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NantHealth and NantOmics Reveal a Novel AI Based Machine-Learning Digital Pathology Software for Lung Cancer by Identifying Tumor Infiltrating Killer Cells From Whole Slide Images

On January 27, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company and NantOmics, LLC, the leader in molecular analysis, reported a novel artificial intelligence platform for aiding pathologists in image-based lung cancer subtyping at the Society for Imaging Science and Technology’s International Symposium on Electronic Imaging 2020 (Press release, NantHealth, JAN 27, 2020, View Source [SID1234553572]). This novel machine vision software platform accurately subtypes lung cancer pathology and achieves high concordance with analysis performed by trained medical pathologists.

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An initial report of the AI technology was presented at the Sixth American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the International Association for the Study of Lung Cancer (IASLC) International Joint Conference. The study entitled, "Tumor-infiltrating lymphocytes (TILs) found elevated in lung adenocarcinomas (LUAD) using automated digital pathology masks derived from deep-learning models" concluded that despite lower overall TMB (tumor mutation burden) and lymphocyte levels, there exists a subset of lung cancers with very high infiltrating lymphocyte counts.

Derived from deep-learning models, together, the findings demonstrate a novel AI-based method for subtyping lung cancer pathologies which impacts treatment options for patients and improved methods of identifying tumor infiltrating white cells found elevated in lung cancer.

"Accurately identifying and quantifying tumor-infiltrating white cells is extremely important for prognosis and treatment decisions in this era of personalized medicine, yet it currently requires manual review of whole slide images by medically trained pathologists, and incurs significant delays and cost," explains Dr. Patrick Soon-Shiong, MD, Chairman and CEO of NantHealth. "Our goal was to develop a scalable remote cloud-based diagnostic imaging system, a NORAD of pathology diagnosis so to speak. To accomplish this, machine vision of digitally transmitted images of tumor tissue would facilitate a scalable cloud-based infrastructure, with an image patch-based, automated system to classify cancers by their immune status."

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, which is further classified as 40 percent adenocarcinoma (Adeno), 30 percent squamous cell carcinoma (Squamous) and the remainder, large cell carcinoma1. As analyses show that lung adenocarcinomas (LUAD) receive slightly more survival benefit from anti-PD1 therapy than squamous-cell lung carcinomas (LUSC), which have a higher TMB, a team of researchers explored whether lymphocyte distribution in the tumor microenvironment may give a rational explanation for the different responses to immuno-oncology agents independent of TMB.

"By focusing on classifying regions detected as tumorous, we achieved identification of adenocarcinomas versus squamous cell carcinomas in non-small-cell lung cancers with an approximate accuracy rate of 86 percent," explained Soon-Shiong. "With highly accurate tumor-region and lymphocyte detection, oncologists may better treat their patients with adeno versus squamous-based therapies and the use of immunotherapies may result in better outcomes."

Study Design:

The system was trained and tested on 876 subtyped NSCLC gigapixel-resolution diagnostic whole slide images (WSI) from 805 patients obtained from The Cancer Genome Atlas (TCGA) sources. Samples were randomly split into training (711 WSIs from 664 patients) and testing (165 WSIs from 141 patients) sets.

Findings show that NantOmics and NantHealth’s fully-automated histopathology subtyping AI method outperforms other algorithms reported in literature for diagnostic WSIs. The system also generated maps of (tumor) regions-of-interest within WSIs, providing novel spatial information on tumor organization.

Details of the oral presentation at the IS&T International Symposium on Electronic Imaging 2020 outlined below:

Title: "Pathology image-based lung cancer subtyping using deep-learning features and cell-density maps"

Authors: Mustafa I. Jaber, Christopher W. Szeto, Bing Song, Liudmila Beziaeva, Stephen Benz, Patrick Soon-Shiong, and Shahrooz Rabizadeh

Session and Number: Image Processing: Algorithms and Systems XVIII (IPAS-064)

