Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today announced the updated interim monotherapy data from its Phase 1/2 clinical trial evaluating HPN328 in small cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO) 2023. HPN328 targets delta-like ligand 3 (DLL3) and is derived from Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC®) platform designed to recruit a patient’s own immune cells to kill tumor cells.
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today announced the updated interim monotherapy data from its Phase 1/2 clinical trial evaluating HPN328 in small cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO) 2023. HPN328 targets delta-like ligand 3 (DLL3) and is derived from Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC®) platform designed to recruit a patient’s own immune cells to kill tumor cells.
Vedanta Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VE202 for the Treatment of Ulcerative Colitis and Receives Fast Track Designation
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 was dosed. Vedanta also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE202, for the treatment of ulcerative colitis (UC). Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that the first patient in the Phase 2 COLLECTiVE202 clinical study of VE202 was dosed. Vedanta also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to Vedanta’s defined bacterial consortium candidate, VE202, for the treatment of ulcerative colitis (UC). Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
CareSource and Spark Pediatrics Partner to Serve Florida Medicaid Enrollees
(MIAMI, FL – Sept. 27, 2023) – CareSource, a nationally recognized managed care organization, and Spark Pediatrics, the leading provider of prescribed pediatric extended centers (PPEC or Medical Daycare) in both Florida and nationally, announced today the launch of ImagineCare -- a partnership to serve Florida Medicaid enrollees as a Provider Service Network (PSN). ImagineCare is an innovative managed care organization focused on deploying a provider-driven, community-centric, value-based care model for enrollees with medical complexities.
(MIAMI, FL – Sept. 27, 2023) – CareSource, a nationally recognized managed care organization, and Spark Pediatrics, the leading provider of prescribed pediatric extended centers (PPEC or Medical Daycare) in both Florida and nationally, announced today the launch of ImagineCare -- a partnership to serve Florida Medicaid enrollees as a Provider Service Network (PSN). ImagineCare is an innovative managed care organization focused on deploying a provider-driven, community-centric, value-based care model for enrollees with medical complexities.
Inozyme Pharma Announces Positive Interim Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE)
BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive interim safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE, pseudoxanthoma elasticum).
BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive interim safety, pharmacokinetic (PK), pharmacodynamic (PD) and exploratory efficacy data from the Company’s ongoing Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency (PXE, pseudoxanthoma elasticum).
Invaio Achieves First Registration for Citrus Greening Solution Featuring Trecise™ Technology
CAMBRIDGE, Mass., August 29, 2023 – Invaio Sciences, a bio platform company accelerating the leap to nature-positive agriculture, today announced that its Citrus Health solution to suppress citrus greening in oranges received approval from the Florida Department of Agriculture and Community Services (FDACS) under section 24(c) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
Inozyme Pharma, Inc. Announces Pricing of Public Offering of Common Stock
BOSTON, July 27, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced the pricing of an underwritten public offering of 12,500,000 shares of its common stock at a price of $4.80 per share, for aggregate gross proceeds of approximately $60 million, before deducting underwriting discounts and commissions and other offering expenses. In addition, Inozyme has granted the underwriters an option for a period of 30 days to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock are being offered by Inozyme.
VBI Vaccines Announces Pricing of $18 Million Public Offering and $3 Million Concurrent Registered Direct Offering
VBI Vaccines Inc. (NASDAQ: VBIV) (VBI or the Company), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the pricing of its previously announced underwritten public offering of 10,909,091 common shares and accompanying common warrants to purchase up to 10,909,091 common shares, and its concurrent registered direct offering of 1,818,182 common shares and accompanying common warrants to purchase up to 1,818,182 common shares, at a combined public offering price of $1.65 per share and accompanying common warrant. The accompanying common warrants have an exercise price of $1.65 per share and expire five years from the date of issuance. VBI also granted the underwriters a 30-day option to purchase up to an additional 1,636,363 common shares and/or common warrants to purchase up to 1,636,363 common shares offered in the underwritten public offering.
VBI Vaccines and Brii Biosciences Expand Hepatitis B Partnership To Address Both Prevention and Treatment in License and Collaboration Agreements for up to $437 Million Plus Royalties
VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the expansion of its hepatitis B (HBV) partnership with Brii Biosciences (“Brii Bio”) (Stock code: 2137.HK). Through two license and collaboration agreements, Brii Bio expanded its exclusive license to VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, to global rights and acquired an exclusive license for PreHevbri, VBI’s 3-antigen hepatitis B vaccine, in the Asia Pacific region (APAC).
ASLAN Pharmaceuticals Enters Into a Strategic Licensing Deal With Zenyaku Kogyo for the Development and Commercialization of Eblasakimab in Japan
SAN MATEO, Calif. and SINGAPORE and TOKYO, June 22, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (“ASLAN”, Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, and a leading Japanese pharmaceutical company Zenyaku Kogyo Co., Ltd. (“Zenyaku”), a subsidiary of privately held Zenyaku Holdings Co., Ltd. (“Zenyaku Holdings”), today announced a strategic licensing agreement granting Zenyaku exclusive rights to develop and commercialize eblasakimab in atopic dermatitis (AD) and all other indications in Japan.
