UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 12, 2023
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(Exact name of Registrant as Specified in Its Charter)
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Registrant’s Telephone Number, Including Area Code: (617 ) 231-0700
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(Former Name or Former Address, if Changed Since Last Report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 7.01 Regulation FD Disclosure.
On December 12, 2023, C4 Therapeutics, Inc. (the “Company”) posted a corporate presentation that includes data from its ongoing Phase 1/2 clinical trial of CFT7455, an orally bioavailable MonoDAC™ degrader, for the treatment of multiple myeloma and non-Hodgkin’s lymphoma on its website at https://ir.c4therapeutics.com/events-presentations. A copy of the corporate presentation is furnished herewith as Exhibit 99.1.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of amended Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
Item 8.01 Other Events.
On December 12, 2023, the Company also issued a press release announcing progress on the dose escalation portion of the ongoing Phase 1/2 clinical trial of CFT7455, an orally bioavailable MonoDAC™ degrader, for the treatment of multiple myeloma and non-Hodgkin’s lymphoma.
A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The exhibits shall be deemed to be filed or furnished, depending on the relevant item requiring such exhibit, in accordance with the provisions of Item 601 of Regulation S-K (17 CFR 229.601) and Instruction B.2 to this form.
Exhibit Number | Description | |||||||
| 99.1 | ||||||||
| 99.2 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| C4 Therapeutics, Inc. | ||||||||
Date: December 12, 2023 | By: | /s/ Kendra R. Adams | ||||||
| Kendra R. Adams | ||||||||
| Chief Financial Officer and Treasurer | ||||||||
CFT7455, IKZF1/3 Degrader, for the Potential Treatment of Relapsed Refractory Multiple Myeloma (R/R MM) December 12, 2023 Phase 1 Dose Escalation Data
Forward-looking Statements and Intellectual Property 2 Forward-looking Statements The following presentation contains forward-looking statements. All statements other than statements of historical fact are forward- looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward- looking statements include, but are not limited to, statements regarding the therapeutic potential of C4 Therapeutics, Inc.’s technology and products. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, as well as the fact that the product candidates that we are developing or may develop may not demonstrate success in clinical trials. Prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The forward- looking statements included in this presentation are subject to a variety of risks and uncertainties, including those set forth in our most recent and future filings with the Securities and Exchange Commission. Our actual results could vary significantly from those anticipated in this presentation, and our financial condition and results of operations could be materially adversely affected. C4 Therapeutics, Inc. undertakes no obligation to update or revise the information contained in this presentation, whether as a result of new information, future events or circumstances or otherwise. Intellectual Property C4 Therapeutics, Inc. owns various registered and unregistered trademarks and service marks in the U.S. and internationally, including, without limitation, C4 THERAPEUTICS, our housemark logo, the name of our TORPEDO platform, and the names of our BIDAC and MONODAC degrader products. All trademarks, service marks, or trade names referred to in this presentation that we do not own are the property of their respective owners. Solely for convenience, the trademarks, service marks, and trade names in this presentation are referred to without the symbols ®, SM and ™, but those references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights to. © 2023 C4 Therapeutics, Inc.
Today’s Agenda 3 • © 2023 C4 Therapeutics, Inc. Topic Participants Introductions Courtney Solberg, Senior Manager of IR Opening Remarks Andrew Hirsch, President and CEO CFT7455 Preclinical Data Stew Fisher, Ph.D., CSO CFT7455 Phase 1 Data Len Reyno, M.D., CMO Q&A Session Andrew Hirsch, President and CEO Stew Fisher, Ph.D., CSO Len Reyno, M.D., CMO Kendra Adams, CFO
C4T is a Leader in Delivering on the Promise of Targeted Protein Degradation 4© 2023 C4 Therapeutics, Inc. WORLD-CLASS DEGRADER PLATFORM Robust patent portfolio of novel cereblon binders and demonstrated ability to design orally bioavailable, catalytically efficient degraders Our Mission To deliver on the promise of targeted protein degradation science to create a new generation of medicines that transform patients’ lives RIGOROUS TARGET SELECTION Focus on targets with a clear degrader rationale ROBUST CLINICAL PIPELINE Oncology degraders against targets of high unmet need BROAD DEGRADER APPROACH Only company with both MonoDAC and BiDAC degraders in the clinic
