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 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically identified, reported that it entered into an option to license agreement with Novartis for its investigational agent AL102 in multiple myeloma (Press release, Ayala Pharmaceuticals, DEC 20, 2018, View Source [SID1234532198]). Under the terms of the deal, Ayala will receive a $10 million equity investment from Novartis and is eligible to receive development, clinical, regulatory and commercial milestones along with tiered royalties on net sales of AL102.

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Novartis will conduct certain studies to evaluate AL102 in combination with its B-cell maturation antigen (BCMA) therapies in multiple myeloma. Ayala will provide the drug supply. All development costs associated with the above studies will be fully born by Novartis. Ayala retains worldwide license rights for AL102 for all other indications.

"We are extremely pleased to enter this agreement with Novartis on AL102. Novartis has a strong commitment and expertise in oncology, and a proven record of success in drug development, making them an ideal strategic partner for AL102 in multiple myeloma," said Roni Mamluk, PhD, chief executive officer at Ayala. "This collaboration is important to Ayala as it immediately strengthens our balance sheet, further validates our technology and accelerates the clinical development of AL102 as a combination therapy in hematologic cancers."

AL102 is an oral small-molecule that inhibits gamma secretase, an enzyme which may be targeted to increase levels of BCMA, which is expressed in most multiple myeloma patients. BCMA is actively shed from multiple myeloma cells by gamma secretase, hence its inhibition by AL102 may increase BCMA levels on multiple myeloma cells. Therefore, AL102 is being studied to evaluate its clinical role in enhancing anti-BCMA therapies.

Ayala is committed to developing new targeted therapies for genomically-defined cancers in patient populations with high unmet medical need. In addition to investigating AL102 as an anti-BMCA therapy in multiple myeloma, Ayala is evaluating AL102 as an inhibitor of the Notch pathway in other hematologic cancers.

Multiple myeloma is a rare and aggressive blood cancer that accounts for approximately one percent of all cancers. In the U.S., there are nearly 90,000 people living with, or in remission from, multiple myeloma. Approximately, 26,850 Americans are diagnosed with multiple myeloma each year and 11,240 patient deaths are reported on an annual basis.

On December 20, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission has granted marketing authorisation to provide healthcare professionals with the option to split the first infusion of Darzalex (daratumumab) over two consecutive days (Press release, Johnson & Johnson, DEC 20, 2018, View Source [SID1234532197]).

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"We are committed to the development of new treatments, combinations, and formulations that will support people living with multiple myeloma across the full disease spectrum," said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. "This is an important decision for healthcare professionals and patients, as it provides flexibility in administration that may help address individual patient needs."

The decision was based on data from the Phase 1b EQUULEUS (MMY1001) clinical trial, which demonstrated daratumumab pharmacokinetics concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma.1 The safety profile of daratumumab was comparable when administered initially as a split or single dose.1

The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 19 November 2018.2

#ENDS#

About daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.3 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.4 A subset of myeloid derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.4 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.5,6,7,8,9,10,11,12 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.13,14 For more information, please see www.clinicaltrials.gov.

In Europe, daratumumab is indicated for use in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy, and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.4 For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.15

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.16 More than 45,000 people were diagnosed with multiple myeloma in Europe in 2016, and more than 29,000 patients died.17 Up to half of newly diagnosed patients do not reach five-year survival,18 and almost 29% of patients with multiple myeloma will die within one year of diagnosis.19

Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure.20 Refractory multiple myeloma is when a patient’s disease progresses within 60 days of their last therapy.21,22 Relapsed cancer is when the disease has returned after a period of initial, partial or complete remission.23 While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.24 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.25

On December 20, 2018 Gilead Sciences, Inc. (NASDAQ: GILD) and Agenus Inc. (NASDAQ: AGEN) reported the companies have entered into an immuno-oncology (I-O) partnership focused on the development and commercialization of up to five novel immuno-oncology therapies (Press release, Gilead Sciences, DEC 20, 2018, View Source [SID1234532196]).

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Under the terms of the agreement, Agenus will receive $150 million upon closing, which includes a $120 million upfront cash payment and a $30 million equity investment. The agreement also includes approximately $1.7 billion in potential future fees and milestones. Gilead will receive worldwide exclusive rights to AGEN1423, which has an estimated IND filing by year-end 2018. Gilead will also receive the exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus has filed the IND for AGEN1223 and has an estimated IND filing for AGEN2373 in first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead will also receive right of first negotiation for two additional, undisclosed preclinical programs.

"Recent advances in immuno-oncology have produced unprecedented benefit to patients; however, many people with cancer still require more effective treatment options," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our collaboration with Agenus gives us access to novel and differentiated immune modulating antibodies that will complement our growing oncology portfolio and cell therapy business. We look forward to partnering with the Agenus team."

"Gilead is an ideal partner for Agenus for the rapid advancement of our pipeline," said Garo Armen, PhD, Chairman and CEO, Agenus. "By year end, our discovery platforms will have resulted in six INDs in 2018 and 13 INDs by the 1H2019. Gilead’s established global presence and commitment to disruptive therapies, combined with our track-record in building a broad pipeline in I-O, has the potential to yield breakthrough I-O treatments for patients with cancer."

This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

Agenus Conference Call Information:

Date: Thursday, December 20, 2018
Time: 8:30 a.m. ET
Domestic Dial-in Number: 1-844-492-3727
International Dial-in Number: 1-412-317-5118
Conference ID: Agenus call

The presentation will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website at agenusbio.com or by using the link below. A replay of the webcast will be available on the Agenus website following the conference.

Webcast link: View Source

AGEN1423, AGEN1223 and AGEN2373 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

On December 20, 2018 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported the successful completion of a $400 million Series C financing (Press release, Relay Therapeutics, DEC 20, 2018, View Source [SID1234532195]).

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Relay Therapeutics combines unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry and biology. The integration of these disparate disciplines, tools and cultures enables Relay Therapeutics to overcome challenges that prior attempts have failed to solve and to design therapies against validated but previously intractable targets. Relay Therapeutics’ initial discovery programs in cancer have led to the development of highly selective inhibitors of disease-causing proteins in genomically defined patient populations.

The Series C financing was led by the SoftBank Vision Fund and included participation from additional new investors including Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors GV, Casdin Capital, BVF Partners, EcoR1 Capital, Alexandria Venture Investments, and an affiliate of D.E. Shaw Research also participated in the round.

Proceeds from this financing are anticipated to be used to accelerate the implementation of Relay Therapeutics’ long-term strategy. It will support the expansion of the company’s discovery efforts, advance existing programs into the clinic and bolster its broad platform and diverse team.

"We are at a unique moment in the evolution of drug discovery where we can realize the promise of integrating ever more powerful experimental and computational discovery tools to tackle previously undruggable protein targets. The success of our early programs validates the potential of our platform to create breakthrough therapies that address a broad range of diseases," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics.

"A financing of this magnitude allows Relay Therapeutics to significantly scale and advance both its platform and its pipeline. We are thrilled by the strong support of our investors for our mission, vision and strategy," said Alexis Borisy, Chairman of Relay Therapeutics and Partner at Third Rock Ventures.

"We are proud to support Relay Therapeutics’ world-class team expand its efforts across a larger number of programs and therapeutic areas to develop tomorrow’s life-saving treatments," said Deep Nishar, Senior Managing Partner at SoftBank Investment Advisers, investment adviser to the SoftBank Vision Fund.