ACCESS Newswire

BioInvent International

11.12.2021 23:46:53 CET | ACCESS Newswire | Press release

Share
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.



View source version on accesswire.com:
https://www.accesswire.com/677141/BioInvents-Latest-NHL-Data-at-ASH-Show-Increased-and-Sustained-Responses-to-BI-1206-in-Relapsed-Patients

To view this piece of content from www.accesswire.com, please give your consent at the top of this page.

About ACCESS Newswire

DK

Subscribe to releases from ACCESS Newswire

Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from ACCESS Newswire

Fermi and Hillcore Energy Capital Announce 2.6 Gigawatt Power Strategic Alliance for Project Matador11.8.2026 23:15:00 CEST | Press release

Doubles Fermi power to market to 4.8 gigawatts (GW) over the next ~30 months Build-Own-Operate-Transfer structure accelerates one of America's largest AI campus power programs - with no capital outlay by Fermi DALLAS, TX / ACCESS Newswire / August 11, 2026 / Fermi Inc. (NASDAQ:FRMI)(LSE:FRMI), operating as Fermi America™ ("Fermi" or the "Company"), announced the execution of a framework agreement with Hillcore Energy Capital Corporation ("Hillcore") under which Hillcore will finance, build, own and operate the Hillcore Power Center, an approximately 2.6 GW power complex at Fermi's Project Matador campus in Carson County, Texas, under a Build-Own-Operate-Transfer (BOOT) structure. The Hillcore Power Center will comprise approximately 2.5 GW of natural gas-fired generation, developed in phases, together with approximately 100 megawatts (MW) of solar generation and battery energy storage. Construction of the first power block, approximately 350 MW, will begin on execution of definitive ag

ePropelled to Increase Manufacturing Footprint with $60 Million in U.S. Government Funding to Strengthen U.S. Drone Propulsion Supply Chain11.8.2026 13:00:00 CEST | Press release

Expansion Increases Manufacturing Capacity by 4X and Positions ePropelled as a Leading Domestic Supplier of Advanced Dual-Use Electric Propulsion Systems COVENTRY, UK / ACCESS Newswire / August 11, 2026 / ePropelled, a leading U.S. manufacturer of advanced electric propulsion systems for uncrewed aerial vehicles, aerospace, defense, and commercial applications, today announced a major expansion of its manufacturing operations, increasing its production footprint from 20,000 square feet to 80,000 square feet. The expansion is supported by $60 million in government funding through the Department of War's Industrial Base Analysis and Sustainment program, reinforcing the nation's commitment to strengthening domestic manufacturing of mission-critical drone technologies and advanced dual-use propulsion systems. The expanded facility will increase ePropelled's propulsion system production capacity by more than 4X, enabling the company to meet rapidly growing demand from U.S. government progra

ePropelled to Increase Manufacturing Footprint with $60 Million in U.S. Government Funding to Strengthen U.S. Drone Propulsion Supply Chain11.8.2026 13:00:00 CEST | Press release

Expansion Increases Manufacturing Capacity by 4X and Positions ePropelled as a Leading Domestic Supplier of Advanced Dual-Use Electric Propulsion Systems COVENTRY, UK / ACCESS Newswire / August 11, 2026 / ePropelled, a leading U.S. manufacturer of advanced electric propulsion systems for uncrewed aerial vehicles, aerospace, defense, and commercial applications, today announced a major expansion of its manufacturing operations, increasing its production footprint from 20,000 square feet to 80,000 square feet. The expansion is supported by $60 million in government funding through the Department of War's Industrial Base Analysis and Sustainment program, reinforcing the nation's commitment to strengthening domestic manufacturing of mission-critical drone technologies and advanced dual-use propulsion systems. The expanded facility will increase ePropelled's propulsion system production capacity by more than 4X, enabling the company to meet rapidly growing demand from U.S. government progra

AI/ML Innovations' Subsidiary NeuralCloud Achieves ISO 13485:2016 (MDSAP) Certification11.8.2026 13:00:00 CEST | Press release

Quality Management System Certification Strengthens NeuralCloud's Regulatory Readiness for ECG Software-as-a-Medical-Device Platform TORONTO, ON / ACCESS Newswire / August 11, 2026 / AI/ML Innovations Inc. ("AIML" or the "Company") (CSE:AIML)(OTCQB:AIMLF)(FWB:42FB), a company advancing artificial intelligence and neural-network-based technologies for digital health, is pleased to announce that its wholly owned subsidiary, NeuralCloud Solutions Inc. ("NeuralCloud"), has achieved ISO 13485:2016 certification under the Medical Device Single Audit Program ("MDSAP") for its quality management system. The certification, issued by TÜV USA, Inc., applies to NeuralCloud's quality management system for the design, development, production, and distribution of Software as a Medical Device ("SaMD") for ECG analysis, including advanced PQRST waveform delineation, interval computation, arrhythmia analytics, signal quality scoring, and artifact reporting. ISO 13485 is the internationally recognized qu

RollerAds Launches a Full-Cycle Ad Platform with Traffic, Offers, and Monetization in One Workspace11.8.2026 11:30:00 CEST | Press release

The updated platform unifies campaign management, CPA offers, and website monetization within a single dashboard to help users manage affiliate marketing activities more efficiently from one place. LIMASSOL, CY / ACCESS Newswire / August 11, 2026 / RollerAds announced the official launch of its new full-cycle advertising platform, designed to simplify digital advertising workflows by bringing the entire process into a single workspace. The new platform is now live at my.rollerads.com following several months of open beta testing and product refinement based on user feedback. "Our goal was to make affiliate marketing management simpler and more efficient," said Pierre Bertin, Head of International Business Development at RollerAds. "With the new platform, users can work with campaigns, CPA offers, and monetization tools in one dashboard without switching between multiple accounts or services." One dashboard for the entire advertising workflow The new RollerAds platform allows users to m

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye