VEGF

AVEO Oncology Announces Completion of Enrollment in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma

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вторник, июня 27, 2023
Apoptosis, RCC, Bristol Myers Squibb, TKI, Immunotherapy, Harvard Medical School, NCCN, VEGF, Journal of the National Comprehensive Cancer Network, Patient, Data, LG Chem, Safety, Nivolumab, Dana–Farber Cancer Institute, Pharmaceutical industry

BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.

Key Points: 
  • BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.
  • The study is evaluating FOTIVDA® (tivozanib) in combination with OPDIVO® (nivolumab), Bristol Myers Squibb's anti-PD-1 immunotherapy.
  • There are currently no National Comprehensive Cancer Network® (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy.
  • The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment.

Coherus to Acquire Surface Oncology

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пятница, июня 16, 2023
Adenocarcinoma, LLP, GSK, Bevacizumab, Non-small-cell lung cancer, FY, SG, Hepatocellular carcinoma, RCC, Survival, Cancer, Arnold, Lung cancer, Head, Latham & Watkins, CCR8, Antibody, Liver cancer, Nasopharyngeal carcinoma, Organization, CHRS, ORR, GSK plc, VEGF, Acquisition, ILT4, MD, Patient, Immunoglobulin G, CVR College of Engineering, Renal cell carcinoma, Growth, Neoplasm, PD-1, IL-27, FDA, Tumor microenvironment, Arnold & Porter, HCC, PD-L1, Novartis, Medical imaging, Vaccine, Pharmaceutical industry, Bank, NSCLC, Surface

– Stock for stock transaction valued at up to $65 million, an approximate three-fold premium over Surface’s anticipated net cash of $20 to $25 million at closing; Surface shareholders will also receive CVRs based on potential future payments for previously partnered assets and for potential ex-US licensing –

Key Points: 
  • – Stock for stock transaction valued at up to $65 million, an approximate three-fold premium over Surface’s anticipated net cash of $20 to $25 million at closing; Surface shareholders will also receive CVRs based on potential future payments for previously partnered assets and for potential ex-US licensing –
    – Coherus projects $48 - 53 million of net product revenue in 2Q 2023, and affirms prior FY 2023 revenue and expense guidance –
    REDWOOD CITY, Calif. and CAMBRIDGE, Mass., June 16, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) and Surface Oncology, Inc. (Surface, Nasdaq: SURF) today announced that the companies have entered into a definitive merger agreement providing that, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.
  • With the agreement to acquire Surface and the expected near-term approval of toripalimab, Coherus is positioned to become one of the very few I-O companies with demonstrated commercial expertise, significant product revenues, and unique, competitively positioned R&D programs addressing critical unmet medical needs,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus.
  • Novel I-O clinical development will extend Coherus’ reach in oncology and expand physician experience with toripalimab.
  • The press release and live webcast of the conference call can be accessed through a link that is posted on Investors section of the Coherus website: https://investors.coherus.com/ and Investors section of the Surface Oncology website: https://investors.surfaceoncology.com/.

Coherus to Acquire Surface Oncology

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пятница, июня 16, 2023
Adenocarcinoma, LLP, GSK, Bevacizumab, Non-small-cell lung cancer, FY, SG, Hepatocellular carcinoma, RCC, Survival, Cancer, Arnold, Lung cancer, Head, Latham & Watkins, CCR8, Antibody, Liver cancer, Nasopharyngeal carcinoma, Organization, CHRS, ORR, GSK plc, VEGF, Acquisition, ILT4, MD, Patient, Immunoglobulin G, CVR College of Engineering, Renal cell carcinoma, Growth, Neoplasm, PD-1, IL-27, FDA, Tumor microenvironment, Arnold & Porter, HCC, PD-L1, Novartis, Medical imaging, Vaccine, Pharmaceutical industry, Bank, NSCLC, Surface

– Stock for stock transaction valued at up to $65 million, an approximate three-fold premium over Surface’s anticipated net cash of $20 to $25 million at closing; Surface shareholders will also receive CVRs based on potential future payments for previously partnered assets and for potential ex-US licensing –

