PanTher Therapeutics, Inc.

AUSTIN, Texas--( BUSINESS WIRE )-- PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for the company’s lead program, PTM-101, to proceed in a phase 1b clinical study in patients with pancreatic ductal adenocarcinoma (PDAC). This phase 1b dose escalation / dose expansion study will be conducted across multiple sites and will enroll patients who have treatment naïve, borderline resectable and locally advanced PDAC, offering the potential to improve therapeutic response for those with limited treatment options. “Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses,” said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. “This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC. PTM-101 was developed using PanTher’s Sagittari™ drug development platform, which creates products that provide continuous delivery of high drug concentrations exclusively at the tumor site for an extended period of time. This novel approach, which maximizes killing of tumor cells, has not previously been possible with other technologies.” Earlier this year, PanTher presented positive first-in-human data in small phase 1 study of three pancreatic cancer patients treated with PTM-101. Two of the three patients who received the lowest dose of PTM-101 followed by standard of care chemotherapy had a >40% reduction in overall tumor volume. PTM-101 was shown to have a favorable safety profile, as it was well-tolerated with no peritonitis, pancreatitis, infection, or hematological toxicity. The chemotherapeutic agent remained localized in the pancreas in all patients, with no detection of systemic paclitaxel at any timepoint. About PanTher Therapeutics PanTher Therapeutics is a clinical-stage oncology company offering transformational localized treatment of cancer. This is accomplished through its proprietary Sagittari™ platform which enables the creation of products that can provide continuous, high-dose treatment of potent oncology agents exclusively at the site of a tumor. This revolutionary technology allows therapeutic agents to be formulated in a wide range of polymer-based dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is designed to continuously deliver drug for weeks or months at a desired dose level, without unwanted dose-limiting side effects. PanTher’s lead clinical candidate, PTM-101, has successfully been evaluated in a Phase 1 clinical trial in treatment naïve, localized non-metastatic pancreatic cancer patients. PanTher is exploring opportunities to utilize its Sagittari™ platform technology in additional solid tumor indications. For more information, visit www.panthertx.com . About PTM-101 PanTher’s lead clinical product, PTM-101, is a proprietary flexible absorbable film that enables continuous, high-dose administration of paclitaxel directly to the peritumoral area, maximizing anti-tumor potency and limiting side effects typically seen with systemic administration of paclitaxel. PTM-101 was designed to easily integrate with well-established laparoscopic procedures that can be used for peritumoral placement. PTM-101 is being evaluated for the treatment of localized non-metastatic pancreatic cancer, where the company recently completed a successful phase 1 study. PanTher is now preparing to initiate a Phase 1b trial of PTM-101, to further assess safety, tolerability, and anti-tumor activity across two different dose levels.

PTM-101 was shown to be well-tolerated by patients with no serious adverse events (SAEs) reported and was easily administered using a well-established laparoscopic procedure Two of the three patients who received PTM-101 followed by standard of care chemotherapy had a >40% reduction in overall tumor volume AUSTIN, Texas--(BUSINESS WIRE)-- PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company developing high-dose, long lasting, localized treatments for cancer, today presented positive data from a first-in-human study of PTM-101, a highly potent chemotherapeutic agent (paclitaxel) combined with an absorbable polymer formulated as a flexible film, at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 5-10th in San Diego. This first-in-human study enrolled three patients at a single center in Australia to assess the safety and surgical feasibility of a single, low-dose treatment of PTM-101. PTM-101 was placed directly onto the pancreas, overlying the location of the tumor using standard laparoscopic equipment as part of a disease staging assessment. Once in place over the tumor site, PTM-101 locally delivered a sustained dose of the chemotherapeutic agent over four