BioInvent International

• Reinforcing previous results and adding up to a total of four complete responses in the intravenous (IV) arm of the study
• Recruitment continues in the subcutaneous (SC) arm of the study; first data to be reported H1 2023
• New patent granted in Japan relating to treatment of relapsed/refractory tumors

Lund, Sweden – April 20, 2023 – 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 that a fourth complete response has been observed in the 100 mg dose expansion cohort in the IV arm of the Phase 1/2 trial of its lead drug candidate BI-1206, the novel anti-FcgRIIB antibody, in combination with rituximab in non-Hodgkin’s lymphoma (NHL).

The study is recruiting patients with NHL who have progressed or are refractory to rituximab. Patients receive an induction regimen of BI-1206 in combination with rituximab and those who show clinical benefit continue on maintenance therapy for up to one year. The new data reinforce previous results showing three complete responses, two beyond two years after end of treatment. For the IV arm of the study in total, clinical responses (complete and partial responses) have been observed in 7 out of 15 evaluable patients and in addition, 4 patients have shown stable disease.

BioInvent is currently recruiting patients to a new arm of the NHL study where the drug is administered subcutaneously. This newly developed formulation is significantly more convenient for both patients and healthcare professionals. No infusion related reactions (IRRs) have been observed with subcutaneous administration at similar doses to intravenous and there have also been no safety concerns or increased toxicity. First data from the subcutaneous arm will be reported in H1 2023.

“We are very pleased to observe this fourth complete response in the Phase 1/2 trial of our anti-FcgRIIB antibody BI-1206 in NHL. In addition to the previously reported positive results, this is very encouraging news for NHL patients who are in urgent need of improved treatment options. At the same time, we are continuing to make good progress with subcutaneous administration, an approach significantly more convenient for patients and healthcare professionals. This method of administration means BI-1206 could have a unique position in the NHL treatment landscape,” said Martin Welschof, CEO of BioInvent.

A second Phase 1/2 trial of BI-1206, investigating the antibody in combination with anti-PD1 therapy KEYTRUDA® (pembrolizumab) in solid tumors, is also continuing as planned.

Independently, the patent office in Japan has issued a decision to grant a patent, relating to treatment of relapsed/refractory tumors, relevant to BI-1206. The patent in Japan covers the combination of anti-FcgRIIB antibodies with for example anti-CD20 antibodies for these purposes. Similar patents in the same patent family have previously been granted in Australia and Russia and BioInvent has pending applications in several countries. This patent will expire in 2035. Previously granted patents in Japan relevant to BI-1206 will expire in 2031.

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 four drug candidates in five 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 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 and providing licensing and partnering opportunities.

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. Follow on Twitter: @BioInvent.

For further information, please contact:
Cecilia Hofvander, Senior Director Investor Relations
Phone: +46 (0)46 286 85 50
Email: 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
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.