Iovance Biotherapeutics

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Iovance Biotherapeutics
TickerIOVA
CIK #0001425205
CUSIP462260100
SectorEnergy & Transportation
IndustryArrangement Of Transportation Of Freight & Cargo
Phone8669632220
Address1601 N Sepulveda Blvd, #632
Manhattan Beach, CA 90266
Source [EDGAR]
Market Cap, 13F ($MM)
1600128096064032002011201320152018
Business

We are a clinical-stage biopharmaceutical company focused on the development and commercialization of cell therapies as novel cancer immunotherapy products designed to harness the power of a patient's own immune system to eradicate cancer cells. Tumor infiltrating lymphocyte, or TIL, therapy is an autologous cell therapy platform technology that was originally developed by the National Cancer Institute, or NCI, which conducted initial clinical trials in diseases such as metastatic melanoma and cervical cancer. We have developed a new, shorter manufacturing process for TIL known as Generation 2, or Gen 2, which yields a cryopreserved TIL product. This proprietary and scalable manufacturing method is being further investigated in multiple indications. Our lead product candidates include lifileucel for metastatic melanoma and LN-145 for metastatic cervical cancer. In addition to metastatic melanoma and metastatic cervical cancer, we are investigating the effectiveness and safety of TIL therapy for the treatment of squamous cell carcinoma of the head and neck, non-small cell lung cancer, and peripheral blood lymphocyte, or PBL, therapy for treatment of chronic lymphocytic leukemia through our sponsored trials, as well as in other oncology indications through collaborations.

In addition to our ongoing trial in metastatic melanoma, we are conducting clinical trials with LN-145 TIL therapy, in cervical, head and neck, lung and other cancers. C-145-04, or NCT03108495, is an ongoing Phase 2, multicenter pivotal trial that will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer. In February 2019, LN-145 received Fast Track designation from the FDA for development in the treatment of cervical cancer with disease progression on or after chemotherapy. In March 2019, the protocol for this trial was amended to modify the primary endpoint of ORR to be determined by IRC. In May 2019, LN-145 received Breakthrough Therapy designation, or BTD, from the FDA for the development in the treatment of cervical cancer. Updated results from the C-145-04 clinical trial were reported at the ASCO annual meeting on June 1, 2019. In 27 patients with metastatic cervical cancer, treatment with LN-145 resulted in an ORR of 44%. At the time of study data cut,there were 3 complete responses and 9 partial responses. The DCR was 85%. Patients were heavily pretreated and had a mean of 2.4 prior therapies. The DOR had not been reached. The median follow-up was 7.4 months. The adverse event

profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens. Based on an End of Phase 2 meeting held with the FDA in June 2019, the FDA has acknowledged that results from the C-145-04 clinical trial may be sufficient to support registration in the treatment of patients with metastatic cervical cancer. In accordance with the FDA's recommendations, the protocol was amended to further define the patient population. In November 2019, in order to position LN-145 for potential future use in broader lines of therapy in cervical cancer, we have amended the C-145-04 trial to collect additional data on early-line patients as well as later-line patients. Enrollment in these additional cohorts is not expected to impact the timing of the completion of Cohort 1.As a result of this amendment, the C-145-04 trial now consists of the following cohorts of cervical cancer patients with recurrent, persistent, or metastatic disease:

CIK Filing 2011 - 2021
[0001425205] 10-K
[0001425205] 10-Q
[0001425205] 3
[0001425205] 4
[0001425205] 5
[0001425205] 8-K
[0001425205] D
[0001425205] SC 13D
[0001425205] SC 13G
Form 13D/13G Filer Form 13D/13G Subject Filed % Owned
Price T Rowe Associates Inc /MD/ Iovance Biotherapeutics Inc [2020-02-14] 5.1
Vanguard Group Inc Iovance Biotherapeutics Inc [2020-02-11] 8.6
Perceptive Advisors LLC Iovance Biotherapeutics Inc [2019-02-14] 9.9
Acuta Capital Partners LLC Iovance Biotherapeutics Inc [2019-02-14] 2.5
Acuta Capital Partners LLC Iovance Biotherapeutics Inc [2018-02-14] 5.4
Broadfin Capital LLC Iovance Biotherapeutics Inc [2018-02-13] 6.75
BlackRock Inc Iovance Biotherapeutics Inc [2018-01-25] 6.7
OrbiMed Advisors LLC Lion Biotechnologies Inc [2017-02-13] 3.92
Acuta Capital Partners LLC Lion Biotechnologies Inc [2017-02-13] 6.1
Franklin Resources Inc Lion Biotechnologies Inc [2017-02-07] 8.4
Quogue Capital LLC Lion Biotechnologies Inc [2016-06-13] 0.6
Venbio Select Advisor LLC Lion Biotechnologies Inc [2016-02-12] 6.7
RS Investment Management Co LLC Lion Biotechnologies Inc [2016-02-12] 5.55
Broadfin Capital LLC Lion Biotechnologies Inc [2016-02-11] 7.31
BlackRock Inc Lion Biotechnologies Inc [2016-01-28] 6.6
Perceptive Advisors LLC Lion Biotechnologies Inc [2015-02-17] 0.76
FMR LLC Lion Biotechnologies Inc [2014-07-10] 0.0
Alpha Capital Anstalt Lion Biotechnologies Inc [2014-01-02] 7.197
Ayer Capital Management LP Genesis Biopharma Inc [2013-06-03] 40.47
[2013-01-09] None
Form 3/4/5 Filer 2011-2021
Bellemin Jean-Marc
Swartzburg Michael
Weiser Michael
Dukes IAIN D
McPeak Merrill A/
Maynard Ryan D
Countouriotis Athena
Fardis Maria
VOGT Frederick G
Graf Finckenstein Friedrich
Morris Timothy E
Rothbaum Wayne P
Hillsberg Sanford
Venkatesan Jay
Valle Franco
Schiffman Gregory T
Henderson Molly
Fischkoff Steven A
Lotze Michael
Hawkins ELMA
Bender James G
Ayer Capital Management LP
Ayer Capital Partners LLC
ACM Capital Partners LLC
Handelman Michael D
Radvanyi Laszlo
Bristol Investment Fund Ltd
Bristol Capital LLC
Singh Manish
Kessler Paul
Voyticky David J
MM Shares Owned of 122.6 MM Total
Firm Period DFND Voting Shares
Vanguard Group Inc [2020-09-30] SOLE 0.0 11.6
Perceptive Advisors LLC [2020-09-30] SOLE 10.1 10.1
venBio Select Advisor LLC [2020-09-30] SOLE 9.5 9.5
BlackRock Inc. [2020-09-30] SOLE 8.7 9.1
Franklin Resources Inc [2020-09-30] DFND 8.3 8.3
ARK Investment Management LLC [2020-09-30] SOLE 7.4 7.9
Price T Rowe Associates Inc /MD/ [2020-09-30] SOLE 1.1 6.9
OrbiMed Advisors LLC [2020-09-30] DFND 1.3 6.6
Farallon Capital Management LLC [2020-09-30] OTR 6.0 6.0
Great Point Partners LLC [2020-09-30] DFND 3.9 3.9
Nikko Asset Management Americas Inc [2020-09-30] SOLE 2.7 3.5
Sumitomo Mitsui Trust Holdings, Inc. [2020-09-30] DFND 3.5 3.5
Bank of America Corp /DE/ [2020-09-30] DFND 0.2 3.2
State Street Corp [2020-09-30] DFND 2.9 3.2
FMR LLC [2020-09-30] DFND 0.4 3.0
Artisan Partners Limited Partnership [2020-09-30] SOLE 2.4 2.8
Victory Capital Management Inc [2020-09-30] SOLE 1.5 2.0
Lord Abbett & Co LLC [2020-09-30] SOLE 1.8 1.8
Invesco Ltd. [2020-09-30] DFND 0.0 1.6
Geode Capital Management LLC [2020-09-30] DFND 1.6 1.6
Balyasny Asset Management LLC [2020-09-30] SOLE 1.6 1.6
Citadel Advisors LLC [2020-09-30] DFND 1.4 1.4
Frazier Management LLC [2020-09-30] SOLE 1.3 1.3
Susquehanna International Group LLP [2020-09-30] DFND 0.8 1.2
AllianceBernstein LP [2020-09-30] DFND 1.0 1.2
Bank of New York Mellon Corp [2020-09-30] DFND 0.9 1.0
Millennium Management LLC [2020-09-30] SOLE 0.8 0.9
Rothschild Asset Management Inc [2020-09-30] SOLE 0.9 0.9
Goldman Sachs Group Inc [2020-09-30] DFND 0.8 0.8
Avidity Partners Management LP [2020-09-30] SOLE 0.8 0.8
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