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Melinta Therapeutics Announces Appointment of John H. Johnson as Interim Chief Executive Officer

On October 24, 2018 Melinta Therapeutics, Inc., (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported that its board of directors has appointed John H. Johnson as interim chief executive officer (CEO), effective immediately (Press release, Cempra, OCT 24, 2018, View Source [SID1234530248]). Mr. Johnson, a director of Melinta, succeeds Dan Wechsler, who is stepping down from his role as president, CEO and director to pursue other opportunities. The Board and Mr. Wechsler mutually agreed that now is the right time to transition leadership of the Company.

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"John is an accomplished biopharmaceutical industry leader with more than 20 years of direct expertise in the antibiotics space, and we are pleased that he is leading Melinta during this pivotal time. Under John’s leadership, we are confident that sales of commercial products, Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection, will continue to accelerate, and that he will focus on strengthening the financial position of Melinta by optimizing the integrations of the infectious disease business of The Medicines Company and Cempra," said Kevin Ferro, chairman of Melinta Therapeutics.

"I am pleased to serve as interim CEO of Melinta and will continue to work closely with the board of directors, executive management and the broader team to further advance the Company’s mission to provide life-saving therapeutic solutions that address the evolving global threat of bacterial infections and antibiotic resistance. This is an exciting time for Melinta and I look forward to contributing to the continued growth and future success of the Company by delivering anti-infective solutions to patients," said John H. Johnson, interim chief executive officer and director of Melinta Therapeutics.

Mr. Ferro added, "On behalf of the board of directors, we would like to thank Dan for his contributions to the Company and we wish him well in his future endeavors."

John H. Johnson has more than 30 years of biopharmaceutical industry, executive leadership and commercial experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone and Pfizer, Inc. In addition to Melinta, Mr. Johnson currently serves on the boards of Aveo Oncology, Histogenics Corporation, Portola Pharmaceuticals, Inc., and is chairman of Strongbridge Biopharma plc. Mr. Johnson previously served as a director at Cempra and Sucampo. He also previously served as president and chief executive officer of Dendreon Corporation from February 2012, became chairman in July 2013, and served as chairman until June 2014 and president and chief executive officer until August 2014. Prior to this role, Mr. Johnson served as president of Eli Lilly & Company’s Global Oncology Unit following the company’s 2008 acquisition of ImClone Systems Incorporated, where he served as chief executive officer and on ImClone’s board. Prior to ImClone, Mr. Johnson served as the company group chairman of biopharmaceuticals within Johnson & Johnson, where he was responsible for biotechnology, immunology and oncology commercial business units. Prior to that role, he held several executive

positions at Johnson & Johnson, Parkstone Medical Information Systems, Inc., Ortho-McNeil Pharmaceutical Corporation and Pfizer Inc. While at Ortho-McNeil, Mr. Johnson was responsible for the company’s anti-infectives portfolio. During his career, Mr. Johnson also served as a member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ.

Agilent Technologies to Host Webcast of Fourth-Quarter Fiscal Year 2018 Financial Results Conference Call

On October 24, 2018 Agilent Technologies Inc. (NYSE: A) reported that it will release fourth-quarter fiscal 2018 financial results after the stock market closes on November 19 (Press release, Agilent, OCT 24, 2018, http://www.agilent.com/about/newsroom/presrel/2018/24oct-gp18056.html [SID1234530244]). The company will host a live webcast of its investor conference call in listen-only mode.

Date: Monday, November 19, 2018
Time: 1:30 PM (Pacific Time)
Web access: http://www.investor.agilent.com

Listeners may log on and select "Q4 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain on the company site for 90 days.

In addition, a telephone replay of the conference call will be available at approximately November 19, 2018 at 4: 30 PM (Pacific Time) after the call and through November 26 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 6519506.

