TaiMed Biologics : First Patient Enrolled in the Study Evaluating Bi-monthly and Quarterly Dosing of the Long-Acting TMB-365/TMB-380 mAb Combination Maintenance Therapy

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Provided by: TaiMed Biologics Inc.
SEQ_NO	1	Date of announcement	2022/07/29	Time of announcement	06:16:00
Subject	First Patient Enrolled in the Study Evaluating Bi-monthly and Quarterly Dosing of the Long-Acting TMB-365/TMB-380 mAb Combination Maintenance Therapy
Date of events	2022/07/28	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2022/07/28 2.Company name:TaiMed Biologics Inc. 3.Relationship to the Company (please enter "head office" or "subsidiaries"):Head Office 4.Reciprocal shareholding ratios:N/A 5.Cause of occurrence: (1)After the FDA approval of TaiMed's IND to evaluate TMB-365/TMB-380 combination therapy in HIV patients, TaiMed announced today that the first patient was successfully enrolled in the study. The objective of the study is to evaluate the safety, pharmacokinetics and antiviral activity in HIV patients with bi-monthly and quarterly dosing of the TMB-380/TMB-365 combination as maintenance therapy. The target patient group is the first and second line HIV patients who are already viral load suppressed. In the US, the majority of HIV patients fall in this category. Both TMB-380 and TMB-365 are long-acting monoclonal antibodies designed for the treatment of HIV patients. If the trial goes well, it is expected that the preliminary results of each dose of the Sentinel Groups will be available in the first half of 2023. (2)Summary for clinical Study design a.Title: A Phase 1b/2a Dose Escalation Study of the Safety, Pharmacokinetics,and Efficacy of the Combination of TMB-365 and TMB-380 in HIV-1 Infected Individuals Suppressed with Combination Antiretroviral Therapy b.Participants and Investigator Sites: A total of 90 participants from approximately 6-8 sites in North America c.Primary Objectives (a)Evaluate the safety and tolerability of various doses and dosing regimens of IV infusions of TMB-365 and TMB-380 given q8wks or q12wks in suppressed, cART treated HIV-1 infected participants. (b)Define the pharmacokinetic (PK) profile of TMB-365 and TMB-380 when given q8wks or q12wks in suppressed, cART treated HIV-1 infected participants (c)Evaluate the antiviral activity of TMB-365 in combination with TMB-380 as maintenance therapy in suppressed HIV-infected individuals d.Study Phase: 1b/2a e.Protocol Number: TMB-a21 f.Clinical Study Design: This is an adaptive dose-escalation study of various dosing regimens of TMB-365 and TMB-380 administered intravenously to HIV-1 infected individuals suppressed on combination antiretroviral therapy (cART). Each cohort of this adaptive study design will be comprised of Sentinel Groups (N=10) and Core Groups (N=20). Sentinel Groups: Sentinel Groups will be comprised of 10 cART suppressed HIV-1 infected volunteers who continue on current cART and receive single intravenous doses of 2400 mg, 3200 mg, 4800 mg of each antibody. Core Groups: Safety and PK results obtained in Sentinel Group participants will inform the conduct of Core Groups. Core Groups will be comprised of 20 cART suppressed HIV-1 infected volunteers who receive multiple IV doses of the combination of TMB-365 and TMB-380 q8wks or q12wks as a stand-alone maintenance regimen for 6 months. 6.Countermeasures:None 7.Any other matters that need to be specified: (1)New drug name or code: TMB-365 and MB-380 (2)Indication: mainly used to provide long-acting monoclonal antibody drugs for AIDS patients website：https://clinicaltrials.gov/ct2/show/study/NCT04027387?term= TMB-365&recrs=ab&cond=HIV+Infections&cntry=US&rank=1 (3)Planned development stages: Phase 1b to phase 3 clinical studies、Biologics License Application(BLA) (4)Current development stage: a.Application submission/approval/disapproval/each of clinical trials (include interim analysis):approval b.Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: None c.After obtaining official approval or the results of statistically significant sense, the future strategy: TMB-365 has been confirmed by clinical trials as an ultra-long-acting new drug, and its target market of first line maintenance therapy is completely different from and much greater than that of the company's first-generation product, Trogarzo, which is an orphan drug and targets multi-drug resistant patients. TMB-380(VRC07-523L), another long -acting monoclonal antibody, was licensed from US National Institutes of Health (NIH). In a separate phase 1 clinical trial, the NIH has successfully demonstratred the efficacy of TMB-380 in HIV patients who received bi-monthly I.V. infusion. The target population for the TMB-365/TMB-380 combination is the early stage (first-line maintenance therapy) HIV infected patients. This combination treatment with bi-monthly