On June 28, 2016 Bayer reported results from the Phase III RESORCE trial investigating its oncology compound regorafenib in patients with unresectable hepatocellular carcinoma (HCC) who progressed during treatment with sorafenib (Nexavar) tablets (Press release, Bayer, JUN 28, 2016, View Source [SID:1234513591]). In this trial, treatment with regorafenib plus best supportive care significantly improved overall survival (OS) compared to the control group receiving placebo plus best supportive care.

The results showed that the Hazard Ratio (HR) for OS in patients who received regorafenib compared with the control group was 0.62 (95% CI 0.50-0.78; p<0.001), which translates to a 38% reduction in the risk of death over the trial period. Median overall survival was 10.6 months for those who received regorafenib versus 7.8 months for those in the control group. The safety and tolerability were generally consistent with the known profile of regorafenib. These data will be presented at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer (WCGC) in an oral abstract session on June 30 at 5.40pm CEST. The congress is taking place on June 29-July 2 in Barcelona, Spain. "The incidence of liver cancer continues to increase globally. There is only one approved systemic treatment option for patients with this disease, and there are currently no proven or approved second-line treatment options for patients with advanced HCC," said Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. Dr. Bruix is the Principal Investigator of the RESORCE study as well as the Phase III study SHARP which investigated sorafenib in HCC. "The regorafenib data seen in RESORCE may translate into additional hope for patients by providing doctors, nurses and other healthcare providers with a much needed second proven option for the treatment of liver cancer. The appropriate and timely start of systemic therapy may be important in improving patients’ treatment outcomes by potentially providing patients with the opportunity of receiving both proven systemic treatment options," Dr. Bruix continued. In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 versus 1.5 months, respectively (HR= 0.46 (95% CI 0.37‒0.56; p<0.001). Median time to progression was 3.2 vs. 1.5 months (HR 0.44; 95% CI 0.36–0.55; p<0.001). Disease control rate (composed of complete and partial responses and stable disease) was 65.2% vs 36.1% (p<0.001). Overall response rate (complete and partial responses) was 10.6% vs 4.1% (p=0.005), respectively. All numerical values of the secondary endpoints are based on mRECIST. The safety and tolerability were generally consistent with the known profile of regorafenib. The most common adverse events (grade 3 or higher) were hypertension (15.2% in the regorafenib group vs. 4.7% in the placebo group), hand-foot skin reaction (12.6% vs. 0.5%), fatigue (9.1% vs. 4.7%), and diarrhea (3.2% vs. 0%). Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in 2016. About the RESORCE trial The Phase III data being presented at WCGC are from the RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial, which enrolled 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC. Patients received 160 mg regorafenib once daily or placebo, for 3 weeks on/1week off, with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability were also continuously monitored. About Hepatocellular Carcinoma Hepatocellular carcinoma (HCC) is the most common form of liver cancer and represents approximately 70-85 percent of liver cancer worldwide. Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally. More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union, and 30,000 in the United States) and the incidence rate is increasing. In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union, and 24,000 in the United States. About Regorafenib (Stivarga) Regorafenib is an oral multi-kinase inhibitor that blocks various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, regorafenib has been shown to inhibit several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3, it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively control tumor growth, formation of a stromal microenvironment and disease progression. Regorafenib is approved under the brand name Stivarga in 90 countries worldwide, including the U.S., countries of the EU and Japan for the treatment of metastatic colorectal cancer. The product is also approved in over 70 countries, including the U.S., countries of the EU and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

On June 28, 2016 Bayer reported results from the Phase III RESORCE trial investigating its oncology compound regorafenib in patients with unresectable hepatocellular carcinoma (HCC) who progressed during treatment with sorafenib (Nexavar) tablets (Press release, Bayer, JUN 28, 2016, View Source [SID:1234513591]). In this trial, treatment with regorafenib plus best supportive care significantly improved overall survival (OS) compared to the control group receiving placebo plus best supportive care.

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The results showed that the Hazard Ratio (HR) for OS in patients who received regorafenib compared with the control group was 0.62 (95% CI 0.50-0.78; p<0.001), which translates to a 38% reduction in the risk of death over the trial period. Median overall survival was 10.6 months for those who received regorafenib versus 7.8 months for those in the control group. The safety and tolerability were generally consistent with the known profile of regorafenib. These data will be presented at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer (WCGC) in an oral abstract session on June 30 at 5.40pm CEST. The congress is taking place on June 29-July 2 in Barcelona, Spain.

