Shanghai Escugen Biotechnology Co., Ltd.

SANTIAGO DE COMPOSTELA, Spain & SHANGHAI--(BUSINESS WIRE)--SunRock Biopharma and Escugen have joined forces in a strategic partnership to co-develop SRB123, a First-in-Class antibody-drug conjugate (ADC) targeting C-C motif chemokine receptor 9 (CCR9), a tumor-associated antigen overexpressed in multiple solid tumors, including pancreatic, ovarian and lung cancer. SunRock Biopharma and Escugen have entered a strategic partnership to co-develop SRB123, a first-in-class antibody-drug conjugate targeting CCR9, a tumor-associated antigen overexpressed in pancreatic, ovarian and lung cancers The collaboration combines SunRock’s proprietary SRB1 antibody, selected for its high binding affinity and efficient tumor cell internalization, with Escugen’s EZWi-Fit™ linker-payload platform, a next-generation ADC technology optimized for the linker stability and selective tumor release of the potent payload. The result is a highly differentiated therapeutic candidate designed exclusively for solid tumors with high CCR9 expression and internalization rates. Under the agreement, both companies will share development responsibilities, file joint patents, and hold reciprocal licensing option rights. The primary goal is to generate robust preclinical proof-of-concept data to support early clinical entry in the near term. “Combining our deep antibody engineering expertise with Escugen’s innovative conjugation platform enables us to deliver a precision oncology candidate with First-in-Class potential,” said Dr. Laureano Simón, CEO of SunRock. “CCR9 remains an underexploited but clinically validated target. This program addresses real unmet needs in aggressive tumors with poor prognosis.” Dr. Qing Zhou, Co-Founder and CEO of Escugen, stated, “This strategic collaboration with SunRock Biopharma aligns with our vision of developing First-in-Class precision oncology candidates through technological innovation. It further highlights the unique advantages of our EZWi-Fit™ platform technology in next-generation ADC development. The platform’s strong anti-tumor activity and favorable tolerability provide a solid foundation for targeting high CCR9-expressing solid tumors. We are confident that combining our expertise will accelerate SRB123’s progress and bring new hope to patients.” CCR9 has been associated with metastatic potential and chemoresistance, particularly in pancreatic and ovarian cancers. SRB1, the unconjugated antibody from SunRock, has already demonstrated strong preclinical efficacy in these models. The ADC format (SRB123) leverages this targeting while enhancing tumor cell killing via Escugen’s payload delivery system. The partnership will be showcased during the BIO International Convention 2025, where both companies will engage with potential development and commercialization partners. About SunRock Biopharma SunRock Biopharma is a biotech company focused on developing next-generation antibody-based therapies targeting unmet medical needs in oncology and immunology. Operating under an open innovation model, SunRock combines cutting-edge academic science, advanced technology platforms, and a selective business approach to generate highly differentiated, licensable assets. Its portfolio includes optimized monoclonal antibodies, next-generation ADCs, and radioconjugates, with validated targets such as CCR9 and HER3. SunRock follows an early-stage out-licensing strategy, designed to maximize risk-adjusted returns, and maintains active collaborations with leading pharma and biotech partners worldwide. About Escugen Escugen is a clinical-stage biotechnology company located in Shanghai, China, focusing on the development of innovative ADC drugs. Currently, Escugen's lead Trop-2 ADC pipeline, ESG401, has entered Phase III clinical trials. Escugen's next-generation linker-payload technology platform, EZWi-Fit®, offers significant competitive advantages in terms of safety, efficacy, anti-multiple drug resistance, and pharmacokinetic characteristics. Leveraging this platform technology, Escugen is rapidly expanding its ADC pipeline targeting new or validated target. The first ADC product baring the EZWi-Fit® technology has successfully launched its FIH clinical campaign. In addition, Escugen has licensed this platform technology to several domestic and international biotechnology companies to empower their innovative ADC projects.

