ETB

WUXI, China, Feb. 25, 2024 /PRNewswire/ -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor selective antagonist SC0062, currently under development for chronic kidney disease (CKD), including IgAN and diabetic kidney disease (DKD). The enrollment of DKD cohort is ongoing with expected completion by the end of Q2 2024. "We appreciate the dedication of our colleagues and collaborators. The IgAN cohort enrollment was initiated in June 2023, and we enrolled all 120 subjects in less than 9 months. Thanks to the investigators, their teams, patients, and related BioCity colleagues", Dr. Ivy Wang, co-founder and executive vice president of BioCity, stated. This accomplishment highlights BioCity's ability to coordinate resources and operate efficiently in clinical trials, and further solidifies its leading position in the field of CKD. Dr. Wang emphasized that this achievement aligns well with the company's strategic objectives and establishes a solid foundation for further corporate development. Dr. Yong jiang Hei, CEO of BioCity, noted the clear trend of drug development focus on chronic diseases globally, with CKD gaining significant attention. The early entry in this field by BioCity reflects its thoughtful vision. There are approximately 700 million potential CKD patients worldwide with 82 million in China. The vast CKD market is growing rapidly, and the unmet medical needs are significant. Proteinuria is a key prognostic indicator of disease progression in CKD and can serve as an end point to evaluate the effectiveness of interventions intended to treat CKD. Of note, the US FDA granted accelerated approval of the first treatment for IgAN using proteinuria as a surrogate clinical endpoint. "CKD (including DKD and IgAN) with proteinuria is the primary indication under development for SC0062 which has demonstrated significant safety advantages in preclinical and Phase 1 studies. Leveraging our efficient clinical operation capabilities, we plan to accelerate the phase 2 study and initiate Phase 3 trials in 2024. Our goal is to bring this innovative medicine to patients and improve their quality of life at the earliest possible time." Dr. Hei says. About SC0062 SC0062 is one of the most unique ETA receptor small molecule antagonists globally to enter clinical development for CKD, which designed with high selectivity for ETA receptors with the objective of ensuring efficacy while avoiding the potential safety risks associated with other molecules in the same class. Preclinical studies have shown that SC0062 improved pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event presumable associated with ETB blockade, was not observed in the phase 1 trial in healthy volunteers. SC0062 is potentially a best-in-class ETA receptor-selective antagonist. About the Phase 2 Clinical Study of SC0062 (CTR20230689) The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The trial is led by professor Jianghua Chen, director of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University School of Medicine and former Chairman of the Chinese Medical Association Nephrology Branch. The study is being conducted simultaneously at over 40 study sites nationwide. Currently, the IgAN cohort enrollment is completed, and the DKD cohort continues to enroll patients. About BioCity Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases (CKD). The company has established a pipeline of more than 10 innovative drug candidates including small molecules, monoclonal and bispecific antibodies as well as antibody-drug conjugates (ADCs). Currently, BioCity Biopharma has 6 oncology assets in Phase 1 development, including the first-in-class CDH3-targeting ADC, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and agents targeting the immune system including a T cell engager (CD3/EGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 clinical development. For more information, please visit . Contact: [email protected] [email protected] SOURCE BioCity Biopharma

AUSTIN, Texas, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Molecular Templates, Inc., (Nasdaq: MTEM, “Molecular Templates,” or “MTEM”), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology with potent differentiated mechanisms of action, today announced that the first patient has been dosed in the Phase 1 clinical trial evaluating MT-8421, a novel engineered toxin body targeting CTLA-4, for the treatment of advanced solid tumors. The Phase 1 study is a multi-center open-label, dose-escalation, dose-expansion, and a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary efficacy of MT-8421. The study will enroll adult patients with tumors where CTLA-4 inhibitors have been proven to provide benefit and in other select tumor types known to frequently have an immune rich tumor microenvironment (“TME”). This will include melanoma, hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), Microsatellite Instability-High (MSI-H) / Mismatch Repair Deficient (dMMR) cancer, mesothelioma, esophageal squamous cell carcinoma (ESCC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, and cervical carcinoma. Approximately 24-30 patients are anticipated to enroll in Part A dose escalation with a starting dose of 32 mcg/kg. “MT-8421 represents a unique approach to immuno-oncology in general and CTLA-4 targeting in particular based on its ability to destroy Tregs in the TME but not in the periphery,” said Eric Poma, PhD., Chief Executive and Chief Scientific Officer of Molecular Templates. “We look forward to this approach providing patient benefit in this first-in-human study.” About MT-8421 (CTLA-4 Targeting ETB) MT-8421, along with MT-6402 (PD-L1 Targeting ETB with Antigen Seeding Technology), represents our unique approach to immuno-oncology based on dismantling the TME through direct cell-kill of tumor and immune cells and not only the blocking of ligand-ligand interactions seen with current antibody therapeutics. The ETB approach includes potent destruction of CTLA4+ regulatory T cells (“Tregs”) via enzymatic ribosome destruction, and the mechanism of cell kill is independent of TME. MT-8421 preferentially destroys high CTLA4 expressing Tregs in the TME relative to peripheral Tregs which are lower CTLA4 expressing. About Molecular Templates Molecular Templates is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted biologic therapeutics. Our proprietary drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. All statements, other than statements of historical facts, included in this press release, including, but not limited to those regarding strategy, inflection points, future operations, the Company’s ability to execute on its objectives, prospects, plans, future execution of corporate goals, and the skills and experiences of the newly appointed officer of Molecular Templates and expectations with respect to his future contributions to the Company and statements, evaluations and judgements regarding the Company’s pipeline, future clinical development of the Company’s product candidates, including any implication that results or observations in earlier clinical trials will be representative of results or observations in later clinical trials and the expected timing of such results and any potential benefits or promise of product candidates. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Molecular Templates may identify forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties. Actual events or results may differ materially from those discussed in the forward-looking statements due to various factors including, but not limited to the following factors: the continued availability of financing on commercially reasonable terms, whether the Company’s cash resources will be sufficient to fund its continuing operations; the results of the Company’s ongoing clinical studies, its ability to effectively operate Molecular Templates and retain key employees, the ability of the Company to maintain the continued listing of its common stock on Nasdaq, and those risks identified under the heading “Risk Factors” in Molecular Templates’ filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and any subsequent reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Molecular Templates specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise. Contacts: Grace Kim grace.kim@mtem.com

