TNFR2

LOS ANGELES, March 04, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today presented the poster “Suppressing Asymptomatic CMV with Letermovir Reshapes Cardiometabolic Proteome in Treated HIV” at the Conference on Retroviruses and Opportunistic Infections (CROI 2024), in Denver, Colorado. Today’s presentation from study A5383 is the first to demonstrate that a specific inhibitor of cytomegalovirus (CMV) is safe and broadly impacts immunologic and cardiometabolic biomarkers in people living with HIV, which may explain the association between CMV and aging-related HIV co-morbidities. CMV is a chronic and usually asymptomatic virus carried by 60 percent of adults in the general population and more than 95 percent of people living with HIV. Prior to the availability of effective antiretroviral therapy (ART) for HIV, CMV caused life-threatening infections in the eyes, brain, and gut in people with compromised immune systems due to advanced HIV. While the immune system recovery resulting from ART has rendered this type of CMV organ disease rare, CMV can still affect immune responses, including inflammation, even when it is not causing obvious symptoms. “Investigators have found associations between CMV and heart disease, cancer, and other aging-related complications among people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “Until now, however, we were unable to prove that CMV is associated with these diseases. A5383 was successful at clarifying some of the underlying mechanisms, bringing us one step closer to developing approaches to support healthy aging over the lifespan in people living with HIV.” A5383 is a phase 2, randomized, open-label, multicenter trial assessing the impact of treating people living with HIV who are virally suppressed on ART and are CMV seropositive without detectable virus in blood plasma (which means that they test positive for exposure to CMV but do not have symptoms) with letermovir, a CMV terminase inhibitor. Letermovir is CMV-specific and has no direct antiviral activity against other herpesviruses, enabling researchers to isolate the effect of CMV on the immune system. Participants in A5383 were randomized to either receive letermovir daily or no treatment for 48 weeks. A planned futility analysis (conducted to assess whether there is a low probability of the trial achieving its primary objective).after the first 39 participants completed eight weeks of therapy (N=18) or no treatment (N=21) found that instead of decreasing, the primary inflammatory endpoint (soluble tumor necrosis factor receptor 2, or sTNFR2) increased unexpectedly in the letermovir arm and the study was stopped early. To explain these findings, the team hypothesized that CMV may suppress pathways of inflammation through its immunoregulatory viral IL-10 protein, which led them to conduct a series of follow-up investigations to characterize the effects of letermovir on various inflammatory and cardiometabolic pathways in the blood. As expected, letermovir decreased IL-10 receptor signaling, which may explain the unexpected increase in sTNFR2 (essentially it took the “foot off the brakes” of the TNF pathway). Researchers found that letermovir reduced many important inflammatory pathways, including IL-1b and IL-6 receptors, which have both been causally linked to heart disease and cancer in other studies. Letermovir also improved several markers associated with atherosclerosis and endothelial dysfunction, suggesting a potential cardiovascular benefit. Metabolic pathways associated with insulin resistance also appeared to improve with letermovir. In addition, of five plasma biomarkers that were previously causally linked to heart disease in people living with HIV, three were suppressed significantly by letermovir. “While it is too soon to say whether letermovir or another anti-CMV therapy will reduce the actual risk of heart attacks, cancer, and diabetes in people living with HIV, these are exciting new data that support this therapeutic concept, which we look forward to testing in future studies,” said Protocol Chair Peter Hunt, M.D., University of California at San Francisco. “It is particularly important because we don’t yet have any treatments that are able to reduce all of these aging-related diseases in people living with HIV.” A5383 is led by Dr. Hunt and Sara Gianella, M.D., University of California San Diego (Co-Chair). ACTG is led by Dr. Currier and Joseph J. Eron, M.D., University of North Carolina (ACTG Vice-Chair). It is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Study drugs are supplied by Merck & Co., Inc., Rahway, N.J., USA. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact: Rachel Reiss, ACTG RLReiss@mednet.ucla.edu

