On April 17, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Duke University School of Medicine, reported that they have entered into a collaborative research agreement to evaluate the use of OncoSec’s proprietary TAVOPLUS (enhanced IL-12 DNA-plasmid) in combination or sequence with a HER2-plasmid vaccine administered with OncoSec’s novel intratumoral delivery system (Press release, OncoSec Medical, APR 17, 2019, View Source [SID1234535161]). The research will be led by Herbert Kim Lyerly, M.D., George Barth Geller Professor, Professor of Immunology, Surgery and Pathology at Duke University School of Medicine.

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"We are eager to expand our immunotherapy research in breast cancer through this collaboration with OncoSec. We have previously demonstrated, in a variety of breast cancer models, that local delivery of IL-12 stimulates an anti-breast cancer immune response with applicability beyond end-stage cancer. This delivery system has the potential to be a foundational therapeutic in the treatment of early-stage disease," said Dr. Lyerly. "The translational work with TAVOPLUS has been very encouraging and we are excited to explore the potential of OncoSec’s IL-12 plasmid delivery technology to enhance immune responses targeting HER2+ tumors and to elicit superior T-cell and B-cell responses to HER2 in a variety of preclinical breast cancer models."

Under the terms of the agreement, OncoSec will provide its proprietary TAVO (IL-12 plasmids) and its new electroporation generator, APOLLO, using lower voltage and a longer pulse width which greatly increased DNA-plasmid cellular transfection rates, to Duke University’s Center for Applied Therapeutics. Duke University investigators will conduct preclinical studies using plasmid vaccines targeting HER2 in combination with plasmid vaccines and TAVO in a newly developed endogenous mouse model of HER2+ breast cancer. Additionally, Duke investigators will use TAVO with their high-intensity ultrasound tumor ablation models to explore the impact of IL-12 delivery on the development of systemic immunity.

On April 17, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a key opinion leader (KOL) breakfast symposium focused on the unmet need, treatment landscape and opportunities for selective cyclin-dependent kinase 7 (CDK7) inhibition in ovarian and breast cancers on Wednesday, April 24, 2019 from 8:30 – 10:30 a.m. ET in New York City (Press release, Syros Pharmaceuticals, APR 17, 2019, View Source [SID1234535180]). Syros is currently evaluating SY-1365, a first-in-class selective CDK7 inhibitor, in a Phase 1 clinical trial as a single agent and in combination with other therapies in multiple ovarian and breast cancer patient populations.

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The event will feature presentations from Dejan Juric, M.D., Medical Oncologist and Director at the Termeer Center for Targeted Therapies, Massachusetts General Hospital and Charles A. Leath, III, M.D., M.S.P.H., Professor in the Division of Gynecologic Oncology and Ellen Gregg Shook Culverhouse Chair in Gynecologic Oncology at the University of Alabama Medical Center. Additionally, members of the Syros management team will provide an overview of SY-1365, including preclinical and clinical data supporting its ongoing development in ovarian and breast cancer patients, and SY-5609, its oral selective CDK7 inhibitor, which is expected to enter a Phase 1 oncology study in early 2020.

A live webcast of the event will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.

On April 17, 2019 Precision BioSciences (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported it has dosed the first patient in the Phase 1/2a clinical trial of PBCAR0191, its first gene-edited allogeneic anti-CD19 chimeric antigen receptor (CAR) T cell product candidate (Press release, Precision Biosciences, APR 17, 2019, View Source [SID1234535181]). Precision is developing PBCAR0191 in collaboration with Servier, an international pharmaceutical company. PBCAR0191 is made from donor-derived T cells that are modified using Precision’s ARCUS genome editing technology. These edits are designed to generate CAR T cells that specifically recognize CD19, an important target in several B-cell cancers, and to prevent graft-versus-host disease, a significant complication associated with existing donor-derived cell-based therapies. This CAR T cell product candidate is being evaluated in adult patients with relapsed or refractory ("R/R") non-Hodgkin lymphoma ("NHL") or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) as an off-the-shelf cell therapy. The first patient dosed in this trial is being treated for R/R NHL, and Precision believes this is the first U.S.-based clinical trial to evaluate an allogeneic CAR T therapy for NHL.

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This multi-center, open label study of PBCAR0191 is expected to enroll up to 80 patients and several dose levels of PBCAR0191 will be investigated. Clinical sites include City of Hope, Moffit Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. The primary objective of the trial is to evaluate the safety of PBCAR0191 and determine the maximum tolerated dose. Secondary objectives include evaluating the anti-tumor activity of PBCAR0191. Precision will also evaluate the expansion, trafficking and persistence of PBCAR0191 in treated patients. Lymphodepletion will be conducted several days prior to PBCAR0191 infusion. Patient outcomes will be collected for up to one year.

On April 17, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, APR 17, 2019, View Source [SID1234535199]).

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"We are delighted for the opportunity to present updated data at the upcoming WCGIC from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of refractory metastatic colorectal cancer" noted Frédéric Lehmann, Head of Global Clinical Development and Medical Affairs at Celyad. "We continue to build upon our clinical experience in the treatment of solid tumors with these novel immunotherapies and the oral presentation at WCGIC represents a special milestone to highlight preliminary data from the industry’s first trial investigating an ‘off-the-shelf ‘ CAR-T candidate for the treatment of solid tumors. In addition, the comparable trial designs between SHRINK and alloSHRINK as well as the similar CAR constructs provide insight into autologous and allogeneic approaches in an advanced solid tumor indication."

Presentation Details:

Abstract #631: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Session: Short Oral Presentation

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.

On April 17, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will release its first-quarter 2019 operating results before market open Tuesday, May 7. A conference call and live webcast will be held at 8:30 a.m. ET (Press release, Diplomat Speciality Pharmacy, APR 17, 2019, View Source [SID1234535182]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participation code 7747209, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.

Diplomat executives Brian Griffin, chairman and CEO, and Dan Davison, chief financial officer, will also participate in the Bank of America Merrill Lynch Healthcare Conference in Las Vegas on May 14.