Quarterly report pursuant to Section 13 or 15(d)

Sponsored Research and Clinical Trial Agreements

v3.21.1
Sponsored Research and Clinical Trial Agreements
3 Months Ended
Mar. 31, 2021
Sponsored Research and Clinical Trial Agreements  
Sponsored Research and Clinical Trial Agreements

7. Sponsored Research and Clinical Trial Agreements

Aevitas

In 2018, Aevitas entered into a Sponsored Research Agreement (“SRA”) with the Trustees of the University of Pennsylvania (“UPenn SRA”), as amended in July 2019, for certain continued research and development activities related to the development of adeno-associated virus (“AAV”) gene therapies in complement-mediated diseases. Also in 2018, Aevitas entered into an SRA with the University of Massachusetts (“UMass SRA”), as amended in January 2020,  for certain continued research and development activities related to the development of AAV. For the three months ended March 31, 2021 and 2020, Aevitas recorded the following expense in connection with its sponsored research and clinical trial agreements:

For the Three Months Ended March 31, 

($ in thousands)

    

2021

    

2020

UMass SRA

$

248

$

UPenn SRA

281

Total

$

248

$

281

Mustang

For the three months ended March 31, 2021 and 2020, Mustang recorded the following expense in research and development for sponsored research and clinical trial agreements:

For the Three Months Ended March 31, 

($ in thousands)

    

2021

    

2020

City of Hope National Medical Center

$

$

500

IL13Rα2 (MB-101)

 

514

 

92

CD123 (MB-102)

 

205

 

230

CS1 (MB-104)

175

HER2 (MB-103)

123

PSCA (MB-105)

50

Fred Hutchinson Cancer Research Center - CD20 (MB-106)

671

527

St. Jude Children's Research Hospital - XSCID (MB-107)

104

Total

$

1,842

$

1,349

City of Hope Sponsored Research Agreement

In March 2015, in connection with Mustang’s license with COH for the development of chimeric antigen receptor (“CAR”) engineered T cell (“CAR T”) technology, Mustang entered into a Sponsored Research Agreement in which Mustang will fund continued research in the amount of $2.0 million per year, payable in four equal annual installments, through the first quarter of 2020. The research covered under this arrangement is for the IL13Rα2-directed CAR T program (MB-101), the CD123-directed CAR T program (MB-102) and the Spacer technology. For the three months ended March 31, 2021 and 2020, Mustang recorded expense of nil and $0.5 million, respectively, in research and development expense in the Company’s Condensed Consolidated Statement of Operations.

IL13Rα2 (MB-101) Clinical Research Support Agreements

On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for the  IL13Rα2-directed CAR T program (the “IL13Rα2 GBM CRA”) with COH. Pursuant to the terms of this agreement Mustang made an upfront payment of approximately $9,300 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated study. Further, Mustang agreed to fund approximately $0.2 million over three years pertaining to the clinical development of the IL13Rα2-directed CAR T program.

In October 2020, Mustang entered into a Clinical Research Support Agreement with COH for the IL13Rα2-directed CAR T program for adult patients with leptomeningeal glioblastoma, ependymoma or medulloblastoma (the “IL13Rα2 Leptomeningeal CRA”). Pursuant to the terms of the IL13Rα2 Leptomeningeal CRA, Mustang made an upfront payment of approximately $29,000 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated study. Further, the Company agreed to fund approximately $0.2 million annually pertaining to the clinical development of the IL13Rα2-directed CAR T program.

For the three months ended March 31, 2021 and 2020, Mustang recorded approximately $0.5 million and $0.1 million, respectively, in research and development expense in the Company’s Condensed Consolidated Statement of Operations.

CD123 (MB-102) Clinical Research Support Agreement

On February 17, 2017, Mustang entered into a Clinical Research Support Agreement for the CD123-directed CAR T program. Pursuant to the terms of this agreement, Mustang made an upfront payment of approximately $20,000 and will contribute an additional $0.1 million per patient in connection with the on-going investigator-initiated study. Further, Mustang agreed to fund approximately $0.2 million over three years pertaining to the clinical development of the CD123-directed CAR T program. For the three months ended March 31, 2021 and 2020, Mustang recorded approximately $0.2 million and $0.2 million, respectively, in research and development expense in the Company’s Condensed Consolidated Statement of Operations.

CS1(MB-104) Clinical Research and Support Agreement with COH

In June 2020, Mustang entered into a clinical research and support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: "Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CS1-Targeting, Hinge-Optimized, 41BB-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients with CS1+ Multiple Myeloma." The CAR T being studied under this protocol has been designated by Mustang as MB-104. Under the terms of the agreement Mustang paid COH $0.8 million during the three months ended March 31, 2020 for costs incurred and will reimburse COH for costs associated with this trial, when incurred, not to exceed $2.4 million. The agreement will expire upon the delivery of the final study report or earlier. Expense of $0.2 million and nil was incurred for the three months ended March 31, 2021 and 2020, respectively.