Robust Pipeline of Degrader Medicines Pursuing Multiple Oncology Targets 5© 2023 C4 Therapeutics, Inc. 1. Exclusive License and Collaboration Agreement with Betta Pharmaceuticals for the development and commercialization in Greater China Program Target Indications CFT7455 IKZF1/3 Multiple Myeloma & Non-Hodgkin’s Lymphoma CFT1946 BRAF-V600 V600 Mutant Cancers CFT89191 EGFR L858R Non-Small Cell Lung Cancers Chromatin Regulating Targets Various Cancers Oncogenic Signaling Targets Various Cancers Transcription Factor Targets Various Cancers Discovery Pre-clinical Early phase development Late phase development Rights
Execution Across Key 2023 Milestones 6 • Cash runway into 2025 © 2023 C4 Therapeutics, Inc. CFT7455 IKZF1/3 CFT8634 BRD9 CFT1946 BRAF V600 CFT8919 EGFR L858R Discovery ✓ Present Phase 1 dose escalation data from the Phase 1/2 trial in R/R MM ✓ Present Phase 1 dose escalation data from the Phase 1/2 trial in Synovial Sarcoma and SMARCB1-null tumors ✓ First patient dosed in the Phase 1/2 trial ✓ Present new preclinical data ✓ Secure China partnership ✓ Achieved FDA clearance of US IND Relapsed/Refractory multiple myeloma (R/R MM); Investigational New Drug Application (IND) ✓ Collaboration with Merk to discover and develop degrader- antibody conjugates; $10M upfront
CFT7455 Phase 1 Update Andrew Hirsch
Schedule Adjustment Yielding Expected Results for CFT7455 as a Potential MM Therapy 8© 2023 C4 Therapeutics, Inc. Established Safety Profile and Dosing Schedule • CFT7455 is well tolerated with no DLTs resulting in treatment discontinuations • The 14 days on/14 days off schedule is optimal Demonstrated Monotherapy Activity • Anti-myeloma activity and immunomodulatory effects observed at well tolerated doses • Opportunity in combination with novel MM agents for early-line patients and as a maintenance therapy option Promising Responses with CFT7455 + Dexamethasone • Multiple patients achieved IMWG responses at low doses with best responses in patients refractory to BCMA therapies • Opportunity in combination with dexamethasone for multi-refractory patients + CFT7455 is a potential treatment for multi- refractory MM patients with the ability to move into earlier lines with numerous combination opportunities Dose Limiting Toxicities (DLTs); multiple myeloma (MM); B cell maturation antigen (BCMA) Source: C4T data on file as 11/28/2023
CFT7455 Background & Preclinical Rationale Stew Fisher
IKZF1/3 Degradation Drives Three Distinct Areas of Hematopoietic Biology; Degrading IKZF1/3 is a Validated Therapeutic Strategy in MM and NHL Ikaros Family Zinc Finger proteins 1 and 3 (IKZF1/3)); Multiple Myeloma (MM); Non-Hodgkin’s Lymphoma (NHL). © 2023 C4 Therapeutics, Inc IKZF1 / IKZF3 Transcription Factors Hematopoietic Stem Cell Neutrophil Drive MM and NHL Cell Growth and Survival Activate Fully Differentiated T-cells Regulate Hematopoietic Stem Cell Differentiation Consequences of IKZF1/3 Degradation: • MM and NHL Cell Death • T-cell Activation • On-target Neutropenia CD8+ activated CD8+ MM and NHL Cells 10
IKZF1/3 Degrader Half Life (hours) Dosing Schedule Dosed + Dexamethasone Grade 3/4 Neutropenia Rate* 3-5 21 Days on / 7 Days off 33% 7.5 21 Days on / 7 Days off 41-48% Iberdomide 9-13 21 Days on / 7 Days off 45% Mezigdomide ~14 21 Days on / 7 Days off 76% IKZF1/3 Degraders are Effective Therapies that Require Drug Holidays Based on PK Properties to Overcome On-Target Neutropenia 11© 2023 C4 Therapeutics, Inc Neutropenia Anti-MM and NHL Activity Effective dosing schedules of IKZF1/3 degraders require dosing breaks to balance efficacy with tolerability Multiple Myeloma (MM); Non-Hodgkin’s lymphoma (NHL) * All data points are in combination with dexamethasone. Source: FDA labels, Ye 2020 Clin Pharmacol Drug Dev, Richardson 2023 NEJM, Lonial 2022 Lancet Haematol.
12 CFT7455 was Designed to Overcome Several Shortcomings of Approved MM and NHL IKZF1/3 Degraders Approved MM & NHL IKZF1/3 Degraders’ Shortcomings ❑ Modest on-target degradation and off-target liabilities ❑ Acquired resistance to approved IKZF1/3 degraders1 ❑ Many MM/NHL therapies require onerous delivery (e.g., frequent dosing, IV administration) ❑ High-risk MM, including extramedullary disease, remains difficult to treat ❑ ~50% of MM patients suffer from renal impairment2, decreasing tolerability of renally cleared drugs CFT7455 Preclinical Solutions ✓Reduce off-target toxicity and provide versatile combo potential ✓Overcome resistance by maintaining efficacy at low cereblon levels ✓Excellent catalytic efficiency and enhanced PK profile leads to enhanced efficacy due to predictable suppression of IKZF1/3 between doses ✓Metabolize through the liver to be better tolerated and potentially avoid kidney clearance Plasma Protein Binding (PPB); Multiple Myeloma (MM); Non-Hodgkin’s Lymphoma (NHL); Pharmacokinetics (PK) Sources: 1. Includes lenalidomide, pomalidomide, and thalidomide 2. Rana 2020 Blood Advances. © 2023 C4 Therapeutics, Inc
