BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Multiple refractory PD1 failure patients experienced prolonged progression free survival (10 months ongoing); confirmed responses observed in patients receiving evalstotug
多例難治性 PD1 衰竭患者的無進展存活時間延長(持續 10 個月);在接受 evalstotug 的患者中觀察到證實的反應
High doses of evalstotug as either a monotherapy or in combination with PD1 are associated with manageable safety with relatively low incidence and severity of immune-mediated AEs allowing patients to continue treatment for extended intervals
無論是單一療法還是與PD1聯合使用,高劑量的evalstotug都與可控的安全性有關,免疫介導的不良反應的發生率和嚴重程度相對較低,允許患者延長治療間隔時間
On track for completion of Phase 1 dose-escalation of evalstotug at 1 gram (14.2 mg/kg for a 70 kg person) and Phase 2 monotherapy study with multiple scans in refractory melanoma and carcinoma patients; ongoing enrollment in 1st line combination therapy expansion cohorts for 2H readout
有望完成對難治性黑色素瘤和癌症患者進行多次掃描的Evalstotug的1期劑量遞增試驗(每人爲14.2 mg/kg)和2期單一療法研究,對難治性黑色素瘤和癌症患者進行多次掃描;正在招收1線聯合療法擴展隊列以獲取2H讀數
A Phase 3 trial of evalstotug in first-line metastatic, unresectable BRAF-mutated melanoma is
anticipated to initiate in 2H of 2024 following planned FDA meeting
evalstotug 治療一線轉移性、不可切除的 BRAF 突變黑色素瘤的 3 期試驗是
預計將在計劃舉行的美國食品藥品管理局會議之後於2024年下半年啓動
SAN DIEGO, May 23, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced expanded data at an upcoming presentation entitled, "Phase 1 study of evalstotug (BA3071), an anti-CTLA-4 Conditionally Active Biologic, in combination with nivolumab in advanced solid tumors", demonstrating confirmed responses with a potentially differentiated tolerability profile with the Company's novel, conditionally active anti-CTLA-4 agent, evalstotug, in combination with anti-PD-1 therapy. The poster will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois on Saturday, June 1, 2024.
聖地亞哥,2024年5月23日(GLOBE NEWSWIRE)——專注於開發用於治療實體瘤的條件活性生物製劑(CAB)抗體療法的全球臨床階段生物技術公司BioATLA, Inc.(納斯達克股票代碼:BCAB)今天在即將舉行的題爲 “抗CTLA-4條件活性生物製劑evalstotug(BA3071)的1期研究” 的演講中宣佈了擴展數據使用nivolumab治療晚期實體瘤”,該公司的新型產品顯示出經證實的反應並具有潛在的差異化耐受性,條件活性抗 CTLA-4 藥物 evalstotug,與抗 PD-1 療法聯合使用。該海報將於2024年6月1日星期六在伊利諾伊州芝加哥的味好美廣場會議中心舉行的 2024 年美國臨床腫瘤學會 (ASCO) 年會上發佈。
"Given the emerging clinical profile observed, we believe evalstotug has the potential to be best-in-class CTLA-4 antibody and holds the promise to be used as often as a PD-1 inhibitor," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Strikingly, we have observed prolonged PFS of greater than 10 months and confirmed responses at high doses (350 mg), of evalstotug, suggesting increased exposure of CTLA-4 blockade in combination with PD-1 inhibition drives clinical benefit. We continue to enroll in the Phase 2 first-line melanoma and mutated NSCLC combination cohorts at the 700 mg flat dose and we anticipate moving to the 1 gram flat dose in June following clearance of the DLT observation period and remain on track for monotherapy and combination data readouts later this year. We anticipate enabling a Phase 3 trial of evalstotug in first-line metastatic or unresectable BRAF-mutated melanoma in the second half of this year.
