• Partial response in metastatic uveal melanoma, a difficult-to-treat indication
• Markedly improvement of stage IV sarcoma

Lund, Sweden – December 17, 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, announces positive early data from the ongoing clinical study of its novel anti-FcyRIIB antibody BI-1206 in combination with anti-PD-1 therapy pembrolizumab (Keytruda®) for the treatment of patients with solid tumors. Early observations are that BI-1206 may stem and reverse metastatic disease progression in patients who have previously progressed on PD-1/PDL-1 therapies and other prior treatments. No major safety concerns have been noted. The study and the observed responses will be discussed as part of BioInvent’s Key Opinion Leader Webinar on BI-1206 on Friday, December 17, 2021, at 1:00 pm ET/7:00 pm CET.

The study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. As of November 29, 2021, eleven patients in three dose cohorts have been treated with BI-1206 in combination with pembrolizumab and four patients are still on treatment.

During the study period, a patient with stage IV sarcoma was able to stop all pain medication, the coughing disappeared, and the shortness of breath markedly improved. From the time of ending participation in the BI-1206 study, the patient did not receive any other anti-cancer treatment and showed on a scan performed in September 2021 that some metastatic lesions have disappeared, some are smaller, and others have not changed. No lesions have grown, and no new lesions are evident. Another patient, with uveal melanoma, demonstrated a partial response and is still on treatment with the combination of BI-1206 and pembrolizumab. Metastatic uveal melanoma is a difficult-to-treat disease, with median overall survival of approximately 13.4 months, with only 8% of patients surviving after 2 years1).

“These are exciting early data that show the potential of BI-1206 in rescuing the effectiveness of pembrolizumab in patients that have progressed on multiple prior treatment cycles. Furthermore, these data encourage our conviction that BI-1206 can potentially be effective in restoring anti-tumor response in combination with a range of antibody therapies. Other recent data have shown that BI-1206 can rescue the activity of rituximab in NHL, and now we see an effect of BI-1206 with pembrolizumab. We look forward to discussing our recent data with investors during our KOL call on December 17,” said Martin Welschof, PhD, CEO of BioInvent.

Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (NYSE: MRK), with whom BioInvent has a clinical trial collaboration and supply agreement for this study.

1) Uveal melanoma: epidemiology, etiology, and treatment of primary disease, Krantz et al, Clin Ophthalmology 31 Jan 2017.

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

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.