Investigational New Drug

BioCity Announces FDA Clearance of the Investigational New Drug Application for its First-In-Class Antibody Drug Conjugate Targeting Glypican 3

Retrieved on: 
Tuesday, April 9, 2024
HCC, Malignancy, Disease, Lung, Patient, Bystander effect, Standard of care, Death, Spacecraft, IND, Investigational New Drug, Cancer, Drug resistance, Liver cancer, Therapy, ADC, Hepatocellular carcinoma, FDA, GPC3, Food, CDH3

SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027.

Key Points: 
  • SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027.
  • BC2027, which is BioCity's second first-in-class antibody drug conjugate (ADC) approved for clinical development, targets Glypican 3 (GPC3), a proteoglycan found in the outer membrane of cancer cells.
  • BC2027 binds with very high affinity to GPC3 and efficiently internalizes into cancer cells where it releases its cancer killing payload.
  • Dr. Yong Jiang Hei, CEO of BioCity, noted that "Drug resistance has increasingly become a challenge in cancer treatment.

Allterum Therapeutics receives $12 million product development grant from CPRIT to advance anti-CD127 therapeutic antibody into clinic

Retrieved on: 
Monday, April 8, 2024
NCI, Acute lymphoblastic leukemia, CLL, Immunotherapy, AML, TTC, Lung, Patient, ALL, NeXT, National Cancer Institute, Breast, Cancer, Pediatrics, Doctor of Philosophy, IND, GMP, Clinical trial, Investigational New Drug, Therapy, Immune system, Prognosis, Research institute, Cancer prevention, FDA, Lymphoma, CD127, Pharmaceutical industry

HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127. CD127 is a receptor that is expressed in major subsets of multiple cancers including hematological cancers (ALL, AML, CLL, and lymphoma) and solid tumors (lung, breast, colorectal, H&N, esophageal cancers).

Key Points: 
  • Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
  • HOUSTON, April 8, 2024 /PRNewswire-PRWeb/ -- Allterum Therapeutics, Inc. has been awarded a $12 million product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT), which will support the clinical evaluation of Allterum's lead candidate, 4A10, a monoclonal antibody targeting CD127.
  • An addition to the $12M Product Development Award, Allterum received a $2.9M CPRIT seed award in 2020, which supported early-stage development work for the 4A10 antibody and laid the foundation for the current grant.
  • "We are pleased to provide Allterum with this TTC product development award to advance their promising anti-cancer drug into clinic," said Dr. Kenneth Smith, CPRIT's Chief Product Development Officer.

ZyVersa Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 25, 2024
Research, Diabetic nephropathy, Cholesterol, Obesity, Institutional review board, Patient, Protocol, MJFF, University, IND, IRB, Investigational New Drug, Therapy, Atherosclerosis, Metabolic syndrome, Government, Inflammasome, Pharmaceutical industry

WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.

Key Points: 
  • Scientific collaboration to assess Inflammasome ASC Inhibitor IC 100 as a potential treatment for atherosclerosis expected to conclude H1-2024.
  • WESTON, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for the treatment of renal and inflammatory diseases with high unmet medical needs, reports financial results for full year ending December 31, 2023, and provides business update.
  • “Throughout 2023 and early 2024, ZyVersa achieved considerable progress in advancing development of our two lead candidates.
  • The impairment is a result of the decline in stock value and the resulting market capitalization of ZyVersa during the 2023 Period.

Senti Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Reviews Recent Highlights

Retrieved on: 
Thursday, March 21, 2024
HCC, Research, AML, Logic, Partnership, Spark Therapeutics, SAN, Patient, Gene, SNTI, Acute myeloid leukemia, Doctor of Philosophy, IND, Investment, Investigational New Drug, Therapy, Hepatocellular carcinoma, FDA, Food, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • SENTI-202 for AML: In December 2023, Senti Bio announced the IND application for SENTI-202 was cleared by the U.S. Food and Drug Administration (“FDA”).
  • Cash, Cash Equivalents and Short-term Investments: As of December 31, 2023, Senti Bio held cash, cash equivalents and short-term investments of $35.9 million.
  • G&A Expenses: General and administrative expenses were $9.3 million for the fourth quarter of 2023, compared to $9.8 million for the same period in 2022.
  • Net Loss: Net loss was $18.7 million, or $0.42 per basic and diluted share, for the quarter ended December 31, 2023.

Cabaletta Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
Research, MPV, IIM, MuSK protein, Toxicity, Conference, Disease, Dermatomyositis, Juvenile dermatomyositis, Federation, Patient, NOL, Observation, CRS, SLE, Health Canada, IND, Immunoglobulin therapy, Pemphigus, Investment, Investigational New Drug, Myopathy, Systemic scleroderma, Marketing, FDA, Clinical trial, Cytokine release syndrome, Cyclophosphamide, CD19, Food, Autoimmune disease, Pharmaceutical industry

In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.

Key Points: 
  • In October 2023, Cabaletta received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) for the Phase 1/2 RESET-SSc trial.
  • In November 2023, Cabaletta announced that its IND application for CABA-201 was allowed to proceed by the FDA for the Phase 1/2 RESET-MG trial.
  • Cabaletta anticipates reporting initial clinical data from the Phase 1/2 RESET-MG trial in the second half of 2024.
  • As of December 31, 2023, Cabaletta had cash, cash equivalents and short-term investments of $241.2 million, compared to $106.5 million as of December 31, 2022.

