The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach

Inspirna Announces Interim Data from Phase 1b/2 Study of Abequolixron (RGX-104) in Relapsed or Refractory Lung Cancer

Retrieved on: 
Thursday, January 5, 2023

Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, announced today interim data from its ongoing Phase 1b/2 clinical trial of abequolixron in patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC).

Key Points: 
  • Inspirna, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule cancer therapeutics, announced today interim data from its ongoing Phase 1b/2 clinical trial of abequolixron in patients with non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC).
  • Abequolixron is currently being evaluated in a Phase 1b/2 clinical trial in combination with docetaxel in second- or third-line (2/3L) NSCLC as well as second-line (2L) SCLC.
  • The primary objectives of the study include characterizing the safety profile and the antitumor activity of the abequolixron and docetaxel combination.
  • In addition, this Phase 1b/2 study includes an ongoing expansion arm of abequolixron in combination with Yervoy (ipilimumab) in second- or third-line endometrial cancer as part of a clinical collaboration with Bristol Myers Squibb.

CASI PHARMACEUTICALS AND CLEAVE THERAPEUTICS ANNOUNCE CLINICAL TRIAL APPLICATION APPROVAL FOR CB-5339 IN PATIENTS WITH MULTIPLE MYELOMA IN CHINA

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Friday, January 6, 2023

ROCKVILLE, Md. and BEIJING, Jan. 6, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that the China National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics. CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy. The Phase 1 development program is expected to start in 2023.

Key Points: 
  • and BEIJING, Jan. 6, 2023 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announces that the China National Medical Products Administration (NMPA) has approved the Company's Clinical Trial Application (CTA) for CB-5339, a first-in-class VCP/p97 inhibitor from Cleave Therapeutics.
  • CASI is planning a Phase 1 development program in China of CB-5339 as a single agent to evaluate the PK/safety profile, select the Recommended Phase 2 Dose, and assess early signs of clinical efficacy.
  • Wei-Wu He, Ph.D., CASI's Chairman, and Chief Executive Officer, commented, "This is exciting news for CASI, as we are now a step closer to make CB-5339 available to patients and healthcare providers across Greater China.
  • CASI is responsible for the conduct of the clinical trials in China and will initiate the studies as soon as possible."

Immunitas Therapeutics Announces First Patient Dosed in Phase 1/2a Study of IMT-009

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Wednesday, January 4, 2023

WALTHAM, Mass., Jan. 4, 2023 /PRNewswire/ -- Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies. The company also announced the addition of James Wooldridge, M.D., to their Clinical Advisory Board.

Key Points: 
  • We look forward to further investigation of IMT-009 and its potential for patients awaiting improved treatment options."
  • The trial will subsequently transition into Phase 2 to assess the safety and efficacy of IMT-009 as a monotherapy and in combination with another anticancer agent.
  • The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D).
  • Immunitas is a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated treatments for patients with cancer.

Olema Oncology Announces OP-1250 Demonstrates Attractive Combinability with CDK 4/6 Inhibitor Palbociclib in Phase 1b Dose Escalation Study

Retrieved on: 
Wednesday, December 7, 2022

There was no dose-related increase in the incidence or severity of adverse events, and neutropenia events observed are consistent with the expected profile of palbociclib plus endocrine therapy.

Key Points: 
  • There was no dose-related increase in the incidence or severity of adverse events, and neutropenia events observed are consistent with the expected profile of palbociclib plus endocrine therapy.
  • “OP-1250 continues to demonstrate its potential to be the best-in-class endocrine therapy for ER+/HER2- breast cancer.
  • “These data show that OP-1250 combines well with palbociclib, including a tolerability profile consistent with palbociclib in combination with an aromatase inhibitor or fulvestrant, no drug-drug interaction, and no induced metabolism of palbociclib.
  • Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers.

First-in-Class Investigational SX-682 Demonstrates Single-Agent Efficacy in Patients with Hypomethylating Agent Failure Myelodysplastic Syndromes

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Friday, December 9, 2022

AUBURN, Wash., Dec. 9, 2022 /PRNewswire/ -- Syntrix Pharmaceuticals today announced results from a single-arm, open-label Phase 1 trial of single-agent SX-682, an investigational CXCR1/2 inhibitor, in patients with any-risk myelodysplastic syndromes (MDS) in whom front-line hypomethylating-agent (HMA) had failed, a high unmet need population.  Results support the clinical activity of SX-682.  The data will be presented by David Sallman, MD of the H. Lee Moffitt Cancer Center and Research Institute, an investigator for the clinical trial, during an afternoon oral session on December 12, 2022 at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #855).

Key Points: 
  • All patients were transfusion-dependent and all had failed prior HMA and 24% lenalidomide (range 1-4 failed prior therapies).
  • The median age was 76, and patients were low (n=1), intermediate-1 (n=10), intermediate-2 (n=5) and high (n=1) risk by the International Prognostic Scoring System (IPSS).
  • Myelodysplastic syndromes (MDS) are a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow.
  • Patients are treated with BID doses of SX-682 in six continuous 28-day cycles with responding patients continuing treatment.

