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

GoodData.AI Launches the Agentic Serving Plane, a New Category of Enterprise Data Infrastructure for AI Agents10.11.2026 15:30:00 CET | Press release

SAN FRANCISCO, CA / ACCESS Newswire / November 10, 2026 / GoodData.AI, the open agentic analytics platform, today launched the Agentic Serving Plane, a governed execution layer designed for the high-concurrency, context-rich data workloads created by AI agents. The Agentic Serving Plane sits between enterprise data platforms and the applications, analytics experiences and agents that consume them. It provides workload serving, business semantics, contextual grounding, access control, and AI execution services through a common governed layer. The current enterprise data infrastructure was designed primarily for humans: occasional queries, predictable workloads, and access by known users. AI agents operate differently. A single business task can generate tens or hundreds of short-lived data operations as an agent investigates, reasons, and decides what to ask next. When many agents operate simultaneously, intermittent human querying becomes continuous, high-concurrency agentic demand. Ag

Envision Pharma Group appoints Leigh Anne Siino as Senior Vice President of Commercial, Two Labs and Riparian10.11.2026 15:00:00 CET | Press release

FAIRFIELD, CT / ACCESS Newswire / November 10, 2026 / Envision Pharma Group (Envision), a global, technology-enabled solutions partner to the life sciences industry, has appointed Leigh Anne Siino as Senior Vice President of Commercial, Two Labs and Riparian. Siino will lead a team providing best-in-class launch and revenue management services to the biopharma community. Pharma and biotech companies across the industry seek suppliers who can support them from their earliest stages, often before they have built in-house commercial, market access, and revenue management capabilities. Two Labs provides commercialization services and consulting support as these companies prepare for and execute successful launches; Riparian offers consulting, managed services, and technology to manage and protect revenue as their therapies reach patients. Together, Envision's Two Labs and Riparian businesses offer a single, connected solution spanning launch and beyond. Under Siino's leadership, clients wi

Securitas Healthcare Introduces a New Era of RTLS Built for the Future of Healthcare Operations10.11.2026 14:00:00 CET | Press release

LINCOLN, NE / ACCESS Newswire / November 10, 2026 / Securitas Healthcare, a leading provider of real-time visibility and protection solutions for the healthcare industry, today announced the next generation of its MobileView® Real-Time Location System (RTLS) platform. The expanded platform introduces MobileView Cloud, new solution capabilities, enhanced user experiences, and flexible deployment, technology, and integration options that help healthcare organizations transform real-time visibility into operational intelligence. As health systems navigate workforce shortages, capacity constraints, and growing demands for efficiency and better patient experiences, timely access to operational and clinical information has become essential to managing increasingly complex care environments. Today's RTLS platforms provide the visibility and intelligence needed to improve patient throughput, enhance safety, optimize resource utilization, and support the connected operations required to enable

Opti Digital Launches NEXA, an AI-Powered Intelligence Layer9.11.2026 12:00:00 CET | Press release

PARIS, FR / ACCESS Newswire / November 9, 2026 / Opti Digital, the leading AdTech company specialising in publisher revenue optimisation, today announced the launch of NEXA, its AI-powered intelligence layer designed to connect signals across the Opti Digital platform and help publisher teams make faster, better-informed decisions. Publisher teams work with revenue data, bidder signals, inventory changes, traffic shifts, alerts and dashboards as part of their daily operations. The opportunity lies in connecting these signals quickly enough to understand what changed, what is driving performance, what deserves attention and where teams should focus next. By streamlining how teams investigate performance changes, NEXA is designed to help them move faster from a signal to an informed decision. NEXA's first client-facing capability, NEXA AI Assistant, brings conversational analysis into publisher monetisation workflows. Connecting the Dots in Monetisation Through NEXA AI Assistant, users c

Valsoft's TAG Software Group Enters the Content Operations Market with the Acquisition of Chalco6.11.2026 16:25:00 CET | Press release

MONTRÉAL, QC / ACCESS Newswire / November 6, 2026 / Valsoft Corporation Inc. ("Valsoft"), a Canadian company specializing in the acquisition and long-term development of vertical market software businesses, today announced the acquisition of 100% of Chalco, a software platform for managing the full lifecycle of product content and information, from Hyphen-Group. The deal marks Valsoft's entry into the content operations market, a fast-growing space that is increasingly critical to organizational growth in the age of AI, and brings the number of industries in which Valsoft operates to more than 20. The acquisition was completed by TAG Software Group through Chalco Technologies Srl ("Chalco Technologies"), a newly formed company wholly owned by Valsoft. Chalco was developed within Hyphen-Group, an Italian company active in the content operations market for more than 25 years, with offices in Affi (Verona), Milan, and Lugano, Switzerland, and a client base that includes some of the world'

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