weeks. Approximately three weeks after placement of PTM-101, all participants began standard of care therapy, which included treatment with mFOLFIRINOX. Results of the clinical trial demonstrated that PTM-101 reduced the size of pancreatic tumors in all three patients. During the 24 weeks of the prospective phase of the study, the reduction in tumor thickness beneath PTM-101 ranged from 16% to 26%. Two patients had a significant reduction in overall tumor volume (40% and 70%). PTM-101 was also shown to have a favorable safety profile, as it was well-tolerated with no peritonitis, pancreatitis, infection, or hematological toxicity. The chemotherapeutic agent remained localized to the pancreas in all patients, with no detection of systemic paclitaxel at any timepoint. “Historically, there have been significant clinical challenges realizing the benefits of chemotherapeutics when they are administered systemically. Maintaining a high drug concentration is limited by the route of administration as well as toxicity, which negatively impacts the effectiveness of the drug,” said Laura Indolfi, PhD, Chief Executive Officer, and co-founder of PanTher Therapeutics. “We are encouraged by the early clinical data of PTM-101 in patients with locally advanced pancreatic cancer, further validating the potential of our Sagittari™ platform to deliver high-concentrations of drug directly to the site of a tumor for an extended period of time, without commonly observed undesired side effects.” “Use of PTM-101 to locally administer a highly potent drug, without the limitations from systemic safety and tolerability issues, offers the potential to facilitate significant improvement in patient outcomes, which is clearly needed in the treatment of pancreatic cancer,” said Charles Pilgrim, MD, PhD, Associate Professor of Surgery at the Alfred Central Clinical School at Monash University, and principal investigator of the PTM-101 phase 1 clinical trial. “The ability of PTM-101, in combination with standard of care chemotherapy, to shrink pancreatic tumors as observed in this initial study is promising. The prognosis for patients with pancreatic cancer can be particularly devastating, as it is often detected at an advanced stage, at which point there are limited treatment options. Given the trajectory for this cancer, I am very encouraged by the results from the clinical trial of PTM-101 in locally advanced cases and the ease of integrating the treatment into current clinical practice and standard laparoscopic procedures.” PanTher presented a second poster at AACR describing the non-clinical development of PTM-101. Both posters are available on the PanTher Therapeutics website. About PanTher Therapeutics PanTher Therapeutics is a clinical-stage oncology company offering transformational localized treatment of cancer. This is accomplished through its proprietary Sagittari™ platform which enables continuous, high-dose treatment of potent oncology agents exclusively at the site of a tumor. The Sagittari treatment platform is a revolutionary solution for local administration of therapeutic agents. This foundational technology was invented at the Massachusetts Institute of Technology by PanTher’s founder and CEO. Sagittari is a polymer-based system that allows therapeutic agents to be formulated in a wide range of dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is designed to continuously deliver drug for weeks or months at a desired dose level, without unwanted dose-limiting side effects. PanTher’s lead clinical candidate, PTM-101, has successfully been evaluated in a Phase 1 clinical trial in treatment naïve, localized non-metastatic pancreatic cancer patients. PanTher is exploring opportunities to utilize its platform technology in additional solid tumor indications. For more information, visit . About PTM-101 PanTher’s lead clinical candidate, PTM-101, is a proprietary flexible absorbable film that enables sustained, high-dose administration of paclitaxel directly to the peritumoral area, maximizing anti-tumor potency and reducing the side effects typically seen with systemic administration of paclitaxel. PTM-101 was designed to easily integrate with well-established laparoscopic procedures that can be used for peritumoral placement. PTM-101 is being evaluated for the treatment of localized non-metastatic pancreatic cancer, where the company recently completed a successful phase 1 study. PanTher is now preparing to initiate a Phase 1b trial of PTM-101, to further assess safety, tolerability, and anti-tumor activity across two different dose levels.

