On December 20, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2018 (Press release, Cel-Sci, DEC 20, 2018, View Source [SID1234532199]). The Company also reported key clinical and corporate developments achieved during fiscal 2018.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016.
The Phase 3 head and neck cancer study’s Independent Data Monitoring Committee (IDMC) completed two reviews of the data from all 928 patients enrolled in the study in December 2017 and August 2018. The IDMC recommended continuing the study as constituted.
CEL-SCI won its arbitration against the clinical research organization (CRO) inVentiv that ran the Phase 3 head and neck cancer study from 2011-2013. The arbitrator ruled that inVentiv materially breached its contract with CEL-SCI. The arbitrator’s decision vindicated CEL-SCI. This successful conclusion ended a difficult period of time for CEL-SCI, and enabled the Company to move forward with a clean slate.
CEL-SCI started work designed to support the use of its first LEAPS vaccine product candidate, CEL-4000, in human studies for the treatment of rheumatoid arthritis, which will be conducted subject to an Investigational New Drug (IND) application. This work is supported by a $1.5 million grant received from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
CEL-SCI fortified its patent portfolio with three new patents for LEAPS and Multikine. The European Patent Office issued a new Multikine patent titled "A Method for Modulating HLA Class II Tumor Cell Surface Expression With A Cytokine Mixture". This patent addresses Multikine’s mechanism of action to make tumors more visible to the immune system. The U.S. Patent and Trademark Office allowed two new patents for the LEAPS platform technology titled "Method for Inducing an Immune Response and Formulations Thereof" and "Method for Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9 influenza viruses and formulations". These patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
CEL-SCI raised approximately $21.4 million in gross proceeds during fiscal 2018 through the sale of stock and the exercise of warrants. This left CEL-SCI with about $10.3 million in cash on September 30, 2018.
"We are awaiting a readout of topline results from our Phase 3 head and neck cancer study, the largest of its kind in the world. Results are expected to be available soon. We cannot give a definite time table since we have to wait for 298 events to occur. If Multikine meets it primary endpoint, we believe it may change the way head and neck cancer is treated. We are hopeful that in addition to prolonging life for newly diagnosed patients, Multikine may significantly improve their quality of life by reaping the benefits of immunotherapy before surgery, chemotherapy and radiation therapy degrade their immune systems," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of $31.84 million in fiscal year 2018 versus a net loss of $14.36 million in fiscal 2017. The increased net loss in 2018 was mainly due to the non-cash derivative loss of approximately $8.6 million recorded during the year ended September 30, 2018 and the approximate $4.8 million non-cash portion of the interest expense. The derivative loss was the result of the change in fair value of the derivative liabilities due to an increase in CEL-SCI’s share price.

The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.

On December 20, 2018 Kleo Pharmaceuticals Inc., a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics, reported that its Chief Executive Officer, Douglas J. Manion M.D. FRCP(C), will present at Biotech Showcase 2019 to be held January 6-9, 2019, at the Hilton San Francisco Union Square (Press release, Kleo Pharmaceuticals, DEC 20, 2018, View Source [SID1234532185]).

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Dr. Manion will present an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including the three proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline, and its discovery collaboration with PeptiDream.

Kleo is well-funded to achieve multiple preclinical and early clinical milestones following the November 2018 closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020.

Details of Kleo’s presentation are as follows:

Event:

Biotech Showcase 2019
Date: Monday, January 7, 2019
Time: 10:45 a.m. (Pacific Time)
Location:Franciscan B Ballroom; Hilton San Francisco Union Square

On December 20, 2018 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that Saqib Islam, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 7, 2019, at 10:30 a.m. Pacific Standard Time (Press release, SpringWorks Therapeutics, DEC 20, 2018, View Source [SID1234532200]).

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On December 20, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported that it has raised an additional $134 million in a second tranche of its Series C financing, bringing the total amount raised to $284 million (Press release, Rakuten Aspyrian, DEC 20, 2018, View Source [SID1234532217]). New investors include the SBI Group, Japan and Rakuten Inc. Rakuten Aspyrian has raised approximately $372 million in equity since it was founded in 2015.

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"My unwavering confidence in the vision and potential of Rakuten Aspyrian’s Photoimmunotherapy platform has grown tremendously and was the impetus behind my further financial investment in the company," said Mickey Mikitani, CEO of Rakuten Aspyrian. "Our entire organization is committed to developing treatments for cancer patients and we will continue pressing forward with our corporate mission of conquering cancer."

"We are excited to support Rakuten Aspyrian, and strongly believe in the potential of its Photoimmunotherapy platform, which the company is studying in clinical trials for the selective destruction of cancer cells with minimal effects on normal cells developed by Dr. Hisataka Kobayashi of the Center for Cancer Research at the National Institutes of Health," said Mr. Yoshitaka Kitao, representative director, president & CEO of SBI Holdings.

The Series C financing supports the advancement of Rakuten Aspyrian’s proprietary investigational compound, ASP-1929 Photoimmunotherapy, currently in Phase 3 development for the treatment of patients with recurrent local regional head and neck squamous cell carcinomas (HNSCC), and new proof-of-concept Phase 1/2 studies in additional solid tumors to be initiated in early 2019. The financing will also support manufacturing processes to support the initial launch and commercialization of ASP-1929 if approved in the United States, Japan and Europe. The company also announced that it has established its corporate headquarters in San Mateo, California, where it will expand clinical, commercial and corporate functions.

"With this financing, we have expanded our team and footprint: We have established our corporate headquarters in San Mateo, California, where we will execute on our goal of building a full-fledged pharmaceutical company, and will continue advancing a number of our photoimmunotherapy programs in various cancer types," said Takashi Toraishi, Ph.D., President and Chief Operating Officer of Rakuten Aspyrian. "In addition, proceeds from this financing will support continued development of our lead program, ASP-1929, which we recently announced has entered into a global, pivotal Phase 3 clinical trial for head and neck cancer. We thank our generous investors for their belief and support of Rakuten Aspyrian as we continue executing on our mission."

About ASP-1929 Photoimmunotherapy
ASP-1929, a conjugate of cetuximab and IRDye 700DX, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which the compound is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures. ASP-1929 received Fast Track designation by the U. S. Food and Drug Administration for the treatment of HNSCC.

Interim results of a Phase 1/2 trial in patients with HNSCC showed a clinically meaningful improvement in the objective response rate, and potential improvements in progression free survival and overall survival when compared to historical data for the standard of care treatments currently available to this patient population. Top line results of the ASP-1929 Phase 1/2 trial are expected in the first quarter of 2019.

ASP-1929 is an investigational compound that is not approved for any use in any country.

On December 19, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) reported its Chairman and Chief Executive Officer, Richard M. Glickman, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00am PST, 1pm EST (Press release, Aurinia Pharmaceuticals, DEC 19, 2018, View Source [SID1234532132]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of will also be archived on the site following the event.