Clinical Trial Expected to Yield Promising Results for Oral Cancer Patients

On October 24, 2018 Privo Technologies reported that it was granted the green light from the FDA and several hospitals this summer to begin patient recruitment for a prospective clinical trial (NCT03502148) targeting early-stage oral cavity squamous cell carcinoma (OCSCC) (Press release, Privo Technologies, OCT 24, 2018, View Source [SID1234530215]). Privo is now actively recruiting stage I and II OCSCC patients for this study.

About PRV111:

Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.
Privo has developed a nano-engineered product called PRV111 consisting of a topical patch designed to deliver and retain high concentrations of various existing systemic agents within the primary tumor and associated nodal basins.

Dr. Manijeh Goldberg, Privo’s founder, and CEO is very encouraged by the result of Privo’s preclinical studies and expects PRV111 to provide a safer and more effective treatment option to patients suffering from oral cancer.

When placed on the tumor, PRV111 releases and retains cisplatin-loaded particles into the tumor, resulting in a dramatic reduction of tumor size, without the accompanying systemic side effects of intravenous cisplatin (i.e., nephrotoxicity and neurotoxicity). Local and regional effects of PRV111 are expected to improve tumor resectability, decrease the need for post-operative radiation and chemotherapy and improve patient survival. According to the National Cancer Institute, 76% of all newly diagnosed oral cancers are locoregional (29% local and 47% regional), and the 5-year survival is about 65%. Privo aims to improve the survival rates with its PRV111 intensive topical treatment. This organ-sparing therapy can preserve oral cavity form and function while improving locoregional disease control, which is the primary driver of disease-specific and overall survival. In patients with the regional metastatic disease, PRV111 can be combined with the standard of care chemo-radiation regimens to provide improved locoregional control while maintaining a tolerable side effect profile and improving quality of life.

When asked about Privo’s clinical trial (NCT03502148), Dr. Vlad Sandulache, surgical oncologist and the clinical study’s principal investigator stated:

"We have learned much about the genomic, epigenetic and proteomic profile of oral cavity squamous cell carcinoma (OCSCC) over the last decade. Unfortunately, this knowledge has not translated into effective novel therapies or improved survival for our patients. Cisplatin, although an old drug, remains by far the most effective systemic agent available for patients with OCSCC; however systemic toxicity limits utilization and can prevent use in patients with pre-existing renal disease. PRV111 presents a unique opportunity to revolutionize utilization of this proven agent. Not only does locoregional delivery completely eliminate systemic toxicity, but the intra-tumoral cisplatin concentrations generated by PRV111exceed those achievable through intravenous administration by over an order of magnitude. This represents a qualitative leap in potential effectiveness which could overcome traditional mechanisms of cisplatin resistance previously described in OCSCC."

Clinical Trial Info

For information regarding this trial, please visit View Source

Participating hospitals include:

Baylor Clinic, 6620 Main Street, Houston, Texas 77030
Baylor St. Luke’s Medical Center, 6720 Bertner Avenue, Houston, Texas 77030
Baylor College of Medicine, 1 Baylor Plaza, Houston, Texas 77030
Houston Methodist Hospital, 6550 Fannin Street, Suite 1701, Houston, Texas 77030
Ben Taub Hospital, 1504 Ben Taub Loop, Houston, Texas 77030
Harris Health System – Smith Clinic, 2525A Holly Hall Street, Houston, Texas 77054
Memorial Hermann-Texas Medical Center, Houston, Texas 77030
The University of Cincinnati Cancer Institute, Head and Neck Cancer Center, 234 Goodman Street, Cincinnati, Ohio 45219
West Chester Hospital, 7700 University Drive, West Chester, Ohio 45069

TP Therapeutics and Almac Diagnostic Services Enter into Agreement to Develop Next-Generation Sequencing Pan-Cancer Companion Diagnostic

On October 24, 2018 TP Therapeutics, a clinical-stage precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global precision medicine company, reported a global collaboration agreement to develop and commercialize a next-generation sequencing (NGS) companion diagnostic (CDx) for repotrectinib, TP Therapeutics’ investigational therapy rationally designed to target ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors (Press release, TP Therapeutics, OCT 24, 2018, View Source [SID1234530193]).

