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 Profile in 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 profile and 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 profile and 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 profile in 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.

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