On May 2, 2018 AmerisourceBergen Corporation (NYSE:ABC) reported that in its fiscal year 2018 second quarter ended March 31, 2018, revenue increased 10.5 percent to $41.0 billion. On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $1.29 for the March quarter of fiscal 2018, compared to $1.86 in the prior year quarter (Press release, AmerisourceBergen, MAY 2, 2018, View Source [SID1234525986]). Adjusted diluted EPS, which is a non-GAAP measure that excludes items described below, increased 9.6 percent to $1.94 in the fiscal second quarter.

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AmerisourceBergen now believes adjusted diluted EPS for fiscal year 2018 will be at the bottom of its guidance range of $6.45 to $6.65, reflecting growth of 10 percent versus last fiscal year. The Company does not provide forward-looking guidance on a GAAP basis, as discussed below in Fiscal Year 2018 Expectations.

"I am pleased with our performance in the March quarter as associates and businesses within AmerisourceBergen continue to execute. Our distribution businesses are creating significant value for our customers as we grow volumes and help support their businesses in a dynamic healthcare market," said Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen.

"Our updated outlook for fiscal 2018 reflects the strong performance of our Pharmaceutical Distribution Services segment, helping to offset a lower contribution from its PharMEDium business. We remain confident in the value, efficiency and safety PharMEDium provides the healthcare system and are committed to providing our customers with the highest quality products and services," Mr. Collis continued. "As we move further into fiscal 2018, we are excited to begin realizing the benefits of investments throughout AmerisourceBergen that further enhance the value and efficiency we offer to our provider customers and manufacturer partners. Our long-term relationships and unique portfolio of integrated pharmaceutical services enable AmerisourceBergen to continue living its purpose as we are united in our responsibility to create healthier futures."

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.

On May 2, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the first quarter ended March 31, 2018. Net loss for the first quarter of 2018 was $21.5 million, or $0.28 per share, compared to net loss of $21.8 million, or $0.32 per share, for the same period in 2017 (Press release, Aduro Biotech, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346437 [SID1234525952]).

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Recent Developments:

Reported preclinical data on ADU-S100, BION-1301 and ADU-1604 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)

Reported initial observations from the first patient treated with our personalized neoantigen-based immunotherapy

Received a milestone payment from Merck for initiation of a Phase 1 trial of our anti-CD27 antibody for patients with advanced solid tumors
Cash, cash equivalents and marketable securities totaled $327.8 million at March 31, 2018, compared to $349.7 million at December 31, 2017.

Revenue was $6.6 million for the first quarter of 2018 compared to $3.8 million for the same period in 2017. The increase of $2.8 million was primarily due to a $3.0 million milestone payment received from Merck for initiation of a Phase 1 trial for our anti-CD27 antibody.

Research and development expenses were $20.1 million for the first quarter of 2018 compared to $20.6 million for the same period in 2017. The decrease of $0.5 million was due to lower contract manufacturing expense of $3.1 million primarily related to BION-1301, partially offset by increases in clinical development and contract research expenses for our ongoing programs including ADU-S100, BION-1301, ADU-1604 and our personalized neoantigen-based immunotherapy, as well as increases in stock-based compensation and personnel related expenses.

General and administrative expenses were $9.0 million for the first quarter of 2018 compared to $8.3 million for the same period in 2017. The increase of $0.7 million was driven primarily by legal fees associated with our patent portfolio and higher stock-based compensation expense, partially offset by decreased compensation expense.

Income tax benefit was approximately $21 thousand for the first quarter of 2018 compared to an income tax benefit of $2.8 million for the same period in 2017. The income tax benefit for 2017 related to federal income tax benefit associated with the carryback of the 2017 losses.

On May 2, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported financial results and a corporate update for the first quarter ended March 31, 2018 (Press release, Immune Design, MAY 2, 2018, View Source [SID1234525968]).

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"The plan to start patient enrollment by mid-year in our pivotal Phase 3 of CMB305 in synovial sarcoma is on track. Moreover, G100 is emerging as an exciting, active immunotherapeutic molecule with great potential," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "The continued progress in our programs increases our confidence in Immune Design’s strategies, differentiation and potential in an underserved immuno-oncology space."

Recent Highlights

CMB305: novel prime-boost targeting NY-ESO-1+ cancers

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The higher dose of CMB305 (4x the vector component compared to earlier clinical studies) was found to be safe by a data monitoring committee and cleared to move forward into the planned pivotal Phase 3 trial in frontline maintenance in synovial sarcoma patients.

G100: novel, synthetic TLR4 agonist for intratumoral therapy

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Updated data in follicular lymphoma patients show that a higher dose of G100 (20ug, 2x the dose studied in the ongoing randomized study with pembrolizumab) has increased activity, as defined by a two-fold increase in tumor infiltrating lymphocytes (TILs) pre- vs. post-G100 treatment.
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Immune Design is planning to interact with the FDA regarding next steps for development of G100.

Financial Results

First Quarter

Immune Design ended the first quarter of 2018 with $131.0 million in cash and cash equivalents, short-term investments, and other receivables compared to $144.2 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $16.4 million.

Net loss and net loss per share for the first quarter of 2018 were $13.3 million and $0.28, respectively, compared to 12.6 million and $0.50, respectively, for the first quarter of 2017.

Revenue for the first quarter of 2018 was $0.5 million and was primarily attributable to the Sanofi G103 HSV2 vaccine collaboration. Revenue for the first quarter of 2017 was $5.5 million and was primarily attributable to $5.2 million in collaboration revenue associated with the Sanofi G103 collaboration and $0.3 million in product sales to other third parties.

Research and development expenses for the first quarter of 2018 were $10.3 million, compared to $14.0 million for the same period in 2017. The $3.7 million decrease was primarily attributable to a decrease of $4.8 million in contract manufacturing costs related both internal and collaboration programs. Offsetting this decrease was an increase of $1.1 million in personnel-related and other research and development expenses.

General and administrative expenses for the first quarter of 2018 were $4.0 million, relatively consistent with general and administrative expenses of $4.1 million recorded in the first quarter of 2017.

Cash Guidance

Based on current expectations, Immune Design expects to have cash to fund operations into the second half of 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss first quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code 1088768.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On May 2, 2018 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present at the following conferences (Press release, Cel-Sci, MAY 2, 2018, View Source [SID1234525987]):

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Mr. Kersten’s presentation will be available in the Investor Relations section of the Company’s website at www.cel-sci.com/investor_relations.html.

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The NYC Oncology Investor Conference 2018 hosted by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, Wilson Sonsini Law Firm, Torreya Partners, and Marcum is the leading conference for early-stage private and public cancer investing.