PRESS RELEASE

Tarveda Therapeutics Provides Year-End Update

-- Data expected from the PEN-221 Phase 2a trial and

PEN-866 Phase 1 dose escalation and safety trial in 2019 --

WATERTOWN, MA — January 4, 2019 — Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins®) for the treatment of patients with a wide range of solid tumors, today summarized its 2018 achievements and outlined expectations for 2019. The Company continues to advance its two clinical programs including PEN-221, which is currently in clinical evaluation for the treatment of patients with somatostatin receptor 2 (SSTR2) expressing neuroendocrine tumors (NETs) and PEN-866, the first miniature drug conjugate from Tarveda’s HSP90 binding conjugate platform, which is being developed for the treatment of patients with solid tumors including but not limited to small cell lung cancer, pancreatic cancer and sarcomas.

“In 2018, we made significant progress in both of our clinical stage programs, our discovery of additional preclinical programs from our HSP90 binding conjugate platform and in building our corporate, clinical and regulatory teams,” said Drew Fromkin, President and Chief Executive Officer of Tarveda. “In the first half of the year, we initiated enrollment in the Phase 2a portion of a Phase 1/2a clinical trial assessing PEN-221 and the Phase 1 portion of a Phase 1/2a clinical trial evaluating PEN-866.” 

Key 2018 Accomplishments 

PEN-221 (Phase 1/2a Trial of PEN-221; NCT02936323)

- Determined the maximum tolerated dose and the recommended Phase 2a dose.

- Presented Phase 1 safety and efficacy data in patients with SSTR2 expressing tumors including NETs at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting.

- Initiated the Phase 2a portion of a Phase 1/2a trial for PEN-221 in patients with SSTR2 expressing NETs.

PEN-866 (Phase 1/2a Trial of PEN-866; NCT03221400)

- Initiated Phase 1 dose escalation and safety portion evaluating PEN-866 in patients with advanced solid tumors.

- Presented data demonstrating the synergy of PEN-866 in combination with Poly ADP ribose polymerase (PARP) inhibitors in preclinical models of human cancer at the 2018 American Association for Cancer Research (AACR) Annual Meeting.

HSP90 Binding Conjugate Platform

Presented preclinical data at the European CanCer Organisation (ECCO) EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium leveraging the HSP90 binding conjugate platform to selectively accumulate and release anti-cancer payloads such as phosphoinositide 3-kinase (PI3K) inhibitors.

Key Appointments

- Appointed Brian Roberts as Chief Financial Officer. Brian brings nearly 25 years of finance, capital markets and operations experience spanning the life sciences, medtech and healthcare media industries with a proven track record of delivering positive results, financing companies and driving shareholder value.

- Appointed Jeffrey D. Bloss, M.D. as Chief Medical Officer. Dr. Bloss brings deep expertise and over two decades of experience leading the clinical development and medical affairs of oncology programs at both biotech and pharmaceutical companies.

- Further strengthened the leadership team with the appointments of Steven Hamburger, Ph.D. as Vice President, Regulatory Affairs and Laura Mei as Vice President, Clinical Operations.

“In 2019, we expect our programs to reach data maturation in Phase 2a for PEN-221 and Phase 1 for PEN-866 and will continue to advance our preclinical programs based on our HSP90 binding conjugate platform,” continued Mr. Fromkin. “We believe that our current clinical programs and preclinical discovery of new miniature drug conjugates will support strong value creation and be increasingly attractive to future collaborators.” 

Tarveda Therapeutics will provide corporate updates throughout the year at industry events.  Mr. Fromkin will provide the first of these updates at 2:30pm Pacific Time on Monday, January 7 at the 2019 Biotech Showcase.

About Tarveda Therapeutics, Inc.
Tarveda Therapeutics, Inc. is discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins®) for the treatment of patients with a wide range of solid tumors. Tarveda’s first drug candidate, PEN-221, is a miniature drug conjugate in clinical evaluation for the treatment of patients with somatostatin receptor 2 (SSTR2) expressing neuroendocrine tumors. PEN-221 comprises a peptide that is highly selective for SSTR2 conjugated to the potent cytotoxic payload, DM1, through a tuned cleavable linker. Tarveda is also advancing its HSP90 binding drug conjugate platform with lead drug candidate PEN-866, which selectively binds in tumors to the activated form of Heat Shock Protein 90 (HSP90) and releases its SN-38 payload, a potent topoisomerase 1 inhibitor. Tarveda’s strategy includes developing its own proprietary miniature drug conjugates as well as applying its miniature drug conjugate platform to enhance the effectiveness of the targeting moieties and novel payloads of pharmaceutical collaborators. http://www.tarvedatx.com/

Contact:
Amanda Houlihan
MacDougall Biomedical Communications 
781 235 3060 
ahoulihan@macbiocom.com