"The incidence of liver cancer continues to increase globally. There is only one approved systemic treatment option for patients with this disease, and there are currently no proven or approved second-line treatment options for patients with advanced HCC," said Dr. Jordi Bruix, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. Dr. Bruix is the Principal Investigator of the RESORCE study as well as the Phase III study SHARP which investigated sorafenib in HCC.

"The regorafenib data seen in RESORCE may translate into additional hope for patients by providing doctors, nurses and other healthcare providers with a much needed second proven option for the treatment of liver cancer. The appropriate and timely start of systemic therapy may be important in improving patients’ treatment outcomes by potentially providing patients with the opportunity of receiving both proven systemic treatment options," Dr. Bruix continued.

In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 versus 1.5 months, respectively (HR= 0.46 (95% CI 0.37‒0.56; p<0.001). Median time to progression was 3.2 vs. 1.5 months (HR 0.44; 95% CI 0.36–0.55; p<0.001). Disease control rate (composed of complete and partial responses and stable disease) was 65.2% vs 36.1% (p<0.001). Overall response rate (complete and partial responses) was 10.6% vs 4.1% (p=0.005), respectively. All numerical values of the secondary endpoints are based on mRECIST.

The safety and tolerability were generally consistent with the known profile of regorafenib. The most common adverse events (grade 3 or higher) were hypertension (15.2% in the regorafenib group vs. 4.7% in the placebo group), hand-foot skin reaction (12.6% vs. 0.5%), fatigue (9.1% vs. 4.7%), and diarrhea (3.2% vs. 0%).

Bayer plans to submit data from the RESORCE study as the basis for marketing authorization of regorafenib in the treatment of unresectable HCC in 2016.

About the RESORCE trial
The Phase III data being presented at WCGC are from the RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial, which enrolled 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care (BSC) or placebo plus BSC.

Patients received 160 mg regorafenib once daily or placebo, for 3 weeks on/1week off, with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary endpoints were time to progression, progression-free survival, objective tumor response rate and disease control rate. Safety and tolerability were also continuously monitored.

About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and represents approximately 70-85 percent of liver cancer worldwide. Liver cancer is the sixth most common cancer in the world and the second leading cause of cancer-related deaths globally. More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union, and 30,000 in the United States) and the incidence rate is increasing. In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union, and 24,000 in the United States.

About Regorafenib (Stivarga)
Regorafenib is an oral multi-kinase inhibitor that blocks various kinases within the mechanisms involved in tumor growth and progression – angiogenesis, oncogenesis and the tumor microenvironment. In preclinical studies, regorafenib has been shown to inhibit several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3, it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively control tumor growth, formation of a stromal microenvironment and disease progression.

Regorafenib is approved under the brand name Stivarga in 90 countries worldwide, including the U.S., countries of the EU and Japan for the treatment of metastatic colorectal cancer. The product is also approved in over 70 countries, including the U.S., countries of the EU and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

On June 28, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that AbbVie Inc. has exercised its right to end its collaboration with Infinity to develop and commercialize duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, JUN 28, 2016, View Source [SID:1234513585]). The companies had been in discussions regarding a potential restructuring of the partnership but were unable to find a mutually attractive financial structure for continuation of the collaboration. With the termination of this agreement, Infinity has regained worldwide rights to duvelisib and neither Infinity nor AbbVie have future financial obligations to the other party.

“Our partnership with AbbVie and the significant, previously disclosed, funding was critical to our advancement of duvelisib through registration-focused clinical studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia,” stated Adelene Perkins, president and chief executive officer. “Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib.”

In parallel with exploring strategic options for the duvelisib program, Infinity is continuing to focus on filing a new drug application (NDA) for duvelisib with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2016. The company’s filing strategy includes the incorporation of data from both DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Earlier this month, Infinity reported that the DYNAMO study met its primary endpoint of overall response rate and that duvelisib demonstrated a manageable safety profile in the enrolled patient population. Infinity plans to seek feedback on the DYNAMO data from the FDA. Infinity also expects to report topline data from DUO, predicated on the results of an interim analysis, in the third quarter of 2016.

At this time, Infinity is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor and FRESCO, a combination study in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib to replace chemotherapy. Infinity plans to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma should duvelisib receive an accelerated approval based on the DYNAMO study.

Infinity will also reduce its workforce by 58 percent, impacting 100 of Infinity’s team members in order to align corporate resources with the company’s strategic decisions which include closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will not proceed with the Phase 1b/2 study of duvelisib in combination with venetoclax.