SAN MATEO, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, and Oqory, Inc., a private biopharmaceutical company dedicated to developing next-generation antibody drug conjugates (ADCs) for the treatment of cancer, today highlighted Phase 1a/1b data for Oqory’s anti-TROP2 ADC, OQY-3258, for patients with solid tumors. The companies also provided insights into their proposed strategic merger, which aims to advance OQY-3258 into global Phase 3 trials and build a differentiated ADC pipeline by leveraging their combined expertise. OQY-3258, also known as ESG401, is an anti-TROP2 ADC currently under evaluation in three clinical trials: A Phase 1a/1b clinical trial for patients with solid tumors (NCT04892342). A Phase 3 study in patients with locally advanced or metastatic HR+/​HER2- breast cancer (NCT06383767). A Phase 3 study as a first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer (NCT06732323), which garnered Breakthrough Designation from China’s National Medical Products Administration (NMPA) on November 6, 2024. As of August 2024, the Phase 1a/1b study had enrolled approximately 150 patients, with promising preliminary results in multiple breast cancer subtypes. Recent data highlights, including those presented at the 2024 European Society for Medical Oncology (ESMO), include: Evaluable patients with previously untreated TNBC (n=25) As presented at ESMO, the confirmed overall response rate (ORR) was 76% and disease control rate (DCR) was 100%. Median duration of response (DOR) and progression-free survival (PFS) had not yet been reached. A recent data cut from January 2025, with ten additional patients (n=35) evaluable for efficacy, showed an improved confirmed ORR of 80%, with median DOR and PFS still not reached. Evaluable patients with late-stage TNBC (n=37) As presented at ESMO, the confirmed ORR was 27% and DCR was 62%, with 6-month DOR and PFS rates of 39% and 25%, respectively. Evaluable patients with HR+/HER2- breast cancer (n=58) As presented at ESMO, the confirmed ORR was 39%, DCR was 78%, and 6-month DOR and PFS rates of 70% and 55%, respectively, with a median (range) PFS of 7.4 (3.7-9.2) months. As presented at ESMO, the confirmed overall response rate (ORR) was 76% and disease control rate (DCR) was 100%. Median duration of response (DOR) and progression-free survival (PFS) had not yet been reached. A recent data cut from January 2025, with ten additional patients (n=35) evaluable for efficacy, showed an improved confirmed ORR of 80%, with median DOR and PFS still not reached. As presented at ESMO, the confirmed ORR was 27% and DCR was 62%, with 6-month DOR and PFS rates of 39% and 25%, respectively. As presented at ESMO, the confirmed ORR was 39%, DCR was 78%, and 6-month DOR and PFS rates of 70% and 55%, respectively, with a median (range) PFS of 7.4 (3.7-9.2) months. Also presented at ESMO, OQY-3258 demonstrated meaningful activity in patients with brain metastases, reporting an intracranial ORR of 41% (n=17), which included three complete and four partial transcranial responses. Additionally, in patients with brain metastases, PFS (95% confidence interval) was 4.6 (2.0-9.8) months with OQY-3258 compared with 2.8 (1.5-3.9) months for historical data with Trodelvy. OQY-3258 has demonstrated a favorable safety profile, with the most common Grade ≥3 adverse events being manageable hematologic toxicities, such as neutropenia and leukopenia, that did not lead to treatment discontinuation. Notably, no Grade ≥3 rash or interstitial lung disease/pneumonitis was observed, and there was only one case each of Grade 3 diarrhea and stomatitis. This differentiated safety profile sets OQY-3258 apart from other TROP2 ADCs. “The compelling clinical activity demonstrated in our Phase 1a/1b trial highlights the potential of OQY-3258 to address significant unmet needs in TROP2-expressing tumors,” said Michael King, CEO of Oqory, Inc. “With its optimized serum-stable linker design, OQY-3258 has shown a markedly lower incidence of severe off-target toxicity compared with other marketed TROP2 therapies, positioning it as a differentiated late-stage ADC for metastatic breast cancer and other TROP2-expressing cancers. Our proposed merger with Vincerx represents a pivotal