Shares of Fusion Pharmaceuticals Inc. (FUSN) have more than halved from their 52-week high of $18.50, recorded last June, to trade around $8.
The company made its debut on the Nasdaq Global Market on June 26, 2020, offering its shares at a price of $17 each.
Fusion Pharma is a clinical-stage oncology company developing next-generation radiopharmaceuticals as precision medicines based on its Fast-Clear linker technology.
What is Precision Medicine?
Precision medicine is a concept of disease prevention and treatment that is based on a person’s unique genetic composition and environmental factors.
The company’s lead drug candidate is FPI-1434, a targeted alpha radioimmunoconjugate that consists of a humanized monoclonal antibody. This compound works by targeting the insulin-like growth factor-1 receptor 1 (IGF-1R), an oncogenic protein that is over-expressed in multiple solid tumors.
A phase I trial of FPI-1434 monotherapy in patients with solid tumors is ongoing. This study consists of a dose escalation portion, including both single and multi-dosing cohorts, of approximately five cohorts and a cold antibody sub-study portion of up to three cohorts.
Earlier this month, the company announced preliminary safety and dosimetry results from the single-dose portion of the phase I trial of FPI-1434.
The preliminary results revealed that FPI-1434, administered at three different dose levels, has a favorable safety profile with no drug-related serious adverse events or dose-limiting toxicity. The imaging showed drug uptake across multiple tumor types.
Enrollment in multi-dosing cohorts of the phase I monotherapy study of FPI-1434 is ongoing. Data from the study is expected in the first half of 2022.
The company also has plans to explore the potential of FPI-1434 in combination with Merck’s Keytruda. A phase I/II combination trial is planned, which will be sponsored by Merck. This trial is expected to be initiated about six to nine months after achieving the recommended phase II dose in the ongoing phase I study of FPI-1434 monotherapy.
The other products in the pipeline are:
— FPI-1966, which targets Fibroblast Growth Factor Receptor 3 (FGFR3), a protein that is overexpressed in head and neck and bladder cancers. The company has completed pre-clinical studies with FPI-1966, with submission of its investigational new drug (IND) application due this month.
— FPI-2059, a small molecule recently acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1), a validated cancer biomarker. The company is planning to submit an IND for FPI-2059 in the first half of 2022.
Fusion Pharmaceuticals has a collaboration with AstraZeneca (AZN) that was inked in November 2020 to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer.
In May 2021, Fusion Pharma signed a clinical trial collaboration with a subsidiary of Merck (MRK) to evaluate lead candidate FPI-1434 in combination with Merck’s blockbuster cancer drug KEYTRUDA in patients with solid tumors expressing insulin-like growth factor 1 receptor (IGF-1R).
The company ended March 31, 2021, with $278.2 million in cash, cash equivalents and investments. The cash on hand is expected to be sufficient to fund operations through year-end 2023.
FUSN has traded in a range of $6.61 to $18.10 in the last 1 year. The stock closed Monday’s (Jun.28, 2021) trading at $8.11, up 0.62%.
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