On May 15, 2019 Kite, a Gilead Company (Nasdaq: GILD), reported that new data from its cell therapy programs will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from May 31 – June 4, 2019 (Press release, Kite Pharma, MAY 15, 2019, View Source [SID1234536353]). Six abstracts highlighting updated Yescarta (axicabtagene ciloleucel) efficacy and safety results, and ongoing research from the company’s chimeric antigen receptor T (CAR T) cell therapy development program in hematologic malignancies will be presented at the meeting.

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"Our CAR T research program is progressing at a rapid pace and we are excited to share the latest data at ASCO (Free ASCO Whitepaper)," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our data at this year’s meeting will include new analyses from the pivotal ZUMA-1 trial of Yescarta, early results from a novel approach to improve the Yescarta safety profile and results from the ZUMA-3 trial of our investigational CAR T therapy KTE-X19 in adults with acute lymphoblastic leukemia. These findings will help physicians better assess the potential role of CAR T in patients with high unmet need and continue to build upon our understanding of cell therapy."

Kite, a Gilead Company (Nasdaq: GILD), reported that new data from its cell therapy programs will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held in Chicago from May 31 – June 4, 2019. Six abstracts highlighting updated Yescarta (axicabtagene ciloleucel) efficacy and safety results, and ongoing research from the company’s chimeric antigen receptor T (CAR T) cell therapy development program in hematologic malignancies will be presented at the meeting.

"Our CAR T research program is progressing at a rapid pace and we are excited to share the latest data at ASCO (Free ASCO Whitepaper)," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our data at this year’s meeting will include new analyses from the pivotal ZUMA-1 trial of Yescarta, early results from a novel approach to improve the Yescarta safety profile and results from the ZUMA-3 trial of our investigational CAR T therapy KTE-X19 in adults with acute lymphoblastic leukemia. These findings will help physicians better assess the potential role of CAR T in patients with high unmet need and continue to build upon our understanding of cell therapy."

Area of Focus, Presentation
Number and Date/Time
(CDT)

Abstract Title
Presentations
Acute Lymphoblastic Leukemia
Abstract #7006 (Oral)
Saturday, June 1 (5:00-5:12 pm)

End of Phase 1 Results of ZUMA-3, a Phase 1/2 Study of KTE-X19, Anti-CD19 Chimeric Antigen Receptor T Cell Therapy, in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia
Large B-Cell Lymphoma
Abstract #7555 (Poster)
Monday, June 3 (8:00-11:00 am)

Outcomes of Patients ≥ 65 Years of Age in ZUMA-1, a Pivotal Phase 1/2 Study of Axicabtagene Ciloleucel in Refractory Large B-Cell Lymphoma
Large B-Cell Lymphoma
Abstract #7558 (Poster)
Monday, June 3 (8:00-11:00 am)

Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Large B-Cell Lymphoma
Abstract #7545 (Poster)
Monday, June 3 (8:00-11:00 am)

Hematopoietic Recovery and Immune Reconstitution After Axicabtagene Ciloleucel Chimeric Antigen Receptor T Cell Therapy in Patients with Relapsed/Refractory Large B-cell Lymphoma
Trials-In-Progress

Chronic Lymphocytic Leukemia
Abstract #TPS7566 (Poster)
Monday, June 3 (8:00-11:00 am)

ZUMA-8: A Phase 1/2 Multicenter Study Evaluating KTE-X19 in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia
Large B-Cell Lymphoma
Abstract #TPS7574 (Poster)
Monday, June 3 (8:00-11:00 am)

ZUMA-12: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel as a First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of cytokine release syndrome and neurologic toxicities; see below for Important Safety Information.

KTE-X19 is an investigational agent that has not been approved by the U.S. Food and Drug Administration or any regulatory authority for any uses. Efficacy and safety have not yet been established.

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS.
CYTOKINE RELEASE SYNDROME (CRS): CRS occurred in 94% of patients, including 13% with ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to infusion of Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 4 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES: Neurologic toxicities occurred in 87% of patients. Ninety-eight percent of all neurologic toxicities occurred within the first 8 weeks, with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 or higher occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%) and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures occurred with Yescarta. Fatal and serious cases of cerebral edema have occurred in patients treated with Yescarta. Monitor patients at least daily for 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 4 weeks after infusion and treat promptly.

YESCARTA REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta REMS. The required components of the Yescarta REMS are: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YESCARTAREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions may occur. Serious hypersensitivity reactions including anaphylaxis may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients, and in 23% with ≥ Grade 3. Grade 3 or higher infections with an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Yescarta infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids and other supportive care as medically indicated. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade 3 or higher cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after Yescarta infusion.

