Carbonyl compounds

BeyondSpring Announces Positive Topline Results from its DUBLIN-3 Registrational Trial of Plinabulin in Combination with Docetaxel for the Treatment of 2nd/3rd Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Wild Type

Retrieved on: 
Wednesday, August 4, 2021

Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.

Key Points: 
  • Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.
  • The DUBLIN-3 Phase 3 trial is a randomized, single blind to patients, active controlled, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with measurable lung lesion.
  • Plinabulin in combination with docetaxel (DP) showed statistically significant improvements compared to docetaxel alone (D) with topline data summarized below for ITT population (DP: n=278; D: n=281).
  • Now that checkpoint inhibitor immunotherapy has moved into first line, there is a vacuum in this indication, where treatment is heavily centered around docetaxel.

Fidia announces the FDA Orphan Drug designation for ONCOFID®-P for the treatment of malignant mesothelioma, the cancer caused by exposure to asbestos

Retrieved on: 
Monday, July 26, 2021

ONCOFID-P is an anticancer drug in advanced clinical development for the loco-regional treatment of non-muscle invasive bladder cancer, on which it has already demonstrated potent efficacy and excellent tolerability.

Key Points: 
  • ONCOFID-P is an anticancer drug in advanced clinical development for the loco-regional treatment of non-muscle invasive bladder cancer, on which it has already demonstrated potent efficacy and excellent tolerability.
  • The onset of mesothelioma is closely related to exposure to asbestos, used as an insulator in many industries, from constructions to naval-aircraft and heavy industries.
  • ONCOFID-P is an innovative anti-cancer drug, a conjugate of paclitaxel (taxol) with hyaluronic acid (HA), resulting from the research of Fidia Farmaceutici.
  • Mesothelioma occurs in subjects exposed to this substance for work or proximity to sources of asbestos and after decades of exposure.

Athenex Provides Update from FDA Type A Meeting Regarding Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer

Retrieved on: 
Tuesday, July 6, 2021

The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer.

Key Points: 
  • The FDA was supportive and encouraged the Company to continue development of oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
  • We continue to believe that, if approved, oral paclitaxel and encequidar has the potential to address a major unmet need in metastatic breast cancer.
  • Athenex is also developing oral paclitaxel and encequidar for the treatment of cutaneous angiosarcoma, for which it has received Orphan Drug Designation from the FDA.
  • Athenex also received Orphan Designations from the European Commission for oral paclitaxel and encequidar for the treatment of soft tissue sarcoma.

SHAREHOLDER ALERT: Robbins LLP is Investigating Athenex, Inc. (ATNX) for Shareholders

Retrieved on: 
Monday, June 7, 2021

Shareholder rights law firm Robbins LLP is investigating Athenex, Inc. (NASDAQ: ATNX) to determine whether certain Athenex officers and directors violated the Securities Exchange Act of 1934 and breached their fiduciary duties to the Company.

Key Points: 
  • Shareholder rights law firm Robbins LLP is investigating Athenex, Inc. (NASDAQ: ATNX) to determine whether certain Athenex officers and directors violated the Securities Exchange Act of 1934 and breached their fiduciary duties to the Company.
  • Athenex is a global clinical stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next generation drugs for the treatment of cancer.
  • One of the Company's main drug candidates is an oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
  • Robbins LLP is a nationally recognized leader in shareholder rights law.

Panbela Presents Clinical Data on Phase 1b Clinical Trial of SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA at 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021

The conclusion of theposter is that SBP-101 may enhance first-line treatment with gemcitabine and nab-paclitaxel patients with metastatic PDA.

Key Points: 
  • The conclusion of theposter is that SBP-101 may enhance first-line treatment with gemcitabine and nab-paclitaxel patients with metastatic PDA.
  • We look forward to initiating a randomized phase 2 study in metastatic PDA mid-year.
  • In the response-evaluable subjects in cohort 4 + Phase 1b (N=29), 11 had treatment with SBP-101 interrupted to evaluate retinal toxicity; this may impact final efficacy results.
  • SBP-101 was well-tolerated when administered at doses and schedules tested in combination with G+A in subjects with previously untreated metastatic pancreatic adenocarcinoma.

Deciphera Pharmaceuticals Presents Data from QINLOCK® and Rebastinib Programs at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 4, 2021

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.
  • As of a March 19, 2021 cutoff date, 38 patients with endometrial cancer initiated treatment with rebastinib in combination with weekly paclitaxel 80 mg/m2.
  • Of the 38 patients with endometrial cancer who initiated treatment with rebastinib, the median duration of treatment was 3.7 months.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

ORIC Pharmaceuticals Reports Initial Clinical Data Being Presented at ASCO from Phase 1b Trial of ORIC-101 in Combination with Nab-Paclitaxel

Retrieved on: 
Wednesday, June 2, 2021

The data will also be presented in two posters at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4 8, 2021.

Key Points: 
  • The data will also be presented in two posters at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4 8, 2021.
  • We are excited to share initial data from our ORIC-101 clinical program in patients with advanced solid tumors.
  • We are continuing to enroll patients in the expansion cohorts and look forward to reporting updated data from the Phase 1b trial in 2022.
  • This press release contains interim results based on initial data from the ORIC-101 clinical trial in combination with nab-paclitaxel, including preliminary safety and antitumor activity analyses, as of the data cutoff date.

AB Science communicates results from Phase 3 study evaluating masitinib in prostate cancer

Retrieved on: 
Wednesday, May 26, 2021

AB Science SA (Euronext FR0010557264 AB) communicated the results from phase 3 study evaluating masitinib in prostate cancer during the webcast that was held on May 25, 2021.

Key Points: 
  • AB Science SA (Euronext FR0010557264 AB) communicated the results from phase 3 study evaluating masitinib in prostate cancer during the webcast that was held on May 25, 2021.
  • The development program in prostate cancer is comprised of AB07004 phase 1/2 proof of concept study (n=34 pts), which supported the combination of masitinib with docetaxel in mCRPC, and AB12003 phase 3 study also in mCRPC patients.
  • Study AB12003 was an international (16 countries), multicenter (67 sites), randomized, double blind, placebo-controlled, 2-parallel group, phase 3 study in mCRPC patients eligible to chemotherapy.
  • A new patent was filed based on results from study AB12003, which would permit AB Science to retain exclusive rights on the use of masitinib in Prostate cancer until 2042.

Apexigen Announces Presentation of Phase 2 Clinical Data on CD40 Antibody, Sotigalimab (APX005M), in Combination Therapy for Metastatic Pancreatic Cancer at the ASCO 2021 Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021

We are encouraged by the clinical benefit observed with the novel combination regimen of sotigalimab and standard of care gemcitabine/nab-paclitaxel.

Key Points: 
  • We are encouraged by the clinical benefit observed with the novel combination regimen of sotigalimab and standard of care gemcitabine/nab-paclitaxel.
  • Yang continued, \xe2\x80\x9cBeyond these promising data, we are particularly encouraged by the pharmacodynamic effects of sotigalimab.
  • These include an increase in activated myeloid dendritic cells and M1 macrophages, which demonstrates the on-mechanism and differentiated activity of sotigalimab.
  • Seven product or product candidates discovered using APXiMAB are currently commercially available or in clinical development, either internally by Apexigen or by its licensees.

Addition of Relacorilant to Nab-Paclitaxel Improves Progression Free Survival (PFS) in Controlled, Phase 2 trial of 178 Patients with Platinum Resistant Ovarian Cancer

Retrieved on: 
Thursday, May 6, 2021

Sixty patients received 150 mg relacorilant the day before, the day of and the day after their infusion of nab-paclitaxel.

Key Points: 
  • Sixty patients received 150 mg relacorilant the day before, the day of and the day after their infusion of nab-paclitaxel.
  • Fifty-eight patients received 100 mg relacorilant every day, with titration up to 150 mg permitted at the investigator\xe2\x80\x99s discretion.
  • Because relacorilant increases nab-paclitaxel plasma levels, the nab-paclitaxel dose in patients receiving relacorilant was 80 mg/m2.
  • Corcept is studying relacorilant in a variety of serious disorders, including ovarian, pancreatic and castration-resistant prostate cancer and Cushing\xe2\x80\x99s syndrome.