IND

Coinsilium Group Limited: Byzant Web3 Social Network Makes Significant Progress and Welcomes New Partners

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星期三, 四月 10, 2024
Indorse, Crypto, Bitcoin, UX, Ecosystem, Growth, Social network, Partnership, Social media, Testnet, IND, Advertising, Cryptocurrency

London, UK, 15 March 2024 - Coinsilium Group Limited (AQSE: COIN) (OTCQB: CINGF), the Web3 advisor, venture builder, and investor, is pleased to provide an update on Byzant (“Byzant”), the Web3 Social Network Ecosystem project under development in partnership with portfolio company Indorse.

Key Points: 
  • London, UK, 15 March 2024 - Coinsilium Group Limited (AQSE: COIN) (OTCQB: CINGF), the Web3 advisor, venture builder, and investor, is pleased to provide an update on Byzant (“Byzant”), the Web3 Social Network Ecosystem project under development in partnership with portfolio company Indorse.
  • Byzant is an active collaboration between a syndicate of major digital advertising and blockchain industry partners, including Coinsilium and Indorse (the “Byzant Collaboration”).
  • Indorse is the principal technology partner for Byzant with Coinsilium providing strategic advisory services.
  • Eddy Travia, Chief Executive of Coinsilium, commented: “We are delighted to see the progress being made in the development of the Byzant Web3 Ecosystem applications and especially with regards to the Byzant social media platform and Adbazaar, its smart-contract powered advertising network.

EQS-News: Abivax reports 2023 financial results and operational update

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星期三, 四月 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

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星期二, 四月 9, 2024
Certification, Therapeutic Goods Administration, DEL, Sale, Psilocybin, IND, GMP, Cannabis, Investigational New Drug, Drug development, TGA, FDA, PIC/S, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.
  • The audit, which aims to expand the Company's Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN's Kelowna production facility by Australia's Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
  • Securing a DEL will enhance HYTN's current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations.
  • HYTN has demonstrated its ability to manufacture these products according to GMP guidelines.

Foghorn Therapeutics Presents New Preclinical Data on Potential First-in-Class BRM Selective Inhibitor FHD-909 and Selective CBP and Selective EP300 Degrader Oncology Programs

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星期二, 四月 9, 2024
Well, BRM, Acetyltransferase, Gene expression, Survival, NSCLC, PD, SMARCA2, Neoplasm, Megakaryocyte, Cancer, Prostate, Lung cancer, Protein, IND, EP300, AACR, ATPase, Therapy, BRG1, Safety, CBP, Lilly, Anemia, ID, Thrombocytopenia, Annual general meeting, Pharmaceutical industry

CAMBRIDGE, Mass., April 09, 2024 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today announced new preclinical data for potential first-in-class medicines including FHD-909, a BRM (SMARCA2) selective inhibitor, selective CBP degrader, and selective EP300 degrader programs at the 2024 American Association for Cancer Research (AACR) Annual Meeting. Foghorn management will hold a conference call and webcast today at 5 p.m. ET to review important pipeline updates.

Key Points: 
  • “Notably, our first-in-class BRM selective inhibitor FHD-909 has demonstrated favorable tolerability and encouraging dose-dependent single agent activity in preclinical models of BRG1 mutated tumors.
  • Additionally, we are applying our long-acting formulation capabilities to our degrader programs, which further enhances the clinical potential of these drug candidates.
  • However, the ATPase domains of BRM and BRG1are 92% identical which has made identifying a selective BRM inhibitor challenging.
  • Attempts to selectively inhibit CBP or EP300 individually have been challenging due to the high homology between the two proteins.

Cogent Biosciences Presents Data Highlighting Potential Best-in-Class Potency and Selectivity of Novel, EGFR Sparing, CNS-Penetrant ErbB2 Inhibitor

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星期二, 四月 9, 2024
Brain, Disease, CNS, Mouse, Neoplasm, IND, AACR, HER2, Poster, Annual general meeting, Cogent, Pharmaceutical industry

and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program.

