On June 1, 2021 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the initiation of NAVAL-1 (Nanatinostat in Combination with Valganciclovir), a global, multicenter, open-label Phase 2 basket trial for the treatment of relapsed/refractory (R/R) EBV-positive (EBV+) lymphoma (Press release, Viracta Therapeutics, JUN 1, 2021, View Source [SID1234583356]). NAVAL-1 is designed to potentially support multiple new drug application filings across various EBV+ lymphoma subtypes.

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"Effective therapies for patients with recurrent lymphomas are limited, and those with EBV-positive lymphoma have even worse outcomes with standard of care therapies. Following the promising Phase 1b/2 data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, we are excited to initiate the NAVAL-1 trial and continue the evaluation of our all-oral combination regimen in patients with a variety of relapsed/refractory EBV-positive lymphomas," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "We are seeing enthusiasm for NAVAL-1 and our therapeutic approach from physicians, both in the United States and internationally, as this is an area of significant unmet medical need."

NAVAL-1 will evaluate nanatinostat in combination with valganciclovir in patients with EBV+ R/R lymphoma and is anticipated to enroll approximately 140 patients at centers in North America, Europe, and Asia-Pacific. The primary endpoint of the trial is objective response rate, with key secondary endpoints including duration of response, survival outcomes, and the safety profile of the combined treatment. Patients with EBV+ relapsed or refractory disease following two or more prior therapies (one or more for extranodal NK/T cell lymphoma) without curative treatment options will be eligible for enrollment.

Ivor Royston, M.D., President and Chief Executive Officer of Viracta, added, "The initiation of NAVAL-1 is an important milestone for Viracta, and we are thrilled to have this pivotal trial open for enrollment. We believe we are uniquely positioned with our all-oral therapeutic approach, together with our novel trial design, to expand the impact and broaden the reach to patients with various lymphoma subtypes in key geographies around the world."

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in multiple subtypes of R/R EBV+ lymphoma in two ongoing Phase 2 trials, including a registration-enabling global, multicenter, open-label basket trial.

On June 1, 2021 Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the Canadian Intellectual Property Office has issued Canadian Patent No. 2,893,962 covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, JUN 1, 2021, View Source [SID1234583308]). The new patent is expected to provide added intellectual property protection for pharmaceutical compositions, manufacturing methods and uses of AllocetraTM.

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Oren Hershkovitz, PhD, CEO of Enlivex, stated, "We are pleased to have this patent granted in Canada, which adds to existing AllocetraTM patents in various countries around the world. We currently continue to focus our clinical development efforts on life-threatening diseases with high mortality rates and no effective treatments such as sepsis, COVID-19, and solid tumors."

AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On June 1, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial will proceed as planned following the review of safety data from more than 20 patients enrolled into the trial to date (Press release, Tracon Pharmaceuticals, JUN 1, 2021, View Source [SID1234583325]). The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab).

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"We are pleased with the recommendation of the Data Monitoring Committee to continue the ENVASARC pivotal trial as planned," said James Freddo, M.D., TRACON’s Chief Medical Officer, "Envafolimab has been well tolerated as a single agent and when combined with Yervoy in these patients with refractory sarcoma who are enrolled in the ENVASARC trial. Based on the current accrual rate, we expect the Data Monitoring Committee to review additional safety data in the third quarter and to review interim efficacy data in the fourth quarter of this year."

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multi-center, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

On June 1, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported that the company will host a conference call and webcast to review updated 90-day efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation (Press release, Jasper Therapeutics, JUN 1, 2021, View Source [SID1234583342]).

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The webcast, which will take place on Tuesday, June 8, 2021 at 12:00 pm ET, will include presentations from Jasper management, along with guest speakers:

Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine and lead investigator of the study. Dr. Muffly will present the JSP191 data in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held online June 4-8, 2021.
Gail Roboz, M.D., Professor of Medicine (Hematology and Medical Oncology) and Director of the Clinical and Translational Leukemia Program at Weill Cornell Medicine.
Conference Call and Webcast Details:
A live webcast of the event, including presentation slides, will be available on Tuesday, June 8, 2021 at 12:00 pm ET by clicking here. To access the investor event by phone and participate in the question and answer session, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and reference conference ID: 13720248. A replay of the webcast will be available for 90 days following the live event.

About MDS and AML
Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.i Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. While hematopoietic cell transplantation is potentially curative in these patients, its use is limited in older and frail patients because standard high dose myeloablative conditioning is associated with severe toxicities and standard low dose conditioning has limited efficacy.

About JSP191
JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. It is currently enrolling in two clinical trials for myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) and severe combined immunodeficiency (SCID) and expects to begin enrollment in three additional studies in 2021 for severe autoimmune disease, sickle cell disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

On June 1, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma (Press release, Johnson & Johnson, JUN 1, 2021, View Source [SID1234583357]). This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11th received by Janssen’s Oncology Therapeutic Area.

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"We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "This program exemplifies our commitment to advancing science for patients living with multiple myeloma, and it builds upon our robust portfolio in this disease."

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.1 PRIME designation offers enhanced interaction and early dialogue to optimize development plans and speed up the evaluation of scientific advances that target a high unmet medical need.2

The Breakthrough and PRIME designations are supported by data from the Phase 1 MajesTEC-1 study (NCT03145181), an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies.3

Updated results from the MajesTEC-1 study will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 8.

About Teclistamab
Teclistamab is an off-the-shelf, T-Cell redirecting, bispecific antibody targeting both BCMA and CD3 receptors. BCMA is expressed at high levels on multiple myeloma cells.4,5,6,7,8 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.5,6 Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.6

Teclistamab is currently being evaluated in a Phase 2 clinical study for the treatment of relapsed or refractory multiple myeloma (NCT04557098) and is also being explored in combination studies (NCT04586426, NCT04108195, NCT04722146). In 2020, the European Commission and the U.S. Food and Drug Administration each granted teclistamab orphan drug designation for the treatment of multiple myeloma. In January 2021, teclistamab was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA). PRIME offers enhanced interaction and early dialogue to optimize drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.9

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.10,11 When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed and more than 12,000 will die from the disease in the U.S.12 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.13