Fusion Pharma Announces First Patient Dosing in a Phase 1 Clinical Trial of [225Ac]-FPI-1434 Injection in Patients with Advanced Solid Tumors

BOSTON & HAMILTON, Ontario–(BUSINESS WIRE)–Fusion Pharmaceuticals, a biopharmaceutical company focused on
radiotherapeutics (specifically, targeted alpha therapeutics), today
announced that the first patient was dosed in a Phase 1, first-in-human
clinical trial of lead product candidate [225Ac]-FPI-1434 in
patients with advanced solid tumors.

“The entire Fusion team takes tremendous pride in having developed a new
targeted alpha therapeutic and in moving it from the discovery phase to
a clinical trial,” said John Valliant, Ph.D., Founder and Chief
Executive Officer of Fusion Pharmaceuticals. “We are excited to start
clinical development of a new generation of radiopharmaceuticals
utilizing our Fast-ClearTM Linker to address
the need for better cancer treatments.”

The Phase 1 clinical study (FPX-01-01) is a dose-escalation study that
will characterize the safety and tolerability of a single dose [225Ac]-FPI-1434
Injection in patients with advanced solid tumors. [225Ac]-FPI-1434
is a targeted alpha radioimmunoconjugate that consists of a humanized
monoclonal antibody targeting the insulin-like growth factor-1 receptor
1 (IGF-1R), Fusion’s Fast-ClearTM Linker, a
bifunctional chelate, and actinium-225. Patients will be screened for
target expression with the imaging agent [111In]-FPI-1547. [111In]-FPI-1547
contains the same targeting antibody, Linker, and bifunctional chelate
as the [225Ac]-FPI-1434 therapeutic form, however it will
contain indium-111 in place of actinium-225. Only those patients who
have IGF-1R expression will be receiving the [225Ac]-FPI-1434
therapeutic radioimmunoconjugate. Investigators will evaluate the safety
and tolerability of a targeted alpha-emitting radiotherapeutic. Up to 30
patients will be treated and followed for safety and for signs of
efficacy. For more information about this study, visit: https://clinicaltrials.gov/ct2/show/NCT03746431

About Fusion’s Fast-ClearTM
Technology Platform and FPI-1434

Fusion uses its proprietary Fast-ClearTM
Technology Platform to convert molecules into radiopharmaceuticals. Fast-ClearTM
linkers promote increased clearance of radoisotopes – the linkers are
engineered to improve the safety of radiopharmaceuticals without
impacting efficacy. The predecessor [225Ac]-FPI-1434 antibody
(AVE1642) is a humanized antibody against IGF-1R (insulin-like growth
factor receptor) that had previously been in Phase I and II clinical
trials. Fusion has an exclusive license to AVE1642 from ImmunoGen, Inc.
Fusion applied its Fast-ClearTM linker to
convert AVE1642 into a potent radiopharmaceutical, [225Ac]-FPI-1434.

About Fusion Pharmaceuticals, Inc.

Fusion Pharmaceuticals is a biopharmaceutical company located in
Hamilton, Ontario, Canada and Boston, MA, focused on becoming the leader
in the targeted alpha therapy field. Fusion will exploit its unique
expertise in linking medical isotopes to targeting molecules to create
highly effective therapeutics. In addition to its lead program, [225Ac]-FPI-1434,
Fusion is expanding its pipeline of products through a proprietary
protein discovery platform, in-licensing targeting molecules, and
forming new strategic partnerships. For more information, please visit www.fusionpharma.com
or contact info@fusionpharma.com.


Fusion Pharmaceuticals
Lynn Wick

KKH Advisors
Kimberly Ha

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