LUND, SWEDEN / ACCESSWIRE / February 22, 2024 / BioInvent International (STO:BINV) "2023 was a landmark year for BioInvent with positive clinical readouts from three Phase 1/2 programs. These data, supported by validating partnerships, a strong cash position and solid investor base, set BioInvent up to have a breakout year in 2024, fueled by expectations for substantial clinical progress across our pipeline." - Martin Welschof, CEO of BioInvent. Events in the fourth quarter Positive data from clinical Phase 1/2a trial of BI-1808 as single agent were presented at SITC Preclinical data providing clear evidence of the potential of anti-TNFR2 antibody BI-1910 were presented at SITC Positive first clinical data on anti-FcyRIIB antibody BI-1607 presented at the San Antonio Breast Cancer Symposium First patient enrolled in Phase 1/2a clinical trial with TNFR2 antibody BI-1910 BioInvent and Transgene announced that the first patient had been treated in Part B of Phase 1 trial assessing the novel oncolytic virus BT-001 in combination with KEYTRUDA® (pembrolizumab) Events after the end of the period Supply agreement signed with AstraZeneca to evaluate BI-1206 in combination with rituximab and Calquence BioInvent regained the rights to immuno-oncology targets from Exelixis Earlier during 2023, in brief (R) BioInvent selected to The Leukemia & Lymphoma Society's Therapy Acceleration Program and received USD 3 million strategic equity investment (R) A fourth complete response announced in Phase 1/2 trial with BI-1206 in non-Hodgkin's lymphoma Management strengthened with the appointment of Ingunn Munch Lindvig as Senior Vice President Regulatory Affairs (R) BioInvent and Transgene reported positive Phase 1a data on oncolytic virus BT-001 in solid tumors (R) Additional efficacy data announced from intravenous part of Phase 1/2 trial with BI-1206 in solid tumors (R) Strong interim safety data and early signs of efficacy reported in Phase 1/2a trial with anti-TNFR2 antibody BI-1808 in advanced malignancies Research milestone event achieved in the collaboration with Exelixis, triggering a USD 1 million milestone payment (R)= Regulatory event Financial information Fourth quarter 2023 Net sales SEK 15.3 (20.6) million. Profit/loss after tax SEK -97.2 (-78.3) million. Profit/loss after tax per share before and after dilution SEK -1.48 (-1.21). Cash flow from operating activities SEK -72.4 (-71.7) million. January - December 2023 Net sales SEK 71.5 (326.1) million. Profit/loss after tax SEK -330.3 (-42.5) million. Profit/loss after tax per share before and after dilution SEK -5.02 (-0.69). Cash flow from operating activities SEK -341.7 (-41.2) million. Liquid funds, current and long-term investments as of December 31, 2023: SEK 1,283.0 (1,593.6) million. Note to reader. Figures in parentheses refer to the outcome for the corresponding period in the preceding year. Read the complete report in the attached pdf. INVITATION TO PRESENTATION OF YEAR-END REPORT 2023 BioInvent's CEO Martin Welschof will present the report together with CFO Stefan Ericsson. The presentation will be held in English. When: Thursday February 22, 2024, at 2:00 pm CET Listen to the presentation webcast: To participate via teleconference, please register via the following link: . Upon registration, a phone number and conference ID for the conference call will be provided. You can ask questions verbally via the telephone conference. The conference call will be made available on the company website after the call. 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 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 . Follow on the social media platform X: @BioInvent. 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 Attachments BioInvent Q4, 2023 EN (21 Februari) SOURCE: BioInvent International View the original press release on accesswire.com

Data from seven different clinical studies expected throughout the year, including combination data for the two lead programs BI-1808 and BI-1206 in H1/mid-2024 Well-financed with 1358 SEK million (~USD 132M), as of September 30, 2023 LUND, SE / ACCESSWIRE / January 4, 2024 / 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 highlighted the Company's strategic priorities and anticipated milestones for 2024. The company expects multiple data readouts from different clinical studies during the year, including Phase 1 combination data from lead programs BI-1808 and BI-1206 in H1/mid-2024. Additionally, data from five other clinical studies are expected from programs BI-1206 in NHL, single agent BI-1808, BI-1607, BT-001 and BI-1910. The company is well financed with SEK 1358 million which supports current development plans. "Going into 2024, we are eager to build on the momentum from a very successful 2023, where we made excellent progress with our six clinical programs. In particular, positive clinical data readouts from three of our programs (BI-1206, BI-1808 and BT-001) provided important validation of our proprietary F.I.R.S.T™ antibody generation platform and we look forward to continuing the development of these programs during 2024 and beyond. Likewise, the encouraging early clinical data from our BI-1607 program, which we believe could be used to increase response rates when used in combination with other antibody therapies, illustrated the ability of our state-of-the art platform to generate important novel antibody candidates. We were also very pleased to further bolster our clinical pipeline by announcing in December the first patient had been enrolled in our Phase 1/2a trial with BI-1910," said Dr. Martin Welschof, CEO of BioInvent. "We expect an equally busy 2024, with multiple value-inflection points including data sets for target engagement and initial Phase 2 clinical proof-of-concept results from our growing portfolio of novel, first/best-in-class immune-modulatory antibodies. We are well-funded with 1358 SEK million (~$120 million USD) in cash