BioInvent Outlines Strong Progress in Clinical and Preclinical Pipeline at R&D Day 2022

Rhea-AI Summary

BioInvent International AB (Nasdaq: BINV) recently highlighted significant advancements in its clinical pipeline during the R&D Day. Key updates include three complete responses for lead drug candidate BI-1206 in non-Hodgkin's lymphoma, with two responses lasting over two years, and successful recruitment in Phase 1/2 trials for BI-1808 and BI-1607. Furthermore, interim results show favorable tolerability for BI-1808 in combination with Keytruda, while BI-1607's IND application has been approved by the FDA, allowing for a trial extension to U.S. centers. The company emphasizes its commitment to transforming cancer therapy.

Positive

• Three complete responses in BI-1206 trial, two lasting over two years.
• Successful recruitment for BI-1808 Phase 1/2a trial with early signs of efficacy.
• FDA approval of IND application for BI-1607, facilitating expansion to U.S. centers.

Negative

• None.

• Current data on BI-1206 show three complete responses (two responses beyond two years) and four partial responses. Full approval received for starting subcutaneous administration.
• Recruitment in single agent and combo arms of BI-1808 Phase 1/2a trial progressing well.
• Dose escalation of BI-1607 progressing well with the first dose cohort completed.
• Results from Part A of BT-001 Phase 1/2a trial to be presented H1 2023E.

LUND, SWEDEN / ACCESSWIRE / December 8, 2022 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies for cancer immunotherapy, today provides an update on its clinical and pre-clinical pipeline, including an update on its lead drug candidate, the novel anti-FcγRIIB antibody BI-1206.

BI-1206 is currently being studied in two Phase 1/2 trials, in combination with rituximab in non-Hodgkin's lymphoma (NHL) and in combination with pembrolizumab in solid tumors. Latest data from the Phase 1/2 trial with BI-1206 in combination with rituximab in NHL show there are three ongoing complete responses, two beyond two years after end of treatment, and four partial responses, one of which is ongoing. The new arm of the NHL study introducing subcutaneous administration is currently recruiting patients. As anti-CD20 based therapy will remain central for the treatment of NHL, BI-1206 has the potential to be uniquely positioned within NHL.

The ongoing clinical trial with BI-1206 in solid tumors is progressing through the dose-escalation part of the trial and the two patients reported last December still show clear clinical improvement. The subcutaneous arm of the study in solid tumors is on track to be initiated in H1 2023.

"BioInvent is making strong progress with its pipeline of novel immune-modulatory antibodies to treat cancer. We now have five clinical trials in progress with four different drug candidates, underlining the strength of our proprietary technology platform. In particular, the data on our lead drug candidate BI-1206 continue to demonstrate its potential to significantly improve treatment for lymphoma and solid tumor patients. We look forward to continuing to develop BI-1206, and our other promising new treatments, to deliver on the promise of transforming the lives of cancer patients," said Martin Welschof, CEO of BioInvent.

BioInvent is also moving several other drug candidates through clinical and preclinical development. The latest updates include:

• Recruitment to both the single agent and combination arms of the Phase 1/2a trial with the anti-TNFR2 drug candidate BI-1808 is progressing well, with two patients already dosed with 1000mg. Interim results from the trial, which is evaluating BI-1808 as a single agent and in combination with the anti-PD-1 therapy Keytruda® (pembrolizumab) in patients with ovarian cancer, non-small cell lung cancer and cutaneous T-cell lymphoma (CTCL), have reinforced the very favorable tolerability profile, no safety concerns and early signs of efficacy.
• A joint paper on BT-001, a vectorized anti-CTLA-4 antibody co-developed with Transgene and currently in a Phase 1/2a trial, has won this year's Journal for ImmunoTherapy of Cancer (JITC) Best Oncolytic and Local Immunotherapy Paper Award. The trial assessing BT-001 as a single agent and in combination with Keytruda against solid tumors is progressing well, and BioInvent and Transgene plan to present results from Part A at a scientific conference H1 2023.
• The U.S. Food and Drug Administration (FDA) has approved BioInvent's Investigational New Drug (IND) application for its FcyRIIB-blocking antibody BI-1607. This allows for the ongoing Phase 1/2a trial of BI-1607 in combination with trastuzumab in HER2+ solid tumors to be extended to U.S. centers. The ongoing clinical study is progressing well with the first dose cohort (75 mg) completed with no safety or tolerability concerns and no infusion-related reactions observed.
• Preclinical development of the anti-TNFR2 antibody BI-1910 continues as planned. While BI-1808 is a ligand blocking FcyR-engaging anti-TNFR2 antibody, BI-1910 has FcyR-independent intrinsic agonist activity.

BioInvent is hosting the R&D Day in Stockholm at 2:00 pm CET, Thursday December 8, 2022. Further details can be found on BioInvent's website www.bioinvent.com.

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

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.

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BioInvent Outlines Strong Progress in Clinical and Preclinical Pipeline at R&D Day 2022

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FAQ

What are the recent updates on BioInvent's drug candidate BI-1206?

Recent updates indicate three complete responses in the BI-1206 trial for non-Hodgkin's lymphoma, with two lasting over two years, and four partial responses.

How is the recruitment process for the BI-1808 trial progressing?

Recruitment for the Phase 1/2a trial of BI-1808 is progressing well, with two patients already dosed.

What is the status of the BI-1607 trial?

The FDA has approved the IND application for BI-1607, allowing the trial in HER2+ solid tumors to expand to U.S. centers.

When will results from the BT-001 trial be presented?

Results from Part A of the BT-001 Phase 1/2a trial are expected to be presented in H1 2023.