2015年4月18日訊 /生物谷BIOON/ --如果十年後生物醫藥產業分析人士再回首，2014年、2015年或許將是一段值得大書特書的時期。在這兩年中，隨著生物醫藥產業的努力，腫瘤免疫療法已經從一個概念逐漸變為現實。而在眾多免疫療法中，CAR-T療法收穫了業界最多的目光。隨著這一概念的興起，科學家們將有望利用免疫系統作為人類最有力的武器去對抗腫瘤病魔。
目前在這一領域中的領頭羊當屬諾華公司和Juno公司等。但是，由於看好這一領域巨大的前景，仍然有眾多的生物醫藥公司紛紛擠入這一領域。最近，來自義大利的MolMed生物醫藥公司就成為這一領域最新的一位參賽者。
MolMed公司最近宣布，公司已經和義大利San Raffaele-Telethon Institute for Gene Therapy （TIGET）達成了合作協議共同開發新型CAR-T療法CAR-CD44v6 。合約雙方並未透露過多的合作細節，但研究人員表示這種療法在小鼠模型上表現出了針對急性粒細胞白血病和多發性骨髓瘤的良好效果。這種藥物主要靶向腫瘤細胞表面CD44信號分子的6型突變。因此，理論上只要與此相關的腫瘤類型都有可能會對這種療法起到良好的反應。這也意味著許多血癌和實體瘤入肺癌和乳腺癌都是這種療法的潛在適應症之一。而後兩者也是當前腫瘤市場上患者人數最多的腫瘤類型之一。
進入2015年，CAR-T療法又不斷取得新進展。今年2月份，諾華公司與賓大聯手開展CAR-T療法治療惡性膠質瘤的臨床研究，將CAR-T療法的應用進一步拓展；（相關閱讀：再下一城，諾華－賓大即將開展CAR-T治療惡性膠質瘤臨床研究）隨後本月初，CAR-T領域兩大先鋒諾華公司和Juno公司又宣布達成有關CAR-T療法專利紛爭和解，這為CAR-T在2015年繼續飛速發展掃清了又一大法律障礙。（相關閱讀：諾華、Juno低調了結專利紛爭 CAR-T療法開發最大法律障礙被掃除！）
可以預見，在未來相當長的一段時間內CAR-T療法仍然是生物醫藥產業關注的焦點。（生物谷Bioon.com）
詳細英文報導：
MolMed (BIT:MLM) has become the latest to buy its way into the CAR-T race. The deal sees it pick up assets from an immune-gene therapy CAR-CD44v6 project run by a group at San Raffaele Scientific Institute, the Milan-based research center that struck a deal with Biogen ($BIIB) in January.
Luigi Naldini, who heads up the San Raffaele-Telethon Institute for Gene Therapy (TIGET) with which Biogen partnered, played a role in the research program licensed by MolMed. Tests in mouse models have assessed the efficacy of the treatment against acute myeloid leukemia and multiple myeloma, but MolMed thinks there is the potential to branch out into a range of hematological and solid tumor indications. In theory, any cancer involving variant 6 of the CD44 antigen--a list which includes the above mentioned hematological indications and carcinomas of the breast and lung--is an option.
The hematological mouse model tests date back to 2013, at which time Naldini and his collaborators said the use of a chimeric antigen receptor with a CD28 signaling domain to target T cells at CD44v6 warranted investigation in clinical trials. MolMed is well placed to assess the strength of the project. The drugmaker struck a deal with San Raffaele Hospital in 2001 that gives it the option to pick up any gene and molecular therapies for oncology and AIDS that emerge from the research center. And it has taken an active interest in the progress of the CAR-CD44v6 project.
MolMed CEO Claudio Bordignon co-authored the CD44v6 paper with Naldini and a who's who of researchers from the Milanese gene therapy scene. "The CAR-CD44v6 project will benefit not only from our extensive experience and knowhow in the field of gene and cell therapy, but also from the conjugation with the suicide gene TK, becoming the first CAR-T product to integrate a control system already extensively tested and validated in clinical trials," Bordignon said in a statement.
The experience and knowhow to which Bordignon refers has started to attract attention. As well as the gene therapy deal with Biogen, TIGET is working with local startup Genenta Science on the targeted use of interferon against hematopoietic malignancies.