Posted: October 20, 2021 at 4:05 p.m. EDT|Update: 8 minutes ago

Single and multiple doses of IPF-1966 demonstrated therapeutic efficacy in a preclinical bladder xenograft model

[²²⁵Ac]-FPI-2059 demonstrated superior efficacy against [¹⁷⁷Lu]-IPN-1087 in a direct comparison in a mouse xenograft model of colorectal cancer

Data presented in oral presentation sessions at 34^e EANM Annual Congress

HAMILTON, Ontario and BOSTON, 20 October 2021 / PRNewswire / – Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision drugs, today announced the presentation of preclinical data who provide additional support to its FPI-1966 and FPI -2059 Alpha Targeted Therapies (TAT) at 34^e Annual Congress of the European Association of Nuclear Medicine. These data support the clinical dosage regimen of FPI-1966 and demonstrate the potential of FPI-2059 as an actinium-225-labeled precision drug targeting NTSR1.

“These data demonstrate the vast potential of our TAT platform on multiple validated targets overexpressed in a variety of solid tumors,” said CEO Jean Valliant, Ph.D. “We are delighted to share the preclinical data on efficacy and tumor uptake resulting from the administration of IPF-1966, and we are confident that these data will translate into meaningful results for patients with the disease. solid tumors overexpressing FGFR3 – a population with a high unmet medical need. We look forward to launching the Phase 1 study later this year. “

Data from preclinical studies of FPI-1966, a TAT designed to target and deliver actinium-225 to cancer cells expressing FGFR3, were presented in an oral presentation titled “FGFR3 Targeted Alpha Therapeutic [225Ac]-FPI-1966 induces regression in preclinical bladder xenograft model. “The results demonstrated that FPI-1966, when administered with vofatamab, results in high tumor delivery and low off-target uptake. , data showed the therapeutic efficacy of both single and multiple dose IPF-1966 in a preclinical model of bladder cancer xenograft.

Data from preclinical studies of FPI-2059, a TAT designed to target and deliver actinium-225 to cancer cells expressing the neurotensin 1 receptor (NTSR1), were presented in an oral presentation titled “NTSR1 Targeted Alpha Therapeutic [²²⁵Ac]-FPI-2059 induces regression in preclinical model of colorectal xenograft “. Study results include a direct comparison of the therapeutic efficacy obtained from FPI-2059, which delivers an alpha emitting isotope, with [¹⁷⁷Lu]-IPN-1087, which delivers a beta emitting isotope on the same targeting molecule. The results demonstrate superior efficiency with [²²⁵Ac]-FPI-2059 in a mouse colorectal cancer xenograft model.

Dr Valliant continued, “Our science is based on the belief that alpha emitting isotopes can offer significant therapeutic advantages over other commonly used radioisotopes. The preclinical results of our product candidate FPI-2059 provide further validation of this belief and support the diversification of our product portfolio will include several types of targeting vehicles, including small molecules. We are excited to advance further preclinical studies of FPI-2059 as we approach a new investigational drug (IND) dossier in the first half of 2022. “

About FPI-1966
[²²⁵Ac]-FPI-1966 is an alpha-targeted therapy designed to target and deliver an alpha-emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor overexpressed on several types of tumors, including head and neck and bladder cancers. FPI-1966 uses Fusion’s Fast-Clear ™ linker to connect vofatamab, the human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a phase 1b/ 2 and would have been well tolerated. FPI-1966 Moves to Phase 1 Study Following Recent Investigational New Drug (IND) Authorization

About FPI-2059
FPI-2059 is an alpha targeted therapy combining actinium-225 with IPN-1087, for development as an alpha targeted therapy for various solid tumors. The target molecule NTSR1, a promising target for the treatment of cancer, which is overexpressed in multiple solid tumors. IPN-1087 was in phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1. Fusion plans to submit an IND for FPI-2059 in the first half of 2022.

About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on the development of next-generation radiopharmaceuticals as precision drugs. Using proprietary Fast-Clear ™ binding technology, Fusion connects alpha-emitting isotopes to various targeting molecules to selectively deliver alpha-emitting payloads to tumors. Fusion’s flagship program, FPI-1434 targeting the insulin-like growth factor receptor 1, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), moving to a phase 1 study after the recent authorization of a new investigational drug (IND); and FPI-2059, a small molecule targeting the neurotensin 1 receptor (NTSR1). In addition to a strong proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel alpha targeted therapies (TATs) and combination programs between Fusion TATs and DNA damage repair inhibitors ( DDRis) from AstraZeneca and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Merger and Hamilton, Ontario-based McMaster University are building a good manufacturing practices (GMP) radiopharmaceutical manufacturing facility designed to support the manufacturing of the company’s growing TAT pipeline.

Forward-looking statements
This press release contains “forward-looking statements” for the purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the future business of Fusion Pharmaceuticals Inc. (the “Company”) and financial performance. To this end, all statements contained in this document that are not statements of historical fact may be considered as forward-looking statements. Without limiting the foregoing, the words “expect”, “plan”, “anticipate”, “intend to”, “will fly” and similar expressions are also intended to identify forward-looking statements, as are express or implied statements regarding the uncertainties inherent in the drug development process, including the early stages of development of FPI-1966 and FPI-2059; the ability to advance licensed targets in the clinic; the process of designing and conducting preclinical and clinical trials; regulatory approval processes; the schedule of regulatory filings; and the challenges associated with manufacturing pharmaceuticals in general and radiopharmaceuticals in particular. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from future results, performance or achievements expressed or implied by such statements. These and other risks that may affect management’s expectations are described in more detail under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30. 2021 as filed with the SEC and in any other current periodical or report that the Company files with the SEC. All forward-looking statements reflect the Company’s estimates only as of the date of this release (unless another date is indicated) and should not be taken to reflect the opinions, expectations or beliefs of the Company in any way. date later than the date of this press release. Although Fusion may choose to update these forward-looking statements at some time in the future, it specifically disclaims any obligation to do so, even if the Company’s estimates change.

View original content to download multimedia:

SOURCE Fusion Pharmaceuticals Inc.

The above press release has been provided courtesy of PRNewswire. The views, opinions and statements contained in the press release are not endorsed by Gray Media Group and do not necessarily state or reflect those of Gray Media Group, Inc.