Amgen and TScan Therapeutics Announce Collaboration to Identify Novel Targets in Crohn’s Disease
THOUSAND OAKS, Calif. and WALTHAM, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN) and TScan Therapeutics, Inc. (NASDAQ:TCRX), today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease. Under the terms of the agreement, TScan will receive a $30 million upfront payment and is eligible to earn over $500 million in success-based preclinical, clinical, regulatory and commercial milestones as well as tiered single-digit royalty payments.
Inspirna Appoints Dr. Usman “Oz” Azam, M.D., as New Chief Executive Officer
NEW YORK– (BUSINESS WIRE) – Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class cancer therapeutics, announced today the appointment of Dr. Usman “Oz” Azam, M.D., as its new Chief Executive Officer. Masoud Tavazoie, M.D., Ph.D., co-founder of Inspirna, recently stepped down as Chief Executive Officer and Director and will assume a new role as Advisor to provide ongoing support to the Company.
89bio, Inc. Announces Upsized Pricing of $275 Million Public Offering of Common Stock
SAN FRANCISCO, March 24, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (“89bio”) (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced the pricing of its previously announced underwritten public offering of 16,923,077 shares of its common stock at a public offering price per share of $16.25. In addition, 89bio has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 2,538,461 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds of the offering to 89bio, before deducting the underwriting discounts and commissions and other offering expenses payable by 89bio, are expected to be approximately $275 million. The offering is expected to close on or about March 28, 2023, subject to the satisfaction of customary closing conditions.
89bio’s Phase 2b ENLIVEN Trial of Pegozafermin in Nonalcoholic Steatohepatitis (NASH) Achieved High Statistical Significance on Both Primary Histology Endpoints
SAN FRANCISCO, March 22, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced positive topline data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis (NASH). In the study, both the 44mg every-two-week (Q2W) and 30mg weekly (QW) doses met, with high statistical significance, both the primary histology endpoints per the U.S. Food and Drug Administration (FDA) guidance on endpoints and statistical analysis.
Inozyme Pharma Reports Full Year 2022 Financial Results and Provides Business Highlights
BOSTON, March 22, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical- stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today reported financial results for the full year ended December 31, 2022, and provided recent business highlights. The Company also today announced that founding chief executive officer (CEO), Axel Bolte, MSc, MBA, will retire from his current role and that Douglas A. Treco, Ph.D., chairman of the Company’s board of directors (Board), will succeed Mr. Bolte as the CEO of the Company, effective April 1, 2023.
Inozyme Pharma Reports Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701
BOSTON, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced positive topline pharmacokinetic (PK), pharmacodynamic (PD), and safety data from the ongoing Phase 1/2 clinical trials of INZ-701 in ENPP1 Deficiency and ABCC6 Deficiency (PXE). The Company also reported encouraging patient reported outcome data as measured by global impression of change (GIC) in the ENPP1 Deficiency trial.
VBI Vaccines Announces Presentation of Interim Phase 2 Data Evaluating Combination of VBI-2601 (BRII-179) and BRII-835 for the Treatment of Chronic Hepatitis B
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients. The data, which will be featured in an oral presentation at APASL on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses, when compared to BRII-835 alone. Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or to the lower limit of quantification (LLOQ) were achieved by Week 40, which were associated with robust HBV-specific antibody and T-cell responses.
Corbus Pharmaceuticals expands oncology pipeline with the addition of a clinical stage Nectin-4 targeting Antibody Drug Conjugate (ADC)
NORWOOD, Mass., Feb. 13, 2023 /PRNewswire/ -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, today announced that it has entered into an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for development and commercialization of CRB-701 (SYS6002): a novel clinical stage antibody drug conjugate (ADC) targeting Nectin-4. The agreement covers exclusive commercialization rights to CRB-701 in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. CSPC will retain all rights to SYS6002 in the remaining global markets. The IND for CRB-701 has been cleared by the US FDA. CRB-701 is currently being investigated by CSPC in a Phase 1 dose escalation clinical trial in advanced solid tumors in China. Corbus is planning to bridge data from this Phase 1 trial to support a US clinical trial starting in 2024. Corbus and CSPC will work collaboratively to execute the clinical development of CRB-701 with Corbus responsible for the clinical development in the US and other licensed territories.
TScan Therapeutics Announces FDA Clearance of Three Investigational New Drug Applications for the Treatment of Solid Tumors
WALTHAM, Mass., Jan. 23, 2023 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for T-Plex, TSC-204-A0201, and TSC-204-C0702.
Surface Oncology Announces First Patient Dosed in a Phase 1/2 Study Evaluating SRF114, a Potential Best-In-Class Anti-CCR8 Antibody, in Patients with Advanced Solid Tumors
CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the first patient has been dosed in its Phase 1/2 clinical study investigating SRF114, a potential best-in-class, fully human, afucosylated anti-CCR8 antibody, as a monotherapy in patients with advanced solid tumors.
Boehringer Ingelheim and Click Therapeutics expand their existing Collaboration to develop Prescription Digital Therapeutics for Schizophrenia
Ingelheim, Germany and New York, New York, 19 December 2022 - Boehringer Ingelheim and Click Therapeutics today announced the launch of an expanded collaboration for the development and commercialization of a second prescription-based digital therapeutic (PDT). The companies will collaborate to develop and commercialize a novel mobile application, which combines multiple clinically validated therapeutic interventions for use alone and in combination with pharmaceutical therapy to help people with schizophrenia achieve positive clinical outcomes. The partnership aims to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to lack of access to psychosocial intervention therapies.