CASI Pharmaceuticals Report Positive Interim Phase 1 Data For BI-1206 In The Treatment Of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma In China

Rhea-AI Summary

CASI Pharmaceuticals and BioInvent International announce positive preliminary efficacy data for BI-1206 in combination with rituximab for patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma in China.

Insights

Oncology Doctor

The preliminary efficacy data for BI-1206 in combination with rituximab presents a significant advancement in the treatment of relapsed/refractory indolent Non-Hodgkin's Lymphoma. The clinical responses observed, including partial and complete remissions, suggest that this combination therapy could enhance the therapeutic landscape for patients who have limited options after standard treatments fail. The durable complete remission maintained for over 20 weeks in a patient with Marginal Zone Lymphoma is particularly noteworthy, as it indicates potential for long-term disease control.

Understanding the mechanism of action of BI-1206, which targets FcγRIIB, is crucial. FcγRIIB is an inhibitory receptor that can dampen the immune response against cancer cells. By blocking this receptor, BI-1206 may enhance the activity of rituximab, a monoclonal antibody that targets CD20 on B cells, including malignant lymphoma cells. This combination could potentially overcome resistance mechanisms, thereby improving patient outcomes. The manageable safety profile is also a critical aspect, as it suggests that patients could tolerate the treatment well, which is paramount in therapies for relapsed conditions.

Medical Research Analyst

The reported data from the Phase 1 dose-escalation study of BI-1206, while preliminary, is a strong indicator of the drug's potential efficacy. From an investment perspective, the development of first-in-class drugs like BI-1206 can significantly impact the market position of companies like CASI Pharmaceuticals and BioInvent. The ability to demonstrate strong and durable responses at lower dose levels is particularly attractive as it may suggest a favorable risk-benefit profile that could lead to a competitive advantage in the market.

For stakeholders, the short-term implications include increased investor confidence and potential stock market gains as the drug progresses through the clinical trial phases. Long-term implications could include the establishment of a new standard of care for R/R iNHL patients, provided subsequent trials confirm these preliminary results. However, it is important to note that the drug is still in the early stages of clinical development and further studies are required to fully ascertain its efficacy and safety profile.

Market Research Analyst

The oncology market is highly competitive, with numerous companies striving to develop novel treatments for various cancers. The preliminary results of BI-1206 can position CASI Pharmaceuticals and BioInvent as emerging leaders in the space of cancer immunotherapy. The market for Non-Hodgkin's Lymphoma treatments is expected to grow and successful therapies that offer durable responses are likely to capture significant market share.

It is essential for investors to monitor the progression of BI-1206 through clinical trials to better understand its market potential. The unique combination of BI-1206 with rituximab could address a significant unmet medical need in R/R iNHL, potentially leading to expedited regulatory review and approval processes. The partnership between CASI and BioInvent could also be strategic in terms of resource sharing and leveraging each other's strengths in the global market, particularly in China, which is a rapidly growing market for cancer therapies.

BEIJING and LUND, Sweden, March 5, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, and 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 announced preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin's Lymphoma (iNHL) in the ongoing development program in China.

BI-1206 is a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB. It is being evaluated in combination with rituximab in patients with R/R iNHL. The Phase 1 study is designed to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206, administered though intravenous (IV) infusion.

The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients.  The results are consistent with the clinical data that have been previously reported by BioInvent. Among the responders in the study being conducted in China, one patient with relapsed Marginal Zone Lymphoma (MZL) patient who achieved CR has maintained a durable complete remission for 20+ weeks. The preliminary results demonstrated a manageable safety profile across all patients.

Dr. Wei-Wu He, CEO of CASI, said "These initial BI-1206 data showed promising response for patients with difficult-to-treat disease. The data are especially notable as they demonstrated strong and durable responses at lower dose levels. We believe these results represent important steps toward validating BI-1206 as a potential treatment as well as de-risk our plan for future development."

Dr. He continued, "Further developing BI-1206 to help treat more patients with iNHL is an important goal we share with our partner BioInvent. The interim results further strengthen our confidence in progressing BI-1206 into the next stage of clinical development as a potential treatment option for patients with R/R iNHL."

Dr. Martin Welschof, CEO of BioInvent commented, "We are encouraged by the promising new interim Phase 1 data reported today by our partner, CASI. BI-1206 is being developed to re-establish the clinical efficacy of cancer therapies such as rituximab by addressing fundamental resistance mechanisms to cancer treatments. The clinical efficacy results reported today, including a long-lasting complete response, reinforce previously reported data. We continue to be enthusiastic about the development of BI-1206 in NHL and look forward to reporting data from additional studies in the first half of 2024."  

About BI-1206 (Anti-FcyRIIB antibody)

The National Medical Products Administration (NMPA) granted the BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being evaluated in the US, the EU, Brazil and China in three Phase 1/2 trials. Two studies are evaluating BI-1206 in combination with rituximab for the treatment of indolent non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and MZL who have relapsed or are refractory to rituximab. The third Phase 1/2 trial is investigating BI-1206 in combination with the anti-PD1 therapy KEYTRUDA^® (pembrolizumab) in solid tumors. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BI-1206 for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma. BioInvent has licensed the rights for BI-1206 to CASI for China, Hong Kong, Macau, and Taiwan.

About CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at www.casipharmaceuticals.com.

About BioInvent International AB

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 five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. 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 immune-modulatory 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 the social media platform X: @BioInvent.

CASI Forward-Looking Statements:

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: the risk that we may be unable to continue as a going concern as a result of our inability to raise sufficient capital for our operational needs; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China, our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; risks relating to the commercialization, if any, of our proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; and risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

BioInvent disclaimer: 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 press release is published in Swedish and English. In the event of any difference between the English version and the Swedish original, the Swedish version shall prevail. For a more detailed description of risk factors, see section "Risks and Risk Management," page 47, in the Company's annual report 2022.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA.

COMPANY CONTACT:
Rui Zhang
CASI Pharmaceuticals, Inc.
240.864.2643
ir@casipharmaceuticals.com

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 

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 2024 03-05 at 13:00 CET.

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SOURCE CASI Pharmaceuticals

FAQ

What is the significance of the preliminary efficacy data announced by CASI Pharmaceuticals and BioInvent International?

The preliminary efficacy data for BI-1206 in combination with rituximab showed 4 partial responses and 1 complete response out of 8 evaluable patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma in China.

What is BI-1206 and how is it being evaluated in patients?

BI-1206 is a first-in-class fully human monoclonal antibody targeting FcγRIIB. It is being evaluated in combination with rituximab in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma.

What did Dr. Wei-Wu He, CEO of CASI, say about the initial data for BI-1206?

Dr. Wei-Wu He mentioned that the initial data for BI-1206 showed promising responses for patients with difficult-to-treat diseases, demonstrating strong and durable responses at lower dose levels.

What are the future plans for BI-1206 development according to Dr. He?

Dr. Wei-Wu He stated that further developing BI-1206 to help treat more patients with indolent Non-Hodgkin's Lymphoma is an important goal shared with partner BioInvent, with plans to progress BI-1206 into the next stage of clinical development.

How did Dr. Martin Welschof, CEO of BioInvent, respond to the interim Phase 1 data?

Dr. Martin Welschof expressed encouragement over the promising new interim Phase 1 data reported by partner CASI, highlighting BI-1206's potential to re-establish the clinical efficacy of cancer therapies by addressing resistance mechanisms.