On July 29, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that as part of its clinical collaboration agreement with Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), Inovio’s prostate cancer immunotherapy INO-5151 will be combined with an immune modulator (CDX-301, FLT3 ligand, a dendritic cell mobilizer) and a PD-1 checkpoint inhibitor (nivolumab) targeting metastatic castration resistant prostate cancer (mCRPC) in a PICI sponsored platform study (Press release, Inovio, JUL 29, 2019, View Source [SID1234537835]).

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This innovative combination trial is an open-label, non-randomized, exploratory platform study designed to assess the safety and antitumor activity of multiple immunotherapy based combinations in participants with mCRPC who have received prior secondary androgen inhibition. Evaluating biomarkers of immune activity and clinical outcomes using a multi-omic, multi-parameter approach is an important aspect of the study. INO-5151 is a combined formulation of INO-5150 (with SynCon antigens encoding for PSA and PSMA) and INO-9012 (DNA vector expressing interleukin 12). Inovio’s immunotherapy is one arm (Cohort C) of this broad PICI-supported study which is a multi-arm, multi-stage platform design (called PORTER Study: ClinicalTrials.gov Identifier: NCT03835533).

Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Inovio is pleased that PICI selected our novel DNA-based immunotherapies to join in this unique combination trial targeting a major unmet medical need. This study demonstrates how Inovio is working with top cancer immunotherapy pioneers to investigate the potential significance of Inovio’s T cell activating immunotherapy in an innovative immuno-oncology combination regimen. Our collaboration with PICI allows us to leverage strategic partnerships with academia, non-profits, and pharma while working with PICI’s team of world-renowned experts from leading cancer centers at the forefront of cancer research."

Metastatic castration resistant prostate cancer, the lethal form of prostate cancer, has shown limited benefit from immune checkpoint inhibition as a monotherapy, with two randomized Phase 3 trials with ipilimumab failing to show a clinically meaningful survival benefit, and a large Phase 2 trial with pembrolizumab demonstrating a modest rate of objective responses.

Under the agreement, PICI will design and execute the clinical study, working in collaboration with its established network of the most pre-eminent clinical academic and industry cancer centers, and with funding support from CRI. Based on PICI’s novel approach to accelerating studies of cancer immunotherapies, Inovio will provide financial contributions if Inovio’s product(s) studied under the collaboration reaches the initiation of a Phase 3 study.

On July 29, 2019 Bellicum Pharmaceuticals presented the corporate presentation (Presentation, Bellicum Pharmaceuticals, JUL 29, 2019, View Source [SID1234537834]).

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On July 29, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported the appointment of Ronald Peck, M.D. to the newly created position of Chief Medical Officer (CMO) (Press release, Arvinas, JUL 29, 2019, View Source [SID1234537833]). Dr. Peck brings to Arvinas more than twenty years of clinical and drug development experience, most recently serving as Senior Vice President, Clinical Research at Tesaro, where he oversaw all clinical development efforts for the company’s entire pipeline, including Zejula (niraparib) and Tesaro’s immuno-oncology programs.

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"Dr. Peck arrives at the right time for our company, as we advance ARV-110 through a Phase 1 clinical trial and expect to initiate a Phase 1 clinical trial of ARV-471 in the third quarter of 2019," said John Houston, Ph.D., President and CEO of Arvinas. "Ron is a highly accomplished clinician with a strong track record of successful drug development, leading novel oncology programs from the earliest phases through to registration. His experience is strongly aligned with our goals at this pivotal time for the company."

"Arvinas is leading the industry with its new and exciting technology platform of PROTAC targeted protein degraders," said Dr. Peck. "The company has tremendous momentum. With one clinical program, which also received Fast Track designation from FDA, and another program entering the clinic soon, I anticipate Arvinas will be the first company in the field to have clinical data with a targeted protein degrader. I am excited to be joining Arvinas, and look forward to pursuing the development of PROTAC protein degraders to benefit patients and address unmet medical needs in oncology and in other devastating and life-threatening diseases."

Prior to his work at Tesaro, Dr. Peck served as the CMO of Kolltan Pharmaceuticals, a privately-held clinical-stage biotechnology company where he oversaw the clinical development of monoclonal antibodies targeting receptor tyrosine kinases. Dr. Peck began his industry career at Bristol Myers Squibb (BMS), where he spent 15 years in drug development, eventually serving as Vice President, YERVOY (ipilimumab) Global Development Lead. At BMS, he played a key role in the approval and commercialization of YERVOY (ipilimumab) across all indications and contributed to the successful development of multiple other oncology assets, including IXEMPRA (ixabepilone). Early in his BMS career, Dr. Peck contributed to the life cycle development of ABILIFY (aripiprazole) within the neuroscience clinical research organization. Dr. Peck received his bachelor’s degree in chemistry from Georgetown University in Washington, D.C., his M.D. from Thomas Jefferson University Medical College in Philadelphia, PA., and completed a residency and hematology/oncology fellowship at Georgetown University in Washington, D.C before serving as Assistant Professor of Medicine at the University of Virginia.

