Provectus Biopharmaceuticals Expands Patent Portfolio with Adoptive Cell Transfer-Based Use of Investigational Cancer Drug

Tuesday September 18, 2018

KNOXVILLE, TN, /GLOBE NEWSWIRE/ — Provectus (OTCQB: PVCT) today announced that the United States Patent and Trademark Office (USPTO) has allowed the Company’s patent application for the use of adoptive cell transfer (ACT) of PV-10-induced T cells for the treatment of solid tumor cancers. Co-inventors include current and former members of a longstanding, PV-10-focused, translational research team at Moffitt Cancer Center (Moffitt) in Tampa, Florida, which has undertaken work in melanoma, breast cancer, and pancreatic cancer starting in 2011¹.

PV-10 is Provectus’ lead investigational drug for the treatment of adult and pediatric solid tumor cancers, and is the first small molecule oncolytic immunotherapy. It is administered via intralesional injection directly into superficial or visceral tumors to elicit immunogenic cell death of these injected tumors. PV-10 is the subject of several ongoing clinical trials of adults in melanoma^2,3 and cancers of the liver^3,4. PV-10 has also been shown to induce cell death in pediatric solid tumor cell lines derived from relapsed neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma⁶.

Under the treatment concept of the allowed patent application, which is entitled “Method of Ex Vivo Enhancement of Immune Cell Activity for Cancer Immunotherapy with a Small Molecule Ablative Compound,” PV-10 is injected into solid tumors and the resulting immune products – T cells trained via PV-10 oncolytic immunotherapy to be functional against treated tumors – are harvested, banked, and amplified. Amplified T cells may be administered via ACT, if needed. The allowed patent application also covers the ACT treatment of either the original patient or other immunologically-suitable patients.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Hundreds of patients have received intralesional PV-10 for a variety of solid tumor types. One of several logical paths for expanding our clinical development program is to explore harnessing functional immunologic activation produced by PV-10 oncolytic immunotherapy via the use of adoptive cell transfer. Protecting Provectus’ intellectual property in this regard was an important and necessary task.”

About PV-10

Provectus’ lead investigational oncology drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company leading the development of a new class of drugs based on halogenated xanthenes, which are chemical small molecules. Information about the Company’s clinical trials can be found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company’s website at www.provectusbio.com.

References

1. Moffitt’s translational research work on PV-10 (rose bengal) to date has resulted in three peer-reviewed publications:
   • Liu et al. T cell mediated immunity after combination therapy with intralesional PV-10 and blockade of the PD-1/PD-L1 pathway in a murine melanoma model. PLoS One. 2018;13(4):e0196033.
   • Liu et al. Intralesional rose bengal in melanoma elicits tumor immunity via activation of dendritic cells by the release of high mobility group box 1. Oncotarget. 2016;7(25):37893-37905
   • Toomey et al. Intralesional injection of rose bengal induces a systemic tumor-specific immune response in murine models of melanoma and breast cancer. PLoS One. 2013; 8(7):e68561.

   Additionally, eight poster presentations about their PV-10 work have been made by the Moffitt team at annual meetings of the:

   • American Association for Cancer Research (2013, 2014, 2016),
   • American Society of Clinical Oncology (2014),
   • Society for Immunotherapy of Cancer (2014, 2015, 2016), and
   • Society of Surgical Oncology (2012).
2. NCT02288897: PV-10 vs Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma
3. NCT02557321: PV-10 in Combination With Pembrolizumab for Treatment of Metastatic Melanoma
4. NCT00986661: A Study to Assess PV-10 Chemoablation of Cancer of the Liver
5. NCT02693067: A Phase 1 Study of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver
6. Swift et al. In vitro and xenograft anti-tumor activity, target modulation and drug synergy studies of PV-10 against refractory pediatric solid tumors. Journal of Clinical Oncology 36, no. 15_suppl (2018) 10557-10557

FORWARD-LOOKING STATEMENTS: This release contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations and express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “would,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation to update such statements after this date.

Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2017).

Contact:

Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: 866-594-5999