Sovateltide is a first of its kind drug to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms India is the first global territory where Tyvalzi™ (Sovateltide) is being introduced Pharmazz, Inc. (“Pharmazz” or the “Company”), a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, announced that it has entered into a license agreement with Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) to commercialise a first-in-class innovative drug, Tyvalzi™ (Sovateltide) in India. Developed by Pharmazz for potential global use, Sovateltide is indicated for treating cerebral ischemic stroke. As per agreement terms, Sun Pharma is granted rights for marketing Sovateltide in India under the brand name Tyvalzi™ (Sovateltide). Pharmazz will be entitled to upfront and milestone payments, including royalties. Kirti Ganorkar, CEO – India Business, Sun Pharma said, “The Phase 3 clinical trial for Tyvalzi™ conducted in India demonstrated statistically and clinically meaningful improvement in neurological outcomes in ischemic stroke. Tyvalzi™ is a first-in-class innovative drug which can help improve the quality of life of stroke patients. The drug can be administered within 24 hours for the treatment of ischemic stroke. The current treatment options provide a narrow time window of 4-5 hours limiting its use in most patients.” Dr. B. S. Paul, a leading neuro-physician at Dayanand Medical College & Hospital, Ludhiana, who was a part of the clinical trials of Tyvalzi™ (Sovateltide), said, “No new drug other than rTPA has been approved for the treatment of stroke for more than two decades. The narrow time window of rTPA of 4.5 hours limits its use in a vast majority of patients with cerebral ischemic stroke. There is an urgent need for new therapies to treat stroke, the 2nd leading cause of mortality & morbidity worldwide. Sovateltide (Tyvalzi™), a selective endothelin B receptor agonist, a new first-in-class drug recently approved for treating cerebral ischemic stroke, can be administered up to 24 hours post cerebral ischemic stroke. Sovateltide (Tyvalzi™) produced statistically significant and clinically meaningful improvements in neurological outcomes at 90 days post-treatment in clinical trials as measured by the NIHSS, mRS, and B.I. scales. Sovateltide (Tyvalzi™) is a neuronal progenitor cell therapy that promotes neurogenesis, angiogenesis, and synaptogenesis, thereby inducing neurovascular remodeling. I believe that Sovateltide (Tyvalzi™) is an exciting new, approved, effective, and well-tolerated therapy for treating cerebral ischemic stroke patients.” Dr. Prof. Anil Gulati, M.D., Ph.D., inventor, CEO, and Chairman of the Board of Directors of Pharmazz, said: “It is a significant step for Pharmazz to partner with Sun Pharma, the largest pharmaceutical company in India. For patients with cerebral ischemic stroke, I believe Sun Pharma is the best partner for Pharmazz to market Tyvalzi™ (Sovateltide), an innovative, first-in-class novel treatment for cerebral ischemic stroke, in India.” The global burden of disease project1 estimated the number of incident cases of stroke in India to be 1,175,778. In India, studies estimate that the incidence of stroke population varies from 116 to 163 per 100,000 population2. Stroke is the fourth leading cause of death and the fifth leading cause of disability3 in India. By 2050, more than 80% of the predicted global burden of new strokes of 15 million will occur in low and middle-income countries. About Tyvalzi™ (Sovateltide) Tyvalzi™ is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Tyvalzi™ is unique in that its site of action is the neural progenitor cells. Tyvalzi™ promotes neurovascular remodeling by forming new neurons (neurogenesis) and blood vessels (angiogenesis). Tyvalzi™ also protects neural mitochondria and enhances their biogenesis. About Pharmazz, Inc. Pharmazz is a privately held company engaged in developing novel products in critical care medicine. Pharmazz, Inc. obtained marketing authorization for two of its first-in-class drug molecules, Centhaquine and Sovateltide, for hypovolemic shock and ischemic stroke, respectively, in India. In addition, U.S. Food and Drug Administration (FDA) has approved two phase III INDs for Centhaquine as an agent for hypovolemic shock and Sovateltide for cerebral ischemic stroke. Additional information may be found on the Company’s website, www.pharmazz.com. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, onco-dermatology and accounts for over 16% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on Twitter @SunPharma_Live. References: GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2019; 48: 439–458. https://main.mohfw.gov.in/organisation/Departments-of-Health-and-Family-Welfare/national-programme-prevention-and-control-cancer-diabetes-cardiovascular-disease-and-Stroke-NPCDCS (accessed on 28th August 2023). The content above comes from the network. if any infringement, please contact us to modify.