step toward advancing this asset into global Phase 3 trials and driving innovation in next-generation ADCs.” Raquel Izumi, Ph.D., Acting CEO of Vincerx, added, “The proposed merger with Oqory reflects our commitment to develop transformative therapies for patients with cancer. The promising efficacy and favorable safety profile demonstrated by OQY-3258 highlights its potential as a best-in-class anti-TROP2 ADC. By bringing together Vincerx’s development expertise and Oqory’s ADC technologies, we aim to accelerate the development of OQY-3258, while building a pipeline of next-generation ADCs that address significant unmet patient needs.” About Proposed Merger Vincerx and Oqory are parties to a binding term sheet, as amended, pursuant to which Oqory would merge into Vincerx, with Oqory equity holders expected to own approximately 95% of the combined entity and Vincerx equity holders expected to hold approximately 5%. The proposed merger provides for a minimum fully diluted equity value of $13.66 million for existing Vincerx stockholders at closing and, as a condition to the closing of the merger, completion of a concurrent private offering of Vincerx equity securities of at least $20 million. Additionally, Oqory-designated investors will provide interim financing to Vincerx of $1.5 million in two tranches, approximately $1,000,000 of which was provided on December 27, 2024, and approximately $500,000 of which is to be provided on or prior to January 31, 2025. The entry into a definitive merger agreement is contingent on a number of conditions, including satisfactory completion of due diligence by Vincerx and Oqory, interim financing for Vincerx in the amount of at least $500,000 on or prior to January 31, 2025, commitments by investors for the concurrent financing, and negotiation of the terms of a definitive merger agreement. Once a definitive merger agreement is executed, the closing of any merger will be subject to customary closing conditions, including regulatory approvals, stockholder approval from both parties, completion of the minimum $20 million financing, and the continued listing of Vincerx's common stock on Nasdaq. The description of the binding term sheet and proposed merger contained herein is only a summary and is qualified in its entirety by reference to the binding term sheet, as amended, a copy of which has been filed by Vincerx with the Securities and Exchange Commission. About OQY-3258 (also known as ESG401) OQY-3258 is Oqory’s anti-TROP2 ADC with an optimized enzyme-dependent linker technology and an SN-38 payload with established efficacy and manageable side effect profile. As of August 2024, OQY-3258 has completed Phase 1a/1b development in about 150 patients with solid tumors, including metastatic HR+/HER2- and triple-negative breast cancer. OQY-3258 has shown efficacy in these patients, including reduction of brain metastasis and responses in heavily pretreated patients. To date, OQY-3258 has exhibited a differentiated safety profile versus other marketed TROP2 ADCs. Notably, no Grade ≥3 interstitial lung disease/pneumonitis or rash have been observed. Gastrointestinal effects have been mild and mainly Grade 1/2. Neutropenia and leukopenia have been the major adverse events, which were manageable and did not result in discontinuation of study drug. OQY-3258 is being evaluated in a Phase 3 study as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer (NCT06732323) and in a Phase 3 study in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer (NCT06383767); both currently conducted by Shanghai Escugen Biotechnology Co., Ltd., Oqory’s development partner. About Oqory, Inc. Oqory, Inc. is an innovator in the field of ADCs with expertise in advancing targeted cancer therapies. The Company’s pipeline includes multiple ADC programs, with two currently in clinical development and several next-generation ADCs in preclinical stages. These programs are designed to address critical unmet needs in indications such as breast cancer, non-small cell lung cancer, small cell lung cancer, multiple myeloma, and other metastatic solid tumors. Powered by a proprietary ADC platform, Oqory is focused on delivering therapies that improve outcomes for patients with cancer. Oqory is based in San Diego, California. About Vincerx Pharma, Inc. Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx’s pipeline consists of a next-generation ADC, VIP943, currently in Phase 1; a small molecule drug conjugate, VIP236, which has completed its Phase 1 study; a CDK9 inhibitor, enitociclib, which has completed a Phase 1 monotherapy study; a preclinical ADC, VIP924; and VersAptx™, a versatile, next-generation bioconjugation platform. Vincerx is based in San Mateo, California, and has a research subsidiary in Monheim, Germany. Forward-Looking Statements This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, the entry into a definitive merger agreement; the anticipated terms and conditions of the merger, including the $20 million equity investment, and the amount and timing of the interim financing; the expected ownership structure and value to Vincerx stockholders upon closing of the merger; the anticipated effects and benefits of a merger transaction; and Oqory’s pipeline, product candidates and attributes, and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside the control of Oqory and Vincerx. Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: the satisfactory completion of the parties’ respective due diligence; the completion of the interim financing; the parties’ capital requirements, availability, and sufficiency of capital, and cash runway; the results of Vincerx's due diligence review of Oqory, which has not been completed as of the date hereof; the ability of the parties to successfully negotiate and enter into a definitive merger agreement and the actual terms thereof; the parties’ ability to satisfy the conditions precedent to the merger to be contained in a definitive merger agreement, including completion of the concurrent offering of Vincerx equity securities of at least $20 million and stockholder approval from both parties; the closing of the merger; the risk that any definitive merger agreement is terminated after it is entered into but before consummation of any proposed merger; market acceptance of the combined company; risks associated with clinical development of the parties’ product candidates; general economic, financial, legal, political, and business conditions; and other risks and uncertainties including those set forth in Vincerx’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and subsequent reports filed with the Securities and Exchange Commission (the “SEC”). Forward-looking statements speak only as of the date hereof, and the parties disclaim any obligation to update any forward-looking statements. Vincerx® and VersAptx™ are trademarks of Vincerx. Oqory and the Oqory logo are trademarks of Oqory. Additional Information In connection with the proposed merger transaction, Vincerx will file relevant materials with the SEC, including a proxy statement on Schedule 14A. A definitive proxy statement will be sent to holders of Vincerx’s common stock when it becomes available. Investors and securityholders and other interested parties are urged to carefully read the proxy statement (including any amendments or supplements thereto) and any other documents filed with the SEC when they become available, because they will contain important information about Vincerx, Oqory, and the proposed merger. Investors and securityholders may obtain free copies of these documents and other documents filed with the SEC by Vincerx (when they become available) through the website maintained by the SEC at http://www.sec.gov, or by directing a request to: Vincerx Pharma, Inc., 1825 S. Grant Street, San Mateo, CA 94402. Copies of the documents filed by Vincerx are also available free of charge in the “Investors—SEC Filings & Financials—SEC Filings” section of Vincerx’s website at: https://investors.vincerx.com/financial-information/sec-filings. Participants in the Solicitation Vincerx, Oqory, and their respective directors and officers are or may be considered “participants” (as defined in Section 14(a) of the Securities Exchange Act of 1934) in the solicitation of proxies from the holders of Vincerx’s common stock with respect to the proposed transactions described herein. Information about Vincerx’s directors and executive officers, including compensation, is set forth in the sections entitled “Election of Directors—Directors and Nominees” and “Executive Officers” of Vincerx’s definitive proxy statement for its 2024 