Differentiated PK and Class-leading Catalytic Activity of CFT7455 Leads to Sustained Degradation Compared to Other Agents in this Class 13 mezigdomide (CC-92480); Ikaros family zinc finger protein (IKZF3); multiple myeloma (MM); pharmacodynamics (PD); pharmacokinetics (PK); once daily (QD) Source: AACR 2022 presentation © 2023 C4 Therapeutics, Inc In Vivo Degradation Kinetics (48 hrs.) In Vivo Tumor PK Extended Plasma and Tumor Exposure 0 12 24 36 48 0 50 100 Hours P e r c e n t o f IK Z F 3 R e m a in in g / N o rm a li z e d t o G A P D H i n N C I- H 9 2 9 T u m o rs CC-92480 (1000 µg/kg) Pomalidomide (3000 g/kg) CFT7455 (100 g/kg) 0 12 24 36 48 0 50 100 Hours P e r c e n t o f IK Z F 3 R e m a in in g / N o rm a li z e d t o G A P D H i n N C I- H 9 2 9 T u m o rs CC-92480 (1000 µg/kg) Pomalidomide (3000 g/kg) CFT7455 (100 g/kg) 0 12 24 36 48 0 50 100 Hours P e r c e n t o f IK Z F 3 R e m a in in g / N o rm a li z e d t o G A P D H i n N C I- H 9 2 9 T u m o rs CC-92480 (1000 µg/kg) Pomalidomide (3000 g/kg) CFT7455 (100 g/kg) Leads to Optimized Degradation Kinetics 0 12 24 36 48 0.1 1 10 100 Hours C o m p o u n d C o n c e n tr a ti o n P la s m a ( n g /m L ) o r T u m o r (n g /g ) CC92480 1000 g/kg plasma CC92480 1000 g/kg tumor CFT7455 100 g/kg plasma CFT7455 100 g/kg tumor CC92480 is not detectable after 4 hrs CFT7455 DC80 (total)
Preclinical Model Demonstrated Significant Synergy when CFT7455 is Combined with Dexamethasone 14 Twice a day (BID); Human Dose (HD), Daily Dosing (QD); Oral administration (PO) Source: C4T data on file 0 7 14 21 28 0 1000 2000 3000 4000 Day R P M I- 8 2 2 6 T u m o r V o lu m e (m m 3 ) CFT7455 (50 g QD human dose equivalent) Vehicle (QD, PO) Dexamethasone (5 mg/kg, QW) CFT7455 (50 g QD human dose equivalent + Dexamethasone) Dosing Interval CFT7455 50 µg QD Human Dose Equivalent +/- Dexamethasone RPMI-8226 Multiple Myeloma Xenograft CFT7455 + Dexamethasone Shows Robust Tumor Regressions Compared to Monotherapy Regimens “Human dose equivalent” dosing schedule is designed to approximate predicted human exposures throughout 14-day treatment with CFT7455 in mice. Increasing doses to simulate pre-steady state Decreasing doses to simulate clearance © 2023 C4 Therapeutics, Inc
CFT7455 Monotherapy Dose Escalation in R/R MM Len Reyno
R/R MM Monotherapy Dosing: QD 21 Days on/7 Days off* N=5 Status: Complete CFT7455 Phase 1 Dose Escalation Trial’s Goal is to Define the Safety Profile and Identify Signs of Anti-Tumor Activity in R/R MM and R/R NHL 16 pharmacokinetic (PK); Monday, Wednesday, Friday dosing (M/W/F); once daily (QD); relapsed refractory multiple myeloma (R/R MM); relapsed refractory non-Hodgkin’s lymphoma (R/R NHL) *Monotherapy arm of 21 days on/7 days off is not included in the Phase 1 data update Phase 1 Dose Escalation Trial Primary: • Safety and tolerability • Determine the maximum tolerated doses Secondary: • Estimate anti-tumor activity • Assess PK Exploratory: • Characterize target engagement • Assess kinetics, depth, recovery and consistency of target engagement • Assess immuno-modulations R/R MM Monotherapy Dosing: M/W/F & QD 14 days on/14 days off N=22 Status: Complete R/R MM Dex Combo Dosing: M/W/F & QD 14 days on/14 days off N = ~20 Status: Ongoing R/R NHL Monotherapy Dosing: M/W/F & QD 14 days on/14 days Off N = ~20 Status: Ongoing Endpoints © 2023 C4 Therapeutics, Inc
CFT7455 Monotherapy Dose Escalation Complete in R/R MM; Sufficient Data Generated to Explore CFT7455 in Combination with Novel MM Agents 17 Multiple myeloma (MM); Eastern Cooperative Oncology Group Score (ECOG); Relapsed/Refractory (R/R); absolute neutrophil count (ANC), Hemoglobin (Hgb); Monday Wednesday Friday (MWF); Daily Dosing (QD) 1. DLT was associated with febrile neutropenia; 2. DLT was associated with Grade 4 neutropenia >7 days; 3. DLTs were associated with febrile neutropenia and Grade 4 neutropenia >7 days Source: C4T data on file as of 11/28/2023 © 2023 C4 Therapeutics, Inc. 75 µg QD N=4 50 µg QD N=5 75 µg MWF N=5 50 µg MWF N=5 25 µg MWF N=3 Phase 1: Dose Escalation Monotherapy 14 Days On/14 Days Off Monotherapy complete: • 75 µg was maximum administered dose • Sufficient data generated for CFT7455 to be combined with novel MM agents 1 DLT1 1 DLT2 2 DLTs3 KEY INCLUSION CRITERIA • Adults with MM, R/R at least 3 prior lines that have included lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid, and an anti-CD38 monoclonal antibody • Nonresponsive to or progressed within 60 days of prior therapy • Measurable disease • Adequate bone marrow function (ANC ≥1000, Hgb ≥8.0, platelets ≥75,000) • Creatinine clearance ≥40 mL/min • ECOG ≤2