Under the agreement, Almac will develop the NGS diagnostic based on the ArcherDx’s Anchored Multiplex PCR (AMP) chemistry, with the intent of submitting it for regulatory approval in the United States. The companion diagnostic will initially allow Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

"Almac provides us with deep experience in the development and regulatory approval of next-generation sequencing diagnostic assays, which will enable the selection of patients who may not otherwise have access to a targeted therapy like repotrectinib," said Dr. J Jean Cui, founder, president and chief scientific officer of TP Therapeutics. "We look forward to working with Almac to co-develop repotrectinib with a next generation sequencing based companion diagnostic that detects the presence of ROS1, NTRK1-3 and ALK gene fusions."

"Molecular testing is critical to identifying patients most likely to benefit from a targeted treatment," said Paul Harkin, managing director, Almac Diagnostic Services. "We have great expertise in the development of biomarker assays across a wide range of technologies and targets, with an extensive track-record in developing and validating assays under design control and according to regulatory requirements. We are very pleased to work with TP Therapeutics on such a promising investigational therapy as repotrectinib."

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Co-development of CDx and therapeutic products is critical to the advancement of targeted therapies and precision medicine. Companion diagnostics are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual molecular characteristics of each person. Incorporating a companion diagnostic strategy into a drug development program may help generate more effective treatments with improved safety profiles for patients.

The financial terms of the agreement were not disclosed.

SignPath Pharma Reports Extremely Beneficial Blood Level Results of Its Phase 1b Clinical Trials of Liposomal Curcumin in Advanced Cancer Patients as Published in the Cancer Research Journal “Cancer Chemotherapy and Pharmacology”

On October 24, 2018 SignPath Pharma Inc. reported in the October issue of "Cancer Chemotherapy and Pharmacology"*, a leading cancer journal, the final results of a Phase 1b cancer study of proprietary Liposomal Curcumin (Press release, SignPath Pharma, OCT 24, 2018, View Source [SID1234530192]). The study showed that the Liposomal Curcumin formulation (Lipocurc) can result in blood levels up to 1000 times that achieved with oral curcumin. In addition, no major toxicity was noted at these high blood levels. Specifically no toxicity was found in kidney, lung, liver and heart organs. The study involved 31 heavily pretreated cancer patients. Significant tumor marker responses and transient clinical benefit were also observed.

Curcumin has long been of interest as an anti-inflammatory modulator and as a potential therapeutic agent for cancer, central nervous system and other diseases. Orally administered curcumin has not been able to achieve sufficient blood levels. LipoCurc addresses these limitations and has the potential to be a potent, non-toxic modality for treating these dire conditions.

Although Phase 1b studies are designed to determine safety of a drug and not to measure efficacy, two patients had obvious and important signs of tumor response. One was a 75 year old male with colon cancer, who had previously failed seven multi-drug chemotherapy combinations. On Lipocurc, his CEA, a tumor-marker which is elevated in patients with cancer, fell from above 18,000 to just above 6,000, and he showed clinical improvement. The other was a patient with prostate cancer who had previously failed radiation therapy as well as six chemotherapy combinations. His PSA level fell from 649 to 350 and he also showed clinical improvement.

On the basis of these results, SignPath is planning several phase 2 trials to test the efficacy of Lipocurc against specific cancer types. Trials are planned in patients with glioblastoma, in multiple myeloma, and in mesothelioma. Dr. Peter Sordillo, Chief Medical Officer of SignPath Pharma, states "We are very pleased with the Phase 1b results with LipoCurc and look forward to testing it in Phase 2 clinical trials. We believe LipoCurc has the potential to be a new potent, non-toxic therapeutic strategy for cancer and other diseases."

SignPath Pharma, Inc. is a clinical stage biopharmaceutical company developing two major drug platforms:

LipoCurc for cancer, neurodegenerative diseases and sepsis.
SPP 4040 for prevention of drug-induced cardiac arrhythmias, and prevention of heart damage and congestive heart failure secondary to chemotherapy.