Preclinical development

Biomea Fusion to Participate in Two Upcoming Investor Conferences

Retrieved on: 
Wednesday, November 10, 2021
Cancer, Acute leukemia, News, NPM1, Mutation, Leukemia, Board, Preclinical development, GLOBE, MEN1, Jefferies, Nasdaq, Patient, Mixed-phenotype acute leukemia, Lymphoma, Pharmaceutical industry

Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively.

Key Points: 
  • Biomea Fusion will participate in 1x1 investor meetings during the conferences hosted by Jefferies and Piper Sandler, respectively.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.
  • The company is utilizing its proprietary FUSION discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer.
  • Biomea Fusions goal is to utilize its capabilities and platform to become a leader in developing irreversible small molecules in order to maximize the clinical benefit when treating various cancers.

Biomea Fusion Publishes Abstract on BMF-219 at ASH Annual Meeting

Retrieved on: 
Thursday, November 4, 2021
Molecule, Society, Safety, AML, TFS, Data, Cancer, Private Securities Litigation Reform Act, Acute leukemia, JUND, Lymph, Immortalised cell line, Factor X, TF, Gene, KMT2A, American Society of Hematology, DHL, Diffusion, DEL, GEO, NPM1, Mutation, BCL2, COVID-19, Leukemia, Menin, Forward-looking statement, Gene expression, Program, Protein, Preclinical development, IC50, Company, GLOBE, U.S. Securities and Exchange Commission, Non-Hodgkin lymphoma, MEN1, MYC, Lymphocyte, Survival, Nasdaq, Patient, MAX, Mixed-phenotype acute leukemia, IND, Vaccine, Pharmaceutical industry, Fine chemical

These results strongly point toward altered MYC-activity mediated by BMF-219 in leukemia cells, prompting additional exploration in MYC-dependent lymphoid malignancies.

Key Points: 
  • These results strongly point toward altered MYC-activity mediated by BMF-219 in leukemia cells, prompting additional exploration in MYC-dependent lymphoid malignancies.
  • TFs with more than one bar represent multiple study sets in GEO that overlap with BMF-219 mediated differentially expressed genes.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.
  • The company is utilizing its proprietary FUSION discovery platform to advance a pipeline of irreversible treatments against key oncogenic drivers of cancer.

Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights

Retrieved on: 
Wednesday, November 3, 2021
Safety, MLL, Cancer, DLBCL, Mutation, Chemistry, Mixed-phenotype acute leukemia, IPO, Acute leukemia, Blood, Leukemia, Patient, Private Securities Litigation Reform Act, FDA, Preclinical development, Menin, Lymph, U.S. Securities and Exchange Commission, Adult, Forward-looking statement, Company, Investment, Spleen, Yissum Research Development Company of the Hebrew University, Board, MM, COVID-19, MEN1, IND, Diabetes, Bone marrow, Program, Nasdaq, AML, Research, Death, Multiple myeloma, R, Therapy, GLOBE, Central nervous system, NPM1, Osteopathic medicine in Canada, Pharmaceutical industry, Vaccine, Fine chemical

The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program.

Key Points: 
  • The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program.
  • We now have our first molecule ready for the clinic, and a number of exciting programs advancing through pre-clinical development.
  • Biomea is conducting preclinical studies to demonstrate the potential for BMF-219 in genetically defined patient subsets of DLBCL and MM.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers.

Mindset Pharma Reports Fiscal Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, October 26, 2021
Safety, Neurology, American Epilepsy Society, Drug discovery, Depression, DMT, Technology, FSE, Leadership, University, Bipolar disorder, Industry, DRS, Canadian Securities Exchange, Drug development, Pharmacology, File, CSE, Patient, Preclinical development, Neuroscience, CGMP, Psilocybin, MSET, Capital market, Senior, Patent, Company, CEO, Growth, PCT, IND, Coronavirus Scientific Advisory Board (Turkey), Publication, Intellectual property, GLOBE, SAB, Pharmaceutical industry

TORONTO, Oct. 26, 2021 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today provided a corporate update and reported financial results for its fiscal year ended June 30, 2021.

