On May 5, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported first quarter 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, MAY 5, 2022, View Source [SID1234613749]).
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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance had a positive start to the year across our lead program lifileucel in metastatic melanoma as well as our growing TIL pipeline. We recently reported favorable feedback from the FDA on our potency assays and assay matrix, which brings us a step closer to our planned BLA submission for lifileucel in metastatic melanoma. We continue to enroll patients in clinical studies to investigate our TIL therapies in multiple solid tumors, with plans to initiate a Phase 3 clinical trial of lifileucel in combination with pembrolizumab in frontline melanoma. In addition, the FDA has allowed an IND to proceed with a clinical trial of our PD-1 inactivated, gene-edited TIL therapy, IOV-4001. Our TIL platform, clinical data, and people are a solid foundation to establish TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."
First Quarter 2022 Highlights and Recent Corporate Updates
Regulatory
Iovance TIL therapy (lifileucel) in metastatic melanoma (post-anti-PD-1): Iovance received positive feedback from the U.S. Food and Drug Administration (FDA) on both its potency assay matrix and its proprietary cell co-culture assay included in the potency assay matrix. Iovance expects to request a pre-BLA meeting in July 2022 and to complete a BLA submission for lifileucel by August 2022.
IOV-4001 (PD-1 inactivated TIL therapy) Investigational New Drug (IND) Application: The FDA allowed an IND to proceed for Iovance’s first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or metastatic non-small cell lung cancer (mNSCLC). IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression. A clinical trial of IOV-4001 is expected to begin in 2022.
Clinical
Iovance TIL therapy (lifileucel) in frontline (anti-PD-1 naïve) metastatic melanoma:
Updated clinical data (Cohort 1A in the IOV-COM-202 trial, n=12): Updated clinical data announced in April 2022 demonstrated an overall response rate (ORR) of 67% for lifileucel in combination with pembrolizumab. Eight out of 12 patients had a confirmed objective response, including three complete responses and five partial responses.
Frontline melanoma strategy: Iovance plans to open a Phase 3 trial of lifileucel in combination with pembrolizumab in frontline metastatic melanoma in late 2022. The FDA previously granted Fast Track Designation for lifileucel in combination with pembrolizumab for the treatment of immune checkpoint inhibitor naïve metastatic melanoma.
Iovance TIL therapy (LN-145) in second-line mNSCLC:
Enrollment is ongoing at more than 30 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. A Trial in Progress (TIP) poster on IOV-LUN-202 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting featured updated eligibility criteria to broaden enrollment in reflection of the unmet need in mNSCLC.
Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.
Lifileucel in cervical cancer: Iovance is engaged in regulatory discussions about a potential BLA for lifileucel in cervical cancer and intends to execute an updated registrational strategy based on FDA dialogue and feedback.
Next-Generation Research Programs
Data presentations:
AACR 2022 Annual Meeting: A poster highlighting preclinical data for IOV-4001 demonstrated that anti-tumor activity of IOV-4001 was superior to non-edited TIL product whether alone or in combination with an anti-PD-1 antibody in a murine model of melanoma.
2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings: Research posters described TIL products manufactured from cryopreserved tumor samples shipped from Australia and a potential approach to optimize TIL memory-like phenotype and increase functionality during the manufacturing process.
Additional updates:
Several additional targets for genetic modification using the TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.
Additional research and preclinical studies of next generation TIL therapies and related technologies include approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets as well as development of a novel interleukin-2 (IL-2) analog (IOV-3001).
Manufacturing
The Iovance Cell Therapy Center (iCTC) was awarded an Honorable Mention by the International Society for Pharmaceutical Engineering (ISPE) in the 2022 Facility of the Year Awards.
Corporate
Cash position of $516.0 million at March 31, 2022 is expected to be sufficient into 2024.
Iovance currently owns more than 40 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio can be found on the Intellectual Property page on www.iovance.com.
First Quarter 2022 Financial Results
Iovance had $516.0 million in cash, cash equivalents, investments and restricted cash at March 31, 2022, compared to $602.1 million at December 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.
Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "With late-stage clinical assets in our pipeline, as well as a strong balance sheet and investments focused on launch preparations, we are well positioned to execute our mission to innovate, develop and deliver TIL therapy for patients with cancer while enhancing shareholder value."
Net loss for the first quarter ended March 31, 2022, was $91.6 million, or $0.58 per share, compared to a net loss of $75.4 million, or $0.51 per share, for the first quarter ended March 31, 2021.
Research and development expenses were $68.3 million for the first quarter ended March 31, 2022, an increase of $12.4 million compared to $55.9 million for the first quarter ended March 31, 2021. The increase in research and development expenses in the first quarter 2022 over the prior year period was primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related costs.
General and administrative expenses were $23.4 million for the first quarter ended March 31, 2022, an increase of $3.8 million compared to $19.6 million for the first quarter ended March 31, 2021. The increase in general and administrative expenses in the first quarter 2022 compared to the prior year period was primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, facility-related costs associated with the build out of the new corporate headquarters, increases in intellectual property filing and legal expenses and enhancements to the information technology infrastructure.
For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss first quarter 2022 financial results and corporate updates. The conference call dial-in numbers are 1 (844) 646-4465 (domestic) or 1 (615) 247-0257 (international), the conference ID is #4655146. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.