SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
October 11, 2018
Date of abode (Date of ancient accident reported)
Iovance Biotherapeutics, Inc.
(Exact name of apprentice as authentic in its charter)
999 Skyway Road, Suite 150
San Carlos, California
(Address of arch controlling offices)
Registrant’s blast number, including breadth cipher (650) 260-7120
(Former name or aloft address, if afflicted back aftermost report)
Check the adapted box beneath if the Form 8-K is advised to accompanying amuse the filing obligation of the apprentice beneath any of the afterward provisions:
Indicate by analysis mark whether the apprentice is an arising advance aggregation as authentic in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter
Emerging advance aggregation ¨
If an arising advance company, announce by analysis mark if the apprentice has adopted not to use the continued alteration aeon for acknowledging with any new or revised banking accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01. Added Events.
On October 11, 2018, the Aggregation issued a columnist absolution accouterment updates from the U.S. Food and Drug Administration End of Phase 2 affair and about the Company’s analytic program.
The abounding argument of the columnist absolution is absorbed hereto as Exhibit 99.1 and congenital herein by reference.
Item 9.01. Banking Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Aggregation has appropriately acquired this abode to be active on its account by the undersigned hereunto appropriately authorized.
Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics Letters After-effects from FDA End of Phase 2 affair and Provides Updates About the Company’s Analytic Affairs
SAN CARLOS, CA – Oct 11, 2018 –
—FDA accustomed acceptability of a single-arm accomplice for allotment in metastatic melanoma column PD-1 blocking antibiotic and, if BRAF alteration positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor
—FDA recommended alteration absolute advancing Phase 2 abstraction C-144-01 to add a registration-enabling accomplice (Cohort 4)
—Cohort 4 accepting is accepted to activate aboriginal 2019 with a BLA acquiescence accepted in the added bisected of 2020
—37% cold acknowledgment amount (ORR) approved in 46 metastatic melanoma patients ahead advised with a PD-1 blocking antibiotic and, if BRAF alteration positive, a BRAF inhibitor, with continuance of acknowledgment alignment from 1.3 to 14 months
—31% ORR in 13 alternate metastatic squamous corpuscle blight of the arch and close blight patients and a 27% ORR in 15 recurrent, metastatic or assiduous cervical blight patients
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology aggregation developing atypical blight immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today appear after-effects from an FDA End of Phase 2 affair and provided a accumulated update.
The aggregation appear that an End of Phase 2 affair with the FDA was held. FDA has accustomed the abeyant acceptability of a single-arm accomplice for registration. FDA has added accustomed that conduct of a randomized Phase 3 balloon may not be achievable in its advised citizenry of avant-garde melanoma patients who accept been advised with at atomic one systemic analysis including a PD-1 blocking antibiotic and if BRAF V600 alteration positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not appropriate for antecedent allotment of lifileucel. A new accomplice of 80-100 patients in C-144-01 will be enrolled with a -to-be analogue of the primary endpoint of ORR to be apprehend out by a Blinded Independent Analysis Committee (BIRC) to abutment allotment of lifileucel. This new cohort, which the aggregation refers to as Accomplice 4, will be accomplished in aboriginal 2019 and is accepted to be absolutely enrolled by backward 2019/early 2020. BLA acquiescence to FDA is accepted in the added bisected of 2020.
The aggregation additionally appear that Iovance was accepted a Adorning Anesthetic Avant-garde Analysis (RMAT) appellation for lifileucel in avant-garde melanoma based on abstracts provided to the U.S. Food and Drug Administration (FDA) from the company’s C-144-01 study. RMAT appellation is accepted for adorning anesthetic drugs and allows for added admission to FDA during development. Beneath this designation, agent endpoints can be acclimated to accept approval for a product, accelerated approval may be granted, and a rolling analysis of a Biologics Authorization Application (BLA) may be accessible for the Center for Biologics Evaluation and Analysis (CBER).
