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Galera Therapeutics buoyed by Positive Interim Data of its Lead Asset Avasopasem Manganese (GC4419)

30 Oct Galera Therapeutics buoyed by Positive Interim Data of its Lead Asset Avasopasem Manganese (GC4419)

Galera Therapeutics (NASDAQ: GRTX), a clinical–stage Biopharmaceutical Company aiming to redefine radiotherapy in cancer, announced positive interim results from a phase 1/2 trial of GC4419 or avasopasem manganese. An investigational, highly selective small molecule superoxide dismutase mimetic, GC4419 has the potential to convert superoxide to hydrogen peroxide and oxygen. The randomized, double-blind, multicenter, placebo-controlled pilot dose escalation Phase 1/2 trial, intended to evaluate the safety and efficacy of GC4419 in combination with stereotactic body radiation therapy (SBRT), in locally advanced pancreatic cancer (LAPC), when compared to a placebo.

Avasopasem manganese (GC4419) demonstrated improvement in overall survival benefit, favorable progression-free survival, locoregional control and time-to-distant metastases compared to the placebo arm.

Mel Sorensen, M.D., President and CEO of Galera stated

“We’re encouraged by the favorable overall survival benefit in this difficult-to-treat cancer observed in the interim data in this trial, which is the first trial evaluating the anti-cancer activity of one of Galera’s dismutase mimetics in combination with SBRT. Galera’s dismutase mimetics are designed to improve radiation therapy by both increasing therapeutic anti-tumor efficacy at higher doses of radiation and by protecting normal cells, and we look forward to advancing the development of this potential combination therapy and expanding into other cancers to improve outcomes for patients undergoing radiotherapy for the treatment of cancer.”

The Company intends to leverage the inputs from this trail to advance its superoxide dismutase mimetic clinical candidate, GC4711 in combination with SBRT, besides a follow-on Phase 2 trial to evaluate GC4711 in combination with SBRT in pancreatic cancer in H1, 2020. Galera is already studying the anti-cancer activity of GC4711 in combination with SBRT in a phase 1/2 trial in non-small cell lung cancer (NSCLC).

Galera Therapeutics, (NASDAQ: GRTX)

Market Cap: $217.72M; Current Share Price: 8.75Chart
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The pancreas, approximately six inches long and located behind the stomach in the abdomen, play a crucial role in regulation of blood sugar as well as digestion. They secrete enzymes such as insulin and digestive juices that assist with the exocrine and endocrine functions of the body. However, the cells in pancreas may develop mutations in their DNA, leading to their uncontrolled growth and formation of tumors. This form of cancer most commonly develops in the cells lining the ducts of the pancreas and is named pancreatic adenocarcinoma or pancreatic exocrine cancer. Less frequently it can even develop in the neuroendocrine cells of the pancreas, leading to pancreatic neuroendocrine tumors.

The American Cancer Society estimates that nearly 57,600 people will be diagnosed with pancreatic cancer in 2020, while 47,050 people will succumb to the disease. In addition, it accounts for 3 percent of cancers in the US alone and about 7 percent of all cancer deaths.

The definite cause of pancreatic cancer is still unknown, however smoking, diabetes, pancreatitis, obesity, presence of BRCA2 gene mutation, family Lynch syndrome and familial atypical mole-malignant melanoma (FAMMM) syndrome are some of the contributing factors. In most cases the symptoms do not manifest early on, until the disease advances and spreads to other organs as well. However unexplained weight loss, Jaundice, irregular bowel movements are some of the indicators.

Screening and diagnosis involves the use of Endoscopic Ultrasound, Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) and Computerized Tomography (CT) scans, besides conducting a biopsy and blood test. The current treatment options are surgery, chemotherapy, radiation and palliative care for more advanced cases.

According to a report by Grand View Research Inc, the treatment market for pancreatic market is expected to reach USD 4.2 billion in 2025. A growing geriatric population, lifestyle-related diseases and increasing awareness and availability of treatment options will drive the growth in the market.

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Galera Therapeutics is building a portfolio of innovative therapeutics that has the potential to transform radiotherapy in cancer. The Company is leveraging its knowledge of superoxide dismutase mimetics to create drugs that can enhance the anti-cancer efficacy of radiotherapy and reduce toxicity in normal tissue.

GC4419 (avasopasem), the company’s lead candidate, is a highly selective small molecule dismutase mimetic, which has received a breakthrough therapy designation from the FDA for the treatment of severe oral mucositis (SOM) induced by radiation in patients with head and neck cancer. The candidate is currently undergoing evaluation in a Phase 3 clinical trial.

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Galera is working on accelerating the conversion of superoxide to hydrogen peroxide, which forms an important part of the oxygen metabolic pathways, and drive cell functioning. The focus is on targeting this pathway to lower the side effects and improve the outcome of radiation therapy.

The Company is also engaged in a randomized, double-blind, placebo-controlled Phase 2 trial to understand the efficacy and safety of avasopasem in improving 28-day all-cause mortality in patients hospitalized due to COVID-19.

Key Takeaways

  • The Company is targeting an area with large unmet medical needs, namely, Severe Oral Mucositis (SOM). Over 70 percent of the patients develop SOM as a side effect of HNC RT Treatment. Furthermore the Company estimates that a patient suffering from Oral Muscositis incurs an additional ~$32,000 in medical expenses. This presents a valuable opportunity as only 1 out of 5 patients believe that current treatment options are effective.
  • Galera is readying a dedicated commercial team consisting of nearly 40 representatives, with the aim of reaching 4000 radiation oncologists in over 2500 radiotherapy sites the U.S, besides evaluating commercialization opportunities worldwide.
  • In May 2018, the company entered into a royalty purchase agreement with Blackstone Life Sciences (Blackstone), which was amended in 2020, adding $37.5 million in additional funding to the existing $80 million. Blackstone is eligible to receive high single-digit percentage of royalties from the sales of avasopasem and GC4711, subject to certain conditions.
  • As per its Q2, 2020 Galera had $104.4 million in cash, cash equivalents and short-term investments as of June 30, 2020. The Company believes that this cash, together with the expected payments from Blackstone, will be sufficient to fund its clinical trials and operations into the H2, 2022.
  • Clinical trials are unpredictable and fraught with risk and uncertainty. Overt dependence on a few candidates may prove to be risky, in case of a failure to meet endpoints. The Company however is trying to diversify the pipeline by targeting a host of diseases in which oxygen metabolic pathways are a critical factor, which will help mitigate risks and make optimal use of its resources.
  • Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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