Key Points: 
  • – Stock for stock transaction valued at up to $65 million, an approximate three-fold premium over Surface’s anticipated net cash of $20 to $25 million at closing; Surface shareholders will also receive CVRs based on potential future payments for previously partnered assets and for potential ex-US licensing –
    – Coherus projects $48 - 53 million of net product revenue in 2Q 2023, and affirms prior FY 2023 revenue and expense guidance –
    REDWOOD CITY, Calif. and CAMBRIDGE, Mass., June 16, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) and Surface Oncology, Inc. (Surface, Nasdaq: SURF) today announced that the companies have entered into a definitive merger agreement providing that, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.
  • With the agreement to acquire Surface and the expected near-term approval of toripalimab, Coherus is positioned to become one of the very few I-O companies with demonstrated commercial expertise, significant product revenues, and unique, competitively positioned R&D programs addressing critical unmet medical needs,” said Denny Lanfear, Chairman and Chief Executive Officer of Coherus.
  • Novel I-O clinical development will extend Coherus’ reach in oncology and expand physician experience with toripalimab.
  • The press release and live webcast of the conference call can be accessed through a link that is posted on Investors section of the Coherus website: https://investors.coherus.com/ and Investors section of the Surface Oncology website: https://investors.surfaceoncology.com/ .

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

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четверг, июня 15, 2023
Priority review, CRC, Progression-free survival, Marketing, TAK, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, JAMA, NDA, Prescription Drug User Fee Act, EMA, American Medical Association, VEGF, HKEX, Journal, Patient, Physician, PMDA, PDUFA, BSC, MAA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Takeda

OSAKA, Japan and CAMBRIDGE, Mass. and HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., June 15, 2023 (GLOBE NEWSWIRE) -- Takeda (TSE:4502/​NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announced that the European Medicines Agency (“EMA”) has validated and accepted for regulatory review the marketing authorization application (“MAA”) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the E.U. for previously treated metastatic CRC.1,2

Key Points: 
  • Placebo plus BSC for Adult Patients with Previously Treated Metastatic Colorectal Cancer —
    OSAKA, Japan and CAMBRIDGE, Mass.
  • If approved, fruquintinib will be the first and only highly selective inhibitor of all three VEGF receptors approved in the E.U.
  • for previously treated metastatic CRC.1,2
    “European patients with metastatic colorectal cancer have not benefitted from a treatment advancement in over a decade,” said Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda.
  • who find treatment options to be limited for previously treated metastatic colorectal cancer,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer, HUTCHMED.

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

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четверг, июня 15, 2023
General Health, Health, Pharmaceutical, Clinical Trials, Oncology, Priority review, CRC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Marketing, Progression-free survival, TAK, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, JAMA, NDA, PFS, EMA, American Medical Association, VEGF, HKEX, Journal, Prescription Drug User Fee Act, Patient, Physician, PMDA, VEGFR, European, PDUFA, BSC, MAA, FDA, HCM, Pharmaceutical industry, EU, Takeda

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
  • “We are thrilled to have submitted the marketing authorization application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease.
  • FRESCO-2 is a global Phase 3 multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC.
  • Submission of an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is also planned in 2023.

Tarsier Pharma Announces Publication of Review Article on Suppressing Inflammation for Treating Retinal Blinding Ocular Diseases, Highlighting dazdotuftide (TRS) as a Promising Therapeutic Candidate

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понедельник, июня 12, 2023
Biomedicine, Inflammation, Diabetes, Therapy, DME, AMD, Diabetic retinopathy, TRS, DR, Intravitreal injection, Retina, Potential New Boyfriend, Open access, DE, TEL, VEGF, Patient, Division, Treatment, Tarsier, NRP1, TLR, Pharmaceutical industry, Ophthalmology

The peer reviewed article "Suppressing Inflammation for the Treatment of Diabetic Retinopathy and Age-Related Macular Degeneration: Dazdotuftide as a Potential New Multitarget Therapeutic Candidate", has been published as Open Access in the journal Biomedicines in May 2023.

Key Points: 
  • The peer reviewed article "Suppressing Inflammation for the Treatment of Diabetic Retinopathy and Age-Related Macular Degeneration: Dazdotuftide as a Potential New Multitarget Therapeutic Candidate", has been published as Open Access in the journal Biomedicines in May 2023.
  • Dazdotuftide demonstrates the ability to target multiple inflammatory pathways, such as NRP1, TLR, and ACE-2, while simultaneously activating anti-inflammatory macrophages.
  • This groundbreaking approach positions dazdotuftide as a potential therapeutic option for effectively managing DR, DME, and AMD.
  • "Dazdotuftide represents an innovative therapeutic approach that addresses the unmet medical need for effective treatment of diseases such as AMD, DE, and DME," said Prof. Chowers. "

Promising Data for Investigational Innovative Bispecific Ivonescimab Featured at ASCO 2023

