: Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502 SOURCE Biohaven Ltd.

SUZHOU, China, Dec. 17, 2023 /PRNewswire/ -- Recently, GeneQuantum Healthcare (GQ), a global leader in ADC new drug development focused on innovative bioconjugation technologies, and BioMap, a global leader in life science AI Foundation protein-centric Large Language Models, announced that they have entered into a strategic collaboration agreement to co-develop FIC/BIC ADC therapeutics for multiple targets. The partnership will combine GQ's proprietary enzymatic site-specific conjugation technology platforms (iLDC® and iGDC®), linker-payload platform, with BioMap's proprietary trillion-parameter life science AI Foundation Large Language Model xTrimo and AI protein generation platform AIGP, to create novel ADCs addressing high unmet medical needs. Under the terms of the collaboration agreement, GQ and BioMap will integrate resources to discover and develop novel ADC therapies. This includes utilizing BioMap's innovative target recommendation platform and high performance antibody design platform AIGP under the xTrimo, the enzymatic site-specific conjugation technology platforms iLDC® and iGDC®, the linker-payload technology platform, and leverage the expertise in high-quality data mining and utilization, cross-model data integration and analysis, target discovery, antibody design, ADC conjugation preparation, ADC drug evaluation, differentiated indication development, and business development collaborations. By leveraging each partner's capabilities, the collaboration aims to create highly competitive and innovative ADC drugs to address global unmet clinical needs. Dr. Gang Qin, Founder and Chairman of GQ, said, "GQ and BioMap share a similar vision and commitment to disruptive innovation that can improve the quality of patients' lives. We both value open collaboration, innovation empowerment, and ecosystem construction. By serving as a central hub for an advanced conjugation solution, we bring together exceptional resources from all partners to foster collaborative synergy, which will significantly enhance the R&D efficiency of innovative ADC drugs, reduce development costs, and cultivate the development of high-quality next-generation ADC therapeutics. The goal is to better address the growing medical needs and bring better treatment options to patients worldwide. With the established collaboration with BioMap, our global bioconjugation ecosystem welcomes another important partner. We look forward to fully integrating GQ' expertise and experience in ADC drug development with BioMap's profound understanding of life sciences foundational large models, high-performance computing, and AI. Our goal is to accelerate the development of a series of breakthrough ADC therapeutics, thereby creating a new paradigm in the global ADC drug development landscape." Ms. Vicky Qu, Senior VP of BioMap, said, "Target discovery is another broad market outside of the protein drug design. BioMap has built its own task model system around immune cell activation, disease-specific target recommendation, and drug combination recommendation, and has also achieved several related collaborations recently. We are honored to collaborate with GQ on the development of next generation ADC drugs. Based on the robust Foundation Model and the extensive accumulation of life science data at BioMap, we recommend novel targets and target combinations for ADC drugs, and rapidly design high-performance antibody components through the BioMap AIGP platform. Our goal is to improve the safety and efficacy of ADC drugs by making more precise disease selections. The Foundation Model for life sciences has even more potential, and we also welcome more biocomputing developers to experience BioMap's platform. Together, we can define diverse demands for life science R&D scenarios and construct dedicated task models, bringing generative capabilities to cutting-edge discovery challenges in the life sciences industry, and achieving breakthrough results in more fields." About GeneQuantum Healthcare GeneQuantum, headquartered in China, is a global leader in the ADC field, distinguished for its advancement of enzymatic site-specific conjugation technologies. Our pioneering technologies, iLDC and iGDC, serve as the foundation of our comprehensive ADC drug development platform, spanning from the initial design to seamless commercial production. For more information about GeneQuantum, please visit: About BioMap Founded in 2020 by Robin Li and Wei Liu, BioMap is a disruptive life science AI company responsible for building xTrimo, the first and largest protein-centric large language model platform. Their technology allows scientists to model life more accurately, from proteins to a system level, and extract novel insights and predictions from limited data. Supported by an international, cross-functional team of over 300 experts, BioMap is solving critical, protein-related drug development problems and charting a course to radically improve patients' lives. For more information about BioMap, please visit: SOURCE GeneQuantum Healthcare