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SHINE closes $50-million financing

On October 7, 2019 SHINE Medical Technologies LLC reported the closing of a $50-million financing with funds managed by Oaktree Capital Management L.P. ("Oaktree"), a leading global investment firm with more than $120 billion under management as of June 30, 2019 (Press release, Shine Medical Technologies, OCT 7, 2019, View Source;pk_kwd=shine-closes-50-million-financing [SID1234540975]). The financing supports the ongoing construction of SHINE’s medical isotope production facility and its commercialization of diagnostic and therapeutic isotopes, including molybdenum-99 (Mo-99) and lutetium-177 (Lu-177).

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"We are excited to welcome Oaktree to SHINE’s growing list of top-tier institutional investors," said Greg Piefer, founder and CEO of SHINE. "Oaktree has broad expertise in complex infrastructure projects like our medical isotope facility. It joins Deerfield Management, a leading health care investment firm, as one of our key partners.

"Oaktree and Deerfield will help us deliver on SHINE’s value proposition, including the completion of our isotope production facility and the development of our therapeutics business. Their participation validates the strength of our business case, team and vision for bringing our lifesaving products to market."

Construction of SHINE’s production facility is expected to be completed in 2021 and commercial-scale isotope production should begin in 2022. The facility will be the first of its kind, utilizing the company’s patented technology to produce Mo-99, which is used in more than 40 million procedures every year.

Chronic global shortages of medical isotopes routinely and significantly affect the diagnosis and treatment of patients around the world. SHINE’s production facility will be capable of supplying more than one-third of the global demand for Mo-99.

"SHINE is an outstanding company with a strong management team, exceptional technology and compelling story," said Milwood Hobbs Jr., managing director of Oaktree. "The need for SHINE’s medical isotope production facility is profound, as millions of patients are affected each year by the ongoing shortage of Mo-99. Oaktree is confident SHINE will play a major role in ending that shortage and we are pleased to support SHINE’s production facility construction."

SHINE also will commercialize Lu-177, a therapeutic isotope currently used to treat neuroendocrine cancers and showing promise for the treatment of metastatic prostate and other cancers. In May, the company entered into an agreement with the Institute of Organic Chemistry and Biochemistry of the CAS (IOCB Prague) that provides SHINE with a global, exclusive license to a novel separation technology that it will use to produce Lu-177. The technology enables SHINE to produce non-carrier-added Lu-177, which should provide the highest therapeutic efficacy.

"Oaktree is pleased to be a partner with SHINE as it executes a growth strategy that includes commercializing therapeutic isotopes and constructing a production facility in Europe," said Aman Kumar, senior vice president of Oaktree. "The global market for therapeutic isotopes, including Lu-177, continues to grow rapidly and SHINE is well positioned to capture significant value in that market. We are equally as excited by SHINE’s commitment to Europe, where the current isotope producers are expected to stop production during the next several years."

About Medical Isotopes
Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium 99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and to stage cases of cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo‑99. Roughly one percent of all Mo-99 in the world decays every hour, meaning it must be produced continuously. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

Aethlon Medical Announces FDA Approval Of IDE For Oncology Indications

On October 7, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic medical device and technology company focused on unmet needs in global health, reported that the FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the Company’s proprietary Hemopurifier in patients with head and neck cancer in combination with standard of care pembrolizumab (Keytruda) (Press release, Aethlon Medical, OCT 7, 2019, View Source [SID1234540098]).

An EFS for a medical device is similar to a phase 1 study for a drug or biologic and as such this trial will enroll a small number of patients with advanced head and neck cancer who cannot be treated with surgery or radiation. In this patient population, pembrolizumab was recently approved for initial first line treatment. Non-clinical studies conducted by Aethlon Medical’s collaborators and other investigators have suggested that a primary mechanism of resistance to pembrolizumab and other immuno-oncology drugs is the secretion by tumor cells of exosomes, which are small, sub-cellular particles that have previously been demonstrated to be cleared by the Hemopurifier. Based on this observation, in November 2018 the FDA granted the Hemopurifier a Breakthrough Designation "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease."

The primary endpoint for the EFS, which will enroll 10-12 subjects at a single center, will be safety, with secondary endpoints including measures of exosome clearance and characterization, as well as response and survival rates. The IDE approval is subject to FDA approval of Informed Consent documents from the trial site. More details on the trial will be disclosed in the future.

"This IDE approval is a critical first step in our plans to develop the Hemopurifier for applications in oncology" stated Timothy Rodell, M.D., Aethlon’s CEO. "We believe that the clearance of immunosuppressive tumor-derived exosomes has the potential to improve response rates to these already game-changing immuno-oncology agents. Our Breakthrough Designation has allowed us to move very quickly with rapid, frequent and helpful communication with the FDA and clearly demonstrates the value of the Breakthrough program."

Kineta Invited to Participate at October 2019 Investor Conferences

On October 7, 2019 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, neuroscience and biodefense reported that Kineta has been invited to participate at multiple investor conferences in October 2019 (Press release, Kineta, OCT 7, 2019, View Source [SID1234540097]). Shawn Iadonato, Kineta Chief Executive Officer, and members of the executive management team will provide a corporate overview at the following conferences:

Solebury Trout Private Company Showcase
Friday, October 18, 2019 at 10:00AM Eastern time at Davis Polk & Wardwell, LLP in New York

BIO Investor Forum
Tuesday, October 22, 2019 at 10:00AM Pacific time at The Westin St. Francis in San Francisco, CA

Family Office & Private Wealth Management Forum West
Thursday, October 24, 2019 at 12:20PM Pacific time at the Napa Valley Marriott Hotel & Spa in Napa, CA

Tikcro Technologies Reports Second Quarter 2019 Results

On October 7, 2019 Tikcro Technologies Ltd. (OTCQB: TIKRF), a pre-clinical stage developer of antibodies for cancer immune-therapy, reported its financial results for the second quarter ended June 30, 2019 (Press release, Tikcro, OCT 7, 2019, View Source [SID1234540096]).

"We continue to pursue the development of a new cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, which has shown strong comparative results in pre-clinical cancer treatment assays," said Aviv Boim, CEO of Tikcro. "The need to have a more effective CTLA-4 antibody is supported by results from early phase clinical trials in additional cancer indications. Results show objective response rates of the combination treatment of a PD-1 antibody with a mid-dose of a CTLA-4 antibody. Our development efforts aim to increase the efficacy of a CTLA-4 treatment and to broaden its approved indications. However, as CTLA-4 antibody treatment continues to gain attention, there is also increased competition involved. Based on pre-clinical results, our new CTLA-4 antibody has the potential to offer improved efficacy."

Several established and emerging pharma companies, including Tikcro, are pursuing new CTLA-4 antibodies to further broaden its clinical scope.

Financial Results for the Second Quarter Ended June 30, 2019
Net loss for the second quarter of 2019 was $248,000, or $0.03 per diluted share, compared to a net loss of $341,000, or $0.03 per diluted share, for the same period last year.

As of June 30, 2019, the company reported $4.68 million in cash, cash equivalents and short-term bank deposits.

ESSA Pharma Board of Directors Approves Stock Option Plan, RSU Plan and Option Grants

On October 7, 2019 ESSA Pharma Inc. ("ESSA" or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that, pursuant to the Company’s existing stock option plan (the "Existing Option Plan"), it has granted incentive stock options ("Options") to certain directors, officers, employees and consultants of the Company to purchase up to an aggregate of 1,441,530 common shares in the capital of the Company (the "Common Shares") (Press release, ESSA, OCT 7, 2019, View Source [SID1234540095]). A total of 1,186,530 of such Options will vest in 48 equal monthly installments, with the first installment vesting on the one-month anniversary of the grant date. A total of 255,000 of the options granted to Directors vest in 12 monthly installments, with the first installment vesting on the one-month anniversary of the grant date. The Options are exercisable on or before October 4, 2029 at the price of US$3.23 per Common share and are granted in accordance with the polices of the TSX Venture Exchange (the "TSXV") and the terms and conditions of the Existing Option Plan.

The Company hereby further announces that on October 4, 2019 the board of directors of the Company ("Board") passed a resolution, subject to shareholder approval, amending and restating the Existing Option Plan (the "Amended Option Plan") and amending and restating the Company’s existing restricted share unit plan (the "Amended RSU Plan"), pursuant to which, amongst other things, the fixed maximum number of Common Shares available for issuance upon the exercise of Options or restricted share units ("RSUs") under the Amended Option Plan and the Amended RSU Plan, respectively, was increased to a maximum of 6,251,469 Common Shares. The Amended Option Plan and Amended RSU Plan both remain subject to shareholder approval, in accordance with the policies of the TSXV.

The Amended Option Plan provides the Company with a share-related mechanism to attract, retain and motivate qualified directors, officers, employees and consultants, and to reward such of those directors, officers, employees and consultants as may be awarded Options under the Amended Option Plan by the Board from time to time for their contributions toward creating shareholder value through achievement of the short and long term goals of the Company. The Amended RSU Plan provides a vehicle by which equity-based incentives may be awarded to the employees, consultants, directors and officers of the Company, to recognize and reward their significant contributions to the long-term success of the Company including to align the employees’, consultants’ directors’ and officers’ interests more closely with the shareholders of the Company. Pursuant to the Amended RSU Plan, the Board, through the Company’s Compensation Committee, may grant RSUs as an incentive payment to eligible persons. The Board intends to use RSUs issued under the Amended RSU Plan, as well as Options issued under the Amended Option Plan as part of the Company’s overall executive compensation plan.

The Company is also announcing that the Board has, following the adoption of the Amended Option Plan, approved the additional grant of an aggregate of 2,551,470 Options (the "New Plan Options") to certain employees of the Company, under the Amended Option Plan. Such New Plan Options will vest in 48 equal monthly installments, with the first installment vesting on the one-month anniversary of the grant date, in accordance with the polices of the TSXV and the terms and conditions of the Amended Option Plan.

The New Plan Options have been reserved for issuance pursuant to the Amended Option Plan and are subject to, and cannot be exercised by their respective holders until, the Company’s shareholders ratify the Amended Option Plan, the TSXV approves the grants thereof, and the Company’s shareholders approve such grants by way of disinterested shareholder approval in accordance with the policies of the TSXV, at a duly constituted meeting of shareholders.

Following the aforementioned grants of Options and New Plan Options, the Company has a total of 5,086,500 Options outstanding, representing approximately 15.5% of the outstanding Common Shares. An aggregate of 1,164,969 Options and/or RSUs remain outstanding for future issuance under the Amended Option Plan and Amended RSU Plan, respectively.

Further details regarding the grant of the Options, the Amended Option Plan, the Amended RSU Plan, and grant of the New Plan Options will be included in the management information circular of the Company that will be made available to shareholders in connection with the annual meeting of shareholders of the Company.

The Option and New Plan Option grants referenced in this press release include grants to certain related parties (as such term is defined under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101")), including directors and senior officers of the Company. Such Option and New Plan Option grants constitute a related party transaction under MI 61-101. These transactions are exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 pursuant to sections 5.5(a) and 5.7(1)(a) of MI 61-101 as neither the fair market value of any securities issued to nor the consideration paid by such persons exceed 25.0% of the Company’s market capitalization.