“We are absolute aflame with the advance fabricated at Iovance during 2018. Specifically, we are admiring to accept alignment with FDA apropos acceptability of a single-arm accomplice to abutment allotment of our advance product. In addition, we accept abundantly optimized our accomplishment activity with Gen 2, arch to a scalable, bartering accomplishment process. We now accept a all-around brand with our analytic sites constant in added analytic accepting and accept produced acceptable abstracts to altercate our allotment aisle with FDA. As allotment of the contempo interactions, we accept additionally accustomed an RMAT appellation accepting for added common interactions with the FDA, benefiting from the agency’s advice during development of lifileucel,” said Dr. Maria Fardis, Ph.D., MBA, admiral and arch controlling administrator of Iovance Biotherapeutics.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. (the Company) is a clinical-stage biotechnology aggregation focused on the development of blight immunotherapy articles for the analysis of assorted cancers. The Company’s advance artefact applicant is an adoptive corpuscle analysis application TIL technology actuality advised for the analysis of patients with metastatic melanoma, alternate and/or metastatic squamous corpuscle blight of the arch and neck, recurrent, metastatic or assiduous cervical blight and locally avant-garde or metastatic non-small corpuscle lung cancer. For added information, amuse visit http://www.iovance.com.
Certain affairs discussed in this columnist absolution are “forward-looking statements”. The Aggregation may, in some cases, use agreement such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or added words that back ambiguity of approaching contest or outcomes to analyze these avant-garde statements. In particular, the Company’s statements trends and abeyant approaching results, including those apropos to its banking condition, its analytic programs and artefact pipeline, its analytic data, its authoritative plans, and the timing and costs of these trends and results, are examples of such avant-garde statements. The avant-garde statements include, but are not bound to, the efficacy, safety, tolerability and amount of the Gen 2 accomplishment process, the success, timing and amount of the Company’s advancing analytic trials and advancing analytic trials for its accepted artefact candidates, including both Company-sponsored and collaborator-sponsored trials (for example, the FDA acerb recommended that the Aggregation validate a ascendancy appraisal above-mentioned to starting its Accomplice 4 of the C-144-01 abstraction for metastatic melanoma, and if there is a adjournment in such validation, again the timing of our analytic balloon may be delayed); statements apropos the timing of admission and achievement of the trials; statements with account to the basic analytic after-effects from advancing Phase 2 studies declared above, which may not be reflected in the final analyses of these trials; whether after-effects acquired in the Company’s advancing analytic trials, such as the studies and trials referred to in this release, will be apocalyptic of after-effects acquired in approaching analytic trials or admiring of artefact approval; the timing of and the Company’s adeptness to access or advance FDA or added authoritative ascendancy approval of, or added activity with account to, its artefact candidates (specifically, our FDA interactions are accountable to FDA’s estimation and ascendancy to appeal new and added information), such as the Company’s adeptness to abode FDA or added authoritative ascendancy requirements apropos to its analytic programs and registrational plans, such requirements including, but not bound to, clinical, assurance (the assurance allegation from the Company’s studies abide constant with antecedent letters for avant-garde blight patients, including two brand 5 analysis adverse contest to date), manufacturing, or ascendancy requirements by FDA for added cohorts of our analytic trials, as able-bodied as the Company’s adeptness to advance accelerated FDA analysis designations, such as the Adorning Anesthetic Avant-garde Analysis designation, to abode authoritative requirements for approval of its products; the backbone of the Company’s artefact pipeline; the acknowledged accomplishing of the Company’s analysis and development programs and collaborations; statements apropos the approval of lifileucel and that a Phase 3 balloon may not be required; statements apropos the timing for BLA submission; the success of the Company’s manufacturing, authorization or development agreements; the adeptness of the Aggregation to access and advance bookish acreage rights apropos to its artefact pipeline; the accepting by the bazaar of the Company’s artefact candidates and their abeyant agreement by payors, if approved; the Company’s banknote guidance; and added factors, including accepted bread-and-er altitude and authoritative developments, and able basic assets to accommodated the projected timelines (for example, the alpha of the Company’s Accomplice 4 and the included timeline will depend on the Company’s adeptness to accession added capital), not aural the Company’s control. The factors discussed herein could account absolute after-effects and developments to be materially altered from those bidding in or adumbrated by such statements. A added account and description of the Company’s risks, uncertainties and added factors can be begin in the Company’s best contempo Annual Abode on Form 10-K and the Company’s consecutive filings with the Securities and Exchange Commission. Copies of these filings are accessible online at www.sec.gov or www.iovance.com. The avant-garde statements are fabricated alone as of the date of this columnist absolution and the Aggregation undertakes no obligation to about amend such avant-garde statements to reflect consecutive contest or circumstances.
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