Paclitaxel

Oncolytics Biotech® Reports First Quarter 2024 Financial Results and Operational Highlights

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木曜日, 5月 9, 2024
Breast cancer, FDA, Cancer, SCCA, Paclitaxel, FOLFIRINOX, International, Pancreatic cancer, Research, Thought, Immunotherapy, Breast, TSX, PR, AB, Conference, ONC, ASCO, TIL, Anal canal, Patient, Society, Pancreatic Cancer Action Network, Anal, Ethics, Annual general meeting, Pelareorep, Type, Anal cancer, CGMP, Medical imaging

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Key Points: 
  • ET
    SAN DIEGO and CALGARY, AB, May 9, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced recent operational highlights and financial results for the first quarter ended March 31, 2024.
  • General and administrative expenses for the first quarter of 2024 were $3.0 million, compared to $3.2 million for the first quarter of 2023.
  • Research and development expenses for the first quarter of 2024 were $5.7 million, compared to $3.5 million for the first quarter of 2023.
  • The net loss for the first quarter of 2024 was $6.9 million, compared to a net loss of $6.4 million for the first quarter of 2023.

Kexing Biopharm Teams Up with Qingfeng Pharma for the Global Market on Olaparib Tablets

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金曜日, 5月 10, 2024
USD, Cancer, NCCN, Trastuzumab, Tablet, GC, PARP, Pancreatic cancer, Breast cancer, Prostate cancer, BRCA, Eribulin, Malignancy, Marketing, GMP, Paclitaxel, EPO, Ovarian cancer, Birth control

Kexing Biopharm signed a cooperation agreement with Kerui Pharma, a subsidiary of Qingfeng Pharmaceutical Group (hereinafter referred to as "Qingfeng Pharma"), for the international commercialization of Olaparib Tablets.

Key Points: 
  • Kexing Biopharm signed a cooperation agreement with Kerui Pharma, a subsidiary of Qingfeng Pharmaceutical Group (hereinafter referred to as "Qingfeng Pharma"), for the international commercialization of Olaparib Tablets.
  • The agreement grants Kexing Biopharm the rights to commercialize Qingfeng Pharma-manufactured Olaparib Tablets in 10 oversea countries.
  • Since the beginning of 2024, Kexing Biopharm has received numerous on-site GMP inspections by health authorities from various oversea countries.
  • As the company licenses in more new products, its global presence will continue to grow, and mark a bright future.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended March 31, 2024

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月曜日, 5月 6, 2024
Charcot–Marie–Tooth disease, FDA, Venetoclax, OHSU, Innovation, National Cancer Institute, BPD, Development, IND, CNS, NET, Schizophrenia, EVOLUTION, JHU, Azacitidine, NCI, FCCC, Deficit spending, IP, Paclitaxel, IIS, Food, European Patent Convention, CMT, Borderline personality disorder, Communication, Conference, AML, Aggression, Convertible bond, FMS, ALS, Phase, Kabuki syndrome, HOPE, Safety, SCLC, DSM-IV codes, EMA, Clinical trial, Medicine, EPO, Investigational New Drug, Duration, Platinum, Bangladesh Technical Education Board, Phase II, MRD, ICIS, MSKCC, Disease, Measure (mathematics), CRADA, Dor, Patent, HDAC6, Data analysis, Genomics, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the first quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the first quarter.
  • Research and development (R&D) expenses were $2.6 million for the quarter ended March 31, 2024, compared to $4.4 million for the quarter ended March 31, 2023.
  • General and administrative expenses were $0.9 million for the quarter ended March 31, 2024, compared to $1.2 million for the quarter ended March 31, 2023.
  • Net losses were $1.1 for the quarter ended March 31, 2024, respectively, compared to $1.4 million for the quarter ended March 31, 2023.

Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer After Surgery With Curative Intent

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木曜日, 5月 9, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, B21, Radiation, DFS, Paclitaxel, Food, Merck & Co., Immunotherapy, Eisai, Data monitoring committee, Rated R, PDUFA, ADC, Patient, Endometrial cancer, Cancer, MSI-H, Carboplatin, MRK, Pharmaceutical industry

The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.

Key Points: 
  • The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Merck will work with investigators to share the results with the scientific community.
  • “We would like to thank all the patients, the investigators and our study collaborators for their participation in this trial.”
    In the U.S., KEYTRUDA has two approved indications in endometrial cancer.