About PROTAC Protein Degraders

Arvinas’ PROTAC protein degraders harness the body’s own natural protein disposal system to degrade disease-causing proteins. PROTAC protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC protein degrader is released and acts iteratively to destroy additional target protein.

PROTAC protein degraders offer numerous potential advantages as therapeutics, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies. Arvinas has developed and optimized a proprietary library of protein targeting ligands, E3 ligase ligands, and linkers, which allow the company to rapidly identify and optimize efficient protein degraders with favorable characteristics for successful drug development.

On July 27, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage U.S.-China oncology drug development company, reported that it will present at the 3rd World-China Immunotherapy & Gene Therapy Congress 2019 to be held in Beijing from August 30th to August 31st (Press release, Xynomic Pharmaceuticals, JUL 27, 2019, View Source [SID1234537796]). The presentation will report the interim data of the ongoing Phase 1b trial, being conducted at University of California, San Francisco, evaluating the safety and efficacy of Xynomic’s abexinostat, a pan-histone deacetylase ("HDAC") inhibitor, in combination with Keytruda, a humanized antibody in cancer immunotherapy, for the treatment of multiple solid tumors.

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Abexinostat is a pan HDAC inhibitor that inhibits HDACs 1, 2, 3, 6, and 10. Thus, HDACs have become a therapeutic target for various types of cancers. Keytruda is a checkpoint inhibitor (CPI), which blocks the PD-1 receptor signaling axis in patients with advanced solid tumors. Keytruda, while effective, has significant limitations including low objective response rate (~20%) and drug resistance issues. Epigenetic modifying agents such as HDAC inhibitors have been reported to have the potential to counteract some of the mechanisms of resistance to CPI treatment. In this trial, Xynomic has already completed the dose escalation portion without any dose-limiting toxicity findings. Xynomic plans to enroll a total of approximately 42 patients in the U.S in this Phase 1b trial and expects to complete this trial by the second quarter of the fiscal year 2020.

We believe the need for cancer treatment will continue to grow, driven by the increasing awareness towards cancer prevention, early screening and diagnosis. According to a report published by Allied Market Research, the global market for cancer therapeutics was valued at $81.2 billion in 2016 and is projected to reach $178.9 billion by 2023, at a CAGR of 11.9% from 2016-2023. Specifically, the global market size for diverse types of solid tumors treated by Keytruda is expected to reach $8.0 billion by 2023.

Furthermore, Xynomic expects to present more detailed data at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, to be held from April 24th, 2020 to April 29th, 2020, in San Diego, California.

On July 26, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended June 30, 2019 (Press release, Zimmer Holdings, JUL 26, 2019, View Source [SID1234537794]). The Company reported second quarter net sales of $1.989 billion, a decrease of 0.9% from the prior year period, and an increase of 1.2% on a constant currency basis. Diluted earnings per share for the second quarter were $0.65, a decrease of 28% from the prior year period. Second quarter adjusted diluted earnings per share were $1.93, an increase of 0.5% over the prior year period. Net earnings for the second quarter were $134 million and $398 million on an adjusted basis.

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"My level of confidence in our turnaround increases with every quarter," said Bryan Hanson, President and CEO of Zimmer Biomet. "Our team is focused, engaged and has positioned the company for offense in the second half of 2019. I’m truly excited by the momentum we are seeing and we have updated our guidance to reflect the progress we made in the first half of the year."

Geographic and Product Category Sales

The following sales tables provide results by geography and product category for the three and six month periods ended June 30, 2019, as well as the percentage change compared to the prior year periods, on both a reported basis and a constant currency basis.

Cash Flow and Balance Sheet

Operating cash flow for the second quarter was $301 million and free cash flow was $161 million. The Company paid down $115 million of debt, paid $49 million in dividends in the quarter and declared a second quarter dividend of $0.24 per share.

Guidance

The Company had previously stated that it expected to achieve constant currency revenue in line with its weighted average market growth rate starting in 2020. Given the progress made in the turnaround, the Company now believes it will achieve this goal beginning in the third quarter of 2019, six months earlier than previously expected. The Company provided updated 2019 financial guidance for the following metrics. All other previous guidance items remain unchanged:

Projected Year Ending December 31, 2019

2019 sales growth vs prior year is provided on an as reported basis and includes 125 to 175 basis points of negative foreign exchange impact (vs. 100 to 150 basis points previously).

These measures are non-GAAP financial measures for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts. See "Forward-Looking Non-GAAP Financial Measures."

Conference Call

The Company will conduct its second quarter 2019 investor conference call today, July 26, 2019, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.