Location: Hyatt Regency San Francisco Airport, Burlingame, CA

Date and Time: January 27, 2020 at 4:10 PM

IntelGenx Announces Pricing of Equity Offering

On January 27, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported the pricing of an agency offering (the "Offering") of up to 20,000,000 units, subject to a minimum offering of 10,000,000 units (the "Units"), for gross proceeds of between $5,000,000 and $10,000,000, assuming no exercise of the over-allotment option granted to the Agent (as defined below), at a price of $0.50 per Unit (Press release, IntelGenx, JAN 27, 2020, View Source [SID1234553570]). Each Unit will consist of one share (each, an "Offered Share") of common stock of the Company ("Common Stock") and one warrant (each, a "Warrant") to purchase one share of Common Stock at an exercise price of $0.75 per share (a "Warrant Share"). The Warrants will be exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the "Agent") in the provinces of British Columbia, Alberta, Manitoba and Ontario. Closing of the Offering is expected to occur on or about February 11, 2020.

The Company has granted to the Agent an option to increase the size of the Offering by up to 15%, exercisable in whole or in part at any time for a period of 30 days after and including the closing date of the Offering.

The net proceeds from the Offering will be used for the Company’s Phase 2A Montelukast Study and general working capital requirements.

The Company has applied to list the Offered Shares, the Warrants and the Warrant Shares underlying the Units on the TSX Venture Exchange (the "TSXV"). The approval is subject to fulfillment by the Company of customary closing conditions of the TSXV.

The Company intends to file a final short form prospectus (the "Prospectus") in the provinces of British Columbia, Alberta, Manitoba, Ontario and Quebec, as well as an amended registration statement on Form S-1 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") with respect to the Offering today. The Offering is subject to certain customary conditions including, but not limited to, the receipt of all necessary approvals, including the SEC declaring the Registration Statement effective.

Before investing, you should read the Prospectus and the Registration Statement, as well as other documents the Company has filed or will file late today with the SEC and the Canadian securities regulators for more complete information about the Company and this Offering. A copy of the Prospectus is available under the Corporation’s profile at www.sedar.com and a copy of the Registration Statement can be obtained from the SEC’s website at www.sec.gov or by request to Echelon Wealth Partners Inc. at [email protected].

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date.

Entry Into a Material Definitive Agreement

On January 27, 2020, INmune Bio, Inc. (the "Company") reported that it has entered into an agreement (the "Repurchase Agreement") to purchase 220,000 shares of its common stock, par value $0.001 per share (the "Shares") from Linda F. Powers. The purchase price is $4.60 per share, resulting in a total purchase price of $1,012,000 (the "Repurchase Transaction") which the company believes is an attractive price and will be accretive (Filing, 8-K, INmune Bio, JAN 27, 2020, View Source [SID1234553569]). Prior to consummating the Repurchase Transaction, Ms. Powers held approximately 10.4% of the Company’s outstanding common stock. Following the consummation of the Repurchase Transaction, Ms. Powers now holds approximately 8.6% of the Company’s outstanding common stock. The Repurchase Agreement and the transactions contemplated therein, were approved by the Company’s board of directors and audit committee.

The foregoing is merely a brief description of the material terms of the Repurchase Agreement, which is attached hereto as Exhibit 10.1 and incorporated herein by reference. The foregoing does not purport to be a complete description of the rights and obligations of the parties thereunder and such description is qualified in its entirety by reference to such exhibit.

ImmunoGen Announces Closing of Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On January 27, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 24,523,750 shares of its common stock at a price of $4.25 per share, which included the exercise in full by the underwriters of their option to purchase up to 3,198,750 additional shares of common stock (Press release, ImmunoGen, JAN 27, 2020, View Source [SID1234553568]). ImmunoGen received total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) of $104.2 million.

ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

Jefferies, Cowen and William Blair acted joint book-running managers for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at [email protected] or by telephone at (800) 621-0687.

GT Medical gains expanded indication in the U.S. for Gammatile therapy

On January 27, 2020 Tempe, Ariz.-based Gt Medical Technologies Inc. reported that it has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy (Press release, GT Medical Technologies, JAN 27, 2020, View Source [SID1234553566]).

Matthew Likens, president and CEO of Gt Medical, noted that the company was excited to offer the therapy to those who are newly diagnosed with malignant brain tumors. Previously, the therapy was available for individuals with recurrent ones.

