On May 27, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on NK cell engager (TriKE) technology. GT reported that the second patient of the lowest dose of an ascending dose finding study has begun treatment of the GTB-3550 TriKE (Press release, GT Biopharma, MAY 27, 2020, View Source [SID1234558535]). The patient will be evaluated following completion of the third cycle of GTB-3550 TriKE therapy. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis. Additional clinical trial sites are now being processed.

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The first patient of the Phase I/II study achieved stable disease and increased NK cell production with no adverse side effects. The first patient elicited an encouraging initial efficacy marker response.

The TRIKE clinical trial evaluates GTB-3550 in patients with acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.

TriKE is a multi-targeted immuno-oncology protein-based therapeutic drug. The TriKE addresses the patient delivery and administration issues of liquid tumor cell therapies and NK engagers. Pre-clinical data shows that The TriKE platform technology works in both liquid and solid tumors.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. The Company is currently in a clinical trial with GTB-3550 in CD33 positive leukemia for acute myeloid leukemia (AML), and is studying myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies along with other solid tumor candidates.

On May 27, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present virtually at the William Blair 40th Annual Growth Stock Conference on Wednesday, June 10, at 12:40 p.m. Central Time (Press release, Veracyte, MAY 27, 2020, View Source [SID1234558534]).

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The link to the live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On May 27, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that Daniel P. Gold, Ph.D., president and chief executive officer of MEI, will present a company overview and business update at the Jefferies Virtual Healthcare Conference on Tuesday, June 2nd, 2020 at 11:00 AM Eastern Time (Press release, MEI Pharma, MAY 27, 2020, View Source [SID1234558532]). The conference is being held in a virtual format.

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A live audio webcast of the event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

On May 27, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported plans for a clinical study intended to support registration in the U.S. of flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule for patients with acute myeloid leukemia (AML) who are refractory to induction therapy (Press release, MacroGenics, MAY 27, 2020, View Source [SID1234558531]).

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Informed by recent discussions with the U.S. Food and Drug Administration (FDA), the Company plans a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure (PIF) or early relapse (ER) AML. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). Complete remission (CR) and CR with partial hematological recovery (CRh) will be the primary endpoint of the pivotal study. Key secondary endpoints will include durability of response and other supportive clinical endpoints.

"Patients with AML who are refractory to induction therapy or relapse early after an initial response have limited treatment options," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Clinical and translational data suggest that such refractory AML patients may be responsive to immunotherapy with flotetuzumab. We are very pleased to advance our first DART molecule into a pivotal study with an opportunity to address a significant unmet need."

Data from the Phase 1/2 clinical study of flotetuzumab in patients with PIF/ER AML were presented in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. A CR/CRh rate of 27% (8 of 30) was observed in the intent-to-treat population. The most common treatment-related adverse event was infusion-related reaction/cytokine release syndrome that occurred in all patients and was mostly of short duration and mild to moderate (grade 1 or 2) in severity.

About Acute Myeloid Leukemia

AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (<6 months; early relapsed). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations.

About Flotetuzumab

Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.

On May 27, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the monotherapy expansion cohort of its ongoing Phase 1 clinical trial of COM701, a first-in-class anti-PVRIG antibody (Press release, Compugen, MAY 27, 2020, View Source [SID1234558530]). The selected indications for the monotherapy expansion cohort focus on those more likely to respond to treatment with COM701 based on biomarker expression studies and clinical data collected to date. As such, the trial will enroll patients with non-small cell lung, ovarian, breast, endometrial and colorectal cancers.

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Erika Hamilton, M.D., Director of Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute and principal investigator in the COM701 Phase 1 study, said, "There is a significant need to develop novel treatments for patients with advanced cancer who are unresponsive to or relapse following treatment with the currently available standard of care immune checkpoint inhibitors. The preliminary signs of anti-tumor activity observed in the heavily pretreated, all-comer patient population included two confirmed partial responses in patients with microsatellite stable colon and platinum resistant primary peritoneal cancer which are tumor types typically unresponsive to immune checkpoint inhibitors. We are excited to advance to the monotherapy expansion stage of the study potentially offering patients a new effective cancer immunotherapy treatment."

Anat Cohen-Dayag, Ph.D., Compugen’s President and Chief Executive Officer, added, "While this monotherapy expansion cohort targets tumor types that are typically unresponsive to cancer immunotherapy, we believe that they are more likely to respond to treatment with COM701 based on our expression studies and initial clinical results. Furthermore, in this study we will be collecting biopsies before and during COM701 treatment to allow retrospective analyses of our biomarker approach and to help inform our future clinical development plan for COM701. We are encouraged by the progress across our clinical programs and the data we have presented on PVRIG and COM701 to date, as well as the possible clinical validation of the TIGIT pathway published by others, which we believe supports our long-standing hypothesis concerning the potential role of the DNAM axis as a foundational axis for cancer immunotherapy."

The monotherapy expansion cohort of the ongoing Phase 1 open-label COM701 clinical trial (NCT03667716) is designed to assess the safety, tolerability and preliminary anti-tumor activity of 20 mg/kg IV Q4 weeks COM701 monotherapy in approximately 20 patients with advanced non-small cell lung, ovarian, breast, endometrial and colorectal cancers who have progressed on standard of care treatment. Expansion cohorts were selected based on preclinical biomarker expression and clinical data.

About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, an immune checkpoint discovered computationally by Compugen in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.