Transgene and BioInvent Announce Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate BT-001 in Combination with KEYTRUDA®
June 28, 2022 02:00 AM Eastern Daylight Time

Responses in 6 out of 9 patients evaluated provide exciting evidence that BI-1206 has the potential to restore activity of rituximab in non-Hodgkin's lymphoma patients who have relapsed after treatment with rituximab
Long-lasting complete responses observed in two patients beyond 12 months
Key opinion leader (KOL) call to discuss results today, January 28, at 5.30 p.m. CET (11:30 a.m. ET)
LUND, Sweden, Jan. 28, 2021 /PRNewswire/ -- BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces positive interim results from the Phase I/IIa trial of the novel anti-Fc?RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).

"The responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. The complete responses we have seen in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after several lines of treatment. Based on these results, we will now move to identify the recommended phase ll dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients," said Martin Welschof, Ph.D, CEO of BioInvent.

Of the 9 patients who completed the induction cycle, 6 patients have shown either complete or partial responses several of which are still ongoing. Two patients (30 mg and 70 mg dose) achieved a complete response, which continues to be sustained 12 and 24 months later. Another patient who had a blastoid form of MCL achieved a partial response, and a complete depletion of peripheral tumor cells. Readout from two patients is still pending.

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies.

To address dose limiting toxicities seen at higher doses earlier in the trial, a new safety protocol was implemented, enabling higher doses to be administered. No dose-limiting toxicities have been observed in the five patients who have been treated under the current protocol, despite receiving higher doses of BI-1206.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, said: "We continue to be excited about this anti-Fc?RIIB antibody's potential in restoring rituximab's activity in NHL patients, and these results provided further encouraging evidence of its potential as a durable and safe treatment alternative. We remain encouraged by its potential application across multiple tumor types in many first line treatments and in refractory settings and are excited to be taking an important step closer to making BI-1206 available to patients and healthcare providers across Greater China."

BioInvent will hold a key opinion leader (KOL) call today, Thursday, January 28 at 5:30 p.m. CET (11:30 a.m. ET) to discuss the results and next steps in clinical development of BI-1206. Renowned lymphoma expert Mats Jerkeman, MD, Lund University, will give a presentation on the current treatment landscape, and unmet medical need for patients with relapsed or refractory NHL. The BioInvent management team will be available for Q&A and partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China.

BI-1206, in clinical development for both hematological and solid tumors, is the lead compound in BioInvent's broad pipeline and one of three products undergoing four clinical trials. BioInvent initiated a Phase I/IIa trial of anti-TNFR2 antibody BI-1808 in January and is ready to initiate a Phase l/lla study of the novel oncolytic vaccinia virus BT-001, together with partner Transgene.

About the Phase I/IIa study of BI-1206 in NHL

The Phase I/IIa study consists of two parts: i) Phase l, with dose escalation cohorts using a 3+3 dose-escalation design and selection of the recommended Phase IIa dose (RP2D); and ii) Phase IIa, an expansion cohort at the RP2D, enriched with patients with mantle cell lymphoma (MCL). Subjects in each phase receive 1 cycle (4 doses) of induction therapy with BI-1206 in combination with rituximab. Subjects who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206.

About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with four programs in 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.

LUND, Sweden and STRASBOURG, France, Dec. 21, 2020 /PRNewswire/ -- BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announced they have received regulatory approval in Belgium for a clinical trial application (CTA) for a Phase l/lla study of the novel oncolytic vaccinia virus BT-001.

BT-001 is a best-in-class oncolytic Vaccinia virus. It has been generated using Transgene's Invir.IO™ platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent's proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Delivering the anti-CTLA4 antibody directly to the tumor microenvironment will allow a local therapeutic activity and will thus greatly increase the safety and tolerability profile of the monoclonal antibody by reducing systemic exposure. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.