"Patients receiving Gammatile therapy immediately after the removal of a brain tumor will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumor cells where treatment is most needed to help prevent recurrence," he added.

Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. It protects healthy brain tissue while delivering a targeted dose to any remaining tumor cells. In addition, it limits certain side effects, such as hair loss.

"The neurosurgeon is handed these tiles by the radiation oncologist. They’re literally tiling the inner wall of the cavity and the base of the cavity and then closing the patient up," Likens told BioWorld last year. "It’s a five-minute procedure right at the end of the resection process." As a result, it does not disrupt the workflow of the operating suite.

With this indication in hand, this new group of patients will not have to wait long for treatment. "Patients will be eligible to receive Gammatile therapy immediately at the 15 centers where the treatment is currently available," Likens told BioWorld.

When asked about other markets, he noted that the U.S. remained the company’s immediate focus. "[B]ut we consider Gammatile to be a global technology, and we plan to deploy it outside the U.S. in the future."

Looking to improve the space

The company placed the number of people in the U.S. living with some type of brain tumor each year at roughly 700,000, citing figures from the American Brain Tumor Association. It also noted that despite the attempts by surgeons, outcomes for patients with brain tumors have not improved very much over the past 30 years. The FDA has approved four drugs and cleared two devices in that time period to help these patients. Now, Gammatile looks to advance the field and is the most recent treatment cleared or approved.

"Approximately 400,000 Americans are newly diagnosed with some type of brain tumor each year, including gliomas, meningiomas and brain metastases," Likens told BioWorld. "This expanded indication more than triples the number of patients who can benefit from Gammatile therapy."

In a clinical study, Gammatile therapy gave the average patient about an extra 10 months without a local recurrence with extended overall survival. Clark Chen, head of the Department of Neurosurgery at the University of Minnesota Medical School, presented data from his first patients treated with Gammatile at the 2019 Society of Neuro-Oncology Annual Meeting.

Consistent with data published in a peer-reviewed article, Chen noted that local control was achieved in about 90% of patients who underwent gross total resection. This result was achieved without an increase in wound complications or length of hospital stay.

For his part, Vincent DiNapoli, neurosurgeon and director of the Brain Tumor Center at The Jewish Hospital in Cincinnati, has been treating patients with Gammatile therapy since August 2019. "Having been encouraged by the outcomes for recurrent brain tumor patients treated with Gammatile therapy in my practice, I am excited by the FDA’s decision to expand this technology to the many patients who can benefit from the treatment during their initial diagnosis," DiNapoli said. "This could potentially create a more meaningful impact on patient outcomes, treatment compliance, and quality of life."

Patients also have been enthusiastic, as they have not had to come back for repeated hospital visits.

Working with Isoray

Gt Medical and its collaborator Isoray Inc., of Richland, Wash., reported July 9, 2018, the receipt of FDA clearance of Gammatile therapy for the treatment of recurrent brain tumors. In January 2018, Isoray revealed the signing of an exclusive manufacturing and supply agreement with Gt Medical for Cesium-131 seeds embedded in the product’s collagen tiles. The term of the agreement was 10 years.

For its part, during its Nov. 12, 2019, first-quarter earnings call, Isoray CEO Lori Woods discussed the potential for the now-realized expanded indication for Gammatile. "We are very interested in how this effort for expanded indication proceeds with the FDA because of its implications for Cesium-131 and Isoray," she said. She noted that the product remained in active review, with revenues for Gt Medical remaining nominal as the company continued to introduce the Gammatile centers around the U.S.

$10M series A

The news regarding the FDA’s decision comes about a year after the company reported that it had raised $10 million in a series A financing to support the commercialization of Gammatile therapy.

At the time, Likens said his company had the intellectual property for use of the therapy in extra-cranial applications, but due to its resources, it planned to concentrate totally on the brain for the immediate future.

"Gammatile therapy was specifically designed with the brain’s delicate environment in mind and our current focus is on improving the lives of patients with brain tumors," told BioWorld in the wake of the expanded clearance. Because of its IP protection beyond the brain "we are currently collecting feedback on other potential indications for the future," Likens concluded.