CCCC C4 Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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CFT7455
Hematologic malignancies
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Phase 1/2
Phase 1/2
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Phase 1/2 trial to be initiated 1H 2021.
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|
CFT8634
Synovial sarcoma
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Phase 1/2
Phase 1/2
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Phase 1/2 trial to be initiated 2H 2021.
|
Latest News
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– CFT7455 Demonstrated High Cereblon Binding Affinity and Rapid, Deep IKZF1/3 Degradation Enabling Activity across a Panel of Multiple Myeloma Cell Lines Including IMiD-Resistant Models –
– CFT7455 Promotes Sustained Degradation of IKZF1/3 and Durable Anti-tumor Response, Including Regressions in an IMiD-Insensitive Myeloma Tumor Xenograft Model –
– CFT7455 Phase 1/2 Trial in Multiple Myeloma and Non-Hodgkin Lymphomas On Track for 1H 2021 Initiation –
WATERTOWN, Mass., April 10, 2021 (GLOBE NEWSWIRE) -- 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, today presented preclinical data for CFT7455, the Company's lead program, a MonoDACTM degrader targeting IKZF1/3 for the treatment of hematologic malignancies. These results, which support clinical evaluation of CFT7455 in multiple myeloma, were delivered as a late-breaking oral presentation during the first session of the American Association for Cancer Research (AACR) Annual Meeting 2021.
"IKZF1/3 proteins are critical dependencies of B cell malignancies including multiple myeloma and subsets of non-Hodgkin's lymphoma," said Stewart Fisher, Ph.D., chief scientific officer of C4 Therapeutics. "We are pleased to share preclinical data demonstrating that potent catalytic IKZF1/3 degradation activity of CFT7455, coupled with optimized pharmacological properties, can result in regression of multiple myeloma xenograft tumors not responsive to approved IMiD therapies. We are optimistic that the in vitro and in vivo data we saw preclinically will translate into improved, clinically meaningful outcomes for patients and we look forward to initiating our CFT7455 Phase 1/2 clinical trial in the first half of this year."
Summary of Results
C4T conducted in vitro studies to confirm CFT7455's intended mechanism. Notable observations include:
- CFT7455 binds with high affinity to the E3 ligase adapter protein, cereblon (Kd = 0.9 nM);
- In vitro, CFT7455 treatment results in deep, rapid degradation of IKZF1/3 proteins, resulting in apoptotic cell death; and
- CFT7455 demonstrated broad, potent anti-proliferative activity in a panel of multiple myeloma cell lines.
In mouse xenograft models of IMiD-insensitive multiple myeloma, data further established CFT7455 as a highly potent, catalytic degrader of IKZF1/3, capable of generating anti-tumor activity as a single agent and in combination with dexamethasone. Notable observations include:
- In the H929 myeloma xenograft tumor model, daily oral administration of CFT7455 at 0.1 mg/kg for three weeks led to partial or complete tumor regression, with the latter being durable even after stopping treatment.
- CFT7455 produced deep and durable degradation of IKZF3 in the RPMI-8226 myeloma xenograft tumor model, which is relatively insensitive to pomalidomide. Tumor regression resulted from treatment with CFT7455 in both naïve RPMI-8226 tumors, as well as those previously exposed, but unresponsive, to pomalidomide.
- The combination of CFT7455 and dexamethasone in the RPMI-8226 tumor xenograft model yielded expected improvements in efficacy and survival outcomes in mice bearing RPMI-8226 xenograft tumors, compared to either agent used alone.
Based in part on these results, C4T plans to explore the therapeutic applications of CFT7455 for the treatment of relapsed or refractory multiple myeloma and non-Hodgkin's lymphomas and expects to initiate a Phase 1/2 clinical study of CFT7455 in the first half of 2021.
C4T's AACR Annual Meeting 2021 presentation will be archived on the "Scientific Publications" page in the Investors section of the Company's website, located at www.c4therapeutics.com.