"This clinical trial approval sets the stage to further broaden BioInvent's promising clinical pipeline. BT-001 is our fourth program in clinical development. We are very excited to move forward this unique oncolytic virus which combines multiple, clinically proven mechanisms of action into a single drug. This clinical study will allow us to test BT-001's potential to treat a range of solid cancer indications. Regulatory approval of this agent demonstrates the excellent performance of our teams," said Martin Welschof, CEO of BioInvent.

Philippe Archinard, PhD, Chairman and CEO of Transgene, said: "We are pleased that we have received a first approval to initiate the Phase l/lla trial of BT-001. This oncolytic virus has induced long-lasting antitumor immune responses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. Thanks to its unique mode of action and the results seen so far, we believe it has the potential to make a significant difference to cancer patients."

This multicenter, open-label, dose-escalation Phase l/lla trial evaluating BT-001 alone or in combination with pembrolizumab will first be including patients in several countries in Europe and then in the USA. The Phase l, which is expected to begin within the next few weeks, will be divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors, who have already been pretreated, including with immunotherapies. Patients will receive single agent, intratumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes, to select the recommended dose and best regimen. Part B will explore the combination of intratumoral injections of BT-001 with pembrolizumab, an anti-PD1 targeting agent in 12 patients. The Phase lla will evaluate the combination regiment in several patient cohorts with different tumors types. These expansion cohorts will offer the exciting possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with four programs in 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.

About Transgene
Transgene (Euronext Paris: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.

The Company's clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).

With Transgene's myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.

With its proprietary platform Invir.IO™, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.

BioInvent announces FDA acceptance of the Investigational New Drug application for the phase I/IIa study with TB-403

Lund, Sweden – 7 January 2016 – BioInvent International (OMXS: BINV) today announces that the FDA has completed the safety review of its Investigational New Drug (IND) application and have concluded that the proposed pediatric clinical investigation can proceed. The IND application is for a Phase I/IIa study that will evaluate the efficacy and safety of TB-403 for the treatment of relapsed or refractory medulloblastoma. This is a rare, life-threatening brain tumor that mainly affects children.

The study, which is planned to commence in Q1 2016, will be conducted at a number of specialist centers in the United States. Initial results from the study are expected by early 2017.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Treatment with TB-403 in pre-clinical models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. The antibody can potentially be used in other pediatric cancer indications, including neuroblastoma, Ewing sarcoma or alveolar rhabdomysarcoma.

A favourable safety profile of TB-403 has been demonstrated in previous clinical trials in healthy volunteers and adult patients with various types of solid tumors.

“We are delighted that the FDA has accepted our IND for TB-403. This is a milestone for commencing the phase I/IIa study evaluating TB-403 in rare pediatric brain cancers according to plans communicated in December 2015. The study will be conducted at an attractive cost and efficacy signals in patients will provide opportunities to approach the FDA regarding expedited approval. TB-403 may in this scenario get a rapid pathway to launch,” says Michael Oredsson, CEO of BioInvent.

The TB-403 drug project is conducted in cooperation with Oncurious, a subsidiary of the Belgian biopharma company ThromboGenics. BioInvent is paying half of the development costs and has the right to 40 percent of all future revenue from the project.

To the editors:

About BioInvent
BioInvent International AB develops immune oncology drugs. With one of the world’s largest antibody libraries, and a unique, proprietary discovery method, BioInvent can identify the optimal cellular targets and antibodies for the treatment of various tumor types. BioInvent has also considerable experience in and a facility for process development and production of antibodies for clinical studies. This makes it possible to develop proprietary drug projects, but also to supply leading international pharmaceutical companies with effective tools for their drug development. BioInvent currently has three proprietary projects in or close to clinical development and partnership agreements with seven global pharmaceutical and biotech companies. More information is available at www.bioinvent.com.

For further information, please contact:
Michael Oredsson
President and CEO
+46 (0)46 286 85 67
+46 (0)70716 89 30
michael.oredsson@bioinvent.com

BioInvent International AB (publ)
Co. reg. No: 556537-7263
Visiting address: Sölvegatan 41
Mailing address: 223 70 LUND
Phone: +46(0)46 286 85 50
info@bioinvent.com
www.bioinvent.com