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Year-end Progress for the Lung Cancer Community: Federal Research Funding & the Women and Lung Cancer Research and Preventive Services Act

On December 21, 2019 Bonnie J Addario Lung Cancer Foundation reported For many weeks, our community has been awaiting passage of the Fiscal Year 2020 (FY20) federal budget, which funds the Lung Cancer Research Program (Press release, Bonnie J Addario Lung Cancer Foundation, DEC 21, 2019, View Source [SID1234553215]). This week, just days before the budget continuing resolution expired, the House and Senate released the long-awaited conferenced agreement that has been signed by the President to avert a repeat of last year’s holiday-time government shutdown. In anticipation of this effort, GO2 Foundation for Lung Cancer (a recent merger of Lung Cancer Alliance and the Bonnie J. Addario Lung Cancer Foundation), led a community letter, co-signed by 22 other lung cancer advocacy groups to speak with one voice for the Lung Cancer Research Program within the Department of Defense’s Congressionally Directed Medical Research Programs (CDMRP).

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We are thankful that the House and Senate reconciled their differences on lung cancer funding. The inconsistencies in the draft reports could have jeopardized the long-standing tradition of dedicated funding for lung cancer research. While disappointed that Congress did not restore the funding level of $20M, as requested by the Congressional Lung Cancer Caucus; we were glad that our advocacy prevailed to have the House stand-alone Lung Cancer Research Program funded at $14M in the final conferenced package. This modest annual funding amount in military research will increase the funding level (for the past 10 years) up to a total of $155.5M for lung cancer research within the CDMRP.

In addition to lung cancer research funding, we secured important bill "report language" in the conferenced Department of Labor, Health and Human Services (LHHS) and Education and Related Agencies Appropriations Bill for FY20 that now signals stronger support for the Women and Lung Cancer Research and Preventive Services Act of 2019. Within the initial House LHHS draft report, "the Committee encouraged the CDC to work to increase public awareness of lung cancer screening for individuals at high risk for lung cancer and increase the percentage of high risk individuals who are screened." At the NIH, "The Committee urged NCI to accelerate research into treatments and implementation of lung cancer preventive services for women"— with a request for an update on these activities in the fiscal year 2021 Congressional Justification.

This is a big WIN for our community and assurance that our voices are being heard! With this achievement of maintaining funding for the Lung Cancer Research Program and language secured in the LHHS bill we have every confidence in even greater outcomes for 2020.

As we conclude this year end season, we thank our lung cancer advocates for making these accomplishments possible. We look forward to working together in the New Year to change the reality of living with lung cancer by addressing stigma, increasing research and ensuring access to care.

Clinical trials planned for brain tumor ‘GPS’ maps

On December 20, 2019 Case Western Reserve University cancer researcher reported that it has shown 90% accuracy in pinpointing brain tumors and will soon be tested in real-time with patients at Cleveland Clinic under a three-year, $600,000 V Foundation grant (Press release, Case Western Reserve University, DEC 20, 2019, View Source [SID1234553317]).

Pallavi Tiwari

The grant was awarded to Pallavi Tiwari, an assistant professor of biomedical engineering at Case Western Reserve with dual appointments in the School of Medicine and Case School of Engineering, and Alireza Mohammadi, an assistant professor of neurosurgery at Cleveland Clinic.

The V Foundation, named for former college basketball coach Jim Valvano, funds innovative cancer research and has awarded more than $200 million since being founded in 1993, the year Valvano died from adenocarcinoma.

The need for neural precision
Tiwari said one particular aspect of the existing clinical workflow for managing treatment for brain tumor patients is imprecise: A post-operative MRI scan can’t effectively discern whether cancer has returned or if the lesion has been altered by what neurologists call a "benign treatment effect."

"So both radiation effects and tumor recurrence have similar clinical symptoms and appearances on routine MRI scans," said Tiwari, a lead faculty member in the Center for Computational Imaging and Personalized Diagnostics in Biomedical Engineering and a member of the Case Comprehensive Cancer Center at the School of Medicine.

"Additionally, a highly invasive brain biopsy is currently the only option for confirmation of disease presence—and each biopsy procedure costs $20,000 to $50,000 per patient," she said. "And more than 15% of patients who undergo a second biopsy will then get an incorrect diagnosis due to the difficulty in sampling of reliable locations of the tumor."

To address those issues, a team led by Tiwari has developed new image-based biomarkers drawn from routine MRI scans to differentiate between these two conditions with an accuracy of 92% on about 200 cases so far.

‘GPS maps’ reveal recurring cancer
Actual images of brain tissue scans showing ‘hot’ areas where cancer is present
An image from the research underpinning the ‘brain GPS’ work done by Tiwari and her team.
They’re calling it a "GPS map" or "heat map" for the brain, as it is expected to reliably show by use of colors which part of a tumor has a recurrence of cancer, or whether it has been instead altered by the radiation.

"We’ll use the routinely acquired MRI scans, feed them into our computational algorithm and create a GPS map that the surgeon can use—one that will have a ‘heat map’ of hot-spots for cancer to guide him or her in finding the correct biopsy site within the lesion," Tiwari said.

Mohammadi said the next step in the project is critical in saving patients and money.