Kronos Bio to Present Preclinical Data for KB-0742, an Oral CDK9 Inhibitor Targeting MYC-amplified Cancers, in Pediatric Cancer Models in Poster Presentation at EORTC-NCI-AACR 2022

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Wednesday, October 12, 2022

The poster will include preclinical data demonstrating that Kronos Bios internally discovered oral CDK9 inhibitor, KB-0742 induced regressions in a preclinical model of MYCN-amplified neuroblastoma tumors and inhibited growth in patient-derived xenograft (PDX) models of transcriptionally addicted Ewing sarcoma (EW) and alveolar rhabdomyosarcoma (ARMS).

Key Points: 
  • The poster will include preclinical data demonstrating that Kronos Bios internally discovered oral CDK9 inhibitor, KB-0742 induced regressions in a preclinical model of MYCN-amplified neuroblastoma tumors and inhibited growth in patient-derived xenograft (PDX) models of transcriptionally addicted Ewing sarcoma (EW) and alveolar rhabdomyosarcoma (ARMS).
  • This is the first preclinical analysis to support the investigational compounds potential in pediatric tumors.
  • Kronos Bio remains on track to provide an update on the study, including the Recommended Phase 2 Dose (RP2D) in the fourth quarter.
  • Kronos Bio is a biopharmaceutical company that is advancing three investigational compounds in clinical trials for patients with cancer.

Abbisko Therapeutics Completed Dosing of First Patient for Its First-in-Class Highly Selective FGFR2/3 Inhibitor ABSK061

Retrieved on: 
Monday, July 4, 2022

SHANGHAI, July 4, 2022 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (HKEX Stock Code: 2256.HK, referred to "Abbisko Therapeutics" hereafter) today announced completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally.

Key Points: 
  • SHANGHAI, July 4, 2022 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (HKEX Stock Code: 2256.HK, referred to "Abbisko Therapeutics" hereafter) today announced completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally.
  • ABSK061 is a next-generation, orally available, highly potent and selective small molecule FGFR2/3 inhibitor independently discovered and developed by Abbisko Therapeutics with global intellectual property rights.
  • Abbisko Therapeutics focuses on the research and development of new oncology drugs, with the core of small molecule precision therapy and small molecule tumor immunotherapy drugs.
  • As of date of press release, Abbisko Therapeutics has received 13 IND or clinical trial approvals in four countries and regions.

Treadwell Announces Initiation of Patient Dosing in TWT-203, a Phase 1b/2 study of TTK Inhibitor, CFI-402257, in Patients with ER+/Her2- Breast cancer

Retrieved on: 
Monday, June 13, 2022

Dosing of the first patient in the trial commenced June 8that START Mountain Region in Salt Lake City, Utah.

Key Points: 
  • Dosing of the first patient in the trial commenced June 8that START Mountain Region in Salt Lake City, Utah.
  • "We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor," said Dr. Michael Tusche, Treadwell co-CEO.
  • "Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors.
  • Treadwell Therapeutics is a clinical-stage multi-modality oncology company developing novel medicines to address unmet needs in patients with cancer.

Treadwell Announces Initiation of Patient Dosing in TWT-203, a Phase 1b/2 study of TTK Inhibitor, CFI-402257, in Patients with ER+/Her2- Breast cancer

Retrieved on: 
Monday, June 13, 2022

Dosing of the first patient in the trial commenced June 8that START Mountain Region in Salt Lake City, Utah.

Key Points: 
  • Dosing of the first patient in the trial commenced June 8that START Mountain Region in Salt Lake City, Utah.
  • "We are excited about the initiation of TWT-203 with our potent and selective TTK inhibitor," said Dr. Michael Tusche, Treadwell co-CEO.
  • "Previous clinical studies have demonstrated that CFI-402257 has a tolerable safety profile and confirmed responses in ER+/Her2- breast cancer after progression on CDK4/6 inhibitors.
  • Treadwell Therapeutics is a clinical-stage multi-modality oncology company developing novel medicines to address unmet needs in patients with cancer.

Olema Oncology Provides Clinical Update Reflecting Strong Progress Across OP-1250 Development Program

Retrieved on: 
Thursday, June 9, 2022

We are extremely pleased with the emerging clinical profile of OP-1250 and the encouraging progress achieved over the last six months.

Key Points: 
  • We are extremely pleased with the emerging clinical profile of OP-1250 and the encouraging progress achieved over the last six months.
  • Olema continues to be well capitalized with sufficient cash to fund our planned research and development operations into the second half of 2024.
  • Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for womens cancers.
  • Except as required by law, Olema assumes no obligation to update these forward-looking statements or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.