Key Points: 
  • and BOULDER, Colo., April 09, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program.
  • The data are being presented in a poster session at the American Association for Cancer Research (AACR) 2024 Annual Meeting taking place in San Diego, California.
  • “These data further demonstrate Cogent’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need.
  • Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies.

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights

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星期一, 四月 8, 2024
Research, SOC, Conference, CPI, Ono Pharmaceutical, Patient, Standard of care, Inflammation, Pembrolizumab, IND, Investigational New Drug, WT1, Nivolumab, SITC, FDA, Autoimmunity, Annual general meeting, Pharmaceutical industry

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.

Key Points: 
  • BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
  • The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.
  • As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.
  • We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.

ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer

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星期一, 四月 8, 2024
JHU, NCI, Development, Carcinoma, CRADA, National Cancer Institute, MSKCC, IND, Investigational New Drug, Genomics, Immune system, Bangladesh Technical Education Board, FDA, SCLC, Food, Pharmaceutical industry

This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

Key Points: 
  • This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.
  • The trial ( NCT06287775 ) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”.
  • “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.
  • “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated.

Coherus Presents Preclinical Data for CHS-1000, a Novel Anti-ILT4 Antibody, at the 2024 AACR Annual Meeting

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星期一, 四月 8, 2024
B cell, Ligand, Patient, CHRS, Tumor microenvironment, LILRB2, Cancer, Macrophage, PD-1, Neonatal Fc receptor, IND, Phenotype, Neoplasm, Poster, ILT4, Vaccine

REDWOOD CITY, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), today presented preclinical data for its immuno-oncology pipeline candidate, CHS-1000, a novel ILT4 monoclonal antibody, at the 2024 AACR Annual Meeting being held in San Diego, California. Data presented show CHS-1000 is a potent monoclonal antibody that binds selectively to human ILT4 (also known as LILRB2) with high affinity, efficiently blocking interaction with its ligands and reversing immunosuppressive functions, leading to activation of human dendritic cells and T cells and promoting polarization of macrophages to an inflammatory M1 phenotype.

Key Points: 
  • “Myeloid cell-mediated immunosuppression in the tumor microenvironment is a major contributor to tumor immune invasion and PD-1 resistance.
  • The data presented in this poster demonstrate the potential for CHS-1000 to reverse myeloid suppression and activate an inflammatory immune response.
  • “CHS-1000 is our first internally discovered development candidate, and we are excited to be filing the IND this quarter.
  • ILT4 and CD163, a marker of suppressive (M2) macrophages, are highly expressed in a broad range of solid tumors.

Ocugen, Inc. Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication

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星期一, 四月 8, 2024
Arm, Retinitis pigmentosa, Disease, Patient, Lux, RP, IND, Clutch (eggs), Vaccine, Food, RHO, FDA, BLA, Pharmaceutical industry

“OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.

Key Points: 
  • “OCU400 is the first gene therapy program to enter Phase 3 with a broad RP indication.
  • Until now, there has been only one marketed product to treat one of the 100 gene mutations associated with RP.
  • In the Phase 1/2 OCU400 clinical trial, a Multi-Luminance Mobility Testing (MLMT) scale was the primary functional endpoint.
  • With the initiation of the Phase 3 clinical trial, OCU400 remains on track for the 2026 BLA approval target.

Zymeworks Presents New Data from Multiple Preclinical Development Programs at 2024 American Association for Cancer Research Annual Meeting

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星期一, 四月 8, 2024
Well, Small-cell carcinoma, Therapeutic index, Glomus tumor, Endometrial cancer, Survival, Environment, Service provider, Trichloroethylene, Patient, Primate, Triple-negative breast cancer, Lead, Zymeworks, 3D, Standard of care, Cancer, TAA, Spacecraft, Lung cancer, IND, CD3, DLL3, AACR, Workflow, Antibody, TCE, CD28, Therapy, Stomach, ADC, Vaccine

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.

Key Points: 
  • The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.
  • An investigational new drug (IND) submission or foreign equivalent is planned for 2024.
  • Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer with a poor prognosis and high unmet medical need2.
  • Displays no cross-linking of T cells and exhibits obligate cis T cell binding of CD28, requiring co-engagement of CD3.