Tafasitamab-Cxix

BEIJING--(BUSINESS WIRE)-- Data of InnoCare's (HKEX: 09969; SSE: 688428) robust pipelines were presented at the European Hematology Association (EHA) 2024 Hybrid Congress. 1. Subcutaneous ICP-B02 (CM355), a Novel Bispecific CD20/CD3 Antibody Showed Promising Efficacy and Favorable Safety Pro Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (Abstract No.: P2097) This study aimed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK)/ pharmacodynamics (PD) of ICP-B02 in relapsed/refractory (R/R) B-cell non-hodgkin lymphoma (NHL). At the doses evaluated, ICP-B02 subcutaneously (SC) demonstrated favorable safety pro promising efficacy in patients with R/R B-cell NHL. All Cytokine release syndrome (CRS) events were manageable with minimal intervention. Rapid and deep responses, as well as the convenience of SC formulation, support further clinical development for treatment of B cell NHL. Efficacy results showed that the overall response rate (ORR) was 100.0% with complete response rate (CRR) was 77.8%. 2. Preliminary Safety and Efficacy Data from Patients with Relapsed or Refractory B-Cell Malignancies Treated with ICP-248, a Novel BCL2 Inhibitor (Abstract No.: P1851) This study aimed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ICP-248 in patients with relapsed or refractory B-cell malignancies. Preliminary results of ICP-248 monotherapy suggest well tolerated safety pro promising efficacy with dose-dependent effect in relapsed or refractory B-cell malignancies. The ORR was 100% at 100 mg dose level, with three patients achieved complete response. Further assessment of safety and efficacy with additional dose levels and dosing strategies will be pursued in expanded patient population and in the combination with Orelabrutinib. 3. A Phase II, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract No.: P2091) Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) remains a high unmet medical need, especially in patients who are ineligible for autologous stem cell transplant (ASCT). The study demonstrates that tafasitamab plus lenalidomide regimen is well tolerated in Chinese population with good efficacy, and the efficacy and safety data are consistent with the L-MIND study. As of the data by Jan. 29, 2024, the ORR assessed by IRC was 73.1%, with 32.7% of patients achieving CR and 40.4% of patients with partial response (PR). The ORR assessed by investigators was 69.2%, with 34.6% of patients reaching CR and 34.6% of patients achieved PR. 4. Orelabrutinib-Lenalidomide-Rituximab in Patients with Untreated Mantle Cell Lymphoma (MCL): Updated Results of the Multicenter, Phase II Polaris Study (Abstract No.: P1141) This study aimed to explore whether orelabrutinib combined with rituximab plus lenalidomide would exhibit synergistic antitumor activity in mantle cell lymphoma (MCL) and improve the depth and durability of response. The data confirmed the potent antitumor activity and manageable safety of the orelabrutinib-lenalidomide-rituximab regimen in patients with untreated MCL. Detection of peripheral blood (PB) ctDNA detection based on NGS could contribute to predicting prognosis. Of response-evaluable patients who had completed 6 cycles of induction therapy, 67.9% achieved CR and 17.9% achieved PR, with an ORR of 85.8%. Median duration of response (DOR) and median progress-free survival (PFS) were not reached. 5. Orient Study: Orelabrutinib Addition to R-Chop-Like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL (Abstract No.: P1167) This is a multicenter, open-label phase II study, aiming to assess efficacy and safety of orelabrutinib plus R-CHOP-like regimen for untreated non-GCB DLBCL patients who respond to induction therapy of orelabrutinib plus rituximab. Primary endpoint was complete remission rate (CRR) after 6-cycle orelabrutinib plus R-Chop-like regimen. All the patients who completed 6-cycle therapy attained CR at the end of cycle 6. Although preliminary, responders to orelabrutinib plus rituximab induction may further benefit from subsequent orelabrutinib plus R-Chop-like regimen, achieving high CRR and sustaining CR throughout post-therapy follow-up; no unexpected safety issue occurred. 6. The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) as the First-Line Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: P1193) This study aimed to investigate the efficacy and safety of rituximab, methotrexate, thiotepa, and orelabrutinib regimen followed by autologous hematopoietic stem cell transplantation (ASCT) in treatment of the patients with PCNSL. The rituximab, methotrexate, thiotepa, and orelabrutinib regimen induction treatment has demonstrated notable efficacy in achieving higher response rates among patients with newly diagnosed PCNSL, and a tolerable safety profile. 7. Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (INHL) Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKI): Preliminary Results from a Phase 2 Study (Abstract No.: P2074) This study aimed to assess the safety and activity of orelabrutinib in prior BTKi-intolerant iNHL. Orelabrutinib improved outcomes of prior BTKi-intolerant AEs, particularly the off-target toxicities (cardiac/infectious AEs). The preliminary result of this study showed promising efficacy and safety data of orelabrutinib in prior BTKi-intolerant iNHL patients. 8. Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (CWCLL-001 Study) (Abstract No.: P680) This study was initiated to evaluate the efficacy and safety of orelabrutinib plus fludarabine, cyclophosphamide and obinutuzumab in younger, fit patients with previously untreated CLL/SLL without restriction by del(17p)/TP53 aberrations and/or IGHV mutation status. The regimen leads to a rapid and deep molecular remission with a manageable safety pro previously untreated CLL patients including those with unfavorable characteristics. 9. Different Subtype of DLBCL Patients Treated with R-Chop (Like) Plus Orelabrutinib Regimen: A Real-World Study (Abstract No.: PB3034) This retrospective study aimed to compare the efficacy and safety of R-CHOP-like regimen combined with orelabrutinib in patients with different subtypes of DLBCL. The study demonstrated that patients with double-expression and extranodal involvement benefit from orelabrutinib and that earlier addition of orelabrutinib results in a higher proportion of complete remissions, and more detailed analyses comparing the benefits in different types of patients are underway. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. View source version on businesswire.com: Contacts Media Chunhua Lu 86-10-66609879 chunhua.lu@innocarepharma.com Investors 86-10-66609999 ir@innocarepharma.com Source: InnoCare Pharma View this news release online at:

Multispecific antibody encoded by NTX-472 preferentially engaged CD47 in presence of co-engagement of CD20 and CD19 One dose of NTX-472 in vivo rapidly depleted B cells with no detectable binding to red blood cells EMERYVILLE, Calif.--(BUSINESS WIRE)-- Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, recently presented a poster on NTX-472, its new preclinical drug candidate for B cell lymphoma, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Monoclonal antibody immunotherapies can provide an effective treatment for B cell lymphoma. However, by only targeting a single tumor antigen, such as CD19 or CD20, these treatments can place selective pressures on tumors, with cancer cells often down-regulating the expression of those specific antigens to become cold tumors, invisible to the immune system. Multispecific antibodies may be able to mitigate these effects with improved specificity to several antigens at once. Nutcracker Therapeutics’ scientists engineered a panel of molecules simultaneously targeting CD20, CD19 and CD47 to compare them to existing monoclonal antibody immunotherapies for B cell lymphoma, including rituximab (monospecific anti-CD20) and tafasitamab (monospecific anti-CD19). Of these molecules, the team identified one which had improved tumor killing and B cell depletion in vitro, which became the NTX-472 program. Using its CodonCrackerTM software and the Nutcracker® Manufacturing Unit, Nutcracker Therapeutics’ scientists then further studied NTX-472 in vivo, which showed rapid depletion of B cells with no detectable binding to red blood cells in cynomolgus monkeys. “We’re proud to be one of the first RNA therapeutics companies to engineer a multispecific antibody,” said Chief Scientific Officer Samuel Deutsch, Ph.D. “The data on NTX-472 is a testament to the capabilities of Nutcracker Therapeutics’ platform and how it enables our scientists to engineer complex molecules by the dozens, and ultimately pinpoint the best option for a viable drug candidate. We plan to further develop NTX-472 as a trispecific immunotherapy with a differentiated therapeutic and safety profile.” Previously Nutcracker Therapeutics presented preclinical data on NTX-471, an mRNA therapeutic candidate that is being developed to target CD47. Unlike the multispecific approach employed by NTX-472, NTX-471 encodes for a multivalent (octavalent) antibody to achieve high specificity via avidity for target cancer cells. During SITC 2023, Nutcracker Therapeutics demonstrated similar cytotoxic activity of NTX-471 to existing anti-CD47 molecules, but with little-to-no binding to red blood cells. More information on NTX-471 can be found in this press release. About Nutcracker Therapeutics, Inc. Nutcracker Therapeutics, Inc. is an RNA therapeutics company that has combined the power of advanced engineering with high-precision biosynthesis to deploy a complete RNA platform that encompasses the design, delivery, and manufacturing of RNA medicines. Armed with this high-tech advantage, the company has initiated multiple therapeutic programs with the support of clinical investigators at leading institutions. Nutcracker Therapeutics’ technology platform has the potential to significantly reduce costs and cycle times for RNA therapeutic development, with dramatic advantages in speed and capacity scaling over other RNA manufacturing approaches. For more information, visit .