CFT7455 Monotherapy Patient Population was Heavily Pre-treated with a Median of 7 Prior Therapies 18 Extramedullary Disease (EMD); Eastern Cooperative Oncology Group (ECOG); Lenalidomide (Len); Pomalidomide (Pom); monoclonal antibody (mAB); International Staging System (ISS) Source: C4T data on file as of 11/28/2023 Characteristics Safety Population (N = 22) Age, median (range) 64 (47-79 years old) Male, n (%) 14 (64%) Time since initial diagnosis, median (range) 11 (3-20 years) ECOG performance status , n (%) 0 1 8 (36%) 14 (64%) Revised ISS at baseline, n (%) Stage 1 Stage 2 Stage 3 Missing 4 (18%) 9 (41%) 6 (27%) 3 (14%) Presence of EMD, n (%) 9 (41%) Characteristics Safety Population (N = 22) Prior therapies, median (range) 7 (3-21) Prior Len, n (%) 22 (100%) Prior Pom, n (%) 22 (100%) Prior CD38 Antibody, n (%) 22 (100%) Prior CAR-T therapy, n (%) 9 (41%) Prior T-cell engager therapy, n (%) 6 (27%) Prior CAR-T or T-cell engager therapy, n (%) 12 (55%) Baseline Characteristics: Prior Therapies: © 2023 C4 Therapeutics, Inc
CFT7455 Monotherapy: Treatment Disposition of 22 R/R MM Patients Source: C4T data on file as of 11/28/2023 © 2023 C4 Therapeutics, Inc. Patient Disposition Safety Population (N = 22) Ongoing, n (%) 3 (14%) Discontinued, n (%) Progressive disease, n(%) Physician decision, n(%) Withdrawal by patient, n(%) Death, n (%) Adverse event, n(%) 19 (86%) 12 (55%) 3 (14%) 2 (9%) 1 (5%) 1 (5%) 19 • Death was not related to CFT7455 • Adverse event was a Grade 2 rash in the setting of early disease progression at the 50 μg dose on the MWF 14/14 schedule so there was limited benefit to continuing therapy
CFT7455 Monotherapy is Well Tolerated with 14 Days on/14 Days off Schedule 20 Patients with AEs of Grade 3 or Higher, N (%) 25 µg MWF (N=3) 50 µg MWF (N=5) 75 µg MWF (N=5) 50 µg QD (N=5) 75 µg QD (N=4) Monotherapy R/R MM Total (N=22) Hematologic AEs Neutropenia 1 (33%) 1 (20%) 3 (60%) 3 (60%) 3 (75%) 11 (50%) Anemia 1 (33%) 0 0 1 (20%) 2 (50%) 4 (18%) Leukopenia 0 0 1 (20%) 2 (40%) 1 (25%) 4 (18%) Thrombocytopenia 1 (33%) 0 0 1 (20%) 1 (25%) 3 (14%) Febrile neutropenia 0 0 1 (20%) 0 1 (25%) 2 (9%) Other AEs Cellulitis 0 0 1 (20%) 0 0 1 (5%) Pseudomonas infection 0 0 0 0 1 (25%) 1 (5%) Arrhythmia 0 0 0 1 (20%) 0 1 (5%) Troponin T increased 0 0 0 1 (20%) 0 1 (5%) Hypokalemia 1 (33%) 0 0 0 0 1 (5%) Hypertension 0 0 0 0 1 (25%) 1 (5%) Manageable neutropenia was the most common side effect; no DLTs resulted in discontinuations Adverse Events (AEs); 14 days on/14 days off (14/14); Once Daily (QD); Monday/Wednesday/Friday dosing (MWF); Dose Limiting Toxicity (DLTs) Note: All doses displayed are with the 14 days on/14 days off dosing schedule. Source: C4T data on file as of 11/28/23 © 2023 C4 Therapeutics, Inc.
Plasma Exposure of CFT7455 Monotherapy Increased Proportionally with Cumulative Dose © 2023 C4 Therapeutics, Inc. Source: C4T data on file as of 11/28/23 21 Daily dosing(QD); Monday, Wednesday, Friday dosing (MWF) 0 6 12 18 24 30 36 42 48 0.00 0.05 0.10 0.15 0.30 0.60 Time (h) P la s m a C F T 7 4 5 5 C o n c ( n g /m L ) 50 μg QD 37.5 μg QD 75 μg MWF 50 μg MWF 25 μg MWF 75 μg QD (Patient 2) 75 μg QD (Patient 3) 75 μg QD (Patient 4) Target Concentration from H929 Monotherapy Pharmacokinetics (PK)
C1D1 PD C1D1 8hrs C1D2 C1D8 C1D14 C1D21 C2D1 -100 -50 0 50 100 150 IKZF1/3 expression measured by Mass Spec on PBMCs % e x p re s s io n r e la ti v e t o b a s e li n e Pharmacodynamics Consistent with 14 Days on/14 Days off Modeling Assumptions; Schedule is Sufficient for Neutrophil Recovery Daily dosing (QD); Pharmacokinetic (PK); Pharmacodynamic (PD); Monday, Wednesday, Friday dosing (MWF) All samples from clinical PD were pre-dose, except C1D1 8 hours Source: C4T data on file as of 11/28/23 © 2023 C4 Therapeutics, Inc. • QD showed greater degradation of IKZF1 and IKZF3 than MWF during the first cycle of the 14 days on/14 days off schedule Time on Treatment 22 IKZF1 - MWF IKZF3 - MWF IKZF1 - QD IKZF3 - QD 0 7 14 21 28 0.01 0.1 1 10 0 25 50 75 100 Time (days) C F T 7 4 5 5 C o n c e n tr a ti o n (n g /m L ) IK Z F 3 T is s u e D e g ra d a tio n (% ) Simulated IKZF3 Degradation 50 µg Simulated 50 μg Plasma PK Modeled PK/PD of 14 Days on/ 14 Days off Schedule Clinical PD of 14 Days on/ 14 Days off Schedule -75 -25 % e x p re ssio n re la tiv e to b a se lin e -100 -50
International Myeloma Working Group (IMWG) Response Criteria sCR Stringent Complete Response CR Complete Response VGPR Very Good Partial Response PR Partial Response MR Minimal Response SD Stable Disease • CR as defined to The right, plus normal FLC ratio and absence of clonal cells in bone marrow by immuno- histochemistry or immuno- fluorescence • Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow • Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h • > 50% reduction of serum M-protein • Reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h • > 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria • If serum, urine M-protein, and serum free light assay is not measurable, > 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30% • In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required • ≥25% but ≤49% reduction of serum M- protein and reduction in 24-h urine M-protein by 50–89% • In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required • Not meeting criteria for sCR, CR, VGPR, PR, or progressive disease © 2023 C4 Therapeutics, Inc. Source: 2016 International Myeloma Working Group uniform response criteria for multiple myeloma 23