Design Therapeutics Outlines Progress Across GeneTAC™ Platform and Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Research, Observational study, Cerebellar ataxia, Biotechnology, Gene expression, FXN, Disease, Webcast, Patient, G&A, DM1, Design, IND, Treatment, Clinical trial, Investigational New Drug, Therapy, Completeness, Evaluation, DMPK, FA, HD, Food, FDA, GLP, HTT, Pharmaceutical industry

R&D Expenses: Research and development (R&D) expenses were $11.0 million for the quarter ended December 31, 2023, and $57.1 million for the year ended December 31, 2023.

Key Points: 
  • R&D Expenses: Research and development (R&D) expenses were $11.0 million for the quarter ended December 31, 2023, and $57.1 million for the year ended December 31, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $4.1 million for the quarter ended December 31, 2023, and $21.1 million for the year ended December 31, 2023.
  • Net Loss: Net loss was $11.8 million for the quarter ended December 31, 2023, and $66.9 million for the year ended December 31, 2023.
  • Cash Position and Operating Runway: Cash, cash equivalents and marketable securities were $281.8 million as of December 31, 2023.

Tourmaline Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Tuesday, March 19, 2024
Research, Moyamoya disease, Quarter, Cardiovascular disease, Spirited, Growth, Exercise, Entrepreneurship, IL-6, Inflammation, Patient, SVP, Business development, Commercial, NASDAQ Biotechnology Index, MD, IND, Investment, Clinical trial, NBI, Investigational New Drug, Therapy, TRML, Medical research, Graves' ophthalmopathy, FDA, Food, Pharmaceutical industry

In October 2023, Tourmaline become a publicly-traded company via reverse merger with Talaris Therapeutics, including a concurrent private placement of $75.0 million.

Key Points: 
  • In October 2023, Tourmaline become a publicly-traded company via reverse merger with Talaris Therapeutics, including a concurrent private placement of $75.0 million.
  • Fourth Quarter and Full Year 2023 Financial Results:
    Cash, cash equivalents and investments were $203.0 million as of December 31, 2023, as compared to $8.3 million as of December 31, 2022.
  • Research and development expenses were $8.0 million for the fourth quarter of 2023, as compared to $3.8 million for the fourth quarter of 2022.
  • General and administrative expenses were $6.9 million for the fourth quarter of 2023, as compared to $1.1 million for the fourth quarter of 2022.

ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update

Retrieved on: 
Thursday, March 14, 2024
SIV, Data, Combination, EGFR, Property, SPI, Patient, Sale, Attention deficit hyperactivity disorder, Syndrome, Lung cancer, IND, Myelodysplastic syndrome, Bank statement, Investment, Note, European, TNBC, ADHD, GAP, BioLite, DSM-IV codes, GMP, Investigational New Drug, MDS, Common stock, UCSF, NSCLC, Dietary supplement, Research, Good manufacturing practice, Cancer, University, Security (finance), Pancreatic cancer, Drug development, TGA, FDA, Map, Consultant, Variable, Toxicity, Metastasis, Patent, MDD, Triple-negative breast cancer, License, Long-term care, Net, US FDA, Pharmaceutical industry

As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).

Key Points: 
  • As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of $10 per share).
  • The Company entered a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd. (“Zhonghui”).
  • On February 06, 2024, ABVC acquired an additional real estate asset via an equity transfer of 703,495 shares at $3.50 per share to develop plant factories for ABVC’s botanical pipeline.
  • ABVC hopes the property will ultimately be used as an integrated platform for the global development of the Asian healthcare business and the medical, pharmaceutical, and biotechnology industries.

Strainsforpains CEO Simon Shainberg Discusses Entering 191 Billion Dollar Anti-Inflammatory Market, and Strategic Partnership and Research Potential with GenBio Corp.

Retrieved on: 
Thursday, March 14, 2024
Toxicity, Health, Longevity, Drug discovery, Science, Media, Partnership, Education, Patient, Research, Security (finance), Investigational New Drug, OTC, Catalog, Immune system, International Cannabinoid Research Society, Nursing, Pharmaceutical industry

Strainsforpains is also progressing towards its change of symbol on the OTC Markets, with its upcoming audited financials within 2024.

Key Points: 
  • Strainsforpains is also progressing towards its change of symbol on the OTC Markets, with its upcoming audited financials within 2024.
  • In Australia, there are natural extracts that demonstrate outstanding potential in the medical and health field.
  • GenBio has reviewed numerous natural extracts over the last five years.
  • GenBio’s current research program is a potentially powerful anti-inflammatory drug program with lower toxicity than existing pharmaceutical drugs.

Monte Rosa Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 14, 2024
Rat, Finance, Patient, Roche, Food and Drug Administration, Therapy, GLP, Rheumatology, Inflammasome, Research, Triple-negative breast cancer, CDK2, Public expenditure, Investigational New Drug, Cancer, VAV1, MGD, Prostate cancer, NSCLC, PD, Neoplasm, Inflammation, Senior, Dermatology, AACR, MYC, Poster, FDA, SCLC, DSM-IV codes, Administration, Growth, Fast Track, NLRP3, Toxicology, Research and development, Pharmaceutical industry

“We made excellent pipeline and corporate progress during 2023 and early 2024, highlighted by the encouraging initial clinical results reported from our MRT-2359 Phase 1/2 study in October.

Key Points: 
  • “We made excellent pipeline and corporate progress during 2023 and early 2024, highlighted by the encouraging initial clinical results reported from our MRT-2359 Phase 1/2 study in October.
  • Edmund has more than 25 years of experience as a finance professional and has been with Monte Rosa since March of 2021.
  • Monte Rosa expects to subsequently initiate proof-of-concept studies in autoimmune diseases spanning gastroenterology, dermatology, rheumatology, and neurology indications.
  • The increase of $54 million was primarily related to the proceeds from the Roche collaboration and registered direct offering in Q4 2023.