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Details:
PCM-075 (onvansertib) is a PLK-1 inhibitor, which is being evaluated in combination with Folfiri & Bevacizumab for the treatment of second-line RAS-mutated metastatic colorectal cancer.
Lead Product(s): Onvansertib,Cetuximab,Bevacizumab
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
PCM-075 (onvansertib) is a PLK-1 inhibitor, which is being evaluated in combination with Folfiri & Bevacizumab for the treatment of second-line RAS-mutated metastatic colorectal cancer.
Lead Product(s): Onvansertib,Cetuximab,Bevacizumab
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
Onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma.
Lead Product(s): Onvansertib,Bevacizumab,Calcium Folinate
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Details:
PCM-075 (onvansertib) is a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as KRAS/NRAS-mutated cancers.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2023
Details:
Durable responses to treatment, with a median duration of response (mDoR) of 11.7 months, reported in Phase 1b/2 clinical trial of PCM-075 (onvansertib) plus FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2022
Details:
PCM-075 (onvansertib) effectively targets PLK1 an enzyme over-expressed in many cancer types. It’s been known for decades to to be hijacked by tumor cells allowing uncontrolled growth in the M phase of the cell cycle.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
Data showed that combining PCM-075 (onvansertib) with olaparib led to a statistically significant survival benefit compared to treatment with either agent alone in each of the three evaluated PDX models. Results showed combination was well tolerated.
Lead Product(s): Onvansertib,Olaparib
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
The webinar will include presentation of new data from Cardiff Oncology's Phase 1b/2 clinical trial evaluating onvansertib in combination with standard-of-care FOLFIRI/bevacizumab in KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Calcium Folinate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2021
Details:
This trial is an open-label, multi-center study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide®), leucovorin, and 5-FU as a second-line treatment in patients with metastatic PDAC.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Fluorouracil
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2021
Details:
Two-fold increase (29% to 63%) in disease control rate at 12 weeks (the trial's primary efficacy endpoint) seen in patients receiving onvansertib for 14 days vs. 5 days in a 21-day cycle.
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Onvansertib
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 11, 2021
Details:
Trial will evaluate the safety and efficacy of onvansertib in combination with standard-of-care for second-line treatment of patients with metastatic PDAC who have failed first line treatment with a gemcitabine-based chemotherapy regimen.
Lead Product(s): Onvansertib,Irinotecan Hydrochloride,Calcium Folinate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
Initial findings from Cardiff Oncology's EAP for onvansertib in KRAS-mutated mCRC are similar to results from the Phase 1b trial. In the EAP, 66% of the patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses.
Lead Product(s): Onvansertib,Bevacizumab,Calcium Folinate
Therapeutic Area: Oncology Product Name: Onvansertib
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
The presentation highlighted the safety, tolerability and anti-leukemic activity of onvansertib in combination with decitabine in patients with difficult-to-treat relapsed/refractory AML.
Lead Product(s): Onvansertib,Decitabine
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2020
Details:
Safety demonstrated across all three dose/dose scheduling cohorts, including cohort C with onvansertib dosed over a longer period of time than cohorts A and B (onvansertib on Days 1 - 14 in a 21-day cycle).
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: PCM-075
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
The addition of onvansertib to standard-of-care shows promise as a novel second-line option for patients with difficult-to-treat KRAS-mutated mCRC.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
Data highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.
Lead Product(s): Onvansertib,Decitabine
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
The Expanded Access Program (or compassionate use) is a program recognized by the FDA as a follow-on to their granting Fast Track Designation to onvansertib.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Details:
The USFDA reviewed Company's request for Fast Track designation and concluded that investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer meets the criteria.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2020
Details:
Cardiff Oncology's agreement with PoC Capital follows the Company's announcement of positive safety and efficacy data from its Phase 1b trial. The data demonstrate clinical benefit in patients treated with onvansertib in combination with FOLFIRI/Avastin.
Lead Product(s): Onvansertib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: PoC Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding May 13, 2020
Details:
In the Phase 1b dose escalation, the 1st two dose levels have been cleared for safety; the 3rd dose level is enrolling; the maximum tolerated dose has not been reached to-date.
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2020
Details:
Data presented at the ASCO-GI meeting in late January showed the effectiveness of onvansertib against all prevalent KRAS mutations associated with mCRC
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2020
Details:
Onvansertib demonstrates efficacy in Zytiga®-resistant metastatic castration-resistant prostate cancer (mCRPC) across known androgen receptor resistance mechanisms.
Lead Product(s): Onvansertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
The trial will evaluate the safety and efficacy of onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab).
Lead Product(s): Onvansertib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2020
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