• BI-1206 restores rituximab activity in relapsed or refractory patients
• Demonstrates ORR 50%, DCR 58%, with complete responses lasting beyond 18 and 24 months

Lund, Sweden – November 4, 2021 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces 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 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 months and beyond 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.

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 in place 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 China and associated markets.

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.

About BioInvent
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.

For further information, please contact:
Cecilia Hofvander
Senior Director Investor Relations
+46 (0)46 286 85 50
cecilia.hofvander@bioinvent.com

BioInvent International AB (publ)
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Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com

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