Dosing Schedule Dose Level EMD Status Prior CAR-T or TCE Prior lines 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 14 days on/ 14 days off 25 µg M/W/F Yes Yes 8 PD Yes No 5 PD Yes No 6 PD 50 µg M/W/F No No 3 PD No Yes 4 MR Yes No 8 SD PD Yes No 10 NE No No 6 PD 75 µg M/W/F Yes Yes 7 PD No No 4 PD No Yes 5 PD No Yes 9 SD No Yes 21 NE 50 µg QD Yes Yes 6 SD PD No No 6 SD MR PD No Yes 8 SD No No 9 PD No Yes 17 PD 75 µg QD Yes Yes 7 SD PD Yes Yes 4 SD PR No Yes 9 SD No No 3 SD © 2023 C4 Therapeutics, Inc. Progressive Disease (PD) Stable Disease (SD) Minimal Response (MR) Not Evaluable (NE) Withdrawal of consent or physician decision Ongoing Partial Response (PR) Evidence of Anti-Myeloma Monotherapy Activity: All 4 Patients at the Maximum Administered Dose Level had Stable Disease or Better Cycles 24Extramedullary Disease (EMD); T-cell Engager (TCE); Daily Dosing (QD); Monday Wednesday Friday dosing (M/W/F) Source: C4T data on file as of 11/28/2023
TEMRA TEM 0 20 40 60 80 100 % positive cells (C1D21 vs C1D1) % p o s it iv e c e ll s C1D1 C1D21 © 2023 C4 Therapeutics, Inc. Clinical Evidence of Immune T-cell Activation with CFT7455 Monotherapy ** **** TEMRA: Terminally differentiated T-cells TEM: Effector memory T-cells Peripheral Blood Mononuclear Cells (PBMCs); daily dosing (QD); Monday, Wednesday,Friday Dosing Schedule (MWF) Multiple Myeloma (MM) Source: C4T data on file as of 11/28/2023 • 19 patient samples (PBMCs) analyzed by flow cytometry • Aggregate data of 25 µg, 50 µg, and 75 µg M/W/F and QD 25 Supports potential of CFT7455 as a maintenance therapy option and in combination with novel MM agents to improve efficacy: ✓ CFT7455 induces CD8+ T-cell activation by increasing effector memory T-cell subset ✓ T-cell activation is observed at well tolerated monotherapy clinical doses ✓ The clinical data consistent with the preclinical in vitro data reported for CFT7455
CFT7455 Enhances Immune Cell Lysis of Daratumumab and Teclistamab in Non-clinical Translational Models 26 Bispecific T-Cell Engager (BiTE) Source: C4T data on file Darzalex is a registered trademark of Janssen; Tecvalyi is a registered trademark of J&J © 2023 C4 Therapeutics, Inc. Cmin and Cmax represent human plasma concentrations for a 50 µg dose of CFT7455 Daratumumab (Anti-CD38) Combo Antibody-Dependent Cell-Mediated Cytotoxicity Assay (ADCC) 0.001 0.01 0.1 1 10 100 0 20 40 60 Teclistamab (25ng/mL) + CFT7455 TDCC CFT7455 (nM) N C I- H 9 2 9 L y s is (% ) Cmin Cmax 0.01 0.1 1 10 100 10 20 30 40 Daratumumab (2ng/mL) + CFT7455 ADCC CFT7455 (nM) N C I- H 9 2 9 L y s is (% ) Cmin Cmax Teclistamab (BCMA BiTE) Combo T-cell Dependent Cellular Cytotoxicity Assay (TDCC)
CFT7455 Monotherapy is Well Tolerated and Demonstrates Anti- Myeloma Activity and Immunomodulatory Effects • Continuous target degradation is associated with CFT7455 dosing across all dose levels and shows anti- myeloma activity at the highest dose level • 14 days on/14 days off schedule provides therapeutic index with anti-myeloma activity at 75 µg • Dose proportional increases in plasma exposure and long half-life of 48 hours supports 14 days on/14 days off schedule • Well tolerated with manageable neutropenia in a heavily pre-treated population utilizing a 14 days on/14 days off schedule • Clinical evidence of immune T-cell activation at doses below the maximum administered dose CFT7455 profile supports combination with novel MM agents and as maintenance therapy © 2023 C4 Therapeutics, Inc. Source: C4T data on file as of 11/28/23 27
CFT7455 + Dexamethasone in R/R MM Len Reyno
CFT7455 + Dexamethasone Dose Escalation in R/R MM 29© 2023 C4 Therapeutics, Inc. Phase 1: Dose Escalation + Dexamethasone 14 Days On/14 Days Off CFT7455: 37.5 µg QD +Dex: 40 mg QW* N = <10 Phase 1 dose expansion currently enrolling CFT7455: 62.5 µg QD +Dex: 40 mg QW* N = <10 Phase 1 dose expansion cohort to open Phase 2: Cohort Expansion N=~30 Eastern Cooperative Oncology Group (ECOG), Monday, Wednesday, Friday dosing (MWF); Daily Dosing (QD), Relapsed/Refractory multiple myeloma (R/R MM); Absolute neutrophil count (ANC); Hemoglobin (Hgb); dexamethasone (Dex) *+Dex is dosed on days 1,8,15, and 22 and dose is reduced for older patients. Source: C4T data on file as of 11/28/2023 KEY INCLUSION CRITERIA • Adults with R/R MM, at least 3 prior lines that have included lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid, and an anti-CD38 monoclonal antibody • Nonresponsive to or progressed within 60 days of prior therapy • Measurable disease • Adequate bone marrow function (ANC ≥1000, Hgb ≥8.0, platelets ≥75,000) • Creatinine clearance ≥40 mL/min • ECOG ≤2 Potential for further dose escalation CFT7455: 62.5 µg QD +Dex: 40 mg QW* N= ~4 Currently Enrolling CFT7455: 37.5 µg QD +Dex: 40 mg QW* N=4 CFT7455: 50 µg; MWF +Dex: 40 mg QW* N=5
