– Investigational New Drug (IND) Application for Lead Candidate CFT7455, a MonoDAC™ targeting IKZF1/3 for the Treatment of Hematologic Malignancies, Under FDA Review; Initiation of Phase 1/2 Trial Expected in 1H 2021 –
– IND Application Submission for CFT8634, a BiDAC™ targeting BRD9 for Synovial Sarcoma and SMARCB1-deleted Tumors, Planned for 2H 2021 –
– BRAF and RET Programs Expected to Advance to IND-enabling Studies During 2021 –
– Year-End Cash, Cash Equivalents and Marketable Securities Expected to Provide Runway to End of 2023 –
WATERTOWN, MA, USA I January 06, 2021 I 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, announces key milestones for 2021, including C4T’s transition into a clinical-stage company and advancement of the Company’s pioneering targeted protein degrader portfolio.
“C4T’s achievements in 2020, including the recent IND submission for our lead candidate, position us for considerable progress in 2021,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Pending FDA clearance, we look forward to initiating our first clinical trial, evaluating CFT7455 for the treatment of hematologic malignancies. In addition, leveraging the capabilities of our TORPEDO™ platform, we are advancing a broad portfolio of differentiated targeted protein degraders, which we believe have distinctive benefits over traditional small molecule approaches. This includes plans to submit an IND for CFT8634 and progress two additional BiDAC programs into IND-enabling studies, alongside continued investment in our discovery efforts. These strategic objectives keep us on track to deliver four programs into the clinic by the end of 2022.”
“This is an exciting time for C4T as we embark on our first clinical study, advancing our mission to transform patient treatment through targeted protein degradation,” said Marc Cohen, executive chairman and co-founder of C4 Therapeutics. “I would like to acknowledge the tremendous work of the entire C4T team over the last five years to get us to this inflection point.”
2021 ANTICIPATED KEY MILESTONES
- Initiate a Phase 1/2 clinical trial for CFT7455 in relapsed or refractory non-Hodgkin lymphomas and multiple myeloma in 1H 2021. CFT7455 is an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma.
- Submit an IND application for CFT8634 in 2H 2021. CFT8634 is an orally bioavailable BiDAC (Bifunctional Degradation Activating Compound) targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
- Advance our BRAF program into IND-enabling studies in 2021. The goal of our BRAF program is to develop an orally bioavailable BiDAC targeting BRAF V600E for the treatment of genetically defined, solid tumors including locally advanced or metastatic melanoma and non-small cell lung cancer (NSCLC). Our BRAF program is partnered with Roche.
- Advance our RET program into IND-enabling studies in 2021. The goal of our RET program is to develop an orally bioavailable BiDAC 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.
RECENT HIGHLIGHTS
In addition, the Company also provided an update on recent progress:
- IND Submitted for CFT7455: In December 2020, C4T submitted an IND application for its lead candidate, CFT7455, targeting IKZF1/3 for the treatment of relapsed or refractory non-Hodgkin lymphomas and multiple myeloma.
- Continued to Strengthen Leadership Team: Kelly Schick has been appointed chief people officer. Ms. Schick will be joining C4T in January 2021 from AMAG Pharmaceuticals, where she served as senior vice president, chief human resources officer and head of corporate engagement. In addition, Kendra Adams was appointed senior vice president, communications and investor relations. Ms. Adams joined C4T in November 2020 from Agios Pharmaceuticals where she served as vice president, external communications and investor relations.
- Completed Upsized Initial Public Offering: In October 2020, C4T completed an upsized initial public offering of 11.0 million shares of common stock, including the full exercise of the underwriters’ over-allotment option, at a price of $19.00 per share. Net proceeds from the offering were $191.1 million.
CASH GUIDANCE
Unaudited cash, cash equivalents and short-term investments as of December 31, 2020, were approximately $370 million. C4T expects its cash, cash equivalents and short-term investments, including payments anticipated to be received under existing collaboration agreements, will be sufficient to fund its operating plan to the end of 2023.
UPCOMING INVESTOR EVENTS
- January 14, 2021 – C4T will present at the 39th Annual J.P. Morgan Healthcare Conference
- March 16, 2021 – C4T will participate in the Guggenheim Targeted Protein Degradation Day
About C4 Therapeutics
C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.
SOURCE: C4 Therapeutics
Post Views: 51
– Investigational New Drug (IND) Application for Lead Candidate CFT7455, a MonoDAC™ targeting IKZF1/3 for the Treatment of Hematologic Malignancies, Under FDA Review; Initiation of Phase 1/2 Trial Expected in 1H 2021 –
– IND Application Submission for CFT8634, a BiDAC™ targeting BRD9 for Synovial Sarcoma and SMARCB1-deleted Tumors, Planned for 2H 2021 –
– BRAF and RET Programs Expected to Advance to IND-enabling Studies During 2021 –
– Year-End Cash, Cash Equivalents and Marketable Securities Expected to Provide Runway to End of 2023 –
WATERTOWN, MA, USA I January 06, 2021 I 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, announces key milestones for 2021, including C4T’s transition into a clinical-stage company and advancement of the Company’s pioneering targeted protein degrader portfolio.
“C4T’s achievements in 2020, including the recent IND submission for our lead candidate, position us for considerable progress in 2021,” said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. “Pending FDA clearance, we look forward to initiating our first clinical trial, evaluating CFT7455 for the treatment of hematologic malignancies. In addition, leveraging the capabilities of our TORPEDO™ platform, we are advancing a broad portfolio of differentiated targeted protein degraders, which we believe have distinctive benefits over traditional small molecule approaches. This includes plans to submit an IND for CFT8634 and progress two additional BiDAC programs into IND-enabling studies, alongside continued investment in our discovery efforts. These strategic objectives keep us on track to deliver four programs into the clinic by the end of 2022.”
“This is an exciting time for C4T as we embark on our first clinical study, advancing our mission to transform patient treatment through targeted protein degradation,” said Marc Cohen, executive chairman and co-founder of C4 Therapeutics. “I would like to acknowledge the tremendous work of the entire C4T team over the last five years to get us to this inflection point.”
2021 ANTICIPATED KEY MILESTONES
- Initiate a Phase 1/2 clinical trial for CFT7455 in relapsed or refractory non-Hodgkin lymphomas and multiple myeloma in 1H 2021. CFT7455 is an orally bioavailable MonoDAC (Monofunctional Degradation Activating Compound) targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma.
- Submit an IND application for CFT8634 in 2H 2021. CFT8634 is an orally bioavailable BiDAC (Bifunctional Degradation Activating Compound) targeting BRD9 for the treatment of synovial sarcoma and SMARCB1-deleted solid tumors.
- Advance our BRAF program into IND-enabling studies in 2021. The goal of our BRAF program is to develop an orally bioavailable BiDAC targeting BRAF V600E for the treatment of genetically defined, solid tumors including locally advanced or metastatic melanoma and non-small cell lung cancer (NSCLC). Our BRAF program is partnered with Roche.
- Advance our RET program into IND-enabling studies in 2021. The goal of our RET program is to develop an orally bioavailable BiDAC 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.
RECENT HIGHLIGHTS
In addition, the Company also provided an update on recent progress:
- IND Submitted for CFT7455: In December 2020, C4T submitted an IND application for its lead candidate, CFT7455, targeting IKZF1/3 for the treatment of relapsed or refractory non-Hodgkin lymphomas and multiple myeloma.
- Continued to Strengthen Leadership Team: Kelly Schick has been appointed chief people officer. Ms. Schick will be joining C4T in January 2021 from AMAG Pharmaceuticals, where she served as senior vice president, chief human resources officer and head of corporate engagement. In addition, Kendra Adams was appointed senior vice president, communications and investor relations. Ms. Adams joined C4T in November 2020 from Agios Pharmaceuticals where she served as vice president, external communications and investor relations.
- Completed Upsized Initial Public Offering: In October 2020, C4T completed an upsized initial public offering of 11.0 million shares of common stock, including the full exercise of the underwriters’ over-allotment option, at a price of $19.00 per share. Net proceeds from the offering were $191.1 million.
CASH GUIDANCE
Unaudited cash, cash equivalents and short-term investments as of December 31, 2020, were approximately $370 million. C4T expects its cash, cash equivalents and short-term investments, including payments anticipated to be received under existing collaboration agreements, will be sufficient to fund its operating plan to the end of 2023.
UPCOMING INVESTOR EVENTS
- January 14, 2021 – C4T will present at the 39th Annual J.P. Morgan Healthcare Conference
- March 16, 2021 – C4T will participate in the Guggenheim Targeted Protein Degradation Day
About C4 Therapeutics
C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.
SOURCE: C4 Therapeutics
Post Views: 51
