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First-in-human Study of Precision Immune Stimulant PIN-2 Demonstrated Pharmacologic Activity and Safety in Patients with Advanced Solid Tumors

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PIN Pharma, Inc., today announced final results of a first-in-human
clinical trial of its novel immunomodulating agent PIN-2 in subjects
with advanced solid tumors.

This was an open-label, repeat-dose study with a primary objective to
assess the pharmacodynamic activity of PIN-2. Pharmacodynamic biomarkers
that signal changes in the human immune system were used to assess the
immunomodulatory potential of PIN-2. Biomarkers evaluated as part of the
primary end point were the following: tumor necrosis factor alpha
(TNF-α), interferon gamma (IFN-γ), and interleukin-12 (IL-12). The
secondary end points were the following: characterization of the safety
profile of PIN-2, its plasma pharmacokinetics, and its immunogenicity.

The study, conducted in Australia by PIN Pharma's wholly owned
Australian subsidiary, PIN Pharma Pty Ltd, included 8 patients who
received a dose of 300 µg of PIN-2 intravenously, 3 times per week for 2
weeks, followed by a 1-week rest period. A second cycle of treatment was
offered according to patient and investigator preference.

There was a rapid onset of action as evidenced by a marked increase in
circulating TNF-α 6 hours post PIN-2 injection, which returned to
baseline. A similar but more pronounced finding was observed during a
second cycle of treatment. This finding demonstrated proof-of-mechanism
for the immunomodulatory effect of PIN-2 and corroborated results
observed in human monocytes in vitro. No clear changes were observed in
the other biomarkers.

PIN-2 was generally safe and well tolerated, with grade 2
infusion-related reactions seen in 3 patients, who responded promptly to
standard therapy. The drug was rapidly cleared from plasma. Anti-drug
antibodies that did not impact the pharmacodynamic end point developed
in 2 patients.

Colin Bier, PhD, CEO, said, "We are pleased that, in patients with
advanced malignancy who failed to respond to multiple therapeutic
regimens, PIN-2 demonstrated a signal indicating induction of innate
immune activation as evidenced by the rapid rise in TNF-α, which is a
key early mediator of the immune response. This is a result we predicted
on the basis of previously reported transcriptomic studies. These study
findings clearly support additional clinical trials to assess the
clinical efficacy and safety profile of our novel immunomodulating
agent. We plan to present complete results of the trial at an oncology
congress in 2019."

About PIN-2

PIN-2 is a novel immunomodulatory peptide with a unique mechanism of
action in that it links the innate and adaptive immune systems,
resulting in an enhanced immune response. In vitro and in vivo
preclinical studies have shown that PIN-2 rapidly and preferentially
penetrates monocytes, modifies the mRNAs involved in the induction of
innate immune activation (with an attendant link to the adaptive
immune system), and promotes endogenous cytotoxic T lymphocytes
infiltration at the tumor site. PIN-2 acts upstream of other
immune-based treatment modalities.

In a validated, highly aggressive breast cancer mouse model, PIN-2 was
shown to impact tumor progression and increase survival (in combination
with cyclophosphamide), override tumor-mediated immune resistance, and
reduce distant site metastasis (in combination with a checkpoint
inhibitor.)

Given its unique, upstream immunomodulatory activity, its extensive
preclinical body of evidence, and its first-in-human study results,
PIN-2 holds the potential to be a new strategy in the fight against
cancer and cancer-mediated immunosuppression. Further clinical research
is warranted to evaluate the full potential of PIN-2 in cancer care.

About PIN Pharma, Inc.

PIN Pharma is a clinical stage, biopharmaceutical company dedicated to
the development of PINs (precision immune stimulants)—immunomodulatory
peptides that link the innate and adaptive immune systems to enhance the
body's ability to fight cancer. Although the company is currently
focusing on immune oncology, PINs have potential application in other
therapeutic areas.

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