CFT7455 + Dexamethasone Patient Population to Date was Heavily Pre-treated with a Median of 6 Prior Therapies © 2023 C4 Therapeutics, Inc. Characteristics Safety Population (N = 9) Prior therapies, median (range) 6 (4-12) Prior Len, n (%) 9 (100%) Prior Pom, n (%) 8 (89%) Anti-CD38 mAB refractory, n (%) 9 (100%) Prior CAR-T therapy, n (%) 4 (44%) Prior T-cell engager therapy, n (%) 2 (22%) Prior CAR-T or T-cell engager therapy, n (%) 5 (56%) Prior Therapies:Baseline Characteristics: Characteristics Safety Population (N = 9) Age, median (range) 68 (59-82 years) Male, n (%) 3 (33%) Time since initial diagnosis, median (range) 9 (5-17 years) ECOG performance status , n (%) 0 1 1(11%) 8 (89%) Revised ISS at baseline, n (%) Stage 1 Stage 2 Stage 3 Missing 6 (67%) 1(11%) 0 2 (22%) Presence of EMD, n (%) 3 (33%) Extramedullary Disease (EMD); Eastern Cooperative Oncology Group (ECOG); Lenalidomide (Len); Pomalidomide (Pom); monoclonal antibody (mAB); International Staging System (ISS) Source: C4T data on file as of 11/28/2023 30
CFT7455 + Dexamethasone is Well Tolerated 31 Patients with AEs of Grade 3 or Higher, N (%) CFT7455: 50 µg MWF +Dex: 40 mg QW (N=5) CFT7455: 37.5 µg QD +Dex: 40 mg QW (N=4) CFT7455+Dex Total (N=9) Hematologic AEs Anemia 1 (20%) 2 (50%) 3 (33%) Neutropenia 1 (20%) 2 (50%) 3 (33%) Febrile neutropenia 1 (20%) 1 (25%) 2 (22%) Thrombocytopenia 1 (20%) 0 1 (11%) Leukopenia 1 (20%) 0 1 (11%) Lymphocyte count decreased 0 1 (25%) 1 (11%) Other AEs Pneumonia 0 1 (25%) 1 (11%) Blood creatinine increased 1 (20%) 0 1 (11%) Mental impairment 1 (20%) 0 1 (11%) Hypocalcemia 0 1 (25%) 1 (11%) Acute kidney injury 1 (20%) 0 1 (11%) Epistaxis 1 (20%) 0 1 (11%) Pulmonary oedema 0 1 (25%) 1 (11%) Intracranial mass 1 (20%) 0 1 (11%) Adverse Events (AEs); Once weekly (QW); Daily dosing (QD); Dex (Dexamethasone); Monday, Wednesday Friday dosing (MWF) Note: All doses displayed are with the 14 days on/14 days off dosing schedule. +Dex is dosed on days 1,8,15 and 22 and dose is reduced for older patients Source: C4T data on file as of 11/28/2023 © 2023 C4 Therapeutics, Inc.
CFT7455 + Dexamethasone Resulted in Multiple Responses at Low Doses with Best Responses in Patients Refractory to BCMA Therapies © 2023 C4 Therapeutics, Inc. Dosing Schedule Dose Level EMD Status Prior CAR-T or TCE # of Prior Lines 1 2 3 4 5 6 7 8 9 10 11 14 days on/ 14 days off CFT7455: 50 µg MWF +Dex: 40 mg QW No No 6 PD No Yes 4 SD PD No No 5 SD MR PR Yes Yes 12 PD No No 6 SD CFT7455: 37.5 µg QD +Dex: 40 mg QW No Yes 5 VGPR sCR No Yes 9 PR Yes No 7 SD Yes Yes 7 NE Stable Disease (SD) Progressive Disease (PD) Minimal Response (MR) Not Evaluable (NE) Withdrawal of consent or physician decision Ongoing Partial Response (PR) Very good partial response (VGPR) Stringent Complete Response (sCR) 32 Cycles Extramedullary Disease (EMD); T-Cell Engager (TCE); Daily Dosing QD); One Weekly (QW); Monday, Wednesday, Friday Dosing (MWF); Dexamethasone (Dex); B cell maturation antigen (BCMA) Source: C4T data on file as of 11/28/2023
Patient Vignette: sCR Achieved in a Pre-treated MM Patient When Treated with CFT7455 + Dexamethasone © 2023 C4 Therapeutics, Inc. • 65, female, enrolled 08/23/2023 into 37.5 µg QD 14/14 CFT7455 + dexamethasone cohort • Diagnosed with MM in 2018 • Received 5 lines of prior therapy; stage 2 R-ISS MM Line Therapy 1 Revlimid + Velcade 2 Daratumumab 3 Daratumumab + Pomalidomide + Dex 4 Cyclophosphamide + Carfilzomib + Dex 5 Abecma (Ide-Cel) C 1D 1 P D C 1D 1 8h rs C 1D 2 C 1D 7 C 1D 21 C 2D 1 C 2D 14 C 3D 1 -100 -50 0 50 100 IKZF1 expression measured by Mass Spec on PBMCs % e x p re s s io n r e la ti v e t o b a s e li n e Patient treated with 37.5 µg QD +Dex Per IMWG response criteria, patient achieved stringent complete response: • Negative immunofixation on the serum and urine plus normal FLC ratio • Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence C 1D 7 C 1D 14 C 1D 21 C 2D 1 C 3D 1 -100 -50 0 50 100 dFLC measurement (37.5ug QD 14/14 +dex) % c h a n g e i n d F L C r e la ti v e t o b a s e li n e dFLC Decrease in serum free light chain (dFLC); Dexamethasone (Dex); Revised International Staging System (R-ISS); multiple myeloma (MM); very good partial response (VGPR); partial response (PR); stringent complete response (sCR); 14 days on/14 days off schedule (14/14); Daily dosing (QD) Values of the IKZF1 degradation are post dose Source: C4T data on file as of 11/28/2023 33
CFT7455 + Dexamethasone is Well Tolerated and Demonstrates Promising Efficacy Signals, Supporting Development in Multi-refractory MM Patients 34 • CFT7455 combined with dexamethasone is well tolerated in a heavily pre- treated population • Manageable neutropenia • Promising efficacy signals with multiple patients responding at low doses, including best responses in patients who were refractory to BCMA • All three patients at second dose level studied responded Now enrolling Phase 1 dose escalation cohort at 62.5 µg and Phase 1 dose expansion cohort at 37.5 µg Pharmacodynamic (PD); Pharmacokinetic (PK); B cell maturation antigen (BCMA) Source: C4T data on file as of 11/28/2023 © 2023 C4 Therapeutics, Inc.
CFT7455 Development Plan and Next Steps Len Reyno
Despite Numerous Treatment Options, Many MM Patients Progress through Several Lines of Therapy, Providing Opportunities for CFT7455 36© 2023 C4 Therapeutics, Inc. • 2/3-line triplet combinations with daratumumab or proteasome inhibitors • Combination partner for BCMA BiTEs, CAR-Ts and other 2/3-line immunomodulatory treatments 1st Line 2nd Line 3rd Line 4th Line 5th Line MM Treatment Annual Addressable Patients (US, 2023) ~22,000 transplant ineligible ~29,000 ~25,000 ~20,000 ~12,000 Potential Opportunity for CFT7455: • Front-line triplet combinations with daratumumab or proteasome inhibitors • Maintenance therapy option post-transplant • Combination with novel agents or with dexamethasone may be a suitable treatment option for multi-refractory patients (patients who progress on anti-CD38s, BCMA BiTEs, CAR-Ts, and other therapies) ~11,000 transplant eligible Annual addressable patient numbers estimated from consulting work done by Health Advances and ClearView, based on primary and secondary research; Bispecific T-cell Engagers (BiTES); Multiple myeloma (MM)
The CFT7455 Profile Supports Multiple Opportunities Across MM Landscape 37© 2023 C4 Therapeutics, Inc. CFT7455 + Dexamethasone Data Potential Enabled Opportunity Accelerated Approval in Multi-Refractory MM Potential Development Path Post-Transplant Maintenance Study + PI Studies + Anti-CD38 Studies + BCMA BiTE Studies + GPRC5D BiTE Studies Other Combination or Sequence Studies* Numerous Approvals in Early Line MM Maintenance Approval in Post-Transplant MM * Other combination opportunities may include CAR-T, anti-SLAMF7, XPO1 inhibitors, FcRH5 BiTE, among others. Bi-specific T-cell Engager (BiTE); Proteasome Inhibitors (PI). CFT7455 + Dexamethasone Registrational Study Approvals in Early Line MM CFT7455 Monotherapy
Schedule Adjustment Yielding Expected Results for CFT7455 as a Potential MM Therapy 38© 2023 C4 Therapeutics, Inc. Established Safety Profile and Dosing Schedule • CFT7455 is well tolerated with no DLTs resulting in treatment discontinuations • The 14 days on/14 days off schedule is optimal Demonstrated Monotherapy Activity • Anti-myeloma activity and immunomodulatory effects observed at well tolerated doses • Opportunity in combination with novel MM agents for early-line patients and as a maintenance therapy option Promising Responses + Dexamethasone • Multiple patients achieved IMWG responses at low doses with best responses in patients refractory to BCMA therapies • Opportunity in combination with dexamethasone for multi-refractory patients + Dose Limiting Toxicities (DLTs); multiple myeloma (MM); B cell maturation antigen (BCMA) Source: C4T data on file as 11/28/2023 Next Milestones: • Present complete CFT7455 dose escalation data + dexamethasone for R/R MM in 2024 • Present complete CFT7455 dose escalation data as a monotherapy for R/R NHL in 2024
Q&A Session
Exhibit 99.1
C4 Therapeutics Announces Positive Data from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma
Data Support 14 Days On/14 Days Off as Optimal Dosing Schedule; CFT7455 is Well Tolerated with Promising Signs of Anti-Myeloma Activity
Completed Monotherapy Dose Escalation Demonstrates Anti-Myeloma Activity and Immunomodulatory Effects to Support CFT7455 in Combination with Novel Multiple Myeloma Agents and as a Monotherapy Maintenance Option
CFT7455 in Combination with Dexamethasone Results in IMWG Responses at the First Two Dose Levels Studied in Multi-Refractory Multiple Myeloma Patients
Dose Escalation Continues for CFT7455 in Combination with Dexamethasone in Relapsed/Refractory Multiple Myeloma, and as a Monotherapy in non-Hodgkin’s Lymphomas; Complete Phase 1 Dose Escalation Data Expected in 2024
C4T to Host Webcast Today at 4:30 pm ET; Webcast Link Available Here
WATERTOWN, Mass., December 12, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today presented clinical data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of CFT7455, a MonoDAC™ degrader of IKZF1/3, for the potential treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL). These data include results from CFT7455 as a monotherapy for relapsed/refractory (R/R) MM patients, which has completed dose escalation, and interim results from CFT7455 in combination with dexamethasone for R/R MM patients, which continues to enroll patients. C4T also continues to enroll patients in the Phase 1 dose escalation trial exploring CFT7455 as a monotherapy for NHL patients.
“We are excited CFT7455 monotherapy is showing promising signs of anti-myeloma and immunomodulatory activity and anti-myeloma activity when combined with dexamethasone, particularly in patients who have undergone numerous lines of prior therapy for multiple myeloma, including BCMA therapies,” said Len Reyno, M.D., chief medical officer of C4 Therapeutics. “We have established 14 days on/14 days off as the optimal dosing schedule, which is consistent with our preclinical data supporting CFT7455 as a rationally designed IKZF1/3 degrader with the potential to offer a new therapy for patients with relapsed/refractory multiple myeloma.”
CFT7455 Phase 1 Dose Escalation
The goal of the CFT7455 Phase 1 dose escalation trial is to define the safety profile of CFT7455, determine the maximum tolerated or administered dose, and identify signs of anti-tumor activity in R/R MM and R/R NHL. The Phase 1 dose escalation portion of the trial includes three arms: CFT7455 as a monotherapy for R/R MM patients, which is complete; CFT7455 in combination with dexamethasone for R/R MM patients, which continues to advance through dose escalation; and CFT7455 as a monotherapy for NHL patients, which also continues to advance through dose escalation. The Phase 1 dose escalation
portion of the ongoing Phase 1/2 trial has utilized a 14 days on/14 days off dosing schedule within which both daily dosing and Monday/Wednesday/Friday (MWF) dosing were explored.
CFT7455 as a Monotherapy for R/R MM Patients
Monotherapy dose escalation is complete. As of the November 28, 2023 data cutoff date, 22 patients had received CFT7455 as a monotherapy. The maximum dose administered was 75 µg daily for 14 days on/14 days off. A maximum tolerated dose was not defined. Patients were heavily pretreated, with a median of seven prior therapies. The majority of patients (n=12) received prior CAR-T or T-cell engager therapy.
Pharmacokinetic and Pharmacodynamic Results
•Clearance of CFT7455 is consistent with a 48-hour half-life.
•Daily dosing (14 days on/14 days off) resulted in deep IKZF1/3 degradation.
•After day 14, as plasma concentrations of CFT7455 begin to decline, degraded proteins recover through day 28, enabling neutrophil recovery.
Safety and Evidence of Anti-Tumor Effect
•CFT7455 was well tolerated.
•22 patients were evaluable for safety. The most common adverse events (AEs) Grade 3 or above were neutropenia (n=11), anemia (n=4) and leukopenia (n=4).
•No dose-limiting toxicities (DLTs) resulted in discontinuation of therapy.
•As of the November 28, 2023 data cutoff date, 20 patients were evaluable for evidence of anti-tumor effect.
•Four patients received the maximum dose administered of 75 µg daily. Three patients were refractory to BCMA therapies. Responses were measured in accordance with the International Myeloma Working Group (IMWG) criteria for multiple myeloma. All four patients achieved Stable Disease (SD) or better and one patient achieved a Partial Response (PR).
Immunomodulatory Results
•CFT7455 induced CD8+ T-cell activation by increasing the effector memory T-cell subset, as required for effective adaptive immunity.
•T-cell activation was observed at well tolerated monotherapy doses, supporting the potential use of CFT7455 in combination with bi-specific T-cell engagers and monoclonal antibody therapies.
CFT7455 in Combination with Dexamethasone for R/R MM Patients
As of the November 28, 2023 data cutoff date, nine patients had received CFT7455 in combination with dexamethasone across two initial dose escalation cohorts (50 µg MWF for 14 days on/14 days off; or 37.5 µg daily for 14 days on/14 days off). Patients were heavily pretreated, with a median of six prior therapies. The majority of patients (n=5) received prior CAR-T or T-cell engager therapy. This arm is ongoing; patients are currently enrolling in either the 62.5 µg escalation cohort or the 37.5 µg expansion cohort.
Safety and Evidence of Anti-Tumor Effect
•CFT7455 in combination with dexamethasone is well tolerated to date.
•The most common AEs Grade 3 or above were consistent with the monotherapy safety signal.
•No AEs have led to dose reductions, discontinuations or DLTs.
•All three patients evaluable for efficacy at 37.5 µg daily achieved SD or better according to IMWG criteria. These assessments include:
◦One patient achieved a Stringent Complete Response (sCR), after initially achieving a Very Good Partial Response (VGPR). This patient was refractory to BCMA therapies.
◦One patient achieved a PR. This patient was refractory to BCMA therapies.
◦One patient achieved SD.
Upcoming Data Presentations for CFT7455
C4T expects to present the following data on CFT7455 in 2024:
•Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in R/R MM.
•Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in NHL.
C4T Webcast for Analysts and Investors
C4T will host an investor webcast today, December 12, 2023, at 4:30 pm Eastern Time, to discuss the CFT7455 Phase 1 clinical data in relapsed/refractory multiple myeloma. To join the webcast, please visit this link or the “Events & Presentations” page of the Investors section on the company’s website at www.c4therapeutics.com. A replay of the webcast will be archived and available following the event.
About C4 Therapeutics C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients’ lives. C4T is leveraging its TORPEDO® platform to efficiently design and optimize small-molecule medicines that harness the body’s natural protein recycling system to rapidly degrade disease-causing proteins, offering the potential to overcome drug resistance, drug undruggable targets and improve patient outcomes. C4T is advancing multiple targeted oncology programs to the clinic and expanding its research platform to deliver the next wave of medicines for difficult-to-treat diseases. For more information, please visit www.c4therapeutics.com.
About CFT7455
CFT7455 is an orally bioavailable MonoDAC™ degrader designed to be highly potent and selective against its intended targets of Ikaros (IKZF1) and Aiolos (IKZF3) and overcome shortcomings of currently approved therapies to treat multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). Initial clinical data show CFT7455 is well tolerated, demonstrates anti-myeloma activity and displays evidence of immunomodulatory effects. The optimal dosing schedule for CFT7455 is 14 days on/14 days off. Dose escalation continues in cohorts exploring CFT7455 in combination with dexamethasone for relapsed/refractory MM patients and as a monotherapy for NHL patients. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04756726).
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 BiDAC™ and MonoDAC™ degraders; the potential timing, design and advancement of our preclinical studies and clinical trials, including the potential timing for and receipt of regulatory authorization related to clinical trials and other clinical development activities including clinical trial commencement; 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 ability to replicate interim or early-stage results from our clinical trials in the results obtained when those clinical trials are completed or when those therapies complete later stage clinical trials; regulatory developments in the United States and foreign countries; the potential timing for updates on our clinical and research programs; and our ability to fund our future operations. 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, advancement 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 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.
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CSolberg@c4therapeutics.com
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