AUSTIN, Texas--(BUSINESS WIRE)-- PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage oncology company developing high-dose, long lasting, localized treatments for cancer, announced that John Edwards has been appointed as the Executive Chair of the Board of Directors. “John has been an outstanding addition to our Board and management team since joining the company in September. We look forward to further benefiting from his experience as we continue to advance our lead program, PTM-101, into later stage clinical trials,” said Laura Indolfi, PhD, Chief Executive Officer and co-founder of PanTher. “John has successfully guided many biotech companies through key stages in their evolution and he is a tremendous resource for our organization.” John brings over 35 years of experience in discovery, development, and global commercialization of biopharmaceuticals to PanTher. His experience includes involvement with ten FDA approved biologics and eight biotech companies with successful exits, including Tilos Therapeutics, Siamab, Adnexus, F-star and Genetics Institute. Most recently, John held the role of Executive Chair and CEO at Abcuro, where he transformed the small preclinical-stage company into a well-funded organization with a highly experienced C-suite, and advanced its lead program into a phase III clinical trial. During his time as Executive Chair at Tilos, he helped the company from founding to acquisition by Merck in just two years. While at F-star, John helped grow the company from discovery-stage into to a leading clinical-stage developer of bispecific antibodies, raising over $230M in non-dilutive capital, including several asset-based M&A transactions. Under his guidance as COO, Adnexus evolved from a start-up to a $450M acquisition by BMS within 4 years; he then continued as President of the company for three years. Early in his career, John was Vice President of Sales, Marketing, and Medical Affairs at Transkaryotic Therapies and had a 15-year tenure with Genetics Institute/Wyeth, during which time he built what has become a >$1B global pharmaceutical business in hematology. He received his MBA from Boston University and his BS in chemical engineering from the University of Massachusetts at Amherst. “I am very impressed with PanTher’s lead program and therapeutic platform, which I feel has the potential to be transformative for the treatment of locally advanced, solid tumors,” said John. “PanTher’s approach combines established cancer treatments, whose dosing is limited by toxicity, with their technology that enables continuous, high-dose, delivery to the tumor. In doing so, drug levels at the site of a tumor are >100 fold higher than what is currently possible, leading to more effective treatments without unwanted dose-limiting systemic side effects. This unlocks the full potential of potent therapeutic agents to more effectively treat cancer. I am excited to work with Laura, the management team, and Board to help guide the company’s future direction as it prepares to enter phase 1b clinical trials with its lead program.” About PanTher Therapeutics PanTher Therapeutics is a clinical-stage oncology company offering transformational localized treatment of cancer. This is accomplished through its proprietary Sagittari™ platform which enables continuous, high-dose treatment of potent oncology agents exclusively at the site of a tumor. The Sagittari™ treatment platform is a revolutionary solution for local administration of therapeutic agents. This foundational technology was invented at the Massachusetts Institute of Technology by PanTher’s founder and CEO. Sagittari is a polymer-based system that allows therapeutic agents to be formulated in a wide range of dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is designed to continuously deliver drug for weeks or months at a desired dose level, without unwanted dose-limiting side effects. PanTher’s lead clinical candidate, PTM-101, has successfully been evaluated in a Phase 1 clinical trial in treatment naïve localized non-metastatic pancreatic cancer patients. PanTher is exploring opportunities to utilize its platform technology in additional solid tumor indications. For more information, visit . About PTM-101 PanTher’s lead clinical candidate, PTM-101, is a proprietary flexible absorbable film that enables sustained, high-dose administration of paclitaxel directly to the peritumoral area, maximizing anti-tumor potency and avoiding the severe side effects typically seen with systemic administration of paclitaxel. PTM-101 was designed to easily integrate with well-established laparoscopic procedures that can be used for peritumoral placement. PTM-101 is being evaluated for the treatment of localized non-metastatic pancreatic cancer, where the company recently completed a successful phase 1 study. PanTher is now preparing to initiate a Phase 1b trial of PTM-101, to further assess safety, tolerability, and anti-tumor activity across two different dose levels. View source version on businesswire.com: Contacts Media: Christine Quern 617-650-8497 cq@christinequern.com Source: PanTher Therapeutics View this news release online at: