Coherus Completes Surface Oncology Acquisition
Coherus Completes Surface Oncology Acquisition
– Clinical-stage product candidates, casdozokitug and CHS-114, significantly advance
next-generation immuno-oncology portfolio focused on the tumor microenvironment –
– I-O combinations will potentially expand toripalimab opportunity into large indications with high unmet need –
REDWOOD CITY, Calif., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) today announced the closing of the previously announced acquisition of Surface Oncology, Inc. (Surface or Surface Oncology), a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment. As a result of the acquisition, Coherus' novel I-O pipeline now includes four differentiated clinical-stage assets:
- Toripalimab, a late-stage, anti-PD-1 monoclonal antibody candidate under BLA review for the potential treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
- Casdozokitug (SRF388 or casdozo), a novel, first-in-class IL-27-targeted antibody currently being evaluated in Phase 2 clinical trials in lung cancer and liver cancer;
- CHS-114 (SRF114), a highly selective, competitively positioned, ADCC-enhanced CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors; and
- CHS-006, a TIGIT-targeted antibody currently in a Phase 1/2 study in combination with toripalimab in patients with advanced solid tumors.
"The addition of the first-in-class IL-27 targeted antibody, casdozo, and the potential best-in-class CCR8 targeted antibody CHS-114, marks Coherus' transition to a next-generation immuno-oncology company focused on the tumor microenvironment," said Denny Lanfear, Chairman and Chief Executive Officer of Coherus. "We will now focus our development efforts on delivering breakthrough survival benefits for cancer patients, beyond the efficacy seen with existing chemotherapy plus checkpoints regimens. Toripalimab combinations with these two new agents have the potential to expand tori use into highly prevalent tumor types including NSCLC and head and neck cancer, where it has already consistently shown clinically meaningful activity."
At the closing of the acquisition, Coherus issued 0.1960 shares of its common stock per share of outstanding Surface common stock and certain outstanding Surface employee equity awards (which exchange ratio was calculated based on a $5.2831 per share price of Coherus common stock) for a total value equal to approximately $66.9 million, the sum of $40 million plus Surface's net cash at closing of the transaction of $26.9 million. Surface shareholders also received contingent value rights (CVRs) for 70% of milestone and royalty-based value of existing programs with Novartis (NZV930) and GSK (GSK4381562), as well as for 25% of upfront payments made pursuant to potential ex-US licensing agreements for CHS-114 and 50% of upfront payments made pursuant to potential ex-US licensing agreements for casdozokitug, subject to certain deductions as set forth in the contingent value rights agreement. Amounts under these CVRs are payable for a period of ten years following the closing of this transaction. As a result of the acquisition, Surface has become a wholly owned subsidiary of Coherus and the common stock of Surface will no longer be listed for trading on the Nasdaq Capital Market, effective as of prior to market open on September 8, 2023.
Truist Securities acted as financial advisor, and Arnold & Porter Kaye Scholer LLP and Latham & Watkins LLP acted as legal advisors to Coherus. Wedbush Securities Inc. acted as exclusive strategic financial advisor, and Goodwin Procter LLP acted as legal advisor to Surface.
About Coherus' Immuno-Oncology Pipeline
Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology. Through an in-licensing agreement with Shanghai Junshi Biosciences Ltd., Coherus is developing toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of NPC is under review by the FDA. Toripalimab is approved in China for the treatment of melanoma, urothelial cancer, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and non-small cell lung cancer.
Through its acquisition of Surface Oncology, Coherus' immuno-oncology pipeline will now include multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug (SRF388) is a novel anti-IL-27 antibody currently being evaluated in Phase 1/2 clinical trials in lung and liver cancer. CHS-114 (SRF114) is a highly selective, competitively positioned anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. There are also two out-licensed partnership programs to advance its next-generation cancer therapies.
Coherus' earlier-stage immuno-oncology pipeline targets immune-suppressive mechanisms in the tumor microenvironment, including CHS-006, a TIGIT-targeted antibody, being evaluated in a Phase 1/2 clinical trial in combination with toripalimab in patients with advanced solid tumors, and CHS-1000, a preclinical program targeting the novel pathway ILT4.
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus' strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.
In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. The Biologics License Application for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA.
Coherus markets UDENYCA (pegfilgrastim-cbqv), a biosimilar of Neulasta, CIMERLI (ranibizumab-eqrn), a biosimilar of Lucentis, and YUSIMRY (adalimumab-aqvh), a biosimilar of Humira.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus' ability to build its immuno-oncology franchise to achieve a leading market position; Coherus' ability to generate cash and net sales; Coherus' investment plans; Coherus' ability to find synergies between its I-O pipeline and its commercial operations; expectations about the efficacy and safety profile of any product candidate in the future; and Coherus' ability to expand toripalimab into highly prevalent tumor types, to further advance its next-generation immuno-oncology portfolio focused on the tumor microenvironment, and to improve survival outcomes in cancer treatment.
Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus' actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks related to integration of Surface's programs and operations; risks related to realizing the anticipated benefits of the acquisition of Surface; risks related to Coherus' existing and potential collaboration partners; risks of Coherus' competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus' business and the timing of Coherus' regulatory filings; the risk of FDA review issues; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus' products and product candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023 filed with the Securities and Exchange Commission on August 2, 2023, including the section therein captioned "Risk Factors" and in other documents Coherus files with the Securities and Exchange Commission.
UDENYCA, CIMERLI and YUSIMRY, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.
Coherus Contacts
Investor Relations
Marek Ciszewski, SVP Investor Relations
IR@coherus.com
Media Relations
Jodi Sievers, VP Corporate Communications
media@coherus.com
— 處於臨床階段的候選產品 casdozokitug 和 CHS-114 取得了顯著進步
專注於腫瘤微環境的下一代免疫腫瘤學產品組合 —
— I-O 組合有可能將 toripalimab 的機會擴大到需求未得到滿足的大型適應症 —
加利福尼亞州雷德伍德城,2023年9月8日(GLOBE NEWSWIRE)——Coherus BioSciences, Inc.(CHERUS,納斯達克股票代碼:CHRS)今天宣佈完成先前宣佈的對錶面腫瘤學公司(表面或表面腫瘤學)的收購,該公司正在開發針對腫瘤微環境的下一代免疫療法。此次收購後,Coherus的新型I-O產品線現在包括四種不同的臨床階段資產:
- Toripalimab,一種晚期抗PD-1單克隆抗體候選藥物,正在接受BLA審查,可用於治療晚期復發或轉移性鼻咽癌(NPC);
- Casdozokitug(SRF388 或 casdozo),一種新型的、同類首創的白細胞介素-27靶向抗體,目前正在肺癌和肝癌的2期臨床試驗中進行評估;
- CHS-114 (SRF114),一種選擇性強、定位具有競爭力的ADCC增強型ccr8靶向抗體,目前正在進行1/2期研究,作爲晚期實體瘤患者的單一療法;以及
- CHS-006,一種 Tigit 靶向抗體,目前正處於 1/2 期研究中,與託瑞普利單抗聯合治療晚期實體瘤患者。
Coherus董事長兼首席執行官丹尼·蘭菲爾表示:“同類首創 IL-27 靶向抗體casdozo和潛在的同類最佳CCR8靶向抗體 CHS-114 的加入標誌着Coherus向專注於腫瘤微環境的下一代免疫腫瘤學公司的過渡。”“除了現有化療和檢查點方案的療效之外,我們現在將把開發工作重點放在爲癌症患者提供突破性的存活益處上。Toripalimab與這兩種新藥物的組合有可能將tori的使用範圍擴大到包括非小細胞肺癌和頭頸癌在內的高度流行的腫瘤類型,在這些腫瘤中,它已經持續顯示出具有臨床意義的活性。”
收購結束時,Coherus發行了每股0.1960股普通股的已發行Surface普通股和某些未償還的Surface員工股權獎勵(其兌換率是根據Coherus普通股每股5.2831美元的價格計算的),總價值約爲6,690萬美元,總額爲4000萬美元,加上Surface在交易結束時的淨現金2690萬美元。Surface股東還獲得了諾華(NZV930)和葛蘭素史克(GSK4381562)現有計劃的里程碑價值和特許權使用費價值的70%的或有價值權(CVR),以及根據潛在的美國以外的 CHS-114 許可協議支付的25%的預付款,以及根據可能的美國以外的casdozokitug許可協議支付的50%的預付款,但須按或有價值權利協議中的規定進行某些扣除。這些CVR下的金額在本次交易完成後的十年內支付。由於此次收購,Surface已成爲Coherus的全資子公司,Surface的普通股將不再在納斯達克資本市場上市交易,自2023年9月8日市場開盤前起生效。
Truist Securities擔任財務顧問,Arnold & Porter Kaye Scholer LLP和Ratham & Watkins LLP擔任Coherus的法律顧問。Wedbush Securities Inc.擔任Surface的獨家戰略財務顧問,古德溫·寶潔律師事務所擔任Surface的法律顧問。
關於 Coherus 的免疫腫瘤學產品線
Coherus正在開發一種創新的免疫腫瘤學產品線,該產品線將與其在腫瘤學領域久經考驗的商業能力協同作用。通過與上海君實生物醫藥科技有限公司簽訂的許可協議,Coherus正在美國和加拿大開發抗PD-1抗體toripalimab。美國食品藥品管理局正在審查用於治療鼻咽癌的toripalimab的生物製劑許可證申請。Toripalimab在中國獲准用於治療黑色素瘤、尿路上皮癌、食管鱗狀細胞癌、鼻咽癌和非小細胞肺癌。
通過收購Surface Oncology,Coherus的免疫腫瘤學產品線現在將包括多種候選抗體免疫療法,重點是增強先天和適應性免疫反應,從而實現強大的免疫學反應並改善癌症患者的預後。Casdozokitug(SRF388)是一種新型的抗白細胞介素-27抗體,目前正在肺癌和肝癌的1/2期臨床試驗中進行評估。CHS-114(SRF114)是一種高選擇性、定位具有競爭力的抗CCR8抗體,目前正在進行1/2期研究,作爲晚期實體瘤患者的單一療法。還有兩個已獲得許可的合作計劃,以推進其下一代癌症療法。
Coherus 早期階段的免疫腫瘤學產品線靶向腫瘤微環境中的免疫抑制機制,包括 CHS-006,一種靶向 TIGIT 的抗體,正在與特里帕利單抗聯合用於晚期實體瘤患者的第 1/2 期臨床試驗中進行評估,以及針對新途徑 ILT4 的臨床前項目 CHS-1000。
關於科赫魯斯生物科學
Coherus是一家處於商業階段的生物製藥公司,專注於治療癌症的創新免疫療法的研究、開發和商業化。Coherus的戰略是建立領先的免疫腫瘤學特許經營權,資金來自其經美國食品藥品管理局批准的多元化療法組合的淨銷售產生的現金。
2021年,Coherus在美國和加拿大獲得了抗PD-1抗體toripalimab的許可。美國食品藥品管理局目前正在審查toripalimab與化療聯合治療復發或轉移性鼻咽癌的生物製劑許可證申請。
Coherus 市場 UDENYCA (pegfilgrastim-cbqv),Neulasta 的生物仿製藥,CIMERLI Lucentis 的生物仿製藥(ranibizumab-eqrn)和 Humira 的生物仿製藥 Yusimry(adalimab-aqvh)。
前瞻性陳述
除此處包含的歷史信息外,本新聞稿中列出的事項均爲1995年《私人證券訴訟改革法》“安全港” 條款所指的前瞻性陳述,包括但不限於關於Coherus建立免疫腫瘤學特許經營權以實現領先市場地位的能力的聲明;Coherus創造現金和淨銷售額的能力;Coherus的投資計劃;Coherus在其I-O之間找到協同效應的能力管道及其商業運營;對管道的期望未來任何候選產品的療效和安全性;以及Coherus能夠將toripalimab擴展到高度流行的腫瘤類型,進一步推進其專注於腫瘤微環境的下一代免疫腫瘤產品組合,並改善癌症治療的存活結果。
此類前瞻性陳述涉及重大風險和不確定性,可能導致Coherus的實際業績、業績或成就與前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在顯著差異。此類風險和不確定性包括臨床藥物開發過程中固有的風險和不確定性;與整合Surface項目和運營相關的風險;與實現收購Surface的預期收益相關的風險;與Coherus現有和潛在合作伙伴相關的風險;Coherus競爭地位的風險;監管批准程序的風險和不確定性,包括監管審查的速度、Coherus業務的國際方面以及Coherus的時機我們的監管文件;FDA審查問題的風險;Coherus無法完成商業交易的風險以及其他可能影響Coherus產品和候選產品可用性或商業潛力的事項;以及可能的訴訟的風險和不確定性。本新聞稿中包含的所有前瞻性陳述僅代表截至本新聞稿發佈之日。Coherus沒有義務更新或修改任何前瞻性陳述。要進一步了解可能導致實際業績與這些前瞻性陳述中表達的結果不同的重大風險和不確定性,以及與Coherus的總體業務相關的風險,請參閱Coherus於2023年8月2日向美國證券交易委員會提交的截至2023年6月30日的財季10-Q表季度報告,包括其中標題爲 “風險因素” 的部分以及Coherus向美國證券交易委員會提交的其他文件。
UDENYCA,CIMERLI 除非另有說明,否則YUSIMRY無論是否以大字形式出現或帶有商標符號,均爲Coherus及其關聯公司、關聯公司或其許可方或合資夥伴的商標。據Coherus所知,本新聞稿中出現的其他公司的商標和商品名稱是其各自所有者的財產。
Coherus 聯繫人
投資者關係
Marek Ciszewski,投資者關係高級副總裁
IR@coherus.com
媒體關係
Jodi Sievers,企業傳播副總裁
media@coherus.com
譯文內容由第三人軟體翻譯。
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