"The first part of this study was done retrospectively, meaning that looking at cases in which they already knew the outcome, but the accuracy was very impressive," Mohammadi said, referring to studies on the mapping Tiwari led in 2016 and early 2019. "Now we are trying to validate this in clinical trials, and if we have that same high accuracy, we won’t need to do that second, expensive biopsy."

Actual brain scan images showing color-coded areas where neurosurgeons would look to find a tumor
Brain scan images used to detect which areas of the lesion should be biopsied.
Clinical trials are expected in the final year of the grant, in late 2021 or early 2022, Tiwari said. In the meantime, researchers will be working to perfect the computational algorithms across multi-institutional data.

Stan Gerson, director of the Case Comprehensive Cancer Center and professor of medicine and environmental health sciences at the School of Medicine, said the new grant will allow to researchers to "focus on patient benefit."

"It enables us to link incredible insight from imaging computational technology with a critical medical need, linking our biomedical engineers to our diagnostic physicians," he said. "I like to say that we are ‘turning clinicians into prognosticators.’ "

Tiwari said the clinical trials are one step closer toward realizing those bringing real benefits.

"We develop these cool technologies and we get excited about 90% accuracy, but it doesn’t mean anything until you can prove it in clinical trials—because that’s when patients can begin to get the benefits," she said. "That’s why this is so exciting for me."

MonTa Biosciences close a Series A investment from existing investors to complete phase I in cancer patients

On December 20, 2019 MonTa Biosciences reported completion of a Series A investment from existing investor Consolidated Biosciences Aps of 40 mDKK to secure completion of a phase I study in cancer patients (Press release, MonTa Biosciences, DEC 20, 2019, View Source [SID1234552933]). The study will test the lead asset of MonTa Biosciences MBS8, which is a promising immunotherapy to boost the immune system of cancer patients using a unique technology to activate the patients immune system. MBS8 is a nanoparticle consisting of a small molecule compound of the TLR7 class formulated in micelles, and is administered by the intravenous route to activate immune cells of the patient. The phase I trial will enroll patients with solid tumors and be conducted in Denmark and Spain.

Entry into a Material Definitive Agreement

On December 20, 2019, Arbutus Biopharma Corporation (the "Company") reported that it has entered into an amendment (the "Amendment") to the Open Market Sale AgreementSM, dated December 20, 2018 (the "Sale Agreement"), by and between the Company and Jefferies LLC, as sales agent (the "Agent"), in connection with the Company’s filing of a new shelf registration statement on Form S-3 (File No. 333-235674), filed with the Securities and Exchange Commission (the "SEC") on December 23, 2019 (the "New Shelf Registration Statement") (Filing, 8-K, Arbutus Biopharma, DEC 20, 2019, View Source [SID1234552579]). The Amendment revised the Sale Agreement to reflect that the Company may sell its common shares, without par value (the "Common Shares"), from time to time for an aggregate sales price of up to $50.0 million under the New Shelf Registration Statement. Under the original terms of the Sale Agreement, the Company, through the Agent, may issue and sell Common Shares pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-215290), previously filed with the SEC on December 23, 2016 and subsequently amended on January 12, 2017, and declared effective by the SEC on January 19, 2017 (the "Original Shelf Registration Statement"), and the Company’s prospectus supplement filed with the SEC on December 20, 2018 (the "2018 Prospectus"). Under the rules of the Securities Act of 1933, the Original Shelf Registration Statement is set to expire on January 19, 2020. The Company has remaining capacity under the Sale Agreement to sell up to approximately $36.2 million of its Common Shares under the Original Shelf Registration Statement until its expiration.

Abeona Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

On December 20, 2019 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported the pricing of its public offering of 26,982,945 shares of its common stock at a public offering price of $2.50 per share and in lieu of common stock, pre-funded warrants to purchase 9,017,055 shares of its common stock at a purchase price of $2.4999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant (Press release, Abeona Therapeutics, DEC 20, 2019, View Source [SID1234552576]). The aggregate gross proceeds from the offering are expected to be $90 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Abeona. All of the shares of common stock and pre-funded warrants are being offered by Abeona. In addition, Abeona has granted the underwriters a 30-day option to purchase up to an additional 5,400,000 shares of its common stock from Abeona at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on December 24, 2019, subject to the satisfaction of customary closing conditions.

An existing holder of the Company’s common stock, Great Point Partners ("GPP"), has agreed to purchase approximately $31 million in the offering, including pre-funded warrants in lieu of common stock, subject to allocation by the underwriters and market and other conditions. The Company has granted GPP the right to nominate two directors, including a new Executive Chairman, to Abeona’s Board of Directors. GPP has indicated that it expects such director nominees would be industry professionals not affiliated with GPP. As a result, Steven H. Rouhandeh will step down as Executive Chairman and will retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne will exit the Board. These changes will be effective upon the Board’s qualification and election of GPP’s nominees.

Jefferies LLC and SVB Leerink LLC are acting as book-running managers and underwriters for the offering.

Abeona intends to use the net proceeds of the offering to fund continued clinical development of pipeline products, as well as for working capital and corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224867) that was filed with the Securities and Exchange Commission (the "SEC") on May 11, 2018 and amended on June 1, 2018, and that was declared effective by the SEC on June 7, 2018. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus that form a part of the registration statement has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, via telephone at (877) 821-7388, or email at: [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected].