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Details:
Under the termination, Infinity has continued to prepare for the initiation of a planned global Phase 2 clinical trial evaluating IPI-549 (eganelisib) in head and neck squamous cell carcinoma.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination July 24, 2023
Details:
IPI-549 (eganelisib) is a first-in-class, oral, once-daily, immuno-oncology candidate that selectively inhibits phosphoinositide-3-kinase gamma, which is investigated in Combination with Pembrolizumab in Patients with Squamous Cell Cancer of the Head and Neck (SCCHN).
Lead Product(s): Eganelisib,Pembrolizumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2023
Details:
The Combination will create a company with a diverse product development pipeline led by a planned new global Phase 2 clinical trial evaluating IPI-549 (eganelisib) in head and neck squamous cell carcinoma (HNSCC)
Lead Product(s): Eganelisib,Pembrolizumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger February 23, 2023
Details:
IPI-54 (Eganelisb) in combination therapy has demonstrated positive resutls total tumor volume reduction is 92.8% and 85.2%, and disease control rates is 92.8% and 81.4%, in PD-L1 frontline TNBC patients.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 05, 2022
Details:
IPI-549 (eganelisib ), a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 December 10, 2021
Details:
IPI-549 (eganelisib) immuno-oncology macrophage reprogramming therapeutic that selectively inhibits phosphoinositide-3-kinase gamma used as a frontline regimentriple negative breast cancer.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 December 06, 2021
Details:
At the one-year landmark, 59% of patients in the ITT population receiving the eganelisib plus nivolumab combination remained alive, compared to 32% in the nivolumab control arm.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 July 27, 2021
Details:
MARIO-3 is a Phase 2 triplet combination study evaluating the addition of eganelisib to the approved standard of care combination of Tecentriq® and Abraxane® in the front-line setting in TNBC.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 July 20, 2021
Details:
In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Arcus Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2021
Details:
The Phase 1b clinical trial is a global multi-center, open-label trial of CERC-007 that will enroll around 12 subjects with active adult onset Still’s disease with a primal goal of the study will be to determine the safety and tolerability of CERC-007 in AOSD patients.
Lead Product(s): Eganelisib,Etrumadenant
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Arcus Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2021
Details:
Infinity intends to use net proceeds from the offering for the continued clinical development of eganelisib, for general corporate purposes and for working capital.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler & Co
Deal Size: $92.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 18, 2021
Details:
Infinity intends to use net proceeds from the offering for the continued clinical development of eganelisib, for general corporate purposes and for working capital.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler & Co.
Deal Size: $80.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 12, 2021
Details:
The objective of MARIO-275 was to address the need for better treatments for second line (2L) advanced UC patients. Combination of eganelisib with nivolumab demonstrated improved ORR, DCR, and PFS versus 2L standard of care nivolumab monotherapy.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
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:
Infinity Pharmaceuticals' randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab in platinum-refractory, I/O naïve patients with advanced, metastatic urothelial cancer over nivolumab monotherapy which is approved in this setting.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
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 06, 2021
Details:
The combination was well tolerated at the 30 mg dose of eganelisib and provided patient benefit relative to the placebo controlled arm on important response rate and progression free survival measures.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
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 06, 2021
Details:
The addition of eganelisib to treatment with atezolizumab and nab-paclitaxel has led to very encouraging overall response rates of 100% in PD-L1 positive patients and 50% in PD-L1 negative patients.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 December 09, 2020
Details:
Data from melanoma and SCCHN cohorts demonstrate eganelisib was well tolerated in combination with Opdivo®. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
Infinity is currently enrolling patients in MARIO-3, the Company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq® and Abraxane® in TNBC.
Lead Product(s): Eganelisib,Atezolizumab,Paclitaxel
Therapeutic Area: Oncology Product Name: IPI-549
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 September 29, 2020
Details:
MARIO-275: MARIO-275 is the company’s ongoing controlled, randomized Phase 2 study evaluating eganelisib in combination with Opdivo® in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb, or BMS.
Lead Product(s): Eganelisib,Nivolumab
Therapeutic Area: Oncology Product Name: IPI-549
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 July 30, 2020
Details:
With commitment to the continued advancement of IPI-549, the Company anticipates potential delays in trial enrollment.
Lead Product(s): Eganelisib,Nivolumab
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 April 07, 2020
Details:
Infinity is currently enrolling patients in MARIO-275 to evaluate IPI-549 in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer.
Lead Product(s): Eganelisib,Nivolumab
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 March 25, 2020
Details:
The funds will be used for all ongoing IPI-549 clinical trials through key data readouts.
Lead Product(s): Eganelisib,Nivolumab,Atezolizumab
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Undisclosed
Partner/Sponsor/Collaborator: BVF Partners L.P
Deal Size: $71.5 million Upfront Cash: Undisclosed
Deal Type: Financing January 09, 2020
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