CSCC

Checkpoint Therapeutics to Present at the Virtual Fortress Biotech R&D Summit Hosted by B. Riley Securities

Retrieved on: 
Lundi, avril 4, 2022
BLA, CSCC, Private Securities Litigation Reform Act, Risk, Pemetrexed, Fortress Biotech, NASDAQ, Patent, Investor, Marketing, Dana–Farber Cancer Institute, Clinical trial, News, Calendar, CKPT, Research, Summit, Webcast, Platinum, EGFR, Biologics license application, Baozou Big News Events, Securities Exchange Act of 1934, U.S. Securities and Exchange Commission, Securities Act of 1933, COVID-19, Data, Regulation, GLOBE, Annual report, Acquisition, Patient, Online gambling, Pharmaceutical industry

The Summit will be hosted by the B. Riley Securities Healthcare Equity Research team and will feature multiple programs from Fortress diversified pipeline.

Key Points: 
  • The Summit will be hosted by the B. Riley Securities Healthcare Equity Research team and will feature multiple programs from Fortress diversified pipeline.
  • Checkpoint will present a corporate overview and participate in a panel discussion on Wednesday, April 6, 2022 at 2:15 p.m.
  • Checkpoint Therapeutics, Inc. (Checkpoint) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.
  • Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO).

Checkpoint Therapeutics Reports Full-Year 2021 Financial Results and Recent Corporate Highlights

Retrieved on: 
Lundi, mars 28, 2022
BLA, CSCC, Private Securities Litigation Reform Act, Risk, Marketing, Pemetrexed, Fortress Biotech, NASDAQ, Biologics license application, Patent, D, Dana–Farber Cancer Institute, Clinical trial, CKPT, Research, Coronavirus Scientific Advisory Board (Turkey), Platinum, EGFR, Safety, Securities Exchange Act of 1934, U.S. Securities and Exchange Commission, Securities Act of 1933, COVID-19, Data, Regulation, GLOBE, Drug Quality and Security Act, Annual report, FDA, Acquisition, Patient, Pharmaceutical industry, Online gambling, Airline

WALTHAM, Mass., March 28, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2021 and recent corporate highlights.

Key Points: 
  • WALTHAM, Mass., March 28, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (Checkpoint) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the full-year ended December 31, 2021 and recent corporate highlights.
  • In March 2021, Checkpoint announced the formation of a Scientific Advisory Board comprised of clinical and scientific thought leaders in oncology.
  • Checkpoint Therapeutics, Inc. (Checkpoint) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.
  • Following positive topline results in metastatic cSCC, Checkpoint intends to submit a Biologics License Application for this indication later this year.

InflaRx Receives Corrected Advice Letter from FDA Related to Phase III Program for Vilobelimab in Hidradenitis Suppurativa

Retrieved on: 
Jeudi, mars 17, 2022
Pyoderma gangrenosum, Letter, Autoimmunity, GLOBE, Hidradenitis suppurativa, Patient, Agency, Therapy, FDA, Nasdaq, Inflammation, COVID-19, CSCC, Pyoderma, Complement, Food, Company, Receptor (biochemistry), Population, Blood, ANCA, End organ damage, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, C5a, Pharmaceutical industry, HS, Phase

We appreciate the prompt feedback from the FDA clarifying the advice received in February, stated Dr. Korinna Pilz, Chief Clinical Development Officer.

Key Points: 
  • We appreciate the prompt feedback from the FDA clarifying the advice received in February, stated Dr. Korinna Pilz, Chief Clinical Development Officer.
  • In light of this corrected advice from FDA, InflaRx believes that further development in HS is feasible.
  • Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, and has recently reported positive Phase II results in ANCA-associated vasculitis and Phase IIa results in pyoderma gangrenosum.
  • Vilobelimab is in Phase III development for the treatment of critically ill COVID-19 patients and in Phase II development for patients suffering from cutaneous squamous cell carcinoma (cSCC).

Shattuck Labs Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Business Highlights

Retrieved on: 
Mardi, mars 15, 2022
Trial of the century, TIGIT, Conference, Skin, ARC, Society, Head, Neck, Regulation Fair Disclosure, HNSCC, Combination therapy, AML, Observation, SEC, Intravenous therapy, Private Securities Litigation Reform Act, Income, Acral lentiginous melanoma, COVID-19, Lymphoma, Disclosure, Immunotherapy, Administration, Clinical trial, CSCC, Ovarian cancer, Research, Safe harbor, Red blood cell, Research and development, OX40, Patient, Monocyte, Squamous cell carcinoma, Regulation, Collaboration, NASDAQ, Cell, Â, TP53, CD47, Pharmacokinetics, GLOBE, Annual report, Investment, PD-L1, Safety, Neoplasm, Acute myeloid leukemia, ARCS, Company, PD-1, R, Autoimmune disease, Azacitidine, Medical imaging, Pharmaceutical industry, Cancer, CD40

AUSTIN, TX and DURHAM, NC, March 15, 2022 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided recent business highlights.

Key Points: 
  • In acute myeloid leukemia (AML), Shattuck plans to evaluate SL-172154 in combination with both azacitidine and venetoclax.
  • Collaboration Revenue: Revenue for the fourth quarter of 2021, was $30.1 million, as compared to $1.3 million for the fourth quarter of 2020.
  • Research and Development (R&D) Expenses: R&D expenses were $16.2 million for the fourth quarter of 2021, as compared to $9.8 million for the fourth quarter of 2020.
  • General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the fourth quarter of 2021, as compared to $3.6 million for the fourth quarter of 2020.

InflaRx Announces Vilobelimab Trial in Pyoderma Gangrenosum Selected for Late-Breaker Oral Presentation at 2022 AAD Annual Meeting

Retrieved on: 
Mardi, mars 8, 2022
Associate, Mayo Clinic, C5a, MA, Patient, American Academy, Complement, CSCC, Inflammation, Blood, ANCA, AAD, COVID-19, Association, PG, Hidradenitis suppurativa, Pyoderma gangrenosum, Receptor (biochemistry), Autoimmunity, Pyoderma, Nasdaq, Clinical professor, GLOBE, Therapy, Pharmaceutical industry, Dermatology

Dr. Alavi will present updated results in her presentation, which will include PG ulcer status during the observational period from the third cohort, along with other outcome measures.

Key Points: 
  • Dr. Alavi will present updated results in her presentation, which will include PG ulcer status during the observational period from the third cohort, along with other outcome measures.
  • Positive data from the third cohort of patients in this study were announced in October 2021.
  • Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated.
  • Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, and has recently reported positive Phase II results in ANCA-associated vasculitis and pyoderma gangrenosum.

Instil Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Lundi, mars 7, 2022
IMPACT, Research, United Kingdom, BLA, Patient, Investment, Cervical cancer, TIL, European Medicines Agency, Population, TILS, Safety, PD-1, Large-cell lung carcinoma, CSCC, HNSCC, MAA, Company, Cancer, Disease, Head, Trial of the century, BRAF, IND, Costar, Initiate, NSCLC, Melanoma, GLOBE, NASDAQ, Pharmaceutical industry, Renewable energy, Vaccine, Video game, DALLAS, Instil

DALLAS, March 07, 2022 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, today reported its fourth quarter and year end 2021 financial results and provided a corporate update.

Key Points: 
  • In 2022, we look forward to the opportunity to expand the targeted patient population for receiving our therapies in multiple indications with ITIL-168 and ITIL-306."
  • Instil expects top-line safety and efficacy data in 2023 which could potentially support BLA submission and a European Medicines Agency marketing authorization application (MAA) filing.
  • Research and development expenses were $42.6 million and $107.3 million for the fourth quarter and full year ended December31, 2021, compared to $10.2 million and $19.4 million for the fourth quarter and full year ended December31, 2020, respectively.
  • General and administrative expenses were $11.2 million and $48.3 million for the fourth quarter and full year ended December31, 2021, compared to $7.2 million and $14.4 million for the fourth quarter and full year ended December31, 2020, respectively

InflaRx Provides Update on Development Plans for Vilobelimab in Hidradenitis Suppurativa

Retrieved on: 
Lundi, février 28, 2022
GLOBE, Therapy, Abscess, HS, Type, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, End organ damage, Letter, Hidradenitis suppurativa, COVID-19, Company, Pyoderma, CSCC, Receptor (biochemistry), Review, Inflammation, Food, Complement, Agency, FDA, Blood, Nasdaq, Patient, C5a, ANCA, Autoimmunity, Pharmaceutical industry, Phase

The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint in the Phase III trial.

Key Points: 
  • The feedback indicates that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint in the Phase III trial.
  • Given the unexpected details of the feedback from the FDA, InflaRx will pause activities related to the Phase III trial.
  • Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, and has recently reported positive Phase II results in ANCA-associated vasculitis and pyoderma gangraenosum.
  • Vilobelimab is in Phase III development for the treatment of critically ill COVID-19 patients and in Phase II development for patients suffering from cutaneous squamous cell carcinoma (cSCC).