or quarterly dosing, if successfully developed, provides a full stand-alone regimen and offers patients greater convenience and better tolerability as well as ensures adherence. At present, the only option on the market for long-acting maintenance therapy is GSK's Cabenuva (containing two small molecule drugs), which requires bimonthly separate intramuscular injections of two drugs. d.Accumulated investment expenditure incurred: Because it involves future international cooperation negotiation information or product marketing strategies to protect the rights and interests of investors, it will not be disclosed for the time being. (5)Upcoming development plan: a.Estimated date of completion: It is expected to be completed in about two years. b.Estimated responsibilities: TMB-365 and TMB-380 will incur development milestone payments to Rockefeller University and NIH, respectively. A certain percentage of sales royalties will be paid according to the sales amount of the new drug in the future. No royalty details can be disclosed due to the confidentiality terms in contract. (6)Market situation: The global anti-HIV drug market is dominated by Europe and the United States with most of the markets controlled by the top five companies. Among them, the leading company Gilead's product line is all first-line treatment drugs, including two-in-one and three-in-one first-line drugs, with a market share of more than half. However, after years of using the anti-HIV drug, AIDS patients gradually developed resistance to the drugs and had to start receiving the second-line treatment drugs. Under the very different competitive market, the market share is carved up by manufacturers such as Merck, Bristol, ViiV, Johnson & Johnson, etc. It is estimated that,driven by new drugs, the global sales of anti-HIV drugs will grow to more than US$30 billion in 2022. In order to overcome the problem of virus resistance, in 1996, Dr. David Ho developed a three-drug combination therapy (HAART), commonly known as cocktail therapy. The basic principle is to use multiple drugs at the same time. When the virus mutation becomes resistant to one of the drugs, the other drugs can also suppress the virus replication and mutation, making the mutation unsuccessful. Due to the emergence of cocktail therapy, the mortality rate of HIV/AIDS virus infections and the morbidity rate of various opportunistic infections have dropped significantly, making AIDS a chronic disease that requires long-term medication to suppress the virus but cannot be cured. The HIV/AIDS market can be roughly divided into four lines based on treatment methods. When the patients have no response to the initial therapy and begin to develop drug resistance, they should enter the second-line therapy and uses a new HIV drug combination. When the patients develop resistance to second-line therapy, the third-line therapy should be applied. If the treatment fails, the final salvage therapy (i.e. fourth-line therapy) will be performed. At present, the target range of the future application of TMB-365 and 380 combination of the Company is not the first-line patients who received the initial drug, but the first-line patients have already controlled their viral load, and intends to use long-acting drugs to stably maintain the disease, no longer daily take medicine. The first-line maintenance therapy will have a market size of US$10 billion. The TMB-365 is an ibalizumab (TMB-355) based, IgG1-scaffold, anti-CD4 recombinant humanized monoclonal antibody used against HIV infections. The major medication or medicament of TMB-365 is mainly focused upon treatment and prevention against HIV infections (including opportunistic infections), said therapeutic and prophylactic usages or medical application. The TMB-365-relevant technology platforms of TMB-365 are licensed from Arron Diamond AIDS Research Center (ADARC). The paper on the development of TMB-365 technology was published in the world-renowned journal Nature Biotechnology, Clinical trials have shown that TMB-365 has a significant improvement in drug resistance, efficacy and pharmacokinetic data compared to TMB-355. TMB-380 (VRC07-523LS) is the new generation of highly potent and broadly neutralizing HIV-1 antibody. The potent neutralizing activity, breadth, and extended half-life of TMB-380 make this antibody a leading candidate for inclusion in HIV-1 prevention and therapeutic strategies. TaiMed has a non-exclusive licensing agreement of TMB-380 from the National Institute Allergy and Infectious Diseases (NIAID) to develop combination of TMB-380 and TaiMed own monoclonal HIV antibodies for treatment use. (7)New drug development requires long process and large investment with no guarantee in success, which therefore may pose substantial investment risks. Investors are advised to exercise caution and conduct thorough evaluation.