On May 2, 2018 Morphogenesis, Inc., a Tampa, FL-based immunotherapy company closed a $16 million Series A investment round led by Dr. Kiran Patel and KP Biotech Group, a company managed by Dr. Kiran Patel (Press release, Morphogenesis, MAY 2, 2018, View Source [SID1234526206]). With the completion of the Series A Round, Dr. Kiran Patel was elected Chairman of the Board of Morphogenesis.

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Newly elected Chairman Dr. Patel reacted to the closing by saying, "It’s extremely rewarding to reach this point with the Morphogenesis team who have been pursuing such formidable endeavors in biotechnology that will put Tampa on the map. Interest in this investment was strong but we had to cap at $16M. I have been investing in the Company for over five years now with a strong belief in the work Pat and Mike have undertaken. The successful outcomes from their companion animal and mouse studies have resulted in a green light by the FDA to move into Phase 1b of human clinical trials."

Morphogenesis is a cell and gene therapy company that produces "off-the-shelf" cancer therapies that mark tumor cells for destruction by the immune system. One of the hallmarks of this technology is that it focuses the immune response specifically to tumor cells. Since healthy cells are ignored in the process, and adverse effects are minimized with these therapies. Initially focused on melanoma, the therapies show promise against both liquid and solid tumors of varying types, as both a monotherapy or in combination with other immunotherapies, including checkpoint inhibitors. The Company intends to use the proceeds to fund its Phase 1b human clinical trial at Tampa’s Moffitt Cancer Center and to develop its executive management team.

Year on year, Morphogenesis continues to reach major milestones towards their goal of human cancer treatments. Last year, Morphogenesis augmented its portfolio with three US patent awards. The Company also made applications for patent protection in Europe, Japan, Australia, Canada, China, Hong Kong. These patents are an important component of Morphogenesis’ exclusive intellectual property portfolio that includes more than 25 issued patents and patent applications.

Morphogenesis CEO Patricia Lawman commented on the closing, "We’ve been concentrating on immunotherapies since 2005 and through so many successful outcomes with naturally-occurring cancers in companion animals and horses, we’ve learned a great deal about the potential in human treatment and look forward to getting our trials started."

Skyway Capital Markets, LLC acted as Placement Agent for the offering.

On May 2, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that it will host a conference call to report its first quarter 2018 financial results and provide a corporate update on Wednesday, May 9, 2018 (Press release, Audentes Therapeutics, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346300 [SID1234525954]).

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The conference call will be held at 4:30 p.m. ET, after the market closes. To access a live webcast of the conference call, please visit the Events & Presentations page within the Investor + Media section of the Audentes website at www.audentestx.com. Alternatively, please call 1-833-659-8620 (U.S.) or 1-409-767-9247 (international) and dial the conference ID 9789828 to access the call.

A replay of the live webcast will be available on the Audentes website for approximately 30 days.

On May 2, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report first quarter 2018 financial results on Wednesday, May 9, 2018 (Press release, Jounce Therapeutics, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346297 [SID1234525971]). Jounce Therapeutics’ management team will host a live conference call and webcast to discuss these results and provide a corporate update at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3760478. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On May 2, 2018 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the first quarter ended March 31, 2018 (Press release, Foundation Medicine, MAY 2, 2018, View Source [SID1234525989]). Highlights for the quarter included:

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Posted revenue of $52.8 million, 101% year-over-year growth;
Reported 21,861 clinical tests, 57% year-over-year growth;
Achieved broad Medicare coverage through a final National Coverage Determination (NCD) from the Centers for Medicare and Medicaid Services (CMS) for FoundationOne CDx across all solid tumors for eligible stage III and stage IV cancer patients;
Launched FoundationOne CDx, the first FDA approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics;
Announced that an expanded version of FoundationACT, which will include an expanded gene set and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB), was granted Breakthrough Device designation (formerly Expedited Access Pathway) by the FDA;
Announced a comprehensive gene expression profiling (GEP) program which leverages deep expertise in DNA and RNA sequencing to support precision oncology clinical research and development and identification of novel genomic and expression-based biomarkers for personalized cancer therapies;
Partnered with Chugai Pharmaceutical Co. to commercialize the company’s CGP tests in Japan, including the filing by Chugai of an application with the Ministry of Health, Labour and Welfare (MHLW) for approval of FoundationOne CDx in Japan;
Announced a partnership with Roche and DIAN Diagnostics, a leading NGS diagnostics laboratory in China, to integrate Foundation Medicine’s CGP assays into clinical patient care in mainland China; and
Published 22 peer-reviewed manuscripts in medical and scientific journals and presented 35 podium talks and posters at scientific and medical meetings.
"Foundation Medicine delivered another strong quarter. Compared to the same quarter last year, we doubled revenue over last year and reported record clinical volume," stated Troy Cox, chief executive officer of Foundation Medicine. "Just four months into the year, we’ve made meaningful progress on our strategic priorities for 2018, including the achievement of Medicare coverage for FoundationOne CDx across all solid tumors for qualifying patients, new partnerships to expand our commercial presence in China and Japan, and new biopharma collaborations. In addition, we continued our focus on innovation by accelerating our path to potential regulatory approval of an expanded version of our liquid biopsy assay, FoundationACT, and by initiating the development of a gene expression profiling platform that could enhance biomarker discovery and clinical decision making particularly in the field of immunotherapy. Our many accomplishments reinforce our leadership position and competitive differentiation and, most importantly, help enable access to personalized cancer care."