Annual Meeting of Stockholders, filed with the SEC on April 10, 2024, the section entitled “Compensation of Directors and Executive Officers” of Vincerx’s definitive proxy statement for its special meeting of stockholders, filed with the SEC on December 10, 2024 (the “2025 Special Meeting Proxy Statement”), as well as the Vincerx’s Current Report on Form 8-K filed on December 27, 2024. Information about the ownership of Vincerx’s common stock by Vincerx’s executive officers and directors is set forth in the section entitled “Security Ownership of Certain Beneficial Owners and Management” in the 2025 Special Meeting Proxy Statement, as well as the Form 3 filed on January 6, 2025 for Kevin Haas. Updated information regarding the identity of potential participants, and their direct or indirect interests (by security holdings or otherwise), will be reflected in Forms 3, 4, or 5 to be filed with the SEC, as well as the section entitled “Security Ownership of Certain Beneficial Owners and Management” of Vincerx’s definitive proxy statement on Schedule 14A and other materials to be filed with the SEC regarding the proposed transactions. All of these documents are or will be available free of charge at the SEC’s website at www.sec.gov and in the “Investors—SEC Filings & Financials—SEC Filings” section of Vincerx’s website at https://investors.vincerx.com/financial-information/sec-filings. Stockholders, potential investors, and other readers should read the definitive proxy statement carefully when it becomes available before making any voting or investment decisions. These documents can be obtained free of charge from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities, in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Contacts: Gabriela Jairala Vincerx Pharma, Inc. gabriela.jairala@vincerx.com Michael King Oqory, Inc. MKing@oqory.com

B7-H3 (also known as CD276) is a type I transmembrane glycoprotein and a member of the B7 family. It has no expression in monocytes, granulocytes, and normal human tissues but is expressed in some dendritic cells, T cells, natural killer (NK) cells, and B cells, making it a newly discovered immune checkpoint. This target not only facilitates immune escape of tumor cells by inhibiting the immune system but also promotes cancer progression through mechanisms of tumor metastasis, drug resistance, and angiogenesis in non-immune pathways. Studies have found that B7-H3 is abundantly expressed in several tumor tissues such as non-small cell lung cancer, pancreatic cancer, primary liver cancer, colorectal cancer, breast cancer, prostate cancer, pharyngeal cancer, melanoma, etc. Its abundant expression in tumor tissues often accompanies poor prognosis in patients, shorter overall survival period, and progression-free survival. Current B7H3 Drug Development ScenarioAccording to an incomplete count, there are over a hundred drugs targeting B7-H3 under research. They include monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADC), antibody-linked nuclides, cellular therapies, fusion proteins, etc.; none of which have been approved yet.  However, the development of drugs targeting B7-H3 has not been smooth sailing. Several clinical trials have been halted, and patient deaths have posed obstacles. For instance, in January 2019, the FDA suspended a Phase I trial for the CD3/B7H3 bispecific antibody MGD009 to treat B7H3-positive solid tumors due to the occurrence of liver-related adverse events. In 2022, enoblituzumab（MGA271）, a B7H3 monoclonal antibody, developed by I-MAB/MacroGenics was halted as patients died during the Phase II trial for advanced head and neck cancer. Additionally, the study of Macrogenics' B7H3 targeted ADC drug, vobramitamab duocarmazine (MGC-018) was also halted due to patient death and severe adverse events in the Phase II clinical trial for prostate cancer. B7H3 Trade StatusDespite these difficulties, deals for B7-H3 drugs have not decreased. According to an incomplete estimate, there have been 18 trades regarding the B7H3 target so far. Taking the past two years as an example:  In July 2024, Biocytogen and IDEAYA Biosciences reached an option and licensing agreement for their BsADC project targeting B7H3/PTK7. The potential total transaction reaches 406.5 million USD, which includes 100 million USD in clinical