Iovance Biotherapeutics and Cellectis have signed a research partnership and an exclusive global license agreement

13 January 2020

Iovance Biotherapeutics, Inc., an advanced phase biotechnology company developing new T-cell based cancer immunotherapies, and Cellectis, a clinical phase biopharmaceutical company specializing in the development of immunotherapies based on genetically modified allogeneic CAR-T cells (UCART), have announced the signing of a research partnership and an exclusive global license agreement granting at Iovance a license for certain applications of Cellectis TALEN® technology to develop tumor infiltrating lymphocytes (TIL) which have been genetically modified to create more powerful cancer therapies.

This global license grants Iovance Biotherapeutics the exclusive use of TALEN® technology targeting several genes to modify TILs for therapeutic purposes in various types of cancer. The financial conditions of this license provide for payments from Iovance Biotherapeutics to Cellectis at the development, regulatory and sales stages, as well as royalties on the net sales of TIL products modified using TALEN® technology.

“We are delighted to collaborate with Cellectis to apply the TALEN® genome editing technology to Iovance's TIL products. We believe that we can genetically modify the TILs to obtain an anti-cancer product that is more reactive to tumors, ”explains Maria Fardis, President and CEO of Iovance Biotherapeutics. “We plan to bring a modified TIL therapy using TALEN® technology to the clinic as soon as possible. "

"We are delighted to work with Iovance and are convinced that the application of our TALEN® technology to its TIL-based products will generate better treatments for various types of cancer," added André Choulika, President and CEO of Cellectis. "Patients remain the primary concern of our company and we sincerely hope that this collaboration will find more effective solutions for those who need them." "

About Iovance Biotherapeutics

Iovance Biotherapeutics aims to improve patient care by making T-cell based immunotherapies widely available for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating therapy (TIL) uses a patient's own immune cells to attack cancer cells. TIL cells are extracted from the patient's tumor tissue, multiplied by an exclusive process, and then re-infused into the patient. After the infusion, the TILs reach the tumor tissue, where they attack the tumor cells. The company is currently conducting pivotal studies in patients with metastatic melanoma or advanced cervical cancer. The company's TIL therapies are also being evaluated for the treatment of patients with advanced local, recurrent or metastatic cancers, including head and neck cancer, and non-small cell lung cancer. A clinical study to determine the effectiveness of Iovance T cell therapy on blood cancers, called peripheral blood lymphocyte therapy (PBL), is being launched. For more information, visitwww.iovance.com .

About Cellectis

Cellectis is developing the very first allogenic immunotherapies based on CAR-T cells, inventing the concept of CAR-T cells engineered on the shelf and ready to use for the treatment of cancer patients. By capitalizing on its 20 years of genome engineering expertise, on its TALEN® genome editing technology and on the pioneering PulseAgile electroporation technology, Cellectis is developing innovative product candidates using the power of the immune system to target and eliminate cancer cells.

As part of its commitment to the research of cancer therapies, Cellectis aims to develop UCART product candidates likely to save the lives of patients suffering from certain types of cancer, in particular acute myeloid leukemia, acute lymphoblastic cell leukemia B, multiple myeloma and Hodgkin and non-Hodgkin lymphoma.

Cellectis' head office is located in Paris. Cellectis is also located in New York and Raleigh in the United States. Cellectis is listed on the Euronext Growth market (code: ALCLS) as well as on the Nasdaq Global Market (code: CLLS). To find out more, visit our website: www.cellectis.com .

Follow Cellectis on social media: @cellectis , LinkedIn and YouTube .

TALEN® is a registered trademark owned by Cellectis.