HYPOGAMMAGLOBULINEMIA: B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES: Patients may develop secondary malignancies. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unpecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

On May 15, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported five abstracts accepted for presentation at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from May 31 to June 4, 2019 at the McCormick Place Convention Center in Chicago, Illinois (Press release, Nektar Therapeutics, MAY 15, 2019, View Source [SID1234536369]). The abstracts published in advance of the ASCO (Free ASCO Whitepaper) Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time today on the ASCO (Free ASCO Whitepaper) meeting website at View Source

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"We are pleased to announce the presentation of five abstracts for our lead I-O investigational candidate, bempegaldesleukin, which includes important translational clinical data for the combination of bempeg with nivolumab as well as early data from an investigator-sponsored pilot study conducted in patients with heavily pre-treated, rapidly progressing and refractory sarcomas," said Stephen Doberstein, Ph.D., Chief Research & Development Officer at Nektar. "We are also highlighting several registrational trials underway for bempeg plus nivo in patients with melanoma and RCC. We believe bempeg has a unique and non-overlapping mechanism which synergizes with various immunotherapies, including checkpoint inhibitors, to improve the body’s cancer-fighting immune response and potentially improve treatment outcomes for patients with a variety of cancers."

Details of abstract presentations are as follows:

Developmental Immunotherapy and Tumor Immunobiology
Abstract #2584/Poster Board #228*
Title: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A
*2019 ASCO (Free ASCO Whitepaper) Annual Meeting Merit Award recipient

Abstract #2623/Poster Board #267
Title: "Baseline tumor-immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab", Hurwitz, M., et al.
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Time
Location: McCormick Place, Exhibit Hall A

Emerging Combinations in Sarcoma Immunotherapy
Abstract #11010
Title: "Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas"
Presenter: Sandra D’Angelo, M.D., Memorial Sloan Kettering Cancer Center
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Time
Location: McCormick Place, S100a

Details of Trials in Progress poster presentations are as follows:

Melanoma/Skin Cancers
Abstract TPS9601/Poster Board #168b (Trials in progress (TiP) abstract)
Title: "CA045-001: A phase III, randomized, open label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)", Khushalani, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

Genitourinary (Nonprostate) Cancer
Abstract TPS4595/Poster Board #416b (Trials in progress (TiP) abstract)
Title: "A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma", Tannir, N., et al.
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Time
Location: McCormick Place, Exhibit Hall A

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is an investigational, first-in-class, CD122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin stimulates these cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3 Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

On May 15, 2019 AnHeart Therapeutics (Hangzhou) Co., Ltd.. (hereinafter referred to as AnHeart) reported the completion of the series A round of financing raising about 100 million Chinese yuan (Press release, AnHeart Therapeutics, MAY 15, 2019, View Source [SID1234555758]). The financing was exclusively provided by Decheng Capital, an internationally known venture capital institution specializing in the biomedical industry. This round of financing will be used to establish the AnHeart team to carry out Phase 2 clinical trials of its leading asset AB-106 and to further enrich the company’s product pipeline.

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AnHeart is a clinical stage company, specialized in acquisition, development and commercializing innovative drugs that improve human health and quality of life. Its leading asset is AB-106, an oral, highly selective ROS1/NTRK small molecule inhibitor. This new anticancer drug was acquired from Japan’s Daiichi Sankyo Co., Ltd. in December 2018.

Early clinical trials have shown that AB-106 had satisfactory safety and efficacy and exhibits long progression-free survival in patients with non-small cell lung cancer with ROS1 fusion mutations. Currently, AB-106 has completed phase 1 clinical trials in the United States and Japan for the treatment of patients with solid tumors and neuroendocrine tumors containing ROS1 or NTRK fusion genes. The latest Phase 1 clinical trial results are expected to be reported in detail at the China Clinical Oncology Association Annual Meeting (CSCO) in September 2019.

"AnHeart is committed to the development of innovative drugs with unmet clinical needs," said Dr. Wang Yuyuan, co-founder and CEO of AnHeart. "With the strong support from Decheng Capital, we successfully acquired worldwide global rights for AB-106 from Japan Daiichi Sankyo and took over the long-term follow-up of the product in the US IND and Phase 1 clinical trials." Strategic collaborations are one of the strategies of Anheart. The company plans to establish and enhance clinically innovative product pipelines with near key value inflection points by working with large and medium-sized biopharmaceutical companies."

Dr. Yan Bing, Co-Founder and CMO of Anheart added: "Our team has very rich clinical development experience, and successful drug approval experience in Asia Pacific, Europe and America. We also have long term collaboration with top industry leaders as well. In fact, leveraging our global clinical development capabilities and interdisciplinary expert networks to optimize the clinical commercial value of assets is another strategy of AnHeart."

"Besides acquiring clinical assets by cooperation with large and medium-sized biopharmaceutical projects, we also consider introducing and developing assets that have not entered the clinical phase but have demonstrated good potential in animal experiments in order to build and consolidate an innovative product pipeline", Dr. Zheng Lihua, Co-Founder and CBO of AnHeart added.

"We are very glad we have the opportunity to support Anheart", said Dr. Cui Xiangmin, Managing Partner of Decheng Capital. "AnHeart has built a very successful clinical development team. We believe that AnHeart can use its strength in clinical development to bring a variety of innovative drugs to the market to meet the clinical needs of patients."

