IP portfolio summary:

  • >50 granted or allowed US and international patents
  • Compositions of matter for TIL products
  • Methods of treatment in a broad range of cancers
  • Manufacturing processes
  • >700 patents and applications worldwide, including major pharmaceutical markets

Streamlined 22-day GMP manufacturing process

1
TUMOR SAMPLE PROCUREMENT
3
NMA-LD
4
TIL INFUSION
5
IL-2 INFUSIONS
TUMOR SAMPLE PROCUREMENT
NMA-LD
TIL INFUSION
IL-2 INFUSIONS

Proprietary manufacturing processes and expansion methods for TIL from:

  • Tumor
  • Marrow infiltrating lymphocytes
  • Peripheral blood lymphocytes
  • Frozen tumor technologies
  • Remnant TIL and digest processes
  • Combination of TIL and ICIs including PD-1 antibodies
  • Methods of treating patient subpopulations
  • IL-2 variants and regimens
Gen 2 Process: 22 Days Image
 
Gen 2 Process: 22 Days
 

TIL products and compositions: Gen 2, Gen 3, use of co-stimulatory molecules, selection of TIL, stable and transient genetic modifications, cryopreservation

1
TUMOR SAMPLE PROCUREMENT
TUMOR SAMPLE PROCUREMENT

Proprietary manufacturing processes and expansion methods for TIL from:

  • Tumor
  • Marrow infiltrating lymphocytes
  • Peripheral blood lymphocytes
  • Frozen tumor technologies
  • Remnant TIL and digest processes
3
NMA-LD
NMA-LD
4
TIL INFUSION
TIL INFUSION
  • Combination of TIL and ICIs including PD-1 antibodies
  • Methods of treating patient subpopulations
5
IL-2 INFUSIONS
IL-2 INFUSIONS
  • IL-2 variants and regimens
Gen 2 Process: 22 Days Image

TIL products and compositions: Gen 2, Gen 3, use of co-stimulatory molecules, selection of TIL, stable and transient genetic modifications, cryopreservation

Broad, Iovance-owned IP around TIL therapy

Iovance owns more than 40 US patents related to TIL therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as US Patent Nos. 10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; and 11,384,337.

Iovance also owns US patents covering methods of manufacturing TIL and TIL manufactured from a tumor digest and the use thereof, such as US Patent Nos. 11,007,225; 11,007,226; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,438; 11,179,419; 11,202,803; 11,202,804; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,304,979; 11,337,998; 11,344,579; and others.

US Patent No. 11,058,728 specifically covers a method of treatment using expanded TILs manufactured from a tumor digest where the expansion steps through the step of cryopreservation of the infusion bag having a harvested TIL population are performed within about 24 days. US Patent No. 11,123,371 specifically covers a cryopreserved TIL composition comprising expanded TILs manufactured from a cryopreserved tumor digest where the expansion steps through the step of cryopreservation of the infusion bag having a harvested TIL population are performed within about 24 days. US Patent No. 11,141,438 specifically covers an expanded population of TILs manufactured from a cryopreserved tumor digest where the expansion steps through the harvest step are performed within about 24 days. US Patent No. 11,179,419 specifically covers a method for expanding TILs from a cryopreserved tumor digest where the expansion steps through the step of cryopreservation of the infusion bag having a harvested TIL population are performed within about 24 days.

Iovance holds an exclusive license from NIH of certain rights under U.S. Patent Nos. 11,077,182; 11,331,385; 11,338,032; and 11,376,318; covering TILs manufactured from T-cells expanded from HPV+ tumor fragments and methods of treating HPV+ cancers in a patient with TILs manufactured from T-cells expanded from HPV+ tumor fragments obtained from the patient.

Furthermore, Iovance owns US patents covering the use of the combination of TIL therapy and an anti-PD-1 antibody, such as US Patent No. 10,272,113, or an anti-PD-L1 antibody, such as US Patent No. 11,013,770.

