PD-1

Tempest Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Donnerstag, Mai 9, 2024
Immunotherapy, FDA, Society, Nivolumab, Research, National Cancer Institute, Bevacizumab, PD-1, ASCO, Journal, Therapy, Liver, Patient, NCI, SITC, RCC, AACR, Kidney cancer, FFA, Growth, HCC, Pharmaceutical industry

BRISBANE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • BRISBANE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2024, and provided a corporate update.
  • These data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO 2022.
  • Tempest ended the quarter with $32.3 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023.
  • Based on its current cash and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2025.

Iovance Biotherapeutics Reports First Quarter 2024 Financial Results and Corporate Updates

Retrieved on: 
Donnerstag, Mai 9, 2024
Momentum, IOV, Epidemiology, FDA, Investment, Lung cancer, Intellectual property, Research, National Cancer Institute, Units of paper quantity, ASCO, Endometrial cancer, TIL, Death, Cancer, Food, Second generation, Food and Drug Administration, Safety, Poster, Uterine cancer, PD-1, Next Generation, Melanoma, Marketing, Clinical trial, Investigational New Drug, Cohort, MMR, Information, Patient, Society, Interim, Growth, Pharmaceutical industry

SAN CARLOS, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2024 financial results and corporate updates. 

Key Points: 
  • Launch Following U.S. Food and Drug Administration (FDA) Approval
    SAN CARLOS, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first quarter 2024 financial results and corporate updates.
  • Iovance remains on track to onboard approximately 50 ATCs by the end of May 2024 and expects to have more than 70 ATCs onboarded by the end of 2024.
  • In the first quarter of 2024, Iovance completed the transfer of marketing authorizations and began distribution of Proleukin.
  • Beginning in the second quarter of 2024, Iovance expects to recognize significant incremental revenues for Proleukin as part of the Amtagvi treatment regimen.

Anaptys Announces First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Donnerstag, Mai 9, 2024
American Academy, Ulcerative colitis, BDCA2, American Association of Immunologists, CDAI, American Academy of Dermatology, PD-1, IND, Week, AAI, Therapy, Patient, Graft-versus-host disease, Rheumatoid arthritis, AAD, Atopic dermatitis, BTLA, SAN, UC, Pharmaceutical industry

“This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist.

Key Points: 
  • “This quarter, we continued to enroll patients globally across three Phase 2 trials for our two best-in-class checkpoint agonists: ANB032, our BTLA agonist, and rosnilimab, our PD-1 agonist.
  • Collaboration revenue was $7.2 million for the three months ended March 31, 2024, compared to $1.4 million for the three months ended March 31, 2023.
  • Research and development expenses were $37.0 million for the three months ended March 31, 2024, compared to $35.0 million for the three months ended March 31, 2023.
  • General and administrative expenses were $12.3 million for the three months ended March 31, 2024, compared to $10.8 million for the three months ended March 31, 2023.

Coherus Announces Clinical Collaboration with the Cancer Research Institute for a Novel Combination Evaluating LOQTORZI® (toripalimab-tpzi) with ENB Therapeutics' ENB-003 for the Treatment of Ovarian Cancer

Retrieved on: 
Mittwoch, Mai 8, 2024
Immunotherapy, CHRS, University, Ovary, Hope, Safety, CRI, Principal investigator, PD-1, CHUM, Cancer Research Institute, Patient, Cancer, DSC, Melanoma, Faculty, Therapy, ENB, Ovarian cancer, Pharmaceutical industry

Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors, including melanoma, ovarian, and pancreatic cancers.

Key Points: 
  • Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors, including melanoma, ovarian, and pancreatic cancers.
  • Dr. Stagg continued, “The iPROC study DSC brings together a group of scientific experts within the CRI community to select promising combinations and rapidly advance them to clinical trials.
  • Importantly, the DSC is not confined by a pipeline but looks to work with companies with drugs that have a strong data package.
  • For this multiparty platform study to succeed, it requires science-driven, highly collaborative, and engaged companies.

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

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Montag, Mai 6, 2024
AAAAI, Angioedema, Cell, Research, Enrollment, Itch, Atopic dermatitis, Injection, Congress, American Academy, Skin, PN, ILT4, Allergy, KIT, Cold urticaria, Therapy, Omalizumab, Neuropeptide, Patient, UAS7, Survival, PD-1, Rockefeller University, EAACI, Hypersensitivity, Clinical trial, Xeroderma, CSU, G&A, B cell, Prurigo nodularis, Myelocyte, Disease, Inflammation, Eosinophilic esophagitis, Pharmaceutical industry

HAMPTON, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Revenues: Total revenue was $0.2 million in the first quarter of 2024, compared to $1.0 million for the comparable period in 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $9.1 million in the first quarter of 2024, compared to $6.6 million for the comparable period in 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

BioNTech Announces First Quarter 2024 Financial Results and Corporate Update

Retrieved on: 
Montag, Mai 6, 2024
Drug discovery, CLDN6, Fast Track, Lung cancer, AI, CRC, Webcast, PDAC, BioNTech, Pfizer, Genentech, Prevalence, Corporation, Vaccination, Deutsche Bundesbank, Influenza, Food, Roche, Omicron, ADC, Toxicity, Tumor antigen, Messenger, NSCLC, Telephone, Combination therapy, Pfizer–BioNTech COVID-19 vaccine, Patient, Safety, HER3, Pembrolizumab, RNA, PD-1, Docetaxel, Digital, DNA, Observational study, Neoplasm, First, Investigational New Drug, EDT, Recurrence, PD-L1, Antigen, Bank statement, Breakthrough therapy, Uridine, COVID-19, Pharmaceutical industry

MAINZ, Germany, May 6, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today reported financial results for the three months ended March 31, 2024, and provided an update on its corporate progress.