On May 15, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, reported financial results for the first quarter 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, CASI Pharmaceuticals, MAY 15, 2019, View Source [SID1234536320]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "We have made good progress in the first quarter of 2019. Most recently, we announced that we acquired exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103). Preclinical data suggests an enhanced safety and efficacy profile against a broad array of hematological malignancies expressing CD38, making CID-103 an excellent strategic fit amid our broader oncology platform. We look forward to announcing progress in this program as well as across other key programs in our pipeline."

First Quarter and Recent Business Highlights

Acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody – On April 17, 2019, CASI acquired worldwide rights to CID-103, a novel anti-CD38 monoclonal antibody. CID-103 is a human monoclonal antibody targeting a specific epitope of the CD38 cell surface antigen. It is at the IND/IMPD submission stage of development with Phase 1 trials expected in late 2019 or early 2020. The addition of CID-103 compliments the Company’s oncology pipeline and allows the Company to provide more treatment options to patients in the future.

Entered into distribution agreement with China distribution partner for EVOMELA (melphalan hydrochloride for injection) – In March 2019, the Company entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd., (CRGK) to be the Company’s exclusive distributor in China for EVOMELA. CASI will maintain responsibility for direct marketing and sales.

Received National Medical Products Administration (NMPA) Clinical Trial Application (CTA) Approvals – In February and March 2019, CASI announced key NMPA clinical trial approvals (CTA) to conduct confirmatory registration trials for both ZEVALIN and MARQIBO, respectively. ZEVALIN is indicated for relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma and MARQIBO is indicated for Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. The Company is working toward getting the trials started in China.

Chairman Wei-Wu He, Ph.D. expanded role to include Chief Executive Officer – On April 2, 2019, CASI appointed its Chairman of the Board of Directors as the Company’s Chief Executive Officer. Dr. He served on CASI’s Board of Directors since 2012. Dr. He has a very successful career building companies from early stage to revenue and profitability stages and most recently was the CEO of OriGene Technologies which he co-founded and built into a profitable life science company; OriGene ultimately merged with a publicly traded Chinese company in 2018.

Financial Results for the Quarter ended March 31, 2019

Cash Position: As of March 31, 2019, CASI had cash and cash equivalents of $99.7 million.

R&D Expenses: R&D expenses for the quarter ended March 31, 2019 were $2.6 million compared to $1.7 million in 2018, an increase of $0.9 million. The increase in R&D expenses primarily reflects costs associated with regulatory, consulting and manufacturing related services, primarily associated with our acquired ANDAs in 2018, as well as an increase in facility costs due to new lease space in China, as well as an increase in personnel costs due to growth in the number of employees.

G&A Expenses: G&A expenses for the quarter ended March 31, 2019 were $5.7 million compared to $1.3 million in 2018. The increase of $4.4 million in G&A over the prior year primarily reflects an increase of $1.6 million in non-cash stock compensation expense largely attributed to stock options issued to the Company’s Chairman and also the President of CASI China, an increase in salary, benefits and recruitment expense, as well as facilities costs primarily in China, related to sales and marketing efforts to prepare for the anticipated launch of the Company’s first commercial product in China, as well as other G&A functions. There were also increased costs associated with professional services fees, including audit and legal services during the 2019 period.

Net Loss: The Company reported a net loss of ($8.2 million), or ($0.09) per share, for the quarter ended March 31, 2019. This compares with a net loss of ($3.6 million), or ($0.05) per share for the first quarter of 2018. The larger net loss for both periods is primarily due to the increase in non-cash stock-based compensation expense during the 2019 period, costs associated with the manufacturing and regulatory support for our ANDA portfolio, and increased costs associated with G&A functions, including employment costs for sales and marketing efforts, as well as increased facilities cost in China and higher professional service fees.

Further information regarding the Company, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, can be found at www.casipharmaceuticals.com.

On May 15, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Leap Therapeutics, MAY 15, 2019, View Source [SID1234536337]).

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"In the first quarter, we presented important new data for both of our programs. DKN-01’s activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We are looking forward to presenting additional clinical data from both programs in the second half of the year."

Recent Developments

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete.

·DKN-01 in GYNECOLOGICAL CANCERS: At the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing.

·DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer patients.

·TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.

· TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First Quarter 2019 Financial Results

Net loss was $8.6 million for the first quarter 2019, compared to $10.6 million for the same period in 2018. This decrease was primarily due to a non-cash charge based on the change in the fair value of the warrant liability in the first quarter 2018, offset by an increase in clinical development expense.

Research and development expenses were $6.8 million for the first quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.0 million for the first quarter 2019, compared to $2.1 million for the same period in 2018. This decrease was primarily due to a decrease in compensation expense as a result of senior management not accepting the cash bonus awarded to them by the compensation committee, partially offset by an increase in stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $21.7 million at March 31, 2019. Research and development incentive receivables, current and long term, totaled approximately $0.9 million at March 31, 2019.