On September 4, 2019 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for diabetes and Alzheimer’s disease, reported that it is scheduled to present a general company update at the H.C. Wainwright 21st Annual Global Investment Conference on Tuesday, September 10, 2019 at 3:00 p.m. Eastern Time in New York City (Press release, vTv Therapeutics, SEP 4, 2019, View Source [SID1234539271]). Company management will also be meeting with members of the investment community during one-on-one meetings at the conference.

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A live webcast of the presentation can be accessed here and will be accessible for 30 days following the presentation at www.vtvtherapeutics.com.

On September 4, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported that they have entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company (Press release, Idera Pharmaceuticals, SEP 4, 2019, View Source [SID1234539270]). The purpose of the collaboration is to conduct a clinical study evaluating whether combinations of an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod), chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181) stimulate the immune system resulting in anti-tumor responses.

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This Phase 1b, multi-center, open-label study is designed to determine the safety, tolerability, pharmacokinetics and preliminary efficacy of combinations of ABBV-368 plus tilsotolimod in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The study will test three separate treatment arms:

ABBV-368 plus tilsotolimod;
ABBV-368 plus tilsotolimod and nab-paclitaxel; and
ABBV-368 plus tilsotolimod, nab-paclitaxel and ABBV-181.
Under the terms of the agreement, Idera will provide clinical trial supply of tilsotolimod to AbbVie and AbbVie will be responsible for conduct of the study.

"We are excited to be entering into this additional clinical collaboration, which continues to advance our strategy of exploring the possibilities to further improve patient outcomes harnessing the immune system against difficult to treat cancers, which historically have not generated significant objective response rates through checkpoint inhibition alone," stated Elizabeth A. Tarka, M.D., F.A.C.C., Idera’s Chief Medical Officer. "We look forward to working together with AbbVie to advance our understanding of the combination effect of ABBV-368 and tilsotolimod for these patients."

On September 4, 2019 SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported that the Company will present in the following investor conferences (Press release, Scynexis, SEP 4, 2019, View Source [SID1234539269]):

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The H.C. Wainwright Global Investment Conference at the Lotte New York Palace Hotel in New York City on Monday, September 9, 2019 at 2:10 p.m. ET.
The Ladenburg Thalmann Healthcare Conference at the Sofitel New York in New York City on Tuesday, September 24, 2019 at 1:30 p.m. ET.
Live webcasts of the presentations will be available on the Investors section of the Company’s website: www.scynexis.com. Replays of the presentations will be available approximately two hours after each event and will be available for two weeks following each presentation.

On September 4, 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 the successful administration of CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial (Press release, Celyad, SEP 4, 2019, View Source [SID1234539267]).

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Jean-Pierre Latere, Chief Operating Officer of Celyad said "The dosing of the first patient with CYAD-01 manufactured with the OptimAb process marks another important milestone for our company. The OptimAb manufacturing process has shown exciting activity in preclinical models and we believe that the integration of the manufacturing process into our autologous relapsed/refractory acute myeloid leukemia program should help us to improve upon the initial signals we have observed to date with CYAD-01. We look forward to reporting preliminary data from patients enrolled in the DEPLETHINK trial treated with CYAD-01 produced with the OptimAb process by the end of the year."

Background on CYAD-01

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.

Background on OptimAb Manufacturing Process

The OptimAb manufacturing process utilizes a shortened cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive acute myeloid leukemia (AML) model compared to CYAD-01 produced with the previous mAb manufacturing process.

Background on DEPLETHINK Phase 1 Trial

In October 2018, Celyad initiated the DEPLETHINK Phase 1 trial (NCT03466320). The open-label, dose-escalation trial will evaluate a single infusion of CYAD-01 for the treatment of relapsed/refractory AML and myelodysplastic syndromes (MDS) following preconditioning chemotherapy (cyclophosphamide [300 mg/m²] and fludarabine [30 mg/m²]). The trial will evaluate three dose levels of CYAD-01 including 100 million, 300 million and 1 billion cells per infusion, respectively. The primary endpoint of the trial is safety and secondary endpoints include clinical activity and pharmacokinetics.

On September 4, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Thursday, September 5, 2019 (Press release, Oncolytics Biotech, SEP 4, 2019, https://ir.oncolyticsbiotech.com/news/detail/469/oncolytics-biotechr-to-host-corporate-update-call-to-discuss-recent-highlights-and-expanded-catalysts-and-milestones [SID1234539266]). The call will focus on a clinical and business development update, the current financial position and the recently updated list of catalysts and milestones.

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The live call may be accessed by dialing 844-407-9500 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at 877-481-4010, using the replay code 53627 and will be available for one week. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.