Key Points: 
  • In September 2021, Mindset announced treatment-resistant depression and end of life cancer angst as initial indications for MSP-1014.
  • In August 2021, Mindset announced its short-duration, psilocybin-based, analogs demonstrated superior efficacy and safety in head-to-head preclinical comparison to psilocin/psilocybin.
  • In September 2021, Mindset identified three pipeline opportunities from its DMT and 5-MeO-DMT-inspired novel drug candidates, MSP-4018, MSP-4019 and MSP-4020 .
  • Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs.

Relay Therapeutics Announces Interim Clinical Data that Support RLY-4008 as a Highly Selective FGFR2 Inhibitor

Retrieved on: 
Friday, October 8, 2021
Private Securities Litigation Reform Act, Twitter, Diarrhea, Neoplasm, Patient, Infrared spectroscopy correlation table, ID, Therapy, Risk, BID, N550, Cholangiocarcinoma, Retinopathy, Conference, COVID-19, Preclinical development, Protein, GLOBE, FGFR2, Safety, Precision medicine, SD, Human, QD, U.S. Securities and Exchange Commission, Hyperphosphatemia, Toxicity, Toxic leukoencephalopathy, Cancer, Security (finance), AACR, Family, Circulating tumor DNA, RPED, News, FGFR, Â, DNA, Media, Disease, Clinical trial, DLT, PR, Nasdaq, Lists of diseases, Pharmaceutical industry, Vaccine, Medical imaging

Relay Therapeutics anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021.

Key Points: 
  • Relay Therapeutics anticipates selecting a once daily recommended Phase 2 dose and initiating expansion cohorts prior to the end of 2021.
  • RLY-4008 clinical data exemplifies the power of the Relay Therapeutics Dynamo platform and approach to discovering innovative medicines, said Don Bergstrom, M.D., Ph.D., executive vice president of R&D at Relay Therapeutics.
  • Together, the interim data suggest that RLY-4008 is a highly selective FGFR2 inhibitor in humans.
  • Consistent with the preclinical profile, these early clinical data support Relay Therapeutics belief that RLY-4008 has broad therapeutic potential across FGFR2 alterations and tumor types.

Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)

Retrieved on: 
Wednesday, October 6, 2021
Goal, Neurodegeneration, Review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Private Securities Litigation Reform Act, AD, Communication, RIPK1, Safety, SEC, Neuron, Food, Biomarker, PTV, Pathology, Traffic barrier, Central nervous system, Adult, Prisoner transport vehicle, MS, Frontotemporal dementia, VWM, CNS, Mouse, Clinical trial, Therapy, Inflammation, White matter, NASDAQ, U.S. Securities and Exchange Commission, FDA, Fast Track, Blood, EIF2B, ISR, Marketing, Human, Lists of diseases, Risk, Brain, Forward-looking statement, FTD, Multiple sclerosis, GLOBE, Pharmacokinetics, PK, Security (finance), Amyotrophic lateral sclerosis, Patient, Preclinical development, COVID-19, PD, ALS, Sanofi, BBB, Pharmaceutical industry, Communications satellite, Medical device

DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively.

Key Points: 
  • DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively.
  • Denali presented positive results from a Phase 1 study in healthy volunteers (n=95) in which safety, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of DNL343 were evaluated.
  • Denali and Sanofi entered into a broad collaboration in October 2018 for the global development and commercialization of RIPK1 inhibitors.
  • The forward-looking statements in this press release are based on information available to Denali as of the date hereof.

Ajax Therapeutics Expands Management Team to Support Advancement of Novel Therapies for Hematologic Malignancies

Retrieved on: 
Wednesday, September 29, 2021
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Biotechnology, Therapy, Wellcome Trust Principal Research Fellow, Computational chemistry, Ajax, Harvard University, NDA, Doctor of Philosophy, Patient, Boston University, Senior, Infection, State University of New York Upstate Medical University, Toxicology, Nimbus, Pharmacology, Leadership, Preclinical development, Lymphatic system, Secondary research, Research, Drug discovery, Amgen, Safety, State university system, SVP, Pharmaceutical industry

Were excited to welcome Christina to the Ajax team.