Bicara Therapeutics Initiates Dose Expansion Arm of Phase 1/1b Clinical Study of BCA101 in Disease-Specific Cohorts

Retrieved on: 
Mardi, février 22, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Harvard Medical School, EGFR, Head, Neoplasm, SCAC, Time, Trust, HNSCC, PD-1, Therapy, CSCC, Safety, TGF, Trial of the century, Cetuximab, Recurrence, Squamous cell carcinoma, Cancer, Assistant, Patient, Tumor microenvironment, Immunotherapy, Anal canal, Pembrolizumab, Vaccine, Pharmaceutical industry, Medicine, BCA101, Bicara Therapeutics, BCA101, BICARA THERAPEUTICS

We are pleased that the observed safety, pharmacokinetic, pharmacodynamic and efficacy profiles of BCA101 to date have enabled us to declare a recommended dose for expansion, said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics.

Key Points: 
  • We are pleased that the observed safety, pharmacokinetic, pharmacodynamic and efficacy profiles of BCA101 to date have enabled us to declare a recommended dose for expansion, said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics.
  • The dose expansion arm of the study follows the successful completion of a Phase 1/1b open-label, multicenter dose escalation study of BCA101 in patients with EGFR-driven advanced solid tumors that identified a recommended dose.
  • It will assess the efficacy, safety and tolerability of BCA101 at 1500mg intravenously weekly in three initial expansion cohorts.
  • Bicaras lead asset, BCA101, a first-in-class EGFR / TGF--trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study.

InflaRx Reports Progress in Ongoing Phase II Clinical Trial with Vilobelimab in Cutaneous Squamous Cell Carcinoma

Retrieved on: 
Mercredi, février 16, 2022
Pembrolizumab, Patient, Immunosuppression, Incidence, Pyoderma, Phase, CSCC, Hope, Enrollment, Nasdaq, Skin, Autoimmunity, Safety, Therapy, Arm, Skin cancer, Skin Cancer Foundation, Steering Committee for Humanitarian Response, Inflammation, ANCA, End organ damage, Disease, Blood, Anti-neutrophil cytoplasmic antibody, PD-1, Squamous cell carcinoma, Committee, Hidradenitis suppurativa, Receptor (biochemistry), COVID-19, Complement, GLOBE, C5a, Pharmaceutical industry

The open label, non-comparative, two-stage, Phase II trial ( NCT04812535 ) is ongoing at sites in Europe, the U.S. and elsewhere.

Key Points: 
  • The open label, non-comparative, two-stage, Phase II trial ( NCT04812535 ) is ongoing at sites in Europe, the U.S. and elsewhere.
  • The study is investigating two independent arms: vilobelimab alone (Arm A) and vilobelimab in combination with pembrolizumab (Arm B).
  • Over 300 people have been treated with vilobelimab in completed clinical trials, and the antibody has been shown to be well tolerated.
  • Vilobelimab is currently being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis and pyoderma gangraenosum, as well as other areas, such as critical COVID-19 and cutaneous squamous cell carcinoma (cSCC).

NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) with PD-L1 Checkpoint Inhibitor in High-Risk Skin Cancers

Retrieved on: 
Lundi, février 7, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Industry, Skin Cancer Foundation, Skin, NIT, GSK, PricewaterhouseCoopers, Eli Lilly, Recurrence, Skin cancer, MCC, Melanoma, Company, Cancer, Hoffmann-La Roche, Clinical trial, BMS, Infection, Amgen, KOSDAQ, IL-7, Patient, Roche, Safety, Squamous cell carcinoma, Novartis, CEO, CSCC, Immunity, Pharmaceutical industry, Pfizer, Genentech, NT-I7, NeoImmuneTech, NT-I7, NEOIMMUNETECH

All three of these skin cancers can grow rapidly and have the potential to be fatal if left untreated.

Key Points: 
  • All three of these skin cancers can grow rapidly and have the potential to be fatal if left untreated.
  • Melanoma and MCC are less common forms of skin cancer, but they are notable for spreading rapidly and carrying a high risk for recurrence.
  • Skin cancer is the most common form of cancer in the U.S., accounting for more diagnoses than all other cancers combined1.
  • This open-label, multicenter Phase 2a study will evaluate the safety, tolerability and anti-tumor effect of the combination therapy.