Teva to Report Third Quarter 2018 Financial Results on November 1, 2018

On October 5, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it will release its third quarter 2018 financial results on Thursday, November 1, 2018 at 7:00 a.m. ET (Press release, Teva, OCT 5, 2018, View Source;p=RssLanding&cat=news&id=2370421 [SID1234529812]).

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Teva will host a conference call and live webcast on the same day, at 8:00 a.m. ET to discuss its third quarter 2018 results and overall business environment. A Question & Answer session will follow this discussion.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time):

United States 1 (866) 966-1396
International +44 (0) 2071 928000
For a list of other international toll-free numbers, click here.
Passcode: 7193665
A live webcast of the call will also be available on Teva’s website at: ir.tevapharm.com Please log in at least 10 minutes prior to the conference call in order to download the applicable software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until November 30, 2018, 9:00 a.m. ET by calling United States 1 (866) 331-1332 or International +44 (0) 3333-009785; passcode: 7193665.

Quest Diagnostics To Release Third Quarter 2018 Financial Results On October 23

On October 5, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2018 results on Tuesday, October 23, 2018, before the market opens (Press release, Quest Diagnostics, OCT 5, 2018, View Source [SID1234529799]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers, no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 23, 2018 until midnight Eastern Time on November 6, 2018.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Generex Biotechnology Provides Update on AE37 Immuno-Therapeutic Clinical Development Program

On October 5, 2018 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported that the Company, in conjunction with its research collaborators Merck and the NSABP Foundation, will file an IND in October to initiate A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer (Press release, Generex, OCT 5, 2018, View Source [SID1234529796]). It is anticipated that the trial will initiate sites in the fourth quarter and begin enrolling patients in the first quarter of 2019.

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Also, as previously announced, AE37 is being developed for the treatment of prostate cancer by the Company’s partner, Shenzhen Bioscien. The Company has nearly completed the non-clinical toxicology and pharmacology work required by the Chinese Food & Drug Administration (CFDA) and is preparing the necessary documentation for application to obtain authorization on the regulatory path for approval in China. Pending acceptance of that regulatory package, Shenzhen plans to initiate a Phase II clinical trial in Europe in 2019, with Generex maintaining Rest-of-World, ex-China rights to AE37 for the treatment of prostate cancer.

Further, in conjunction with the launch of the AE37/KEYTRUDA combination trial, and as part of the continuing restructuring of Generex, the Antigen Express name will be changed to NuGenerex Immuno-Oncology, remaining a wholly-owned subsidiary under the umbrella of the parent Company.

"We are excited to launch the clinical development of our HER2/neu immunotherapeutic vaccine AE37 in combination with Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with triple-negative breast cancer," said Dr. Eric von Hofe, President of NuGenerex Immuno-Oncology. "With this trial and our partnership with Shenzhen Bioscien, NuGenerex Immuno-Oncology is positioned to realize the full potential of AE37 while advancing our proprietary Ii-Key technology platform for use in other cancers and diseases."

Generex Chief Medical and Scientific Officer, Dr. Jason Terrell, added: "NuGenerex Immuno-Oncology will be an important division within our restructured and diversified organization. This represents a successful advancement of our overall strategy to improve patient care through the development of innovative products and healthcare solutions."

Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only to advance the Antigen Express core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. Generex has long demonstrated a belief and commitment to immune-therapy for the treatment of cancer through our extensive Ii-Key research & development program, and we are proud to be a leader in this emerging era of personalized, immuno-therapeutic cancer care."

Termination of Phase I, open-label, dose finding study (NCT02641002) of CC-90002 in subjects with acute myeloid leukemia and high-risk myelodsplastic syndrome

A Phase I, open-label, dose finding study (NCT02641002) of CC-90002 in subjects with acute myeloid leukemia and high-risk myelodsplastic syndrome has been terminated due to that preliminary monotherapy data in relapsed/refractory AML and high-risk MDS did not offer a sufficiently encouraging profile for further dose escalation/expansion (Clinical trial, ClinicalTrials.gov, OCT 4, 2018, View Source;B=13&C=merged#StudyPageTop [SID1234531854]).

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However another Phase I, open-label, dose finding study (NCT02367196) of CC-90002 in subjects with advanced solid and hematologic cancers is still active and confirmed by Celgene October 16, 2018 (Clinicaltrials.gov, OCT 16, 2018, View Source).

Celyad Announces Exclusive Agreement for
Horizon Discovery’s shRNA Platform to Develop Next-Generation Allogeneic CAR-T Therapies

On October 4, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, reported an exclusive agreement with Horizon Discovery Group plc (LSE: HZD), for the use of its shRNA technology to generate Celyad’s second non-gene-edited allogeneic platform (Press release, Celyad, OCT 4, 2018, View Source [SID1234530340]).

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Celyad recently announced its first-in-class non-gene edited allogeneic CAR-T candidate, CYAD-101 a non-gene-edited allogeneic NKG2D-based CAR using the TIM (TCR Inhibiting Molecule). As a result of the agreement with Horizon Discovery, Celyad now also has access to a novel shRNA-based platform.

Data from preclinical studies demonstrating the versatility of the shRNA platform in the allogeneic setting, will be presented at the upcoming 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C., November 7th – 11th. These promising preclinical data will pave the way for the next steps in the development of Celyad’s differentiated non-gene edited allogeneic approach to CAR-T cell therapy.

"We are excited to have the opportunity to leverage Horizon’s shRNA platform to further advance our pioneering approach to non-gene edited allogeneic CAR-T cells", said Dr. Christian Homsy, CEO of Celyad. "Celyad is committed to rapidly advancing its allogeneic program based on highly promising preclinical data which will be presented at SITC (Free SITC Whitepaper). These data provide proof of concept for our shRNA based non-gene-edited allogeneic approach. In addition to very promising preclinical data, our allogeneic approach is also strengthened by Celyad’s strong patent estate in the U.S., which broadly covers the use of allogeneic CAR-T using cells that are TCR inhibited or suppressed by any means."

Jon Moore, CSO of Horizon Discovery added: "The high performance shRNA technology licensed by Celyad is the same as that deployed in our range of SMARTvector products and is designed to deliver efficient target knock down with high specificity. Horizon’s collaboration with Celyad is designed to let Celyad find a highly effective solution for its needs. Horizon sees its shRNA technology as a serious rival to gene editing approaches for delivering enhanced performance to therapeutic cell products. We see enormous promise in cell therapies and are committed to develop and supply innovative technologies that allow our partners to bring transformative cell therapies to the clinic and fulfil unmet clinical needs."