OUR PATENT PORTFOLIO ALSO INCLUDES PATENTS AND PATENT APPLICATIONS RELATING TO:

  • Frozen tumor-based TIL technologies
  • Remnant TIL and digest TIL compositions and methods
  • Use of co-stimulatory and T cell modulating molecules in TIL therapy and manufacturing
  • Stable and transient genetically-modified TIL therapies
  • Methods of using immune–checkpoint inhibitors in combination with TIL therapies
  • TIL selection technologies
  • Methods of treating patient subpopulations

US patent/
application information for Iovance clinical products

Product
Pursued Indication*
Composition of Matter
Method of Use
Method of Manufacturing
Product

Lifileucel (TIL)

Pursued Indication*

Patients with metastatic melanoma or cervical cancer

Composition of Matter

US 10,894,063;
US 10,398,734;
US 10,537,595;
US 10,695,372;
US 10,653,723;
US 11,337,998;
US 11,344,579

Method of Use

US 10,166,257;
US 10,130,659;
US 10,272,113;
US 10,463,697;
US 10,363,273;
US 10,646,517;
US 10,905,718;
US 11,202,803;
US 11,241,456;
US 10,953,046;
US 10,946,044;
US 10,953,047;
US 10,933,094;
US 10,946,045;
US 10,925,900;
US 11,013,770;
US 11,202,804;
US 11,273,181

Method of Manufacturing

US 10,420,799;
US 10,639,330;
US 10,918,666;
US 11,273,180;
US 11,291,687;
US 11,304,979

Product

Lifileucel or tumor digest TIL

Pursued Indication*

Patients with metastatic melanoma or cervical cancer

Composition of Matter

US 11,337,998;
US 11,344,579

Method of Use

US 11,202,803;
US 11,202,804;
US 11,241,456;
US 11,273,181

Method of Manufacturing

US 11,273,180;
US 11,291,687;
US 11,304,979

Product

LN-145 (TIL)

Pursued Indication*

Patients with metastatic melanoma, HNSCC, or NSCLC

Composition of Matter

US 10,894,063;
US 10,398,734;
US 10,537,595;
US 10,695,372;
US 10,653,723;
US 11,337,998;
US 11,344,579

Method of Use

US 10,166,257;
US 10,130,659;
US 10,272,113;
US 10,463,697;
US 10,363,273;
US 10,646,517;
US 10,905,718;
US 10,953,046;
US 10,946,044;
US 10,953,047;
US 10,933,094;
US 10,946,045;
US 10,925,900;
US 11,013,770;
US 11,202,803;
US 11,202,804;
US 11,241,456;
US 11,273,181

Method of Manufacturing

US 10,420,799;
US 10,639,330;
US 10,918,666;
US 11,291,687;
US 11,304,979

Product

Gen 3 TIL

Pursued Indication*

Patients with metastatic melanoma, HNSCC, or NSCLC

Composition of Matter

US 10,894,063;
US 10,398,734;
US 10,537,595;
US 10,695,372;
US 10,653,723;
US 11,337,998;
US 11,344,579

Method of Use

US 10,166,257;
US 10,130,659;
US 10,272,113;
US 10,463,697;
US 10,363,273;
US 10,646,517;
US 10,905,718;
US 11,202,803;
US 11,241,456;
US 10,953,046;
US 10,946,044;
US 10,953,047;
US 10,933,094;
US 10,946,045;
US 10,925,900;
US 11,013,770;
US 11,202,804;
US 11,273,181

Method of Manufacturing

US 10,420,799;
US 10,639,330;
US 10,918,666;
US 11,168,304;
US 11,273,180;
US 11,291,687;
US 11,304,979

Product

IOV-2001 (PBL)

Pursued Indication*

Patients with CLL or SLL

Composition of Matter

WO 2020/180733 A1;
US 2020/0224161 A1;
US 2020/0347350 A1

Method of Use

WO 2020/180733 A1;
US 2020/0224161 A1;
US 2020/0347350 A1

Method of Manufacturing

WO 2020/180733 A1;
US 2020/0224161 A1;
US 2020/0347350 A1

Product

IOV-4001 (PD1 KO TIL)

Pursued Indication*

Patients with metastatic melanoma or NSCLC

Composition of Matter
Method of Use
Method of Manufacturing

US 11,384,337

*Subject to FDA approval.
CLL=chronic lymphocytic leukemia; HNSCC=head and neck squamous cell carcinoma; HPV=human papilloma virus; ICI=immune checkpoint inhibitors; IL-2=interleukin 2; IP=intellectual property; NMA-LD=non-myeloablative lymphoid depletion; NSCLC=non-small-cell lung cancer; PBL=peripheral blood lymphocytes; PD-L1=programmed cell death protein-1; SLL=small lymphocytic leukemia.

Learn More About Our Manufacturing

TIL and PBL therapies are investigational therapies that have not been approved for any indication by the Food and Drug Administration (FDA) or any other regulatory agency. The safety and efficacy of these therapies have not been determined.