CD32B

Immunology continues to be one of the most active areas for drug research as the field aims to bring patients new ways to eliminate the antibodies driving autoimmune disease, but in a manner that does not also compromise the immune system. Merida Biosciences, a startup formed by venture capital firm Third Rock Ventures, emerged from stealth Tuesday, revealing $121 million in financing and a lead program for a common autoimmune condition that has not had a new approved therapy in decades. The lead disease target of Cambridge, Massachusetts-based Merida is Graves’ disease, which develops as antibodies produced by the immune system attack the thyroid gland, a butterfly-shaped gland located at the front of the neck. Thyroid hormone regulates functions such as metabolism and growth. In Graves’ disease, the attack on the gland results in excess thyroid hormone production that speeds up the heart rate and weakens bones among other problems. Standard Graves’ treatment includes radioactive iodine therapy to shrink the gland, anti-thyroid medications, or beta blockers that block the effect of thyroid hormone on the body. Each of these treatments introduces complication risks elsewhere in the body. Surgical removal of the thyroid gland is another treatment option, but patients need lifelong hormone replacement therapy afterward. presented by Sponsored Post What Are the Best Medical Coding Outsourcing Companies? Outsourcing your medical coding can help ensure a healthy revenue cycle. Discover the best medical coding outsourcing companies and find the right one for you. By Global Healthcare Resources Merida is developing drugs designed to selectively bind to Fc receptors, receptors on immune cells that regulate immune responses. The company says its protein engineering platform generates unique Fc therapeutics that selectively bind to their antibody targets. The drugs then lead to the elimination of these antibodies by leveraging built-in mechanisms for clearing antibody complexes, which are molecular structures formed when an antibody binds to its specific target antigen. The company says its drugs are designed to eliminate only pathogenic antibodies, sparing healthy components of the immune system. In Graves’ disease, this approach is intended to spare healthy thyroid signaling. The Merida drugs are biotherapeutics that the startup describes as “antibody-like” in the way they move through the body. For example, these drugs could provide longer-lasting effects that enable less frequent dosing compared to some other therapies. The Graves program is currently undergoing the preclinical research that could support an investigational new drug application. Other disclosed Merida programs are in preclinical development for primary membranous nephropathy, which is a chronic inflammatory kidney disease, and food allergies mediated by immunoglobulin E antibodies. “At the heart of Merida is understanding the mechanisms behind antibody-driven diseases like Graves’ at the molecular level, and leveraging these insights to develop precision therapeutics that have thus far evaded the field,” Merida co-founder and Chief Scientific Officer Dario Gutierrez said in a prepared statement. “Our highly differentiated approach has the potential to yield best-in-class treatments by going after the root causes of these devastating diseases.” Merida’s launch comes as other immunology-focused biotech companies, including startups, make headway with their own selective Fc-receptor targeting drugs. Roivant Sciences subsidiary Immunovant is pursuing various immunological indications with IMVT-1402 and batoclimab. Both drug candidates are monoclonal antibodies. The clinical program for IMVT-1402 includes a Phase 2/3 study underway in Graves’. Batoclimab is currently in Phase 2 testing in Graves’. Last September, Immunovant reported preliminary data showing batoclimab achieved a strong response and a lowering of levels of antibodies associated with the disease. The study is expected to post additional data this summer. Sponsored Post Changes in Nurse Staffing Answer Clinician Demands The ongoing nursing shortage facilitates high turnover rates since nurses know they won’t have difficulties finding new jobs. In order to retain and attract staff, it’s in a facility’s best interest to understand what nurses want. By Tomasz Rezik Zenas Biopharma is developing bifunctional antibodies for immunology and inflammation indications. Lead program obexelimab is designed to bind to CD19 and Fc gamma receptor IIb, both of them targets expressed on B cells. A Phase 3 test is underway in immunoglobulin G4-related disease, supported by a $225 million IPO last September. Meanwhile, startup Nuvig Therapeutics is developing proteins engineered to target Fc receptors. Late last year, the Nuvig raised $161 million to support mid-stage clinical development of its lead program, a potential treatment for the rare autoimmune condition chronic inflammatory demyelinating polyneuropathy. Merida received seed financing from Third Rock in 2022, when Gutierrez was an entrepreneur in residence at the firm. The Series A financing announced Tuesday was co-led by Bain Capital Life Sciences, BVF Partners, and Third Rock. The other investors in the new round are GV and Perceptive Xontogeny Venture Funds. The startup is led by CEO Adam Townsend, who was most recently chief operating officer at Apellis Pharmaceuticals, a company that develops drugs that address the complement system, a part of the immune system. Illustration: Sebastian Kaulitzki/Science Photo Library, via Getty Images