and combined with the expertise and hard work of our team I am looking forward to another productive year at BioInvent." UPDATE & MILESTONES FOR LEAD PIPELINE PROGRAMS BI-1808 AND BI-1206 BI-1808: an anti-TNFR2 antibody targeting regulatory T cells (Treg) in solid tumors and lymphoma The anti-TNFR2 antibody BI-1808 is a first-in-class drug candidate. TNFR2 has been shown to be important for tumor expansion and survival, representing a new and promising target for cancer immunotherapy. BI-1808 is being developed under the Leukemia & Lymphoma Society's Therapy Acceleration Program® (LLS TAP) aimed at supporting and accelerating the advancement of the most promising and innovative blood cancer therapeutics worldwide. BI-1808 is currently evaluated as a single agent in Phase 2 and in combination with pembrolizumab in Phase 1. Positive interim results from the Phase 1 part presented at SITC in November 2023 showcased early signs of efficacy together with a strong safety profile. BI-1808 administered as single agent induced a robust partial response (PR) in a patient with a gastrointestinal tumor (GIST) who had received 12 previous lines of treatment. This patient is still receiving BI-1808 treatment, and a recent scan showed a 59% reduced tumor burden. Another patient, with lung cancer, experienced a 20% reduction in the tumor size but had to be taken off study due to an unrelated reason. There are a further 7 cases of stable disease out of 21 evaluable patients and pharmacokinetic/ pharmacodynamic data has enabled identification of a wide dose range where complete target coverage can be achieved with a remarkable safety profile. The efficacy of BI-1808 as single agent is further explored in an ongoing Phase 2a trial in a larger sample of patients. In addition to the originally planned expansion cohorts in lung cancer, ovarian cancer, and cutaneous T cell lymphoma (CTCL), BioInvent plans to enlarge the scope of the signal seeking cohorts to include new cohorts in melanoma and other forms of T cell lymphomas. This is driven by the exciting data observed so far. Next milestones: Mid-2024: Initial data from Phase 1 part of the combination study of BI-1808 and pembrolizumab. YE 2024: Initial data from Phase 2a BI-1808 single-agent trial. BI-1206 - an anti-FcyRIIB antibody for the treatment of NHL and solid tumors BI-1206 is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab, drugs with combined global sales of approximately USD 23 billion annually. The product is being evaluated in two separate clinical trials, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. Two delivery formulations intravenous (IV) and (subcutaneous (SC) of BI-1206 are being evaluated. An SC administration would provide an improvement in terms of convenience and flexibility to both patients and healthcare professionals. BI-1206 in NHL: All patients in the ongoing Phase 1/2a study have previously been treated with one or more rituximab containing treatments. In the intravenous (IV) Phase 1 part, responses have been observed across the dose range of 30-100 mg, including 4 complete responders (CR), 3 partial responders (PR) and 4 cases of stable disease (SD) out of 15 evaluable patients. Among the CR population, responses have been long-lasting, three of them lasting years after end of treatment, while the 4th is still on treatment. As of June 2023, the median duration of complete response was 2.5 years, with three patients still ongoing. No maximum tolerated dose has been defined, and Phase 2a dose IV expansion cohort is currently enrolling patients. BI-1206 in solid tumors: As reported in June 2023, the Phase 1 IV arm of the study has already generated early signs of efficacy, e.g., two long-lasting partial responses and two patients displaying stable disease, out of a total of 18 evaluable patients having received BI-1206 in combination with pembrolizumab. Both responding patients have melanoma, and both had previously been treated with immune checkpoint inhibitors. In September 2023, the first patient was recruited to the subcutaneous (SC) arm of the Phase 1/2a study. Next milestones: H1 2024: Data from the Phase 1 dose escalation segment evaluating BI-1206 SC dosing in combination with rituximab in NHL. Further data from the Phase 1 dose escalation of BI-1206 IV in combination with pembrolizumab for the treatment of solid tumors. YE 2024: Initial Phase 2 data for BI-1206 in NHL. Participation in the 13th Annual LifeSci Partners Corporate Access Event Martin Welschof and part of the BioInvent Management Team will be in San Francisco during JPM week. The Company will be meeting with institutional investors on January 9th and 10th at the LifeSci Partners Corporate Access Event. Registration can be accessed through this link. 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 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 . Follow on the social media platform X: @BioInvent. 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 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. For a more detailed description of risk factors, see section "Risks and Risk Management," page 47, in the Company's annual report 2022. Attachments BioInvent announces 2024 strategic priorities and anticipated milestones SOURCE: BioInvent International View the original press release on accesswire.com