About CFT7455
CFT7455 is an orally bioavailable MonoDAC™ (Monofunctional Degradation Activating Compound) degrader designed to bind with high affinity to the E3 ligase adapter protein, cereblon, to target and degrade IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin's lymphoma, including peripheral T cell lymphoma and mantle cell lymphoma. In preclinical studies, CFT7455 has demonstrated potent and selective protein degradation with favorable pharmacological properties.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 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.Forward-Looking Statements
This press release contains "forward-looking statements" of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy or safety profile of our therapeutic approaches; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for regulatory authorization related to clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of preclinical and clinical studies and other development requirements for our product candidates and the risk that the results of preclinical studies and/or clinical trials will or will not be predictive of future results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in C4 Therapeutics' most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.Investor & Media Contact Kendra Adams SVP, Communications & Investor Relations Kendra.Adams[email protected]
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– Phase 1/2 Trial for Lead Candidate CFT7455, a MonoDAC™ Degrader Targeting IKZF1/3 for the Treatment of Hematologic Malignancies, On Track for 1H 2021 Initiation Following FDA Clearance of Investigational New Drug (IND) –
– Abstract Highlighting the Discovery and Preclinical Development of CFT7455 Accepted for Presentation in the Late Breaking Mini-Symposium at AACR in April –
– IND Application Submission for CFT8634, a BiDAC™ Degrader targeting BRD9 for Synovial Sarcoma and SMARCB1-deleted Tumors, Planned for 2H 2021 –
– Year-End 2020 Cash, Cash Equivalents and Marketable Securities of $372M Expected to Provide Runway to End of 2023 –
WATERTOWN, Mass., March 11, 2021 (GLOBE NEWSWIRE) -- 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, today reported business highlights and financial results for the year ended December 31, 2020. In addition, C4T highlighted key anticipated 2021 milestones for its targeted protein degrader portfolio.
"C4T's operational execution in 2020 provided the foundation for the recent progress with our lead program CFT7455, a highly potent, catalytic degrader of IKZF1/3, for the treatment of hematologic malignancies, culminating in the FDA's clearance of our IND application," said Andrew Hirsch, chief executive officer at C4 Therapeutics. "We look forward to sharing CFT7455 pre-clinical data at AACR and dosing patients in our inaugural clinical study in the coming months. In parallel, we continue to make good progress on our additional programs including BiDAC degraders targeting BRD9, BRAF and RET, positioning us to deliver four clinical-stage programs by year-end 2022."
ANTICIPATED 2021 KEY MILESTONES
- Initiate a Phase 1/2 clinical trial for CFT7455 in 1H 2021. The Phase 1/2 clinical trial will be an open-label, two-part dose escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies such as multiple myeloma and various non-Hodgkin lymphomas, including peripheral T-cell lymphoma and mantle cell lymphoma. The trial will primarily investigate the safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455.
- 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 our 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.
- Advance the RET program into IND-enabling studies in 2021. The objective of our 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
- March 16, 2021 – C4T will participate in the Guggenheim Targeted Protein Degradation Day
- April 10, 2021 – C4T will present pre-clinical data on CFT7455 in the late breaking mini-symposium at the American Association for Cancer Research Annual Meeting (AACR). CFT7455 is a novel, IKZF1/3 degrader that has demonstrated potent tumor regression in IMiD-resistant multiple myeloma xenograft models.
FOURTH QUARTER 2020 AND RECENT HIGHLIGHTS
- Presented at the North American Protein Degradation Congress: In February 2021, Rhamy Zeid, Ph.D., director of target biology at C4T, delivered a presentation highlighting CFT8634, a novel degrader of the protein BRD9. This case study showcased C4T's TORPEDO™ platform's capabilities to enable the development of novel, selective, orally bioavailable degraders.
- Received IND Clearance for CFT7455: In January 2021, the U.S. Food and Drug Administration (FDA) cleared C4T's first IND application for its lead candidate, CFT7455, an orally bioavailable MonoDAC degrader targeting IKZF1/3 for the treatment of relapsed or refractory multiple myeloma and non-Hodgkin's lymphomas.
