On November 4, 2021 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 third quarter and year-to-date 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 4, 2021, View Source [SID1234594412]).
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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During 2021, we have continued to report long-term clinical data demonstrating the durability of one-time treatment with lifileucel in metastatic melanoma while broadening the potential for TIL cell therapy to address more patients in additional indications and treatment settings. We look forward to highlighting our TIL cell therapy platform at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration (FDA) regarding the potency assays for lifileucel to support our planned biologics license application (BLA) submission. We remain increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."
Third Quarter 2021 Highlights and Recent Corporate Updates
Regulatory
Potency assays for lifileucel: Following FDA feedback regarding the potency assays for lifileucel, Iovance has continued ongoing work developing and validating its potency assays and has engaged in discussions with the FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. Resolution of the potency assay for lifileucel in melanoma is also a key step towards our regulatory plans in other indications.
U.S. FDA Fast Track designation for lifileucel in combination with pembrolizumab in metastatic melanoma: The FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. Fast Track designation allows for potential Accelerated Approval and Priority Review as well as more frequent interactions with the FDA.
Clinical
TIL therapy in combination with pembrolizumab in advanced solid tumor cancers: Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in metastatic melanoma, cervical cancer, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC) patients who are naïve to therapy with immune checkpoint inhibitors (ICI). Data for certain indications for TIL in combination with pembrolizumab will be highlighted in an oral presentation at the upcoming SITC (Free SITC Whitepaper) annual meeting. Early clinical data previously presented in metastatic melanoma (ASCO 2021) and HNSCC (SITC 2020) suggest that the response rate for TIL in combination with pembrolizumab may be increased in patients who are ICI-naïve.
TIL therapy in NSCLC:
LN-145 clinical data in metastatic NSCLC (mNSCLC): Detailed results from Cohort 3B in the IOV-COM-202 study will be highlighted in a poster presentation at the SITC (Free SITC Whitepaper) annual meeting. As previously reported, clinical data for LN-145 showed a 21.4% overall response rate (ORR) and 64.3% disease control rate in heavily pretreated mNSCLC patients who received one or more prior systemic therapies, including anti-PD-1 therapy.
LN-145 in second-line mNSCLC: Enrollment is ongoing and more than 20 clinical sites are activated in the U.S. and Canada for the IOV-LUN-202 study of LN-145 in patients with mNSCLC.
Research
Iovance continues to advance the next generation of TIL and related therapies and technologies. Late preclinical programs in investigational new drug (IND)-enabling studies include a novel IL-2 analog (IOV-3001) as well as a genetically modified TIL (IOV-4001). IOV-4001 leverages TALEN technology licensed from Cellectis S.A. to inactivate PD-1 expression by the TIL product.
Iovance and the National Institutes of Health (NIH) extended their Cooperative Research and Development Agreement (CRADA) through August 2024. The CRADA focuses on emerging areas of translational and clinical research for TIL therapies.
Manufacturing
TIL manufacturing success: To date, more than 500 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Iovance Cell Therapy Center (iCTC): Clinical manufacturing of TIL commenced at the iCTC in September of 2021. Commercial manufacturing remains on track to commence with a potential regulatory approval. The iCTC achieved LEED Gold Certification through the U.S. Green Building Council (USGBC).
Corporate
Cash position of $660.8 million at September 30, 2021 is expected to be sufficient well into 2023.
A strong organization of more than 300 employees with an average of more than 3.5 years of cell therapy experience is in place to advance research, development, manufacturing, and commercial launch preparations.
Iovance continues to expand its intellectual property portfolio and currently owns more than 30 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers. Iovance’s Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products.
Third Quarter and Year-to-Date 2021 Financial Results
Iovance has $660.8 million in cash, cash equivalents, investments and restricted cash at September 30, 2021 compared to $635.0 million at December 31, 2020. The cash position is expected to be sufficient to fund current and planned operations well into 2023.
Jean-Marc Bellemin, Chief Financial Officer, stated, "With the continued strength of our balance sheet and focused investment on pipeline development and launch preparations, we are well positioned to execute our operating plan with no immediate need to raise additional capital. Following completion of the iCTC, we have also concluded our initial $85 million investment in constructing the facility."
Net loss for the third quarter ended September 30, 2021, was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021, was $242.9 million, or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2020.
Research and development expenses were $65.4 million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.
The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in costs associated with growth of the internal research and development team and increases in clinical trial costs and iCTC facility related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in iCTC facility related costs.
General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5.0 million compared to $15.9 million for the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020.
The increases in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss the third quarter 2021 financial results and corporate updates. The conference call dial-in numbers are 1-(844) 646-4465 (domestic) or 1-(615) 247-0257 (international) and the access code is 7286232. 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.