On May 19, 2020 Chonnam National University College of Medicine reported the company’s research team has developed an ultra-sensitive PET molecular imaging probe that can sensitively detect metastatic lesions of malignant melanoma (Press release, CNCure, MAY 19, 2020, View Source [SID1234649030]).

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Professor Min Jeong-jun and Dr. Kim Dong-yeon’s research team at Chonnam National University developed a new molecular imaging precision diagnostic technology by utilizing the chemical structure called benzamide, which can bind to melanin molecules secreted by malignant melanoma.

We synthesized a novel structure that can enhance the targeting ability and uptake rate of malignant melanoma through chemical methods and produced an imaging probe labeled with the positron-emitting nuclide 18F.

This compound, named [18F]DMPY2, showed significantly higher cancer-specific uptake and rapid excretion than previously reported imaging probes.

In particular, results evaluated in small animals showed that it sensitively detects not only primary malignant melanoma but also small cancer metastases less than 1 mm in size, showing superior diagnostic performance and biological characteristics than PET imaging probes currently undergoing clinical trials in the United States.

The research team has registered a domestic patent for this technology and applied for an overseas patent. The technology has been transferred to CNCure, a company founded by the researchers, and is currently preparing for clinical trials.

[18F]DMPY2 showed the highest tumor uptake among melanoma targeting drugs reported so far, with approximately 25% of the injected dose being taken up by malignant melanoma.

This means that there is a very good chance that this imaging technology will be used to diagnose malignant melanoma in humans in the near future.

In addition, if the structural characteristics of DMPY2 are maintained while successfully conjugating a therapeutic radionuclide, it is highly likely that this will lead to the development of a new radiopharmaceutical for the targeted treatment of malignant melanoma.

The research team is developing a theranostic agent that can be used for both diagnosis and treatment based on the DMPY2 structure.

This study was conducted with the support of the Ministry of Science and ICT’s Future Promising Convergence Technology Pioneer Project and the Ministry of Health and Welfare’s Health and Medical Technology Research and Development Project, and the paper was published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS, 5-year impact factor: 10.600) on May 19, 2020.

The title of the paper is ‘Ultrasensitive detection of malignant melanoma using PET molecular imaging probes’ and the authors are Professor Min Jeong-jun (corresponding author, Chonnam National University), Dr. Kim Dong-yeon (corresponding author, Chonnam National University Hwasun Hospital), and Dr. Pyo Ah-young (first author, Chonnam National University).

Malignant melanoma is a very aggressive and highly lethal skin cancer. If diagnosed early, it can be surgically removed, but once it has metastasized, the mortality rate within one year is 75%, so early diagnosis is the only effective way to increase the patient’s survival rate.

Professor Min Jeong-jun said, "This study not only proves that the approach and results are excellent, but also means that there is a very high possibility that this diagnostic technology will be used to diagnose malignant melanoma in humans in the near future." He added, "We look forward to more research on the treatment of malignant melanoma in the future, as we can develop new substances that can not only diagnose but also treat malignant melanoma."

On May 19, 2020 – STELLA PHARMA CORPORATION (Head office: Chuoku, Osaka City; President: Tomoyuki Asano) is pleased to announce that Steboronine intravenous drip bag 9000 mg/300 mL (Generic name: Borofalan [ 10B]; "Steboronine "), a boron drug for boron neutron capture therapy ("BNCT"1), has been listed on the National Health Insurance Drug Price List, as published in the Official Gazette today (May 19,2020). We are also pleased to announce that the product will be available for sale on May 20.

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The Ministry of Health, Labour and Welfare ("MHLW") in Japan designated Steboronin as a product subject to the "SAKIGAKE Designation System." Stella Pharma received approval on March 25, 2020, to manufacture and sell Steboronin for the treatment of locally unresectable recurrent or unresectable advanced head and neck cancer.

On May 19, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 20, 2020, at 11:30 a.m. ET (Press release, Athenex, MAY 19, 2020, View Source [SID1234573877]).

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A live audio webcast of the presentation can be accessed through the Events & Presentations section of the Company’s website at ir.athenex.com. An archived replay of the webcast will be available on the Company’s website following the live presentation.

On May 19, 2020 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or "the Company"), reported financial results for the year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards ("IFRS") (Press release, iCo Therapeutics, MAY 19, 2020, View Source [SID1234562020]).

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Stated William Jarosz, President and CEO of iCo Therapeutics Inc., "2019 represented a year of significant advances as we entered into a Phase 1b clinical trial for Oral Amphotericin B and we welcomed a new partner, Alexion Pharmaceuticals Inc., who are developing our iCo-008 (also known as bertilimumab). While COVID-19 has disrupted our business as with many other companies, we remain encouraged by our progress in 2019."

