On May 2, 2018 Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company developing cutting-edge CAR-T optimization and oncology treatments, reported that preclinical findings on lenzilumab’s potential as a new strategy to increase the safety and efficacy of chimeric antigen receptor T-cell (CAR-T) therapy were presented at The Essential Protein Engineering Summit (PEGS) by Dr. Saad Kenderian, director, T cell engineering program at Mayo Clinic (Press release, Humanigen, MAY 2, 2018, View Source [SID1234525967]).

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Lenzilumab is a first-in-class Humaneered recombinant monoclonal antibody that targets and is an antagonist of soluble granulocyte-macrophage colony-stimulating factor (GM-CSF). Neutralization of circulating GM-CSF has the potential to blunt or prevent an inflammatory cascade that can result in serious and life-threatening CAR-T-induced side effects – neurotoxicity and Cytokine Release Syndrome – and possibly boost efficacy of CAR-T therapy. Improved treatment response could come through increased expansion of CAR-T, as seen in the ZUMA-1 pivotal trial.

The PEGS presentation on May 1 highlighted findings from preclinical studies using validated animal models. The key findings included:

Lenzilumab effectively neutralizes GM-CSF.
Lenzilumab does not inhibit CAR-T efficacy in vivo, as CAR-T plus lenzilumab exhibited an improved rate of survival compared to a control in the same mouse xenograft model.
GM-CSF depletion by lenzilumab may increase CAR-T expansion in vivo, as a more robust proliferation was observed after adding lenzilumab.
"There’s significant need for new science to find therapeutic combinations to improve the safety and efficacy of CAR-T therapy. These encouraging findings reinforce our belief that lenzilumab has the potential to make CAR-T safer, better and more routine in the treatment of cancer," said Cameron Durrant, M.D., chairman and chief executive officer of Humanigen. "We look forward to starting clinical work soon with the goal of improving this groundbreaking treatment for patients."

The company anticipates commencing a potentially pivotal phase I/II trial of lenzilumab as a prophylactic therapy prior to CAR-T infusion to optimize treatment and minimize or prevent neurotoxicity associated with CAR-T cancer therapy in the summer of 2018.

About Lenzilumab

Lenzilumab is a first-in-class, novel Humaneered recombinant monoclonal antibody designed to target and neutralize circulating granulocyte-macrophage colony-stimulating factor (GM-CSF), the myeloid inflammation factor involved in the recruitment of myeloid cells to a tumor and a central actor in leukocyte differentiation, autoimmunity and inflammation. There is also extensive evidence linking GM-CSF expression to serious and potentially life-threatening side effects in chimeric antigen receptor T-cell (CAR-T) therapy, such as neurotoxicity and Cytokine Release Syndrome (CRS). Humanigen is working with leading CAR-T experts to develop lenzilumab as a potential prophylactic therapy to optimize treatment and minimize or prevent neurotoxicity associated with CAR-T cancer therapy. In addition, lenzilumab is currently being evaluated as a potential treatment for rare leukemias in a phase I trial (NCT02546284) in patients with chronic myelomonocytic leukemia (CMML), with additional potential in juvenile myelomonocytic leukemia (JMML), a rare pediatric cancer. In previous clinical trials, lenzilumab has shown to be safe and well tolerated in more than 100 patients, including those with rheumatoid arthritis, asthma and healthy volunteers. It is a potent inhibitor of GM-CSF in vivo

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 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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