development and regulatory milestone payments. In July 2024, Escugen and Innolake Biopharm agreed on an exclusive global license for using Escugen’s new ADC technology platform EZWi-Fit® to develop ADC products targeting specific targets. Meanwhile, Innovent's ground-breaking bispecific ADC product ILB-3103 that was designed using the EZWi-Fit® technology has successfully completed pharmacological verification of PCC (preclinical candidate compounds). This product targets DLL-3 and B7H3, two promising tumor-related targets.In December 2023, Hansoh Pharma and GSK have reached an exclusive licensing agreement on HS-20093, a B7H3 ADC drug independently developed by Hansoh Pharma. Hansoh Pharmaceuticals will grant GSK the exclusive rights to develop, manufacture, and commercialize HS-20093 globally (excluding Mainland China, Hong Kong, Macau, and Taiwan). According to the agreement, Hansoh will receive an upfront payment of $185 million and is eligible to receive up to $1.525 billion in success milestone payments. Upon commercialization of the product, GSK will also pay tiered royalty fees based on net sales outside of Mainland China, Hong Kong, Macau, and Taiwan.In October 2023, Daiichi Sankyo and Merck reached a global development and commercialization agreement for Daiichi Sankyo's three ADC candidate drugs: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd). They will develop and potentially commercialize these candidate ADC therapies globally. Daiichi Sankyo will retain exclusive rights in Japan and will be fully responsible for the production and supply. The potential transaction value for the three projects is up to $22 billion, among which ifinatamab deruxtecan is a B7H3-targeting ADC drug.In April 2023, BioNTech and DualityBio reached an exclusive licensing and collaboration agreement on two ADC pipelines, DB-1303 and DB-1311. Under the agreement, DualityBio will receive an upfront payment of $170 million and is expected to earn over $1.5 billion in milestone payments for development, registration, and commercialization, as well as a percentage of future potential sales in the single to double-digits as royalty fees. DB-1311 is a B7-H3-targeting antibody-conjugated drug.Which advantages do these targeted B7H3 ADC drugs have that are worth large pharmaceutical companies' investments? We will provide a brief analysis for some representative drugs. Latest Advances in B7H3 ADCsAccording to incomplete statistics, there are approximately 33 B7H3 ADC drugs currently in research, and around 14 drugs are in clinical research stages. 1.Ifinatamab Deruxtecan  Ifinatamab Deruxtecan (I-DXd，DS-7300a), an ADC targeting B7-H3, is exclusively designed with Daiichi Sankyo DXd ADC technology. It consists of a humanized anti-B7-H3 IgG1 monoclonal antibody coupled with a cleavable tetrapeptide linker and Topoisomerase I inhibitor payload (a derivative of Exatecan, DXd). It is currently in phase III of clinical trials. According to data presented at the IASLC 2023 World Lung Cancer Conference, sub-group analyses of phase 1/2 trials of ifinatamab deruxtecan for treating SCLC revealed an objective response rate of 52.4%, median progression-free survival of 5.6 months, and overall survival of 12.2 months.  In July 2024, it was shown on the Chinese Clinical Trial Registry that the company had registered DS-7300a for Phase III clinical trials. The aim is to compare the safety and efficacy of DS-7300a with treatments chosen by physicians in recurring small cell lung cancer (SCLC) trial participants. 2.HS-20093 Developed by Hansoh Pharma, HS-20093, a novel ADC targeting B7-H3, is composed of a humanized anti-B7-H3 monoclonal antibody covalently linked to a Topoisomerase I inhibitor (TOPOi) payload. Currently, several phase I and II clinical trials are underway in China to treat various cancers, including lung cancer, sarcoma, head and neck cancer, and other solid tumors.  At the 2024 ASCO, the therapeutic potential of HS-20093 in small-cell lung cancer and osteosarcoma was showcased. Firstly, the company revealed research data from the phase II trial, ARTEMIS-002, for the treatment of relapsed/refractory osteosarcoma patients. From June to December 2023, a total of 34 relapsed/refractory osteosarcoma patients were enrolled and received HS-20093 doses of 8.0mg/kg (N=15) or 12.0mg/kg (N=19). At baseline, most patients had stage IV disease and lung metastases. Among them, 22 patients (64.7%) had received ≥3 types of previous treatments. 26 patients (76.5%) received 4 types of standard therapies including platinum complex, anthracyclines, ifosfamide, and methotrexate. As of December 25, 2023, 10 patients treated with 12.0 mg/kg HS-20093 had an objective response rate (ORR) of 20.0%; two confirmed partial responses were noted in the 12.0mg/kg group, with the longest response lasting for 4.0 months. The disease control rate for patients in the 8 mg/kg HS-20093 treatment group was 81.8% (9/11) and 100% (10/10) for those in the 12.0 mg/kg HS-20093 treatment group. The median progression-free survival of all 21 patients was not yet mature. In terms of safety, 33 patients experienced treatment-emergent adverse events (TEAEs); the most common grade 3/4 TEAEs were neutropenia, leukopenia, thrombocytopenia, lymphopenia, and anemia. No deaths caused by TEAEs were reported. Secondly, the company revealed results on the efficacy and safety of extended dose for SCLC patients previously treated with platinum standard. Data was collected until November 30, 2023, with relapsed treatments completed. In post-baseline scans, 96.2% (50/52) of patients showed a reduction in target tumor lesions, and 44.2% (23/52) had deep remission, defined as a tumor shrinkage of ≥50%. The median overall survival was not yet reached. Regardless of B7-H3 expression, a response was noted in all patients. Pharmacokinetics (PK) showed that exposure increased roughly proportionate with the dosage, with a half-life of 3-7 days. The PK curves of total antibodies and ADC were similar and effective payload exposure was relatively low. Safety was consistent with previous reports; the most common grade ≥3 treatment-related adverse events (≥10%) were neutropenia, leukopenia, lymphopenia, thrombocytopenia, and anemia. 3.Vobramitamab Duocarmazine  Vobramitamab duocarmazine (MGC-018) is an ADC drug independently developed by MacroGenics. It is composed of a humanized B7-H3 monoclonal antibody, a cleavable linker, and the toxic drug Duocarmycin (DUBA). It can disrupt DNA in dividing and non-dividing cells, thereby causing cell death. It is proposed for the treatment of B7-H3 positive solid tumors.  According to previously published data, in phase I/II dose-escalation and cohort expansion studies: in the dose-escalation part, among 9 prostate cancer patients, 5 exhibited a ≥50% decrease in prostate specific antigen (PSA) levels during treatment, and 2 patients had reduced target lesions (one reduced by 29%). The recommended phase II dose (RP2D) is 3mg/kg, IV, Q3W. In the cohort expansion part, among 16 evaluable patients, 4 (25%) had a reduction in target lesions by more than 30% (2 confirmed for PR, 2 unconfirmed for PR), and 21 out of 39 evaluable patients (53.8%) had a PSA reduction of over 50%. A total of 83 patients (96.5%) experienced at least one treatment-emergent adverse event. The most common treatment-related adverse events (TRAEs) (with an incidence rate of at least 20%) were fatigue, neutropenia, hand-foot syndrome, pleural effusion, nausea, and weakness. Febrile neutropenia was not reported. The safety was manageable. 4.YL201 YL201 is a B7H3-targeted ADC drug, developed using the proprietary TMALIN® technology platform by MediLink Therapeutics. This B7-H3 target is highly expressed in esophageal cancer, and with the tumor microenvironment and traditional lysosome extracellular and intracellular dual-dissolution mechanism of MediLink 's TMALIN® technology, YL201 effectively kills esophageal cancer cells which is reflected in pre-clinical and clinical trial data. Currently, the YL201 project is carrying out dose-expansion studies in multiple cancers in China and the US, including further efficacy exploration in esophageal cancer indications. 