2019 Operational and Financial Highlights

Oral Amp B Delivery System

On December 9, 2019, we initiated a second study using oral Amphotericin B (Phase 1b) exploring safety and pharmacokinetics of multiple ascending drug doses (MAD) in healthy subjects. On February 25, 2020 we announced that that this study was successfully completed with no serious adverse events. On April 15, 2020, we announced the pharmacokinetic data from this study which showed a doubling in the AUC (0-inf), a measure of drug accumulation, after 10 days dosing compared to day 1 dosing.

iCo-008

On October 21, 2019, the US Court approved a sales order which assigned IMMUNE’s rights and obligations under the IMMUNE License Agreement to Alexion Pharmaceuticals Inc. This approval was followed by the Israeli court’s approval of the US driven sales order. Under the terms of the sales order, Alexion was required to pay US$6 million into the Court in the settlement of IMMUNE’s creditor claims in exchange for IMMUNE’s rights under the IMMUNE License Agreement.

Corporate

During the year, we completed two private placements for net proceeds of approximate $3 million.

Financial Results for Year End 2019

We incurred a total comprehensive loss of $1,932,202 for the year ended December 31, 2019 compared to a total comprehensive loss of $1,712,724 for the year ended December 31, 2018, representing an increased loss of $219,478. The increase in the loss is primarily the result of higher general and administrative expenses and lower research and development tax credits offset by lower research and development expenses recognized during 2019.

Research and development expenses were $917,475 for the year ended December 31, 2019 compared to $1,420,457 for the year ended December 31, 2018, representing a decrease of $502,982. The decrease related to lower contract research expenses because there were no clinical trials conducted on the Oral Amp B program until December 2019. In the prior year, research and development expenses related to the manufacture of clinical drug supplies and the initiation and successful conclusion of its Phase 1a clinical study in Australia.

For the year ended December 31, 2019 general and administrative expenses were $1,288,198 compared to $781,282 for the year ended December 31, 2018, representing an increase of $506,916. The increase reflects higher professional fees and management consulting fees during the period due to the Company’s participation in the IMMUNE bankruptcy process.

Liquidity and Outstanding Share Capital

As at December 31, 2019, we had cash and cash equivalents of $989,937 compared to $10,140 as at December 31, 2018.

As at May 15th, 2020, we had an unlimited number of authorized common shares with 153,747,713 common shares issued and outstanding.

For complete financial results, please see our filings at www.sedar.com.

On May 19, 2020 Hoag Family Cancer Institute and Pickup Family Neurosciences Institute at Hoag, in collaboration with Nascent Biotech, Inc reported a first in the nation clinical trial for a novel immunotherapy treatment that holds considerable promise for glioblastoma (GBM), the deadliest form of brain cancer (Press release, Nascent Biotech, MAY 19, 2020, View Source [SID1234558391]).

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Pritumumab is a unique monoclonal antibody that attacks cancers originating in the cells lining an organ – referred to as epithelial cells. These include cancers of the brain, breast, colon and pancreas, as well as melanoma. Prior Phase I and II clinical trials in Japan focused on the treatment of high-grade gliomas including GBM.

This Phase I clinical trial leverages the Hoag Family Cancer Institute and Pickup Family Neurosciences Institute’s assets in their collaboration when treating all aspects of brain tumors. With more than 20,000 new cases of GBM diagnosed in the U.S. every year, Hoag’s infrastructure in its Center for Research Education, as well as Hoag’s neurosciences and cancer expertise and reputation appealed to Nascent Biotech as they chose a national site.

The study will be conducted by Hoag’s Neuro-Oncology Clinic that helps guide the entire continuum of comprehensive care for patients with brain tumors.

"The trial is a natural fit for Hoag, which is devoted to compassionate patient-centric care, creative innovation, and clinical excellence," said Jose Carrillo, M.D., Hoag neuro-oncologist and principal investigator on the trial. "By offering our patients access to targeted immunotherapy, we expand our toolkit to include a treatment option that has the potential to turn the tables on brain cancer."

"Targeted immunotherapy, unlike chemotherapy, fights only the cancer cells, without damaging healthy cells. This has the potential to improve outcomes and help our patients beat cancer while minimizing the debilitating side effects normally associated with cancer treatment," added Dr. Carrillo.

Pritumumab works by targeting ectodomain vimentin, a protein expressed on the surface of epithelial cancers. Because vimentin is found in a variety of cancers, the clinical trial at Hoag could have implications for more common cancers, such as breast or lung. In fact, the Hoag trial will employ a unique Phase I design that can ultimately treat a variety of brain cancers from gliomas and other primary brain tumors to brain metastases and leptomeningeal cancers arising from breast, lung and other solid tumors.

"There are significant unmet medical needs in a variety of cancers," said Sean Carrick, CEO of Nascent Biotech, makers of the immunotherapy treatment. "Nascent is committed to changing patient expectations and outcomes in one of the world’s most debilitating cancers and Hoag is a natural partner towards achieving this goal. We’re highly encouraged by the potential of Pritumumab to deliver an innovative, first-in-class treatment option, and we are delighted to be working closely with Hoag in this study."

Hoag’s Phase I clinical trials and many aspects of its cancer research are significantly supported by philanthropy.

For more information on the research studies and clinical trials at Hoag, visit www.hoag.org/clinicaltrials.