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~ BI-1206 restores rituximab activity in relapsed or refractory patients
~~ Demonstrates ORR 50%, DCR 58%, with complete responses lasting beyond 18 and 24 months
ROCKVILLE, Md., and BEIJING, Nov. 5, 2021 - CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that its partner BioInvent International AB (“BioInvent”) (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, announced additional positive interim top-line data from its novel anti-FcγRIIB antibody BI-1206. The data update comes from the company’s Phase 1/2a clinical trial of BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) treating patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The latest data will be published in a poster at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021) in December 2021.
BI-1206, in combination with rituximab, demonstrated an objective response rate (ORR) of 50%, with three complete responses and three partial responses seen in twelve patients evaluated for therapeutic benefit. The treatment stabilized the disease in one additional patient, giving a disease control rate of 58% (7 out of 12 patients). The complete responses also appear to be long-lasting, sustaining beyond 18 and 24 months in two patients completing the study. Previous rituximab treatments without BI-1206 had failed in these patients. The data were obtained from the dose-escalation phase of the trial up to July 2021 (the ASH abstract cut-off date). BI-1206 showed a good safety profile: infusion-related reactions can be managed with a steroid regimen.
“The current data are very encouraging and already show the benefit of BI-1206 in advanced NHL. Without BI-1206, single agent rituximab does not work well for this group of patients. These results suggest that BI-1206 not only restores the anti-tumor response but can do it in a prolonged manner in many patients. All this has been achieved with a dosing regimen for BI-1206 that may yet be further improved, and we look forward to continuing its clinical development with the aim of improving treatment options for these patients,” said Martin Welschof, PhD, CEO of BioInvent.
Wei-Wu He, Ph.D., CASI’s Chairman, and Chief Executive Officer, said, “We are excited about the progression our partner BioInvent continues to make with BI-1206. We are optimistic about this anti-FcγRIIB antibody and its potential in restoring rituximab’s activity in relapsed/refractory NHL patients. These clinical data provide more evidence of its safety and activity profile. We believe BI-1206 has potential application across multiple tumor types in both first line treatments and in relapsed/refractory settings, and are excited BioInvent’s development and commercialization partner for making BI-1206 available to patients and healthcare providers across Greater China.”
Pharmacodynamic studies highlighted in the ASH 2021 abstract suggest that increasing the dosing of BI-1206 could lead to complete receptor saturation over an extended time, potentially leading to additional clinical benefits.
BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of non-Hodgkin’s lymphoma; and the other evaluates BI-1206 in combination with anti-PD1 therapy Keytruda® (pembrolizumab) in solid tumors.
Since October 2020, BioInvent has a licensing agreement with CASI Pharmaceuticals for China, including Hong Kong, Macau, and Taiwan. Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological and solid cancers, with CASI responsible for commercialization in Greater China.
ASH 2021 will take place on December 11–14, 2021, at the Georgia World Congress Center - Atlanta, GA, and virtually. BioInvent will present a poster entitled “Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to FcγRIIB (CD32B), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab”. The abstract is available online from November 4, 2021, at 9.00 am EDT (2 pm CET) and will be presented on December 11 at 5.30 pm ET (11:30 pm CET).
In mid-December, BioInvent will hold a live-streamed KOL event where the ASH poster data will be discussed. In addition, the first data from the Phase 1/2a study of BI-1206 in combination with Keytruda for the treatment of solid tumors will be reviewed.
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.
The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 100+ hematology-oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com.
|For further information, please contact:|
|Martin Welschof, CEO||Cecilia Hofvander, Senior Director Investor Relations|
|+46 (0)46 286 85 50||+46 (0)46 286 85 50|