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BioInvent’s Latest NHL Data at ASH Show Increased and Sustained Responses to BI-1206 in Relapsed Patients

  • Objective response rate (ORR) 67% and disease control rate (DCR) 78% in Follicular lymphoma
  • Complete responses lasting beyond 18, 24 and 36 months

LUND, SWEDEN / ACCESSWIRE / December 11, 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 updated positive interim top-line data from its novel anti-FcyRIIB antibody BI-1206 that show increased response levels and sustained complete responses. The data represent the status - to early November 2021 - of 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). They are published today in a poster at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021).

The ASH 2021 poster shows that BI-1206 in combination with rituximab provided an objective response rate (ORR) of 54%, with three complete responses and four partial responses in 13 patients evaluated for therapeutic benefit for the three indications (Mantle cell lymphoma, Marginal zone lymphoma and Follicular lymphoma) enrolled in the clinical study. The treatment stabilized disease in one additional patient, giving a disease control rate of 62% (8 out of 13 patients).

When considered alone, the response rate for Follicular lymphoma is particularly impressive: of nine evaluable patients, three developed a CR, three developed a PR and one patient had SD at the cut-off date, giving a 67% ORR and 78% DCR. Previous rituximab treatments without BI-1206 had failed in these patients, prior to participation in the trial all patients had relapsed on earlier lines of rituximab-containing treatments.

All complete responses have been sustained for extended periods, with the longest complete response enduring beyond 36 months. In two additional patients, complete responses have lasted beyond 12 and 24 months after end of treatment.

"The current data are highly encouraging and already show the benefit of BI-1206 in rescuing rituximab treatment in advanced NHL. Without BI-1206, rituximab did not work well in these patients. Based on our deep understanding of the immune mechanisms at play, these data indicate that BI-1206 not only restores the anti-tumor response but does it safely and in a prolonged manner in many patients, notably in Follicular lymphoma. Adjusting the dosing regimen of BI-1206 could lead to yet further improvements. We look forward to discussing all these aspects with investors during our forthcoming KOL call on December 17," said Martin Welschof, PhD, CEO of BioInvent.

BioInvent will host a key opinion leader (KOL) webinar on BI-1206 featuring Michael Wang, M.D., from the MD Anderson Cancer Center, who will discuss the current NHL treatment landscape and unmet medical needs. Senior management will discuss the data presented at ASH 2021 and first data from the Phase 1/2a study of BI-1206 in combination with pembrolizumab for the treatment of solid tumors. The webinar will take place on Friday, December 17, 2021, at 1:00 pm ET/7:00 pm CET.

To register for the webinar, please click here .

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. BI-1206 has also received approval to start clinical trials in China.

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's poster is entitled "Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to FcyRIIB, in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab". The poster is presented today December 11 at 5.30 pm ET (11:30 pm CET).

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 and a fifth program just initiating clinical development. 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)
Co. Reg. No. Org nr: 556537-7263
Visiting address: Ideongatan 1
Mailing address: 223 70 LUND
Phone: +46 (0)46 286 85 50
www.bioinvent.com

Disclaimer - BioInvent
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2021-12-11 23:30 CET.



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