“We have incredibly talented and dedicated Citizen-Owners at Infinity, and I would like to personally express my gratitude and appreciation for all of their hard work and contributions. The decisions we have made are difficult but necessary to enable a path forward for duvelisib and IPI-549, our second development program. The team we have in place is deeply committed to exploring strategic opportunities for duvelisib, and ultimately IPI-549, to bring benefit to patients,” said Ms. Perkins.

IPI-549 is Infinity’s wholly owned immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3

Duvelisib is being evaluated in several studies, including DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL)4, DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)5, SYNCHRONY, a Phase 1b combination study designed in patients with CLL or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor6 and FRESCO, a Phase 2 combination study in patients with relapsed/refractory follicular lymphoma.7

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On June 28, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that AbbVie Inc. has exercised its right to end its collaboration with Infinity to develop and commercialize duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, JUN 28, 2016, View Source [SID:1234513585]). The companies had been in discussions regarding a potential restructuring of the partnership but were unable to find a mutually attractive financial structure for continuation of the collaboration. With the termination of this agreement, Infinity has regained worldwide rights to duvelisib and neither Infinity nor AbbVie have future financial obligations to the other party.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our partnership with AbbVie and the significant, previously disclosed, funding was critical to our advancement of duvelisib through registration-focused clinical studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia," stated Adelene Perkins, president and chief executive officer. "Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib."

In parallel with exploring strategic options for the duvelisib program, Infinity is continuing to focus on filing a new drug application (NDA) for duvelisib with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2016. The company’s filing strategy includes the incorporation of data from both DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Earlier this month, Infinity reported that the DYNAMO study met its primary endpoint of overall response rate and that duvelisib demonstrated a manageable safety profile in the enrolled patient population. Infinity plans to seek feedback on the DYNAMO data from the FDA. Infinity also expects to report topline data from DUO, predicated on the results of an interim analysis, in the third quarter of 2016.

At this time, Infinity is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor and FRESCO, a combination study in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib to replace chemotherapy. Infinity plans to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma should duvelisib receive an accelerated approval based on the DYNAMO study.

Infinity will also reduce its workforce by 58 percent, impacting 100 of Infinity’s team members in order to align corporate resources with the company’s strategic decisions which include closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will not proceed with the Phase 1b/2 study of duvelisib in combination with venetoclax.

"We have incredibly talented and dedicated Citizen-Owners at Infinity, and I would like to personally express my gratitude and appreciation for all of their hard work and contributions. The decisions we have made are difficult but necessary to enable a path forward for duvelisib and IPI-549, our second development program. The team we have in place is deeply committed to exploring strategic opportunities for duvelisib, and ultimately IPI-549, to bring benefit to patients," said Ms. Perkins.

IPI-549 is Infinity’s wholly owned immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

About Duvelisib
Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3

Duvelisib is being evaluated in several studies, including DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL)4, DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL)5, SYNCHRONY, a Phase 1b combination study designed in patients with CLL or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor6 and FRESCO, a Phase 2 combination study in patients with relapsed/refractory follicular lymphoma.7

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On June 28, 2016 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer as well as autoimmune disorders and infectious diseases, reported the closing of the global collaboration and license agreement for MGD015 with Janssen Biotech, Inc (Press release, MacroGenics, JUN 28, 2016, View Source [SID:1234513583]). The agreement was announced on May 18, 2016 and was subject to a waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Such waiting period has since expired.

Under the terms of the agreement, MacroGenics will receive a $75 million upfront license fee. Janssen will be responsible for developing MGD015, a product candidate that incorporates MacroGenics’ proprietary Dual-Affinity Re-Targeting, or DART, platform to simultaneously target CD3 and an undisclosed tumor target for the potential treatment of various hematological malignancies and solid tumors. Assuming successful development and commercialization of MGD015, MacroGenics could receive up to an additional $665 million in clinical, regulatory and commercialization milestone payments. If commercialized, MacroGenics would be eligible to receive double-digit royalties on any global net sales and has the option to co-promote MGD015 with Janssen in the U.S. In addition, MacroGenics may elect to fund a portion of late-stage clinical development to receive a profit share in the U.S. and Canada in lieu of royalties with respect to these territories.

About MGD015

MGD015 is designed to redirect T cells, via their CD3 component, to eliminate cells that overexpress an undisclosed antigen in various hematological malignancies and solid tumors. MacroGenics has demonstrated that MGD015 is able to kill these targeted cells both in vitro and in vivo, with high response rates in several mouse tumor xenograft models. In addition, this product candidate and the Company’s other DART molecules that redirect T cells against cancer targets are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T-cells.