Iovance Biotherapeutics Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements” of Iovance Biotherapeutics, Inc. (hereinafter referred to as the “Company,” “we,” “us,” or “our”). We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may, ”“ Could, ”“ might, ”“ will, ”“ should ”or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. The forward-looking statements include, but are not limited to, risks and uncertainties relating to the success, timing, projected enrollment, manufacturing and production capabilities, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates (including both Company-sponsored and collaborator-sponsored trials in both the US and Europe), such as statements regarding the timing of initiation and completion of these trials; the timing of and our ability to successfully submit, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, our product candidates, including those product candidates that have been granted breakthrough therapy designation (“BTD”) or regenerative medicine advanced therapy designation (“RMAT”) by the FDA and new product candidates in both solid tumor and blood cancers; the strength of the Company's product pipeline; the successful implementation of the Company's research and development programs and collaborations; the Company's ability to obtain tax incentives and credits; the guidance provided for the Company's future cash, cash equivalent, and short term investment positions; the success of the Company's manufacturing, license or development agreements; the acceptance by the market of the Company's product candidates, if approved; and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the preliminary clinical results, which may include efficacy and safety results, from ongoing Phase 2 studies may not be reflected in the final analyzes of these trials or subgroups within these trials; a slower rate of enrollment may impact the Company's clinical trial timelines; enrollment may need to be adjusted for the Company's trials and cohorts within those trials based on FDA and other regulatory agency input; the new version of the protocol which further defines the patient population to include more advanced patients in the Company's cervical cancer trial may have an adverse effect on the results reported to date; the data within these trials may not be supportive of product approval; changes in patient populations may result in changes in preliminary clinical results; the Company's ability or inability to address FDA or other regulatory authority requirements relating to its clinical programs and registrational plans, such requirements including, but not limited to, clinical, safety, manufacturing and control requirements; the Company's interpretation of communications with the FDA may differ from the interpretation of such communications by the FDA; risks related to the Company's ability to maintain and benefit from accelerated FDA review designations, including BTD and RMAT, which may not result in a faster development process or review of the Company's product candidates (and which may later be rescinded by the FDA), and does not assure approval of such product candidates by the FDA or the ability of the Company to obtain FDA approval in time to benefit from commercial opportunities; the ability or inability of the Company to manufacture its therapies using third party manufacturers or its own facility may adversely affect the Company's potential commercial launch; and additional expenses may decrease our estimated cash balances and increase our estimated capital requirements. A further list and description of the Company's risks, uncertainties and other factors can be found in the Company's most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at A further list and description of the Company's risks, uncertainties and other factors can be found in the Company's most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at A further list and description of the Company's risks, uncertainties and other factors can be found in the Company's most recent Annual Report on Form 10-K and the Company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online atwww.sec.gov or www.iovance.com . The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Warning

This press release contains forward-looking statements about the objectives of the Company, which are based on our current estimates and assumptions and the information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause material differences between our current results, performance and achievements and the future results, performance and achievements expressed or suggested by the forward-looking statements. More information on the risk factors that may affect the company's activity and its financial performance is given in the Cellectis annual report in English entitled "Form 20-F" for the year ended December 31, 2018, in the financial report (including the management report of the board of directors) for the year ended December 31, 2018 and the documents subsequently registered by Cellectis with the Securities Exchange Commission. Unless required by applicable law, we disclaim any obligation to update and publish these forward-looking statements, or to update the reasons why the results may differ materially from those expected in the forward-looking statements, even if new information was available in the future.

contacts
Media for Cellectis:

Jennifer Moore, VP Communications, + 1 917-580-1088, [email protected]
Caroline Carmagnol and Najette Chaib, ALIZE RP, 06 64 18 99 59, [email protected]

Investor relations for Cellectis:
Simon Harnest, VP of Corporate Strategy and Finance, +1 646-385-9008, [email protected]

Investor relations for Iovance Biotherapeutics:
Annie Chang
Solebury Trout
646-378-2972
[email protected]

Chad Rubin
Solebury Trout
646-378-2947
[email protected]

Media for Iovance Biotherapeutics:
Rich Allan
Solebury Trout
646-378-2958
[email protected]

 

Source: businesswire.com