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Northern Biologics Reports Initial Phase I Data for MSC-1 at AACR

March 29, 2019 Off By BusinessWire

TORONTO–(BUSINESS WIRE)–Northern Biologics Inc., a company focused on developing first-in-class
immuno-oncology products, today announced the presentation of initial
results from the Phase I trial of their lead antibody, MSC-1, at the
American Association for Cancer Research meeting in Atlanta, Georgia.

Session Title: Phase I Clinical Trials: Part 1
Session Date and
Time: Sunday Mar 31, 2019 1:00 PM – 5:00 PM
Session Location:
Georgia World Congress Center, Exhibit Hall B, Poster Section 16 Poster
Board Number: 9

MSC-1 is a humanized antibody against a soluble cytokine called LIF (see
“About LIF” below). LIF plays a multi-faceted role in cancer, and as a
result of inhibiting the target opens-up two therapeutic avenues:
reversal of tumor immunosuppression and modulation of cancer initiating
cells (CICs) to promote tumor cell differentiation and sensitivity to
chemotherapy.

The open-label, dose-escalation, dose-expansion Phase I trial in the
U.S., Europe and Canada is testing MSC-1 as monotherapy in patients with
relapsed or refractory advanced solid tumors. The primary objectives of
the dose escalation part of the study are to evaluate the safety and
tolerability of MSC-1 and determine the recommended dose for MSC-1
monotherapy in dose expansion. Secondary and exploratory objectives
include assessing progression-free survival and characterizing the
pharmacodynamic effects of MSC-1 in peripheral blood through
stabilization of LIF levels and in tumor biopsies as measured by
changes in the tumor microenvironment and cell signaling.

The dose escalation portion of the study completed enrollment in early
March, with 41 patients enrolled in 9 months, in dose cohorts ranging
from 75 mg to 1,500 mg. This includes expanded escalation cohorts being
evaluated for additional safety, PK/PD and biomarker analyses, including
studying the tumor microenvironment in matched pre- and post-treatment
tumor biopsies. There have been no dose-limiting toxicities or
tolerability issues observed at any dose.

Six patients have been treated for 16 weeks or longer. Moreover, some
patients displayed decreases in tumor biomarkers CA19-9 and CA125. MSC-1
has shown a favorable PK profile, typical of an antibody, and evidence
of durable peripheral LIF stabilization.

“We are pleased with the preliminary safety profile of MSC-1 in this
trial that has enrolled patients at a very rapid pace,” said Joan
Seoane, Ph.D., ICREA Professor and Director of Translational Research at
Vall d’Hebron University Hospital’s Institute of Oncology (VHIO). “We
are excited to report on the effect of this first-in-class molecule on
multiple measures in hopes of bringing benefit to patients with advanced
cancers.”

“These clinical results, coupled with exciting preclinical data,
increase our conviction that targeting LIF can bring therapeutic benefit
to defined populations of cancer patients,” said Philip Vickers, Ph.D.,
CEO of Northern Biologics. “We now have a deep understanding of the
biology underlying our first-in-class antibody.”

About LIF

LIF, or leukemia inhibitory factor, is an exciting emerging target in
the immuno-oncology space. Northern Co-Founder Joan Seoane first
elucidated a role for the cytokine in cancer in a seminal 2009
publication in Cancer Cell. Since that time, several independent labs
have demonstrated the role of LIF in many cancers. LIF is hypothesized
to contribute to tumor growth and progression by acting on multiple
aspects of cancer biology, including immunosuppression within the tumor
microenvironment (TME), and regulation of cancer initiating cells
(CICs), which are thought to underpin tumor growth, metastasis and
resistance to therapy.

About Northern Biologics

Northern Biologics was launched in June 2014 from Blueline Bioscience, a
Canadian biotechnology incubator operated by venture capital firm
Versant Ventures, in partnership with the University of Toronto and
University Health Network’s Princess Margaret Cancer Centre.
Headquartered in the MaRS Discovery District of Toronto, the company is
developing a portfolio of antibody-based therapeutics based on relevant
targets in the tumor microenvironment. Learn more at northernbiologics.com.