Ira Pastan

Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

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Friday, October 27, 2023
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REDWOOD CITY, Calif. and SHANGHAI, China, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and  Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 1877; SSE: 688180) today announced that the U.S. Food and Drug Administration (FDA) approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. LOQTORZI is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-1 ligands PD-L1 and PD-L2 with high potency at a unique site on the PD-1 receptor, enabling the immune system to activate and kill the tumor.

Key Points: 
  • The approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status.
  • LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone.
  • “Following etesevimab, toripalimab has become Junshi Biosciences’ second product to receive FDA approval for commercialization—an achievement that will further enhance the company’s international presence.
  • Currently, the establishment of toripalimab’s global commercialization network is in progress, and the network aims to span over 50 countries.

OncoHost to Present Proteomics-Based Predictive Biomarker for Immune-Related Adverse Events in NSCLC Patients at SITC 2023

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Tuesday, October 31, 2023
NSCLC, Incidence, Gastrointestinal tract, ICIS, Biomarker, SomaLogic, MD, Liver, Skin, Protein, Quality of life, SITC, Immunotherapy, Growth, Immune system, Medicine, Risk, Annual general meeting, Lung cancer, Society, Patient, Vaccine, Pharmaceutical industry, Plasma, CARY, Ira Pastan

BINYAMINA, Israel and CARY, N.C., Oct. 31, 2023 /PRNewswire/ -- OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, has developed a novel computational model for predicting significant immune-related adverse events (irAEs) in patients with non-small cell lung cancer (NSCLC) based on proteomic profiling of pre-treatment blood samples. The study was conducted using OncoHost's PROphet® platform and will be presented as a poster at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting.

Key Points: 
  • The study was conducted using OncoHost's PROphet® platform and will be presented as a poster at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting.
  • IrAEs can manifest at any point during a patient's treatment, with the highest incidence occurring within the first three months.
  • We are excited about these results and look forward to improving the overall quality of cancer care for patients worldwide."
  • OncoHost's predictive model was developed on a cohort of 426 ICI-treated NSCLC patients taking part in the company's ongoing, multicenter PROPHETIC clinical trial ( NCT04056247 ).

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

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Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Qilu Pharmaceutical announces the latest results from its clinical study on QL1706, in combination with chemotherapy, as a first-line treatment for recurrent or metastatic cervical cancer

Retrieved on: 
Wednesday, October 25, 2023
CR, Response evaluation criteria in solid tumors, Bevacizumab, Survival, Patient, PD-L1, Carboplatin, New Drug Application, Cervical cancer, Incidence, ESMO, Progression-free survival, Trae tha Truth, Center for Drug Evaluation and Research, DOR, DCR, Squamous-cell carcinoma, Cisplatin, The New England Journal of Medicine, Neoplasm, Treatment, European Society for Medical Oncology, PFS, PD-1, American Society of Clinical Oncology, HIV disease progression rates, CC, Chinese, Multimedia, CPS, Paclitaxel, Immunotherapy, CDE, Diagnosis, Oncology, ORR, Anemia, RECIST, NDA, Safety, Ira Pastan, OS, Toxicity, Cohort, Performance, CI, Pharmaceutical industry, Medical imaging

This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).

Key Points: 
  • This trial studied the use of QL1706 (iparomlimab and tuvonralimab) in combination with chemotherapy, with or without bevacizumab, as a first-line treatment of recurrent or metastatic cervical cancer (r/mCC).
  • Moreover, the treatment exhibited a manageable safety profile without any new safety signals observed, making it a potential new first-line treatment option for r/mCC patients.
  • Currently, the preferred standard first-line treatment for r/mCC patients is cisplatin or carboplatin and paclitaxel plus bevacizumab, and efficacy and safety of the treatment also need to be considered.
  • For r/mCC patients with positive PD-L1 expression, the PD-1 inhibitor pembrolizumab, administered with chemotherapy and with or without bevacizumab, is recommended as the standard first-line treatment.

Checkpoint Therapeutics Announces Publication of Cosibelimab Pivotal Trial Results in the Journal for ImmunoTherapy of Cancer

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Wednesday, October 18, 2023
Patient, Paper, PD-L1, Immunodeficiency, PDUFA, Food, Immunotherapy, Safety, Society for Immunotherapy of Cancer, PD-1, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV disease progression rates, Journal, CKPT, JITC, Radiation, ORR, Biologics license application, Oncology, Immunology, Society, Toxicity, Ira Pastan, Vaccine, Pharmaceutical industry, Neoplasm, Cancer

WALTHAM, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma (“cSCC”), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer. The paper, entitled, “Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma” (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.

Key Points: 
  • Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity.
  • The study’s primary endpoint was objective response rate (“ORR”) assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1.
  • As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results.
  • “We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time.

Checkpoint Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

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Monday, August 14, 2023
CKPT, Immunotherapy, U.S. FDA, Patient, Autoimmune disease, PDUFA, Ira Pastan, Oncology, Research, FDA, Oliviero, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, Food, D, Pharmaceutical industry, Cryptocurrency, Video game

WALTHAM, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2023, and recent corporate highlights.

Key Points: 
  • Biologics License Application for cosibelimab under review by U.S. FDA; Successful mid-cycle meeting with U.S. FDA completed; PDUFA goal date of January 3, 2024
    WALTHAM, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2023, and recent corporate highlights.
  • R&D Expenses: Research and development expenses for the second quarter of 2023 were $13.9 million, compared to $12.1 million for the second quarter of 2022, an increase of $1.8 million.
  • General and administrative expenses for the second quarter of 2023 included $0.8 million of non-cash stock expenses, compared to $0.5 million for the second quarter of 2022.
  • Net loss for the second quarter of 2023 included $1.0 million of non-cash stock expenses, compared to $0.7 million for the second quarter of 2022.

Checkpoint Therapeutics Announces Cosibelimab Longer-Term Results Demonstrating Substantial Increases in Complete Response Rates in Advanced Cutaneous Squamous Cell Carcinoma

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Thursday, July 27, 2023
Radiation, Neoplasm, Immunotherapy, Autoimmunity, Prescription Drug User Fee Act, Ira Pastan, Patient, Autoimmune disease, PD-1, Oncology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, PD-L1, FC, Food, Safety, Pharmaceutical industry

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:

Key Points: 
  • “We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint.
  • Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity.
  • The application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024.
  • Checkpoint plans to present these updated results at an upcoming medical conference.

BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO

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Friday, June 2, 2023
Survival rate, BioNTech, Interim, Doctor of Philosophy, Therapeutic index, Cancer, Fast Track, Treatment of lung cancer, Lung cancer, Immunotherapy, ASCO, American Society of Clinical Oncology, Patient, BNTX, Ira Pastan, PD-1, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PD-L1, Society, Food, Pharmaceutical industry, NSCLC

The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile.

Key Points: 
  • The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile.
  • The results featured at the ASCO Annual Meeting include a total of 27 patients with metastatic, PD-(L)1-resistant NSCLC, available for tumor response assessment who have received at least two doses of 10 mg/kg of BNT316/ONC-392.
  • “Metastatic NSCLC has a very poor prognosis with a 5-year survival rate of only 9%2.
  • The Phase 3 trial, PRESERVE-003 ( NCT05671510 ), is planned to start in Q3 2023.

Results of Phase I Clinical Study of Qilu Pharma's PD-1/CTLA-4 Bifunctional Antibody Iparomlimab/Tuvonralimab Published Online in Journal of Hematology & Oncology

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Friday, May 12, 2023
Carcinoma, Human, Index, Ira Pastan, PD, JHO, Half-life, Hematology, Neoplasm, CI, Sun, Trae tha Truth, Pharmacokinetics, Lung cancer, NSCLC, Immunotherapy, Hypothyroidism, Sun Yat-sen University Cancer Center, Rash, Nasopharyngeal carcinoma, Incidence, Journal, Dor, Cervical cancer, Patient, Phases of clinical research, Itch, MTD, NPC, PD-1, ORR, Safety, Pharmaceutical industry, Vaccine, Medical imaging

JINAN, China, May 12, 2023 /PRNewswire/ -- On May 8, 2023, Journal of Hematology & Oncology (JHO, 2022 impact factor of 23.168) published the results of the Phase I clinical study of Qilu Pharma's immunotherapy bifunctional antibody, QL1706 (J Hematol Oncol.

Key Points: 
  • JINAN, China, May 12, 2023 /PRNewswire/ -- On May 8, 2023, Journal of Hematology & Oncology (JHO, 2022 impact factor of 23.168) published the results of the Phase I clinical study of Qilu Pharma's immunotherapy bifunctional antibody, QL1706 (J Hematol Oncol.
  • The results provide further support for the use of dual immunotherapy in patients with advanced solid tumors.
  • The CTLA-4 antibody has a shorter elimination half-life in vivo, with a shorter exposure for CTLA-4 antibodies in a dosing cycle.
  • This study provides strong support for further clinical research of QL1706, which is expected to become a new approach of dual immunotherapy.

Results of Phase I Clinical Study of Qilu Pharma's PD-1/CTLA-4 Bifunctional Antibody Iparomlimab/Tuvonralimab Published Online in Journal of Hematology & Oncology

Retrieved on: 
Thursday, May 11, 2023
Carcinoma, Human, Index, Ira Pastan, PD, JHO, Half-life, Hematology, Neoplasm, CI, Sun, Trae tha Truth, Pharmacokinetics, Lung cancer, Toxicity, Multimedia, NSCLC, Immunotherapy, Hypothyroidism, Sun Yat-sen University Cancer Center, Rash, Nasopharyngeal carcinoma, Incidence, Journal, Dor, Cervical cancer, Patient, Immunoglobulin G, Phases of clinical research, Itch, MTD, NPC, PD-1, ORR, Safety, Pharmaceutical industry, Medical imaging

The results provide further support for the use of dual immunotherapy in patients with advanced solid tumors.

Key Points: 
  • The results provide further support for the use of dual immunotherapy in patients with advanced solid tumors.
  • The CTLA-4 antibody has a shorter elimination half-life in vivo, with a shorter exposure for CTLA-4 antibodies in a dosing cycle.
  • QL1706 therefore not only has a synergistic mechanism to block PD-1 and CTLA-4, but also reduces the toxicity of CTLA-4 antibodies.
  • First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.