BioAtla, Inc.董事長、首席執行官兼聯合創始人傑伊·肖特博士說:“鑑於觀察到的新興臨床特徵,我們認爲 evalstotug 有可能成爲同類中最好的 CTLA-4 抗體,並有望經常用作 PD-1 抑制劑。” 引人注目的是,我們觀察到 evalstotutus 的 PFS 持續時間超過 10 個月,並證實了高劑量(350 mg)下的反應 g,這表明 CTLA-4 阻滯劑與 PD-1 抑制劑相結合的暴露量增加,可帶來臨床益處。我們將繼續以700 mg的平坦劑量註冊2期一線黑色素瘤和突變的非小細胞肺癌組合隊列,我們預計在DLT觀察期結束後,將於6月份改爲1克的平坦劑量,並有望在今年晚些時候公佈單一療法和聯合療法的數據。我們預計將在今年下半年啓動針對一線轉移性或不可切除的BRAF突變黑色素瘤的evalstotug的3期試驗。
Data highlights from poster include:
海報中的數據亮點包括:
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A Phase 1 dose-escalation study evaluated evalstotug (7 mg – 1 g Q3W) in combination with nivolumab (240 mg), conducted in 21 patients
Data cut of March 29, 2024 unless otherwise specified
Patients received a median of 3 prior lines of systemic therapy
All patients had experienced failure of anti–PD-1 therapy
Patients treated with 350 mg evalstotug received more doses (mean, 7.2) compared with reported ipilimumab or tremelimumab dosing; no dose reductions occurred
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Three patients have tolerated their first 1-gram evalstotug infusion; clearing the DLT observation period is anticipated by early June
Population PK modeling suggests that 1 g flat dose will enable over 98% of patients to maintain Cmin levels greater than EC50 throughout treatment potentially driving clinical benefit
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Evalstotug was generally well-tolerated with relatively low incidence and severity of immune-mediated AEs
Four patients experienced Grade 3 related treatment-emergent AEs
No Grade 4 or 5 related TEAEs were observed
Two patients experienced Grade 3 immune-related TEAEs (diarrhea [evalstotug 350 mg] and diabetic ketoacidosis [evalstotug 700 mg])
Only two treatment related discontinuations
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Evalstotug demonstrated clinical benefit in heavily pre-treated patients (data cut as of April 30, 2024)
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Responses in three of eight patients who received evalstotug 350mg
One confirmed complete response in cervical carcinoma
One confirmed partial response in gastroesophageal carcinoma
One unconfirmed partial response in cutaneous melanoma patient who was dose escalated and who remains on therapy
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Disease control rate of 52%
Three patients (two with cutaneous melanoma, one with metastatic small cell lung cancer) remained without progression for greater than 1 year (69 weeks)
One uveal melanoma patient without progression for 9.8 months
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一項1期劑量遞增研究評估了evalstotug(7 mg — 1 g Q3W)與nivolumab(240 mg)聯合對21名患者進行的
除非另有說明,否則數據截止日期爲2024年3月29日
患者接受的中位數爲先前接受的三線全身治療
所有患者均出現抗PD-1治療失敗的經歷
與報告的ipilimumab或tremelimumab劑量相比,接受350 mg evalstotug治療的患者接受的劑量更多(平均值爲7.2);劑量未減少
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三名患者已耐受首次1克的evalstotug輸液;預計將在6月初完成DLT觀察期
人群 PK 建模表明,1 g 的平坦劑量將使超過 98% 的患者在整個治療過程中保持高於 EC50 的 Cmin 水平,這可能會帶來臨床益處
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Evalstotug 的耐受性普遍良好,免疫介導的 AE 的發病率和嚴重程度相對較低
四名患者出現了3級相關治療的急診不良反應
未觀察到與 4 級或 5 級相關的 TEAE
兩名患者出現了 3 級免疫相關的 TEAE(腹瀉 [evalstotug 350 mg] 和糖尿病酮症酸中毒 [evalstotug 700 mg])
只有兩次與治療相關的停藥
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Evalstotug 在經過大量預治療的患者中顯示出臨床益處(截至 2024 年 4 月 30 日的數據)
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在接受 evalstotug 350mg 的八名患者中,有三名患者的反應
一項證實對宮頸癌有完全反應
一項經證實的胃食管癌有部分反應
在劑量增加且仍在接受治療的皮膚黑色素瘤患者中有一項未經證實的部分反應
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疾病控制率爲 52%
三名患者(兩名患有皮膚黑色素瘤,一名患有轉移性小細胞肺癌)沒有進展超過1年(69周)
一名葡萄膜黑色素瘤患者已經 9.8 個月沒有進展
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A copy of the presentation materials can be accessed on the "Publications" section of the Company's website at once the presentation has concluded.
演示結束後,可以在公司網站的 “出版物” 部分訪問演示材料的副本。
About Evalstotug (BA3071)
關於 Evalstotug (BA3071)
Evalstotug, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy at least comparable to the approved anti-CTLA-4 antibodies, but with lower toxicities due to the CAB's tumor microenvironment-restricted activity. This may enable safer anti-CTLA-4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy and deliver greater efficacy. Like our other CAB candidates, this Phase 2 clinical asset is designed to be conditionally and reversibly active in the tumor microenvironment. Evalstotug is being developed as a potential therapeutic for several solid tumor indications that are known to be responsive to CTLA-4 treatment in combination with a PD-1 blocking agent.
Evalstotug是一種CAB抗CTLA-4抗體,是作爲一種免疫腫瘤學藥物開發的,其目標是提供至少與批准的抗CTLA-4抗體相當的療效,但由於CAB的腫瘤微環境活性受限,毒性較低。這可以實現更安全的抗CTLA-4抗體聯合療法,例如使用抗PD-1抗體檢查點抑制劑,並有可能擴大對聯合療法的耐受性並提供更高的療效。與我們的其他CAB候選藥物一樣,該2期臨床資產旨在有條件和可逆地在腫瘤微環境中發揮活性。Evalstotug 正在開發爲幾種實體瘤適應症的潛在治療藥物,這些適應症已知對與 PD-1 阻斷劑聯合使用 CTLA-4 治療有反應。