On October 5, 2018 Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, reported data from its OSPREY 2301 Study of PyLTM (18F-DCFPyL). PyL is the Company’s PSMA-targeted small molecule PET imaging agent designed to visualize prostate cancer (Press release, Progenics Pharmaceuticals, OCT 5, 2018, View Source [SID1234530641]). In the study, PyL demonstrated high sensitivity in reliably detecting distant metastatic prostate cancer lesions and high specificity in confirming the absence of pelvic lymph node disease. The associated strong positive predictive values (PPV) and negative predictive value (NPV) of PyL imaging in these disease settings indicate its potential high clinical utility.

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Dr. Michael Morris, Associate Professor at Memorial Sloan Kettering, and a lead investigator of the trial said, "These are highly encouraging results in a large, well-controlled and rigorous trial showing PyL has excellent positive and negative predictive value in assessing the distribution of disease in men with high-risk prostate cancer. Furthermore, in men intended to go to surgery, the specificity of PyL was exceedingly good. Taken together, a PyL PET avid lesion is a reliable reflection of histologically proven disease and may provide additional important information to men with prostate cancer and their doctors. That information may provide important guidance in the decision-making for their treatment."

Phase 2/3 Trial Results

The trial examined the diagnostic performance of PSMA-targeted PET imaging agent, PyL, to detect prostate cancer in pelvic lymph nodes in patients with high risk locally advanced prostate cancer (Cohort A) and distant metastases in patients with metastatic or recurrent (Cohort B) prostate cancer. The diagnostic performance of PyL PET imaging in this "gold standard" trial was evaluated against histopathology as the standard of truth. The OSPREY study dosed 385 patients with either high-risk locally advanced prostate cancer (268) or metastatic or recurrent prostate cancer (117). The study’s co-primary endpoints were the assessment of specificity and sensitivity of PyL PET imaging in Cohort A to detect prostate cancer in pelvic lymph nodes in patients scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. Key secondary endpoints for Cohort A were positive predictive value and negative predictive value. The study also evaluated several key secondary endpoints in Cohort B, including the sensitivity and positive predictive value of PyL PET imaging in detecting metastatic prostate cancer in patients where lesion biopsies (bone, soft tissues, lymph nodes other than pelvic lymph nodes) were feasible.

In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed a high specificity (96-99% among the three blinded independent readers), meeting the first co-primary endpoint of the trial, with the lower bound of the 95th percent confidence interval (94-96%) exceeding 80%. The sensitivity of 31-42%, did not meet the second co-primary endpoint, as the lower bound of the 95th percentile confidence interval (19-30%) did not exceed the required 40%. The positive predictive value and negative predictive value of pelvic lymph node detection were 78-91% and 81-84%, respectively.

In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and positive predictive value of 81-88% in detecting metastatic lesions. Specificity and negative predictive value were not endpoints specified in the protocol for Cohort B as all men in Cohort B were suspected to have disease.

PyL was very well tolerated. A total of 27 (7%) subjects experienced at least one treatment related adverse event. There were no serious adverse events related to study drug. The most frequent drug related events included dysgeusia (2.1%) and headache (2.1%).

"The data from this trial shows the strength of PyL in prostate cancer detection, and its potential to be highly valuable for disease and treatment monitoring," said Dr. Vivien Wong, Executive Vice President of Development at Progenics. "While specificity and sensitivity are often used to describe diagnostic performance, PPV and NPV are increasingly considered more relevant indicators of actual clinical utility. Following our discussions with FDA, our Phase 3 trial design will use a primary endpoint based on PPV parameters in the biochemical recurrence setting."

"PyL imaging holds great promise in transforming how physicians manage and treat high risk, metastatic, and recurrent prostate cancer," said Mark Baker, Chief Executive Officer of Progenics. "Our data from OSPREY provides strong rationale for continued development, and we look forward to launching our Phase 3 trial by year-end."

Progenics plans to submit the full results from the trial for presentation at a medical meeting.

Progenics Reports Results of Phase 2/3 Trial of PSMA PET Imaging Agent PyL Page 3

About PyL for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography ("PET") imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

Investor Conference Call

Progenics will host a conference call today at 8:30 AM Eastern Time to discuss the approval. The live and replayed webcast of the call will be available through the Company’s website at www.progenics.com. To participate in the live call by phone, dial (877) 250-8889 (USA) or (720) 545-0001 (international) and enter the passcode 4282148. The replay of the call will be available for 90 days.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 161,360 new cases of prostate cancer will be diagnosed and about 26,730 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

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.

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."

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."

On October 4, 2018 Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that the Company will report its financial results for the third quarter ended September 30, 2018 before the US financial markets open on October 24, 2018 (Press release, Alexion, OCT 4, 2018, View Source [SID1234529852]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00 a.m. Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 5947065 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.