HER2 (MB-103) Clinical Research Support Agreement

In September 2020, Mustang entered into a clinical research support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “Phase I Study of Cellular Immunotherapy using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients with Recurrent/Refractory Malignant Glioma.” The CAR T being studied under this protocol has been designated as MB-103. Under the terms of the agreement Mustang paid COH approximately $29,000 upon execution and will reimburse COH for costs associated with this trial not to exceed $3.0 million. The agreement will expire upon the delivery of a final study report or earlier. For the three months ended March 31, 2021 and 2020, Mustang recorded $0.1 million and nil, respectively, in research and development expense in the Company’s Condensed Consolidated Statement of Operations pursuant to this agreement.

PSCA (MB-105) Clinical Research Support Agreement

In October 2020, Mustang entered into a clinical research support agreement with COH in connection with an investigator-sponsored study conducted under an Institutional Review Board-approved, investigator-initiated protocol entitled: “A Phase 1b study to evaluate PSCA-specific chimeric antigen receptor (CAR)-T cells for patients with metastatic castration resistant prostate cancer.” The CAR T being studied under this protocol has been designated as MB-105. Under the terms of the agreement Mustang paid COH $33,000 upon execution and will reimburse COH for costs associated with this trial not to exceed $2.3 million.  The agreement will expire upon the delivery of a final study report or earlier. For the three months ended March 31, 2021 and 2020, Mustang recorded $0.1 million and nil, respectively, in research and development expense in the Company’s Condensed Consolidated Statement of Operations pursuant to this agreement.

CD20 (MB-106) Clinical Trial Agreement with Fred Hutchinson Cancer Research Center

On July 3, 2017, in conjunction with the CD20 Technology License from Fred Hutchinson Cancer Research Center (“Fred Hutch”), Mustang entered into an investigator-initiated clinical trial agreement (“CD20 CTA”) to provide partial funding for a Phase 1/2 clinical trial at Fred Hutch evaluating the safety and efficacy of the CD20 Technology in patients with relapsed or refractory B-cell non-Hodgkin lymphomas. In connection with the CD20 CTA, Mustang agreed to fund up to $5.3 million of costs associated with the clinical trial, which commenced during the fourth quarter of 2017. In November 2020, the CD20 CTA was amended to include additional funding of approximately $0.8 million for the treatment of five patients with chronic lymphocytic leukemia. For the three months ended March 31, 2021 and 2020, Mustang recorded $0.7 million and $0.5 million of expense, respectively, related to this agreement in research and development expense in the Company’s Condensed Consolidated Statement of Operations.

XSCID (MB-107) Data Transfer Agreement with St. Jude Children’s Research Hospital

In June 2020, Mustang entered into a Data Transfer Agreement with St. Jude Children’s Research Center (“St. Jude”) under which Mustang will reimburse St. Jude for costs associated with St. Jude’s clinical trial for the treatment of infants with X-linked Severe Combined Immunodeficiency (“XSCID”).  Pursuant to the terms of this agreement Mustang paid an upfront fee of $1.1 million on July 1, 2020 and will continue to reimburse St. Jude for costs incurred in connection with this trial. For the three months ended March 31, 2021 and 2020, Mustang recorded $0.1 million and nil, respectively, related to this agreement in research and development expense in the Company’s Condensed Consolidated Statement of Operations.

Oncogenuity

For the Three Months Ended March 31, 

($ in thousands)

    

2021

    

2020

Columbia

$

188

$

Oxford

79

McCormick Labs

56

Total

$

323

$

Columbia Sponsored Research Agreement

Pursuant to the terms of a SRA entered into with the Trustees of Columbia University in the City of New York (“Columbia”) in May 2020, to develop novel oligonucleotides for the treatment of genetically driven cancers (the “Columbia SRA”), Oncogenuity will make semi-annual research payments to Columbia semiannually for five years ending in November 2024, such payments not to exceed $4.8 million. For the three months ended March 31, 2021, Oncogenuity recorded expense of $0.2 million and nil, respectively, in research and development in the Company’s Condensed Consolidated Statement of Operations.

The Regents of the University of California Sponsored Research Agreement

In December 2020, Oncogenuity entered into a SRA with The Regents of the University of California, with Frank McCormick PhD, FRS as principal investigator (“McCormick SRA”). For the three months ended March 31, 2021, Oncogenuity recorded expense of $0.1 million in research and development in the Company’s Condensed Consolidated Statement of Operations. No expense was recorded in 2020.

The Chancellor Masters and Scholars of the University of Oxford Sponsored Research Agreement

In December, 2020, Oncogenuity entered into a Sponsored Research Agreement with The Chancellor Masters and Scholars of the University of Oxford, (the “Oxford SRA”). For the three months ended March 31, 2021, Oncogenuity recorded expense of $0.1 million in research and development in the Company’s Condensed Consolidated Statement of Operations. No expense was recorded in 2020.