LUND, SWEDEN / ACCESSWIRE / January 8, 2025 / BioInvent International (STO:BINV)The first two patients enrolled in the Phase 2a study triplet arm combining BI-1206 with rituximab and Calquence® responded to treatmentOne complete response (CR) and one partial response (PR)The treatment has been well-tolerated with no safety or tolerability concernsStudy now expanding to additional clinical investigational sites and patient enrollment on track with further Phase 2a results expected by mid-2025BioInvent 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 promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca\'s Bruton\'s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin\'s lymphoma (NHL).The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025.The triplet arm in the Phase 2a study is combining the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm.\"It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses\". said Martin Welschof, Chief Executive Officer of BioInvent . \"The treatment is so far well-tolerated and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.\"In addition, the Phase 1/2a study of BI-1206 in combination with MSD\'s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress. The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study.The complete response (CR) in solid tumors previously reported in May 2024 at this year\'s ASCO Annual Meeting for a patient with metastatic melanoma is nearing the two-year milestone, with the response maintained.\"With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin\'s lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients,\" said Martin Welschof, Chief Executive Officer of BioInvent. \"We look forward to further data from both studies next year and continue to believe that BI-1206 can play an important part in future treatment options for patients with different types of cancers.\"Calquence® is a registered trademark of the AstraZeneca group of companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.About BI-1206BI-1206 is one of BioInvent\'s lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin\'s lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors.BI-1206 in NHLAll patients in the ongoing Phase 1/2a study (NCT03571568) have previously been treated with one or more rituximab containing treatments. Latest results for the combination of BI-1206 and rituximab were presented in connection with EHA (European Hematology Association) congress in June 2024: the intravenous (IV) Phase 1 part (dose escalation) showcased responses across the dose range of 30-100 mg, including 5 patients with complete response (CR), 1 with partial response (PR) and 6 patients with stable disease (SD) out of 17 evaluable patients. Data from the subcutaneous (SC) Phase 1 part (dose escalation) with BI-1206 + rituximab has showed 2 CR, 3 PR and 3 SD out of 9 evaluable patients.In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the triple combination arm of BI-1206 + rituximab + Calquence®.BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing. In May 2024, the company announced promising Phase 1 data for BI-1206 in combination with MSD\'s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. Out of 28 evaluable patients (as of Oct 14th, 2024), the results included one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) as best response, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained a stable disease throughout the two-year study duration. The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression.About BioInventBioInvent 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 us on the social media platform X: @BioInvent.For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: [email protected]BioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.comThe 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 2025-01-08 08:00 CET.AttachmentsBioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin\'s lymphomaSOURCE: BioInvent InternationalRelated Documents:

The first two patients enrolled in the Phase 2a study triplet arm combining BI-1206 with rituximab and Calquence® responded to treatment One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Study now expanding to additional clinical investigational sites and patient enrollment on track with further Phase 2a results expected by mid-2025 One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Lund, Sweden – January 8, 2025 – 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 promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin's lymphoma (NHL). The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025. The triplet arm in the Phase 2a study is combining the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. "It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses”. said Martin Welschof, Chief Executive Officer of BioInvent. “The treatment is so far well-tolerated and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.” In addition, the Phase 1/2a study of BI-1206 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress. The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study. The complete response (CR) in solid tumors previously reported in May 2024 at this year's ASCO Annual Meeting for a patient with metastatic melanoma is nearing the two-year milestone, with the response maintained. "With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin's lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients," said Martin Welschof, Chief Executive Officer of BioInvent. "We look forward to further data from both studies next year and continue to believe that BI-1206 can play an important part in future treatment options for patients with different types of cancers." Calquence® is a registered trademark of the AstraZeneca group of companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. BI-1206 in NHLAll patients in the ongoing Phase 1/2a study (NCT03571568) have previously been treated with one or more rituximab containing treatments. Latest results for the combination of BI-1206 and rituximab were presented in connection with EHA (European Hematology Association) congress in June 2024: the intravenous (IV) Phase 1 part (dose escalation) showcased responses across the dose range of 30-100 mg, including 5 patients with complete response (CR), 1 with partial response (PR) and 6 patients with stable disease (SD) out of 17 evaluable patients. Data from the subcutaneous (SC) Phase 1 part (dose escalation) with BI-1206 + rituximab has showed 2 CR, 3 PR and 3 SD out of 9 evaluable patients. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the triple combination arm of BI-1206 + rituximab + Calquence®. BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing. In May 2024, the company announced promising Phase 1 data for BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. Out of 28 evaluable patients (as of Oct 14th, 2024), the results included one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) as best response, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained a stable disease throughout the two-year study duration. The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. About BioInventBioInvent 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 us on the social media platform X: @BioInvent. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.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.