Precision oncology company Race Oncology (ASX: RAC) is seeking to raise capital to enable the execution of its expanded business strategy and to advance the clinical program for its anti-cancer drug Zantrene following a recent breakthrough discovery.

The company has opened a stock purchase plan to raise up to $ 29.7 million to fund a number of Phase 2 clinical trials, as well as to make improvements to Zantrene formulations and undertake further development. other research and development.

Zantrene® (bisantrene dihydrochloride) is a small molecule anticancer drug that has been shown to be a highly targeted, precision oncologic agent at low doses and a chemotherapeutic agent at high doses.

It has been identified as a very potent inhibitor of the Fatso / Fat Mass and Obesity Associated (FTO) protein, overexpression of which has been shown to be the genetic driver of a wide range of cancers.

Race Oncology is exploring the use of Zantrene as a novel therapy for melanoma (skin cancer) and renal clear cell carcinoma (kidney cancer), both of which are common cancers overexpressing OTF.

It also has compelling clinical data for Zantrene as a chemotherapeutic agent and is currently in a Phase 2 clinical trial in acute myeloid leukemia (AML). This follows a small phase 2 proof-of-concept trial in AML in 2020 that provided a clinical response rate of 40% in a group of difficult-to-treat patients.

Revolutionary discovery of heart protection

Last month, the company announced a breakthrough in its preclinical research, finding that Zantrene protects against anthracycline-induced heart damage, while working in tandem with anthracyclines (chemotherapy drugs) to improve their ability to target breast cancer. .

Race Oncology intends to further assess this important discovery, by accelerating the planning of a Phase 2b trial for 2022 in breast cancer patients at high risk for heart damage caused by anthracyclines.

Newcastle University associate professor Aaron Sverdlov said the concept of potential cancer therapies, both non-cardiotoxic and cardioprotective, had not been evaluated or even considered before, largely in because of disease-specific approaches in health care.

“Our results suggest that Zantrene, an effective anticancer drug, may simultaneously provide protection against the toxic effects on the heart of one of the most commonly used chemotherapy agents, doxorubicin.”

“This is the first such evidence to show that there is a therapy that both targets cancer and protects the heart.”

“It has the potential to improve health outcomes for countless cancer patients and survivors by improving their cancer treatment while preventing the development of cardiovascular disease,” added Professor Sverdlov.

Race Oncology Scientific Director Dr Daniel Tillett described this groundbreaking development as a “best of both worlds” result.

“Given that anthracyclines are used in millions of cancer patients each year, it is difficult to overstate the clinical and commercial potential of this breakthrough,” he said.

Stock purchase plan fund

The stock purchase plan opened on November 23, offering eligible existing shareholders the option to purchase up to $ 30,000 in fully paid shares at $ 3 each. This represents a 17.4% discount from the volume weighted average price over the previous five trading days.

The use of funds will depend on the amount raised, but in order of priority, Race Oncology said $ 8 million will fund a Phase 1/2 FTO clinical trial in solid tumors, with an additional $ 2.2 million dedicated to improved formulations of Zantrene, $ 1 million for preclinical cardioprotection studies and $ 800,000 for the development of new molecules.

In an interim scenario, the budget to improve Zantrene formulations would increase to $ 2.6 million, while an additional $ 7.5 million would cover a Phase 2b clinical trial of cardioprotection in patients with breast cancer.

If the full $ 29.7 million is raised, a Phase 2 clinical trial in extramedullary acute myeloid leukemia / myelodysplasia (AML / MDS) (EMD) could also be funded to the tune of $ 9.2 million and $ 600. An additional $ 000 would be spent on Zantrene formulation improvements for a total of $ 3.2 million.

The share purchase plan will close on December 17 with the results and the issue of new shares expected on December 21. The offer is not subscribed.

The commercial strategy of the “three pillars” of Race

Race Oncology pursues a “three pillar” strategy for the clinical development of Zantrene.

The first pillar concerns the maximization of the current formulation of Zantrene, including inhibition of FTO, cardioprotection and the routes of marketing of AML.

The second pillar is to enhance Zantrene with new formulations and intellectual property for solid tumors targeting FTO. The third pillar is focused on new molecular development and could potentially involve partnerships and / or acquisitions.

Commercial opportunity for Zantrene as a cardio-protective drug

Race Oncology CEO and CEO Phil Lynch said in a video presentation that the development of Zantrene as a cardioprotective agent offers “a potential opportunity for millions of cancer patients every year” because it could be used in most patients using anthracyclines.

“Commercially, we could sell Zantrene independently and it can be used as a supplement to anthracyclines, we could potentially have co-formulated products and solutions, we can license or partner up. There is a huge range of opportunities that will be explored later, ”he said.

Dr Tillett said this breakthrough is especially important for cancer patients because it means they can receive optimal chemotherapy treatment without the risk of long-term cardiac effects.

“At this time, many cancer patients may receive suboptimal treatment because oncologists are so concerned about the risk of permanent damage to the heart that they will give the patient lower or lower doses of chemotherapy,” did he declare.

“This discovery also potentially eliminates the major risk that accompanies [anthracycline] treatment, which is damage to the heart and which can be unpredictable – even some patients receiving low doses of the drug can have long term consequences and doctors do not know until they are treated whether this will happen or not ”, Dr Tillett added.