- Expanded Senior Leadership Team and Board of Directors: In January 2021, Kelly Schick was appointed chief people officer and Mayra Reyes-Armour, Ph.D. was appointed vice president of technical operations. Ms. Schick joined C4T from AMAG Pharmaceuticals, where she served as senior vice president, chief human resources officer and head of corporate engagement. Dr. Reyes-Armour joined C4T from Biogen, where she served as head of asset development and portfolio management operations. In addition, Glenn Dubin was reappointed as a member of the C4T Board of Directors, effective March 12, 2021. Mr. Dubin is the Principal of Dubin & Co., a private investment company based in New York, and a founder and former chair of the board of directors of the Robin Hood Foundation, a philanthropic organization in New York that applies investment principles to charitable giving.
- Added to the Russell 2000® and Russell 3000® Indexes: C4T was added to the Russell 2000 and Russell 3000 Indexes as part of the Russell quarterly update, effective December 21, 2020. The Russell U.S. Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
FULL YEAR 2020 FINANCIAL RESULTS
Revenue: Total revenue for the year ended December 31, 2020 was $33.2 million, compared to $21.4 million for the year ended December 31, 2019. Total revenue reflects revenue recognized under collaboration agreements with Roche, Biogen and Calico and increased by $11.8 million compared to the same period of 2019. The increase in revenue was primarily due to increased reimbursements from Biogen related to research activities and additional progress made on our targets under our collaboration agreements with Biogen and Roche.
Research and Development (R&D) Expense: R&D expense for the year ended December 31, 2020 was $78.4 million, compared to $48.1 million for the year ended December 31, 2019. The increase in R&D expense was primarily attributable to higher preclinical costs related to our lead programs, increased third-party chemistry and biology costs, and increased workforce expenses to support our growing clinical development activities.
General and Administrative (G&A) Expense: G&A expense for the year ended December 31, 2020 was $15.2 million, compared to $8.8 million for the year ended December 31, 2019. The increase in G&A expense was primarily attributable to higher professional fees and insurance costs resulting from our transition to a public company, as well as increased workforce expenses from our growing G&A function.
Net Loss and Net Loss per Share: Net loss for the year ended December 31, 2020 was $66.3 million, compared to $34.1 million for the year ended December 31, 2019. Net loss per share for the year ended December 31, 2020 was $5.83, compared to $31.03 for the year ended December 31, 2019. The decrease in net loss per share despite the increase in net loss was driven by a significant increase in the weighted-average shares outstanding caused by our initial public offering (IPO) of 11,040,000 common shares in October 2020 and the resultant conversion of our outstanding redeemable convertible preferred stock to 30,355,379 shares of common stock. However, as these shares were outstanding as shares of common stock only in the fourth quarter of fiscal year 2020, the weighted-average equivalent impact of these shares for the full year in 2020 is approximately 25%. For the year ending December 31, 2021, the weighted-average shares outstanding will reflect the full number of shares issued in the IPO and the common shares issued upon the conversion of redeemable convertible preferred stock, representing a total of 41,395,379 shares, as the shares from these events will have been outstanding for the full year in 2021.
Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2020 were $371.7 million, compared to $90.5 million as of December 31, 2019. The increase was primarily attributable to $191.2 million in net proceeds from our IPO completed on October 6, 2020, $145.5 million of net proceeds from our issuance of shares of Series B redeemable convertible preferred stock in June and July 2020, and $12.0 million of net proceeds from the issuance of long-term debt and a related warrant to purchase shares of Series B redeemable convertible preferred stock in June 2020. The increase resulting from these transactions was offset by net expenditures to fund our operations. We expect that our cash, cash equivalents and marketable securities as of December 31, 2020, together with future payments expected to be received under existing collaboration agreements, will be sufficient to fund our planned operating expenses and capital expenditures to the end of 2023.
