Tarveda Therapeutics Provides Year-End Update and Outlines Milestones for 2018

WATERTOWN, Mass.--(BUSINESS WIRE)-- Tarveda Therapeutics, a clinical stage biopharmaceutical company discovering and developing Pentarins™ as a new class of potent and selective cancer medicines, today summarized its achievements in 2017 and outlined expected milestones for 2018.

“With the completion of dose escalation for our Phase 1/2a trial of PEN-221 in selected patients with somatostatin receptor 2 (SSTR2) expressing solid tumors, we have defined our recommended Phase 2 dose and are moving seamlessly into Phase 2a in early 2018,” said Drew Fromkin, President and Chief Executive Officer of Tarveda. “In Phase 1, PEN-221 was well-tolerated and demonstrated encouraging signals of biological activity in patients with a range of SSTR2 expressing tumor types. Furthermore, we are advancing PEN-866, our miniature drug conjugate that comprises an HSP90-targeting, small molecule ligand linked to SN-38, to the clinic. In addition, we are exploring the broad range of payloads that can be enabled via this unique conjugate platform. It is also important to note that our company has been granted key intellectual property rights by the U.S. Patent and Trademark Office for both PEN-221 and PEN-866 that extend well into the 2030s and beyond. In 2018, we will be focused on advancing our clinical programs to address the considerable patient needs in these solid tumor indications.”

Key 2017 Accomplishments

• Raised $30 million in equity financing to advance PEN-221 and PEN-866 to key program milestones, and new investor Versant Ventures led the round. Existing investors New Enterprise Associates, Novo A/S, NanoDimension and Flagship Pioneering also participated. With the financing, Dr. Guido Magni, Partner at Versant Ventures and former Global Head of the Medical Science Department of Roche Pharmaceuticals joined the Tarveda board.
• Expanded board expertise with the appointment of Michael Metzger. Mr. Metzger, President and Chief Operating Officer of Syndax Pharmaceuticals, Inc., has more than 20 years of experience leading value-creating corporate development, strategic and financial transactions and operating biotechnology companies.
• Established a Scientific Advisory Board consisting of internationally-recognized academic and scientific leaders. Scientific Advisors
• Presented preclinical efficacy of PEN-221 in SSTR2 expressing pre-clinical models:
  • Rapid tumor accumulation with complete and durable tumor regression on dosing of PEN-221 (American Association for Cancer Research Annual Meeting).
  • SSTR2 in prostate cancer and the potential for PEN-221 (Prostate Cancer Foundation Annual Scientific Retreat).
  • Developing potent and selective miniature conjugates for the treatment of patients with solid tumors (Precision Lung Cancer World R&D Summit).
  • Optimization of the formulation of PEN-221 (Controlled Release Society Annual Meeting & Exposition).
• Presented evidence demonstrating efficacy of PEN-866 in pre-clinical models:
  • Rapid accumulation and sustained release of the SN-38 payload leading to cancer cell death and efficacy (American Association of Pharmaceutical Scientists National Biotechnology Conference).
  • Synergistic efficacy when combining PEN-866 with a PARP inhibitor in pre-clinical experiments (World ADC, San Diego).

Expected Key 2018 Milestones

• Present interim results of PEN-221 Phase 1/2a first in human clinical trial in patients with advanced SSTR2 expressing neuroendocrine tumors and small cell lung cancer.
• Initiate Phase 2a portion of the PEN-221 Phase 1/2a trial in three cohorts of patients with SSTR2-expressing cancers: those with mid-gut neuroendocrine tumors, pancreatic neuroendocrines tumors and small cell lung cancer.
• Initiate the first-in-human trial of PEN-866, a Phase 1/2a dose escalation/expansion study evaluating safety and efficacy of PEN-866 in advanced cancer patients.

Tarveda Therapeutics will provide corporate updates throughout the year at industry events. Mr. Fromkin will provide the first of these updates at 10am PST on January 10^th at the 2018 Biotech Showcase.

About Pentarins™

Tarveda is developing Pentarins™, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets in solid tumors. Pentarins are engineered to bind to their tumor cell targets, accumulate and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell-killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into solid tumors, the ligand’s targeting ability allows for high affinity, selective binding and retention in tumor cells, the chemical linker is tuned to optimize the release and accumulation of the potent, cell-killing payload inside the cancer cells for efficacy, and the design of the unique components together to provide for the pharmacokinetics required for the critical level Pentarin concentrations in the tumor.

About Tarveda Therapeutics, Inc.

Tarveda Therapeutics, Inc. discovers and develops Pentarins™, a new class of potent and selective miniature drug conjugates with enhanced targeting capabilities and pharmacokinetics for the treatment of patients with a wide range of solid tumor cancers. Tarveda’s lead Pentarin clinical drug candidate, PEN-221, targets the somatostatin receptor 2 (SSTR2) for treatment of patients with tumors that express SSTR2 including neuroendocrine, small cell lung and other cancers that express SSTR2. PEN-221 comprises a peptide, which is highly selective for SSTR2 conjugated to the potent cytotoxic DM1 through a tuned cleavable linker. Tarveda is also advancing its HSP90 drug conjugate platform with lead drug candidate PEN-866, which is a miniature drug conjugate that selectively binds to the intracellular target, Heat Shock Protein 90 (HSP90), and is linked to the payload SN-38. Tarveda’s strategy includes developing its own proprietary Pentarins as well as applying the Pentarin platform to enhance the effectiveness of novel payloads of pharmaceutical collaborators. www.tarveda.com

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