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

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金曜日, 5月 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

Top Five Cancer Types Dominate New US Cases as Biotech Sector Eyes $314B Market by 2032

Retrieved on: 
金曜日, 5月 3, 2024
PFS, United Nations, FDA, Mutation, Daiichi Sankyo, Pancreatic cancer, Bio-Rad Laboratories, MBC, ONC, Prostate cancer, Paper, Behavior, Breast cancer, AstraZeneca, Paclitaxel, Fast track (FDA), Woman, TSX, CELC, DdPCR, Oncolytics Biotech, Ageing, Therapy, Pelareorep, Combination therapy, Combination, Mutant, Survival, Research, Cancer, MRD, Progression-free survival, Marketing, Immunotherapy, AHN, PCR, United, Patient, Type, Pharmaceutical industry

VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- According to a "highly troubling" new study, the rising number of cancer cases in young people is being attributed to "accelerated aging." Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).

Key Points: 
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer.
  • "These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

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火曜日, 4月 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

Retrieved on: 
火曜日, 4月 30, 2024
FDA, Pancreatic cancer, News, Breast, Fulvestrant, Fast track (FDA), ONC, MBC, PFE, Classification, ICE3, Breast cancer, Paclitaxel, Learning, Kidney, Woman, Economics, Hand, Traction, TSX, Optimism, Eli Lilly and Company, Patient satisfaction, Proteolysis, Freezing, Survival, NEO, Marketing, Clinical trial, CDK, University, Progression-free survival, Recurrence, Disease, Chimera, Patient, Liver, Neoplasm, Type, Growth, Pharmaceutical industry

VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).

Key Points: 
  • Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients.
  • "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics.
  • "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer.
  • The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer.

Compass Therapeutics Receives FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Patients with Metastatic or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated

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木曜日, 4月 25, 2024
Compass, FDA, FTD, Paclitaxel, Food, BTC, Survival, R&D, MD, Doctor of Philosophy, Fast track (FDA), Observation, Therapy, Patient, Pharmaceutical industry

CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study

Key Points: 
  • CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study
    Top-line data readout for COMPANION-002, the Company’s randomized Phase 2/3 BTC U.S. study, is expected by the end of 2024
    BOSTON, April 25, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel for the treatment of patients with metastatic or locally advanced BTC that have been previously treated.
  • “We are delighted that CTX-009 has received FDA Fast Track Designation highlighting the large unmet need in patients with advanced BTC where current therapies have low, single digit response rates, and limited effect on patient survival,” said Thomas Schuetz, MD, PhD, Co-founder, President of R&D, and Vice Chairman of the Compass board.
  • “Our current study is evaluating the combination of CTX-009 with paclitaxel following the observation of nine partial responses in 24 patients treated in our Phase 2 study, leading to an overall response rate of 37.5% (n= 9/24), a median progression free survival of 9.4 months and a median overall survival of 12.5 months.
  • Compass remains on track to complete enrollment by mid-year and reporting top-line data by year end.”

PEP-Therapy and Institut Curie Announce First Patients Dosed in Phase Ib Clinical Trial Evaluating PEP-010 in Ovarian and Pancreatic Cancers

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木曜日, 4月 25, 2024
Phases of clinical research, Paclitaxel, Cell, Safety, Pharmacokinetics, Drug development, PP2A, Apoptosis, Index, Conference, PDAC, MTD, Patient, Principal, OC, AACR, Curie Institute (Paris), Pharmaceutical industry

PEP-010 is a pro-apoptotic agent which has demonstrated a good safety and tolerability profile and first signals of efficacy in the CLEVer-PEPtide Phase Ia dose escalation clinical trial.

Key Points: 
  • PEP-010 is a pro-apoptotic agent which has demonstrated a good safety and tolerability profile and first signals of efficacy in the CLEVer-PEPtide Phase Ia dose escalation clinical trial.
  • Four sites in France are currently recruiting: Institut Curie, Gustave Roussy, Centre François Baclesse and Institut de Cancérologie de l'Ouest.
  • “We are thrilled to see the first patients dosed in this Phase Ib trial.
  • Christophe Le Tourneau, Medical Oncologist at Institut Curie, Head of the Department of Drug Development and Innovation (D3i), and Principal Investigator of the CLEVer-PEPtide trial.