Key Points: 
  • 1 Calculated applying the average foreign exchange rate for the three months ended March 31, 2024, as published by the German Central Bank (Deutsche Bundesbank).
  • BioNTech is now focused on preparing for variant strain vaccine adaptation to be ready for commercial launch ahead of the upcoming 2024/2025 vaccination season, pending approvals.
  • In March, BioNTech announced that Annemarie Hanekamp will be joining the Company’s Management Board as Chief Commercial Officer on July 1, 2024.
  • Second Quarter 2024 Financial Results and Corporate Update: August 5, 2024
    Innovation Series (Digital & AI Day): October 1, 2024
    BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, May 6, 2024, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for three months ended March 31, 2024.

Arcus Biosciences Reports First-Quarter 2024 Financial Results and Provides a Pipeline Update

Retrieved on: 
Mittwoch, Mai 8, 2024
Oncology, Health, FDA, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, PFS, Cancer, Research and development, CD73, Security (finance), HR, Pancreatic cancer, Progression-free survival, Research, Renal cell carcinoma, Access code, Bevacizumab, Webcast, OS, PD-1, Administration, Roche, PD-L1, ASCO, PDAC, TKI, Data, Lung, TIGIT, AACR, Clinical trial, AXL, Pharmaceutical industry

Financial Results for First Quarter 2024:

Key Points: 
  • Financial Results for First Quarter 2024:
    Cash, Cash Equivalents and Marketable Securities were $1.1 billion as of March 31, 2024, compared to $866 million as of December 31, 2023.
  • Net Loss was $4 million for the first quarter 2024, compared to $80 million for the same period in 2023.
  • Arcus will host a conference call and webcast today, May 8, at 1:30 PM PT / 4:30 PM ET to discuss its first-quarter 2024 financial results and pipeline updates.
  • To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com .

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

Retrieved on: 
Montag, Mai 6, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, BMY, Safety, Pharmacokinetics, Food, Ipilimumab, Research, Biologics license application, PD-1, ASCO, PDUFA, Checkmate, Patient, Society, Physician, Serum, BLA, Bristol Myers Squibb, File, Pharmaceutical industry

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025.

Key Points: 
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025.
  • “We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb.
  • Additionally, subcutaneous nivolumab showed noninferiority of the key powered secondary endpoint of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) vs. IV Opdivo.
  • The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

Retrieved on: 
Sonntag, Mai 5, 2024
UTI, Congress, FDA, FGFR, Cancer, Urinary diversion, Pyelonephritis, Erdafitinib, Hospital, Safety, Food, American Urological Association, Survival rate, FGFR3, Johnson & Johnson, Recurrence, Abstract, Cohort, BCG, PD-1, PD-L1, Disease, Bladder cancer, Patient, Medicine, AUA, Urinary bladder, MUC, Face, SAN, Sepsis, EAU, Pharmaceutical industry

SAN ANTONIO, May 5, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from an open-label, multicenter, multi-cohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. These data were featured today in an Oral Presentation Session (Abstract # PD48-02) at the 2024 American Urological Association (AUA) Annual Meeting taking place May 3-6, 2024, in San Antonio, Texas.

Key Points: 
  • First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.
  • "Results presented today further underscore that TAR-210 for the localized treatment of bladder cancer may offer a promising alternative for patients with limited treatment options."
  • At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the 2 cohorts.
  • Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence-free (RF) survival rate was 90%.

Purple Biotech's Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting

Retrieved on: 
Donnerstag, April 25, 2024
PFS, Efficacy, Safety, DCR, Risk, Nivolumab, Randomness, SOC, Drug resistance, Death, CM24, Tumor microenvironment, OS, PD-1, PDAC, ASCO, Cancer, Patient, Society, CA19-9, Interim, BMS, Neoplasm, Bristol Myers Squibb, Annual general meeting, Pharmacodynamics, Escape Room, Pharmaceutical industry

REHOVOT, Israel, April 25, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced that interim results from its randomized, controlled, open label, multicenter Phase 2 study of CM24, a first in class immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC), have been selected as late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting which will take place on May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • The primary endpoint of the study is overall survival (OS), with progression free survival (PFS) and objective response rate (ORR) as secondary endpoints.
  • The study was designed as Bayesian to evaluate the potential benefit of the experimental arm vs SoC and is not powered for hypothesis testing.
  • Approximately 60 patients have been enrolled in the randomized study in 18 centers in the U.S., Spain and Israel.
  • “We are honored to be selected by the ASCO committee with our late breaking abstract poster presentation and are looking forward to presenting our interim results from our randomized Phase 2 CM24 study at the ASCO 2024 annual meeting.” stated Gil Efron, Chief Executive Officer of Purple Biotech.