protein C

82.4% of patients without prior CAR-T achieving Complete Response (CR) or better ROCKVILLE, Md. and SUZHOU, China, Sept. 28, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, and IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced updated long-term follow-up data from two studies for BMCA CAR-T: ( 1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023. Poster Presentation #1 Overview Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-290 Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST Equecabtagene Autoleucel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China. This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646). As of the data cutoff date of December 31, 2022, a total of 105 participants received Equecabtagene Autoleucel at 1.0×106 CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23). Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy. Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR, the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51). Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR. Safety: Among the 105 participants, 93.3% (98/105) experienced cytokine release syndrome (CRS). The majority experienced Grade 1-2 CRS, with only one experiencing ≥ Grade 3 CRS. The median time to CRS onset was 6.0 days (range 1, 13) post- infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered. Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion. Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion. Poster Presentation #2 Overview Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T treatment Conference Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-288 Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST Patients with RRMM treated with BCMA CAR-T cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia. The principal investigators Prof. Lugui Qiu ， MD ， from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated, "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, the updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients." About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 assets under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics

82.4% of patients without prior CAR-T achieving Complete Response (CR) or better SHANGHAI and NANJING, China and SAN JOSE, Calif., Sept. 28, 2023 /PRNewswire/ -- IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced updated long-term follow-up data from two studies for BMCA CAR-T: (1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (IASO Bio R&D code: CT103A, Innovent R&D code: IBI326, Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023. Poster Presentation #1 Overview Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-290 Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST CT103A (Equecabtagene Autoleucel) is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China. This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646). As of the data cutoff date of December 31, 2022, a total of 105 participants received Eque-ce at 1.0×106 CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23) Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy. Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR,the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51). Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR. Safety: Among the 105 participants, 93.3% (98/105) experienced cytokine release syndrome (CRS). The majority experienced Grade 1-2 CRS, with only one experiencing ≥ Grade 3 CRS. The median time to CRS onset was 6.0 days (range 1, 13) post-infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered. Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion. Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion. Poster Presentation #2 Overview Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after antiBCMA CAR-T treatment Conference Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-288 Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST Patients with relapsed/refractory multiple myeloma (RRMM) treated with anti-B cell maturation antigen (BCMA) chimeric antigen receptor-T (CAR-T) cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia. "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, our updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients," said principal investigators Prof. Lugui Qiu, MD, from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . About Innovent Biologics Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 asset under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Contact: IASO Bio Media: pr@iasobio.com Investors: ir@iasobio.com Innovent Biologics Media: pr@innoventbio.com +86 512-6956 6088 Investors: ir@innoventbio.com +86 512-6956 6088 View original content to download multimedia: SOURCE IASO Bio

BOSTON and LONDON, May 22, 2023 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors. "We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B. We believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety pro persons with hemophilia B, subject to review and approval.” According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate’s development plan and, if relevant criteria are met, eligibility for Accelerated Approval, Priority Review, or Rolling Review. About SerpinPC SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and which may also be developed to prevent bleeding associated with other bleeding disorders. Centessa is advancing the registrational program for SerpinPC in hemophilia B, which includes a set of clinical studies with multiple components. PRESent-5, initiated in late 2022, is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with and without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at (NCT05605678, NCT05789524, NCT05789537). SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority. About Centessa Pharmaceuticals Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients. Our programs span discovery-stage to late-stage development and cover a range of high-value indications. We operate with the conviction that each one of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit , which does not form part of this release. Forward Looking Statements This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; its expectations regarding the implications of Fast Track designation; its expectations regarding the timing of commencement of new studies or clinical trials or clinical and preclinical data related to SerpinPC, and other Company programs (if any); its ability to continue to meet the criteria for Fast Track designation; its ability to be eligible for Accelerated Approval, Priority Review, or Rolling Review; its ability to identify, screen, recruit and register a sufficient number of or any subjects in its anticipated new studies or clinical trials including PRESent-5, the observational feeder study, PRESent-2 and PRESent-3; its expectations on executing its research and clinical development plans and the timing thereof; the Company’s ability to differentiate SerpinPC and other Company programs (if any) from other treatment options; the development and therapeutic potential of SerpinPC and other Company programs (if any); the Company's ability to present profiles or data of any of the Company's products at scientific meetings and conferences and regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates, assumptions and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability pro our product candidates; our ability to maintain Fast Track designation; our ability to identify, screen and recruit a sufficient number of or any subjects in our anticipated new studies or clinical trials including PRESent-2, PRESent-3, PRESent-5; our ability to execute IND-enabling activities in a timely manner or at all; our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to maintain our cash runway and obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses into 2026; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; economic risks to the United States and United Kingdom banking systems; and geo-political risks such as the Russia-Ukraine war. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law. Contact: Kristen K. Sheppard, Esq. SVP of Investor Relations investors@centessa.com