5.MHB088C MHB088C is an Antibody-Drug Conjugate (ADC) targeting B7H3, comprising of humanized anti-B7H3 monoclonal antibody coupled with a highly effective DNA topoisomerase I inhibitor that is 5 to 10 times stronger than DXd. Preclinical studies show that MHB088C possesses potent binding affinity, excellent internalization rate, and strong tumor-killing activity; it is 3 to 10 times stronger than DS-7300a analog in CDX models. Toxicology studies revealed no particular toxicity or interstitial lung disease (ILD) incidence with MHB088C, compared to other B7H3 ADCs. According to the phase 1/2 study disclosed at 2024 ASCO, the trial recruited patients with recurrent/metastatic solid tumors, divided into two stages: Dose Escalation (D-esc) and Dose Expansion (D-exp). During the D-esc stage, MHB088C was administered intravenously at doses of 0.8, 1.6, 3.0 mg/kg Q2W; 3.0, 4.0 mg/kg Q3W. Results showed that as of December 31, 2023, among 12 evaluable patients, 5 displayed Partial Responses (PRs), with an Objective Response Rate (ORR) of 41.7%, and a Disease Control Rate (DCR) of 91.7%. Among 3 SCLC patients, all reached PRs, hence an ORR of 100.0%, with one achieving Complete Response (CR) and another showing nearly 80% tumor volume reduction. The efficacy in 2 SCLC patients was achieved in the 1.6 mg/kg Q2W group. All SCLC patients showed response at the first tumor evaluation. The most common Treatment-Related Adverse Events (TRAEs) observed in ≥25% of patients were decreased neutrophil count, decreased lymphocyte count, and decreased white blood cell (WBC) count. The most common Grade ≥3 TRAEs (in ≥5% of patients) were decreased neutrophil count (33.3%), decreased lymphocyte count (30.0%), decreased WBC count (26.7%), decreased platelet count (23.3%), and anemia (15.0%). No reports of ILD were made. 6.DB-1311 DB-1311, the third-generation ADC product based on Duality Biologics's unique DITAC technology platform, exhibited powerful antitumor activity in various tumor models and demonstrated good safety and promising pharmacokinetic features in preclinical safety evaluations. Currently, the company is conducting a Phase I/IIa multi-center, open-label, first-in-human study evaluating DB-1311's safety, tolerability, pharmacokinetics, and preliminary anticancer activity in patients with advanced/metastatic solid tumors. In June 2024, the FDA granted BNT324/DB-1311 Fast Track designation for the treatment of patients with metastatic/unresectable castration-resistant prostate cancer (CRPC) showing disease progression during or after standard systemic therapy. 7.7MW3711 7MW3711, developed by Mabwell based on the novel antibody-drug conjugate technology platform IDDC™ (Interchain-Disulfide Drug Conjugate), consists of an innovative antibody molecule, a novel linker, and a novel Payload (Topoisomerase I inhibitor), and possesses full intellectual property rights. After injection into the human body, 7MW3711 can bind to tumor cell surface antigens, enter tumor cells, and release small molecules targetedly through specific enzymatic actions, thereby achieving precise tumor destruction. 8.IBI3001 IBI3001 is a potentially world-first dual-specific ADC targeting B7-H3 and EGFR, using the clinic-validated SYNtecanE® site-specific conjugation platform, and possesses multiple antitumor mechanisms: (1) enhanced EGFR signal blocking; (2) EGFR and B7-H3-mediated drug endocytosis and cytotoxicity; (3) powerful ADC bystander effects. The optimized B7-H3 arm not only strengthens the effect of EGFR signal blocking, but also reduces the toxicity of the EGFR target. In multiple in vitro and in vivo tumor models, IBI3001 has demonstrated potent tumor-killing effects and high tolerability, with a treatment window up to 40-fold. 9.ILB-3101 ILB-3101 is an antibody-drug conjugate targeting B7H3, developed based on Innolake's proprietary antibody and ADC platforms, and owns full, independent intellectual property rights. The antibody of B7H3, screened and optimized by the drug, has significant advantages over the B7H3 antibody used by leading international benchmark ADC products in key indicators such as internalization and in vitro and in vivo pharmacodynamics tests. For linker-effective payload, Innolake has selected a uniquely toxic payload substance, which offers higher efficacy and better safety than vinblastine type toxins (such as Dxd). Its linker is specifically designed, highly stable in plasma and possesses independent intellectual property rights.  In preclinical CDX studies, ILB-3101 has demonstrated superior antitumor effects compared to two leading international B7H3 ADC products. In pre-toxicological studies in crab-eating macaques, ILB-3101 also exhibited a wider therapeutic window. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!