Foundation Medicine reported total revenue of $52.8 million in the first quarter of 2018, compared to $26.3 million in the first quarter of 2017. Effective January 1, 2018, the company began recognizing revenue in accordance with FASB ASC Topic 606. The company adopted ASC Topic 606 utilizing the modified retrospective method. Additional details of the adoption of this new accounting standard and our revenue recognition policies will be included in the company’s first quarter 10-Q. A summary of revenue for the first quarter of 2018

Revenue from clinical testing in the first quarter of 2018 grew 62% year over year and was driven by increasing clinical volume. The company reported 21,861 clinical tests in the first quarter of 2018, a 57% increase from the same quarter last year. This number includes 17,685 FoundationOne tests, 2,005 FoundationOneHeme tests, 2,123 FoundationACT tests, and 48 FoundationFocus CDx BRCA tests.

Molecular Information Services revenue from biopharmaceutical companies was very strong and was driven by clinical study sample testing. The company reported 7,184 tests to biopharmaceutical customers in the first quarter of 2018 compared to 1,802 tests in the first quarter of 2017.

Total operating expenses for the first quarter of 2018 were $62.0 million compared with $55.0 million for the first quarter of 2017. Net loss was $37.4 million in the first quarter of 2018, or $1.02 loss per share.

Cash and cash equivalents at March 31, 2018 was approximately $60.3 million, including $30 million borrowed during the first quarter under the company’s Credit Facility Agreement with Roche Finance.

2018 Outlook

The company expects 2018 revenue will be in the range of $200 million to $220 million.
The company expects to deliver between 90,000 and 100,000 clinical tests in 2018.
The company expects operating expenses will be in the range of $250 million to $260 million in 2018.
Conference Call and Webcast Details
The company will conduct a conference call today, Wednesday, May 2nd at 4:30 p.m. Eastern Time to discuss its financial performance for the 2018 first quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-844-784-1732 from the United States or dial 1-412-902-6714 internationally. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.

On May 2, 2018 EpicentRx, a San Diego biotechnology company developing a next-generation immunotherapy platform of viruses that infect and kill cancer cells for the treatment of several tumor types, reported that it has developed the first ever series of oncolytic viruses tailored to tumors of individual patients (Press release, EpicentRx, MAY 2, 2018, View Source [SID1234528889]). The first patient, treated at the University of Cincinnati (UC) in Cincinnati, Ohio, by John Morris, MD, professor at the UC College of Medicine and director of the area’s only Phase I/Experimental Therapeutics Program, has been enrolled to receive a personalized virus that has been "armed" with peptide fragments or neoantigens from his specific tumors.

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Neoantigens are ideal targets for the immune system because they are selectively expressed on tumors not on normal cells. Viruses naturally target and kill cancer cells and these personalized viruses, which are derived from viruses that cause the common cold, have been engineered to improve on that ability since they use the machinery of the cancer cell to produce thousands of copies of themselves and the neoantigens that they are carrying. Hence, these viruses are administered with the goal of training the immune system to seek out and destroy the cancer cells that display these neoantigens.

This trial "provides proof-of-principle that personalized viral vaccines tailored and targeted to patient tumors can be made quickly and on demand," said Dr. Tony R. Reid, Chief Scientific Officer of EpicentRx and Associate Professor of Oncology at UCSD in California.

Dr. Corey A. Carter, CEO of EpicentRx, added that while current treatment paradigm in oncology relies on off the shelf, one size fits all therapies, "we know that every patient and patient’s tumor is different. To target an individual tumor in individual patients is nothing short of a revolution."

Drs. Carter and Reid felt that further development of personalized viral vaccines is warranted in combination with other immunotherapy weapons such as checkpoint inhibitors, which also trigger immune responses against cancer neoantigens, albeit non-specifically. "The reality is that other immunotherapies, such as checkpoint inhibitor drugs, only benefit 20-25% of patients in selected tumor types. There’s nothing for the other 75-80% of patients that don’t benefit. We can and must do better. These viruses are potentially a way to increase response rates so that the other 75-80% of patients start to benefit," said Dr. Carter.

"No two cancer cells are exactly alike, making it difficult to target cancer cells with drugs that inhibit one receptor or even one pathway since the cancer cells may and often do vary with respect to genetic changes and survival mechanisms," says Dr. Morris. "This personalized viral vaccine has the ability to contain express many different neoantigens from the tumor, targeting multiple genetic mutations in tumor cells, which could potentially prevent the cancer cells from sidestepping the immune system. We are excited to be part of this trial, which could prove beneficial for many patients."

"When you infect a cancer cell with a virus, it is like waving a big red flag at a bull, which stimulates the immune system to ‘go after’ the cancer. But like a matador cancer often has the ability to maneuver away from the threatening attack. In our experiments we have found that when the virus is personalized to the tumor with multiple neoantigens, the tumor is unable to escape the immune system’s charge and is ‘gored’," said Dr. Reid. "Effectively what we are doing with these viruses is to use the immune system’s natural ability to attack many target antigens, which is what happens every time we get an infection."

Oncolytic viruses have been tested in thousands of patients in the clinic and generally appear to only cause flu-like symptoms for about a week, according to Dr. Reid.

The viruses were manufactured in house according to Good Manufacturing Practice (GMP) regulations and samples of patient tumors and normal DNA from blood underwent whole-exome sequencing to reveal mutations present only in the tumor.

According to Dr. Carter, "Future personalized viral vaccine trials will be done under a separate Investigational New Drug application to the FDA, so many more patients with advanced disease may be enrolled to test the efficacy of the viruses both alone and with checkpoint blockade and other immunotherapeutics. Personalized viruses have the potential to be applied to any cancer with enough neoantigens for vaccination."

Tumor-targeting viruses can rally the immune system against cancers, boosting the efficacy of immunotherapy drugs and opening the door to promising combination treatments for aggressive and difficult-to-treat cancers. Many viruses naturally target and kill cancer cells, and experimental oncolytic viruses are often engineered to improve that ability.