미국 나스닥 상장사인 C4 테라퓨틱스 주가가 전일 대비 무려 +98.31% 폭등하면서 시장의 기대감을 한몸에 받고 있습니다.
C4 테라퓨틱스는 어떤 기업이고, 주가 폭등 이유와 기술적 분석 등을 통해 주가 전망까지 체크해 보도록 하겠습니다.
C4 테라퓨틱스(CCCC)는 어떤 기업?
C4 테라퓨틱스는 천연 단백질 재활용 시스템을 활용한 미국 바이오 기업으로 질병을 유발하는 단백질을 빠르게 분해하는 경구적, 생물학적 이용 가능한 소분자 분해제를 개발한 기업입니다.
TPD 의약품이 현재 약물로 사용할 수 없는 단백질을 포함하여 질병을 유발하는 단백질을 치료하고, 궁극적으로 환자 상태를 개선할 수 있는 역량을 보유하고 있는 기업입니다.
C4 테라퓨틱스가 보유한 TORPEDO® (Target Oriented Protein Degrader Optimizer)플랫폼은 단백질 분해(TPD). TORPEDO® 플랫폼을 통해 우리는 MonoDAC™ 분해기라고 부르는 분자 접착제와 BiDAC™ 분해기라고 부르는 이종이기능성 분해기를 모두 고유하게 설계할 수 있는 장점이 있습니다.
TORPEDO® 플랫폼은 분해 성능을 설계, 분석 및 예측할 수 있는 기능을 제공하는 플랫폼으로 컴퓨터 기반 도구를 활용하여 분자 수준에서 분해제를 설계해 효능을 상승시킬 수 있습니다.
C4 테라퓨틱스 시가총액
C4 테라퓨틱스 시가총액은 12월 12일 종가 기준 약 115,318,000달러, 우리나라 돈으로 약 1517억원 정도입니다.
C4 테라퓨틱스 주가가 급등하기 전 58,151,580달러, 약 764억원에 비해 하루 만에 2배 가까이 시가총액이 늘어났습니다.
C4 테라퓨틱스 주가 상승 이유
C4 테라퓨틱스는 지난 12월 12일, 재발성/불응성 다발성 골수종에 대한 CFT7455 1상 시험의 긍정적인 데이터를 발표했습니다.
재발성/불응성 다발성 골수종에 대한 CFT7455 1상 시험 데이터 원문은 아래와 같습니다.
December 12, 2023
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.
WATERTOWN, Mass., Dec. 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.
위의 원문을 대략적으로 해석해보면
데이터 지원 14일간 투여/14일간 휴식이 최적 투여 일정으로 지원
CFT7455는 잘 견디며, 공약적인 임파종 활동의 희망적인 징후가 있다.
단일요법 용량 증가 완료, 골수종 활동 억제 및 면역조절 효과 입증
CFT7455의 용량 증가는 재발/불응성 다발성 골수종에서 덱사메타손과의 조합으로 계속 진행
CFT7455를 단독치료로 사용하는 NHL 환자를 대상으로 한 1상용량 증가 임상시험에 대한 환자 모집을 계속하고 있음
정도로 요약해 볼 수 있습니다. 위와 같은 CFT7455의 긍정적인 임상 결과 발표로 인해 C4 테라퓨틱스 주가는 장 중 최고 +128.81% 상승한 2.7달러 부근까지 치솟기도 했습니다.
C4 테라퓨틱스 주가 전망
C4 테라퓨틱스 주가 일봉차트를 체크해보면 최근 하락 추세가 진행되다가 어제, CFT7455의 긍정적인 임상 결과 발표 소식과 함께 전일 대비 +98.31% 급등한 2.34달러에 장을 마감했습니다.
C4 테라퓨틱스 주가는 장 중 최고 +128.81%까지 상승했고, 일봉차트상 기술적으로는 위로 저항이 약한 구간입니다.
때문에 단기적으로는 추가 상승을 기대해 볼 수 있지만, 아래 주봉차트상 중장기 매물대 저항이 강해 추가적인 상승이 지속되기 위해서는 대량 거래가 몇 차례 더 필요해보입니다.
C4 테라퓨틱스 주가 주봉차트를 보면 어제 거래량이 급증하기는 했지만 5.9달러 부근까지 비교적 중장기 매물대 저항이 강하게 남아 있는 것을 볼 수 있습니다.
CFT7455의 긍정적인 임상 결과 발표로 인해 주가 반등의 모멘텀은 만들어 놨지만 위의 저항을 완벽히 소화하지는 못해 저항에 눌릴 가능성도 분명 존재합니다.
미국 주식의 경우 상하한가 변동 폭이 없기 때문에 하루만에도 주가가 5달러 위로 상승할 수 있으나 이번 모멘텀으로 위의 중장기 물량을 모두 소화하기에는 역부족이었던 것으로 보입니다.
그럼에도 불구하고 C4 테라퓨틱스 주가가 반등 모멘텀을 받아 하락 추세에서 벗어난 점은 긍정적이기 때문에, 부디 이번 상승 추세를 발판 삼아 주가가 상승하기를 바래봅니다.