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 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.Forward-Looking Statements
This press release contains "forward-looking statements" of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO platform in the development of novel, selective, orally bioavailable degraders; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for regulatory authorization related to clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of preclinical and clinical studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will cost more to develop or may not be successfully developed and commercialized; and the risk that the results of preclinical studies and/or clinical trials will or will not be predictive of future results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in C4 Therapeutics' most recent Annual Report on Form 10-K and/or Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4 Therapeutics undertakes no duty to update this information unless required by law.Condensed Consolidated Balance Sheet Data (in thousands) December 31, 2020 2019 Cash, cash equivalents and marketable securities $ 371,689 $ 90,549 Total assets 400,138 118,260 Deferred revenue, current and net of current 81,220 93,423 Long-term debt—related party 10,052 — Redeemable convertible preferred stock — 110,995 Total stockholders' equity (deficit) 280,791 (111,963 ) Condensed Consolidated Statement of Operations (in thousands, except per share data) Years Ended December 31, 2020 2019 Revenue from collaboration agreements $ 33,195 $ 21,381 Operating expenses: Research and development 78,440 48,059 General and administrative 15,204 8,774 Total operating expenses 93,644 56,833 Operating loss (60,449 ) (35,452 ) Other (expense) income Change in fair value of warrant liability—related party (5,676 ) — Interest expense and amortization of long-term debt—related party (1,229 ) — Interest and other income, net 393 2,157 Total other (expense) income (6,512 ) 2,157 Loss before income taxes (66,961 ) (33,295 ) Income tax benefit (expense) 626 (804 ) Net loss $ (66,335 ) $ (34,099 ) Accrual of preferred stock dividends — (8,468 ) Net loss attributable to common stockholders—basic and diluted $ (66,335 ) $ (42,567 ) Net loss per share attributable to common stockholders—basic and diluted $ (5.83 ) $ (31.03 ) Weighted-average common stock outstanding—basic and diluted 11,370,328 1,371,905 Investor & Media Contact: Kendra Adams SVP, Communications & Investor Relations [email protected]
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WATERTOWN, Mass., March 10, 2021 (GLOBE NEWSWIRE) -- 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, today announced that a late-breaking abstract featuring preclinical data for CFT7455 has been selected for presentation at the first session of the American Association for Cancer Research (AACR) 2021 Annual Meeting, being held virtually April 10-15, 2021. CFT7455, the Company's most advanced protein degrader, targets IKZF1/3 for the treatment of hematologic malignancies.
Abstract Presentation Details
- Abstract: 5446
- Title: CFT7455: A novel, IKZF1/3 degrader that demonstrates potent tumor regression in IMiD-resistant multiple myeloma (MM) xenograft models
- Session: Late-Breaking Mini-symposium 1
- Session Time: 1:30 p.m. ET on Saturday, April 10, 2021
- Presenter: David Proia, Ph.D., Senior Director, In Vivo Pharmacology at C4T
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 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.Investor & Media Contact Kendra Adams SVP, Communications & Investor Relations [email protected]
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WATERTOWN, Mass., Feb. 24, 2021 (GLOBE NEWSWIRE) -- 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, today announced that the Company will participate in the following upcoming March investor conferences:
- Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 11:40 a.m. ET
- Guggenheim Targeted Protein Degradation Day panel discussion on Tuesday, March 16, 2021 at 10:30 a.m. ET
A live webcast of each event can be accessed under "Events & Presentations" in the Investors section of the company's website at www.c4therapeutics.com. Replays of the webcasts will be archived on the C4T website for at least two weeks following each presentation.
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.Investor & Media Contact Kendra Adams SVP, Communications & Investor Relations [email protected]
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WATERTOWN, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- 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, today announced that the Company will participate in the BMO BioPharma Spotlight Series: Proteins – Degraders and Other Next Gen Technologies, including a panel discussion, "Ligating" Competitors for Collaboration in the Protein Degradation Space, on Thursday, February 18, 2021 at 10:30 a.m. ET.
A recording of the panel discussion will be available for replay four hours following the conclusion of the event and can be accessed under "Events & Presentations" in the Investors section of the company's website at www.c4therapeutics.com. The replay will be archived on the C4T website for at least two weeks following the presentation.
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.Investor & Media Contact Kendra Adams SVP, Communications & Investor Relations [email protected]