Key Points: 
  • Were excited to welcome Christina to the Ajax team.
  • Dr. Craig Masse joined Ajax in 2019, and previously served in R&D leadership roles at Nimbus, Concert Pharmaceuticals and Amgen.
  • He is an inventor on over 60 patents and has co-authored more than 65 scientific publications including several book chapters.
  • Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies.

TYME Announces First Patient Dosed in Phase II OASIS Trial Evaluating the Potential Benefits of Oral SM-88 for Patients with Metastatic HR+/HER2- Breast Cancer After Treatment with a CDK4/6 Inhibitor

Retrieved on: 
Monday, September 27, 2021
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Methoxsalen, RECIST, Clinical trial, Cancer, Cell death, Breast, Private Securities Litigation Reform Act, HER2, National Cancer Institute, Annual report, MedStar Health, Collection, NASDAQ, Survivor, Breast cancer, U.S. Securities and Exchange Commission, DNA, Patient, Population, LinkedIn, Biomarker, Sarcoma, JNCI, Phase, Georgetown University, Twitter, Lymphoma, Company, Phenytoin, Coronavirus, Woman, Prostate, Disease, Sirolimus, Risk, Preclinical development, COVID-19, Uncertainty, American Cancer Society, Research, Oxidative stress, Forward-looking statement, Incidence, Journal of the National Cancer Institute, Quality of life, Howlader, Lung, Pharmaceutical industry, Medical imaging, Breast Cancer, TYME Technologies, Inc., SM-88, BREAST CANCER, TYME TECHNOLOGIES, INC., SM-88

We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients.

Key Points: 
  • We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients.
  • Dosing the first patient is a critical milestone in advancing oral SM-88 as a potential treatment option prior to chemotherapy for this patient population.
  • This is a significant opportunity for TYME, and we look forward to providing updates as the OASIS trial progresses, concluded Cunningham.
  • The Company is enrolling a Phase II study evaluating SM-88 in breast cancer (HR+/HER2-) and continues enrollment of a Phase II study in high-risk metastatic sarcomas.

Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219

Retrieved on: 
Thursday, September 16, 2021
Form, FIH, U.S. Securities and Exchange Commission, Preclinical development, Cancer, Phase 1, Food, Lymph, Security (finance), Spleen, Menin, Mutation, Osteopathic medicine in Canada, Central nervous system, Board, FDA, Institutional review board, PD, AML, Forward-looking statement, Leukemia, Consultant, TEAM, Mixed-phenotype acute leukemia, Patient, Contract research organization, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Company, Private Securities Litigation Reform Act, Blood, Nasdaq, Clinical trial, Acute leukemia, Disease, Adult, Safety, MEN1, Growth, Investigational New Drug, NPM1, COVID-19, Contract, MLL, Death, GLOBE, Time, Bone marrow, Pharmaceutical industry, Fine chemical

Food and Drug Administration(FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

Key Points: 
  • Food and Drug Administration(FDA) has cleared the company's Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.
  • This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule.
  • This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs.
  • Biomea Fusion is a biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers.

Relay Therapeutics to Present Clinical Data on RLY-4008 and Preclinical Data on RLY-2608 at AACR-NCI-EORTC Molecular Targets Conference

Retrieved on: 
Monday, September 13, 2021

RLY-4008 is a potent, selective and oral small molecule inhibitor of FGFR2 that entered a first-in-human clinical trial in September 2020.

Key Points: 
  • RLY-4008 is a potent, selective and oral small molecule inhibitor of FGFR2 that entered a first-in-human clinical trial in September 2020.
  • Relay Therapeutics will host a live webcast on October 8, 2021 at 12:30 pm E.T.
  • The presentation and poster will be available shortly after being presented on the Relay Therapeutics website at https://ir.relaytx.com/news-events/events-presentations.
  • In addition, RLY-4008 demonstrates strong activity against known clinical on-target resistance mutations in cellular and in vivo preclinical models.