On May 26, 2021 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, reported that it has decided to advance CFT8919, a novel degrader of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC), into investigational new drug (IND)-enabling studies and anticipates filing an IND for this program by mid-2022, with the goal to initiate a Phase 1/2 clinical trial by year-end 2022 (Press release, C4 Therapeutics, MAY 26, 2021, View Source [SID1234580610]).
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"The ongoing progress we have made across our portfolio reflects our goal of transforming patient care through the development of novel protein degraders," said Andrew Hirsch, chief executive officer of C4 Therapeutics. "We are excited to announce that we recently determined we will advance CFT8919, a BiDAC degrader targeting EGFR in NSCLC, into IND-enabling studies and now expect to submit an IND for this program in mid-2022 to enable the initiation of a clinical trial by year-end 2022. We are also looking forward to sharing the first preclinical data for CFT8919 at the upcoming Keystone Symposium for Targeted Protein Degradation in early June. These efforts are part of our ongoing efforts to advance treatments for patients through targeted protein degradation and, with the advancement of this program, we remain on track to achieve our goal to have four product candidates in the clinic by year-end 2022."
CFT8919, a Potent and Mutant-Selective BiDAC Degrader of EGFR L858R
The preclinical data C4T will present at the upcoming Keystone Symposium establish CFT8919 as a potent and selective degrader of EGFR L858R that is based on an allosteric EGFR binding motif. As a single agent, CFT8919 is active in both in vitro and in vivo models of EGFR L858R-driven NSCLC without resistance-causing secondary mutations in EGFR, as well as in similar models that harbor secondary resistance mutations such as EGFR T790M and C797S. Additionally, CFT8919 demonstrates intracranial activity, indicating that it has the potential to treat brain metastases. Together, these data suggest CFT8919 may be active, as single agent, in patients with resistance to EGFR inhibitors due to secondary mutations in EGFR, including T790M and C797S, as well as in the front-line setting with the potential to avoid the emergence of resistance-causing secondary EGFR mutations seen with currently approved EGFR inhibitors.
Progress to 2021 Key Milestones:
Initiate patient dosing for CFT7455 in 1H 2021. The Company’s first-in-human Phase 1/2 clinical trial of CFT7455 is open for enrollment and clinical sites have begun to screen patients. The program remains on track to begin dosing patients in 1H 2021. The Phase 1/2 clinical trial is an open-label, two-part, dose-escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies, including multiple myeloma and various non-Hodgkin’s lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
Submit an IND application for CFT8634 in 2H 2021. CFT8634 is an orally bioavailable BiDAC degrader targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
Advance the BRAF program into IND-enabling studies in 2021. The objective of the BRAF program is to develop an orally bioavailable BiDAC degrader targeting BRAF V600E mutations for the treatment of genetically defined solid tumors, including locally advanced or metastatic melanoma and non-small cell lung cancer (NSCLC). The BRAF program is partnered with Roche.
Continue lead optimization activities for the RET program through 2021. The objective of the RET program is to develop an orally bioavailable BiDAC degrader targeting genetically altered RET for the treatment of solid tumors, including relapsed or refractory NSCLC and sporadic medullary thyroid cancers that are resistant to RET inhibitors.
Upcoming Events
May 26, 2021 – C4T will participate in a Fireside Chat at 8:00 am ET at the UBS Global Healthcare Conference. Details of this event are available on the Investors section of the C4T website, under Events & Presentations.
June 1, 2021 – C4T will participate in a Fireside Chat at 10:30 am ET at the Jefferies Global Healthcare Conference. Details of this event are available on the Investors section of the C4T website, under Events & Presentations.
June 6-9, 2021 – C4T will present preclinical data from CFT8919 in a virtual poster presentation at the Keystone Symposium, Targeted Protein Degradation: From Small Molecules to Complex Organelles.
June 7, 2021 – C4T will host a live webcast at 8:00 a.m. E.T. to discuss the CFT8919 preclinical data presented at the Keystone Symposium. Details of this event are included below.
June 18-22, 2021 – C4T will present preclinical data on CFT7455 in non-Hodgkin’s lymphoma (NHL) at the 16th Annual ICML meeting. CFT7455 is a novel, IKZF1/3 MonoDAC degrader that has demonstrated potent tumor regression in a spectrum of NHL xenograft models.
Investor Event and Webcast Information
C4T will host a live webcast on Monday, June 7, 2021 at 8:00 a.m. E.T. to discuss the CFT8919 data presented at the Keystone Symposium. The webcast can be accessed through the Events and Presentations page on the Investors section of C4T’s website at www.c4therapeutics.com. A replay of the webcast will be available on C4T’s website for 30 days following the event.