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воскресенье, июня 4, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Histology, Progression-free survival, Cohort, Neoplasm, DOR, Survival, OS, Sun, Trae tha Truth, Lung cancer, Constipation, TKI, NSCLC, Paranal Observatory, Immunotherapy, PFS, Trial of the century, ASCO, ORR, VEGF, Hair, HKEX, American Society of Clinical Oncology, Patient, EGFR, Anaplastic lymphoma kinase, Anemia, Annual general meeting, TME, SMMT, Poster, PD-1, Phase, Summit, Tumor microenvironment, Society, Safety, ALK, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today from 8:00 to 11:00am at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today from 8:00 to 11:00am at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • AK112-201 (NCT04736823) is an open-label Phase II study evaluating ivonescimab plus chemotherapy for 174 patents across three cohorts of patients.
  • After a median follow-up time of 13.3 months, median overall survival (OS) was not reached; although, estimated 9-month OS was 93.2%.
  • Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

Stonegate Healthcare Partners Announces Publishing of a Thematic Report - Beyond VEGF: Therapies Revolutionizing Diabetic Eye Disease

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четверг, июня 1, 2023
DME, SHP, DR, OCS, Diabetic retinopathy, Unity Biotechnology, VEGF, Pharmaceutical industry, Telescopic sight, Pecten oculi

Dallas, Texas--(Newsfile Corp. - June 1, 2023) - Stonegate Healthcare Partners (SHP), a healthcare strategy consulting firm, is pleased to announce the release of a thematic report that examines innovative advancements in the treatment of diabetic eye disease, including diabetic retinopathy (DR) and diabetic macular edema (DME).

Key Points: 
  • Dallas, Texas--(Newsfile Corp. - June 1, 2023) - Stonegate Healthcare Partners (SHP), a healthcare strategy consulting firm, is pleased to announce the release of a thematic report that examines innovative advancements in the treatment of diabetic eye disease, including diabetic retinopathy (DR) and diabetic macular edema (DME).
  • The report, Beyond VEGF: Therapies Revolutionizing Diabetic Eye Disease, highlights the unmet needs and the companies leading innovation in this field.
  • This thematic report will serve as the foundation for Stonegate Healthcare's ongoing market intelligence in diabetic eye disease, providing valuable insights for investors and companies.
  • Based on interviews and analysis with dozens of companies and KOLs, this report offers an important resource for anyone seeking an understanding of diabetic eye disease treatment.

Ivonescimab Updated Data to be Featured at ASCO 2023

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четверг, июня 1, 2023
Oncology, Medical Supplies, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Metastasis, Sun, Lung cancer, TKI, NSCLC, Central Time, Paranal Observatory, Immunotherapy, Trial of the century, ASCO, VEGF, HKEX, American Society of Clinical Oncology, Patient, EGFR, Anaplastic lymphoma kinase, TME, Annual general meeting, SMMT, Poster, PD-1, Phase, Summit, Tumor microenvironment, Society, Safety, ALK, Pharmaceutical industry, Medical imaging

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • The poster with updated clinical data from Phase II clinical trials will be displayed on Sunday June 4 from 8:00 to 11:00am Central Time during the Lung Cancer – Non-Small Cell Metastatic Poster Session.
  • The poster provides updated data supporting promising anti-tumor activity of ivonescimab in first line advanced or metastatic NSCLC, while displaying that ivonescimab may have an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with squamous or non-squamous advanced or metastatic NSCLC in this clinical study.
  • Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

Enterome announces sustained positive clinical outcomes with EO2401, its lead OncoMimics™ immunotherapy, in combination therapy in Glioblastoma at ASCO

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среда, мая 31, 2023
Maintenance, Bevacizumab, GBM, Vaccination, Nivolumab, Inflammation, Edema, Survival, Cancer, German Cancer Research Center, DSM-IV codes, Glioblastoma, ASCO, Service provider, VEGF, American Society of Clinical Oncology, Patient, Data, Memory, Annual general meeting, Immunosuppression, Society, Pharmaceutical industry, Vaccine, MD

Nivolumab is used as an adjuvant to EO2401, to support T cell expansion and tumor infiltration.

Key Points: 
  • Nivolumab is used as an adjuvant to EO2401, to support T cell expansion and tumor infiltration.
  • By itself, nivolumab has no observed clinical effect on GBM tumors.
  • Pierre Belichard, CEO at Enterome said, “We are thrilled with the clinical and immunological data emerging from the ROSALIE trial, which we are presenting at ASCO.
  • EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific CD8+ T cells, correlating with clinical efficacy.