On December 20, 2018 Novartis reported that Susanne Schaffert, Ph.D., currently President, Advanced Accelerator Applications (AAA), a Novartis company, has been appointed CEO Novartis Oncology (Press release, Novartis, DEC 20, 2018, View Source [SID1234532213]). She will report to Vas Narasimhan, CEO, Novartis, and will join the Executive Committee on January 1, 2019. Liz Barrett will be stepping down as CEO of Novartis Oncology effective December 31, 2018.

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Vas Narasimhan, CEO, Novartis, said: "I would like to thank Liz for her leadership and her contributions to our business and our patients this past year. She made a significant positive impact on the organization in a relatively short time and I wish her the very best in her future endeavors. As testament to our pipeline of talent, I am delighted that Susanne Schaffert, current president of AAA and a long-time Oncology and Novartis executive, has accepted the role of CEO, Oncology. Susanne is a successful business leader with very deep expertise in Oncology, an unwavering commitment to patients, and a strong track record of inspiring talent and building empowered, high performing organizations. She has our full support and confidence as we continue to invest in both our internal pipeline as well as external assets to strengthen our presence."

Regarding her appointment, Susanne Schaffert said: "Becoming CEO of Novartis Oncology is a great honor and I am humbled to be given the opportunity to lead one of the top-tier oncology businesses in the world. There is still much work to be done to help people with cancer live longer and better lives and I am excited to reimagine medicine together with my colleagues at Novartis."

Susanne Schaffert joined Novartis more than 20 years ago and has spent the last six years in the Oncology business in leadership roles, including Region Head, Novartis Oncology Europe, where she led that organization through 5 years of sustained growth (excluding Glivec which lost exclusivity during this period). Earlier this year she was appointed President, AAA, launching Lutathera, a radioligand therapy for the treatment of certain cancers, in the U.S. and E.U. Also during her tenure in Oncology, she was instrumental in the GSK Oncology integration and served on the Board of Directors of the Consumer Health joint venture between Novartis and GSK until early 2018. In addition, Susanne was Head of Investor Relations, Novartis, from 2010-2013. She transitioned back to Oncology in 2013, and has been a member of the Global Novartis Oncology Leadership Team since then. Prior to 2010, Susanne worked in Sales and Marketing in both the pharmaceuticals and oncology business units. She received her master’s degree and PhD in chemistry from University Erlangen, Germany.

Liz Barrett said: "After much personal reflection, it became clear that my family would be unable to relocate to Basel where the Oncology headquarters is based. Therefore, I decided to accept a new role as CEO of a U.S. based biotech. I want to thank Vas for the opportunity to work at this great company and to everyone in Oncology for their commitment to transforming cancer for patients and their families. I am confident that under Susanne’s leadership, Novartis will continue to expand its impact in Oncology."

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "will," "commitment," "continue," "pipeline," or similar expressions, or by express or implied discussions regarding potential future sales or earnings of the Novartis Group. You should not place undue reliance on these statements. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying

assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. There can be no guarantee that Novartis will be commercially successful in the future, or achieve any particular financial results. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the significant acquisitions, divestments and reorganizations of recent years may not be realized or may take longer to realize than expected; the uncertainties inherent in the research and development of new healthcare products; our ability to obtain or maintain proprietary intellectual property protection on key products; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; uncertainties regarding actual or potential legal proceedings; and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise

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 Novartis reported an offer to acquire CellforCure from LFB. CellforCure, a French company, is one of the first and largest contract development and manufacturing organizations (CDMO) producing cell and gene therapies in Europe (Press release, Novartis, DEC 20, 2018, View Source [SID1234532214]).

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Under the proposed agreement, Novartis would acquire the share capital of CellforCure from LFB including the cell and gene manufacturing facility located in Les Ulis and the related adjacent land. If the offer is accepted, CellforCure would become a wholly owned Novartis manufacturing site, joining the network of cell and gene therapy sites including Morris Plains, New Jersey, USA and Stein, Switzerland, where construction continues to progress as planned.

In July 2018, Novartis announced that it had signed an agreement with CellforCure to produce CAR-T cell therapies including Kymriah (tisagenlecleucel), the first CAR-T cell therapy approved by the United States Food and Drug Administration (FDA) and indicated for two distinct, difficult-to-treat cancers in the United States, European Union, Switzerland, Canada and Australia. Novartis and CellforCure have successfully completed technology transfer and Kymriah clinical supply production is expected to begin by mid-2019. The proposed acquisition of CellforCure is another example of continued commitment by Novartis to investing in cell and gene therapies as well as in France.

Novartis has made several steps recently to strengthen and expand its cell and gene manufacturing, including signing a strategic licensing, collaboration and share purchase agreement with Cellular Biomedicine Group (CBMG) to manufacture and supply Kymriah in China; expanding an alliance with the Fraunhofer Institute in Germany to support manufacturing for clinical trials and post approval manufacturing; and a contract manufacturing collaboration in Japan.

Novartis Global Head of Technical Operations Steffen Lang said, "The proposed acquisition of CellforCure is another strategic step in our pursuit of additional manufacturing capacity to make our transformational CAR-T cell therapy Kymriah available to more patients in need around the world. If completed, this acquisition also would potentially increase manufacturing capacity for other cell and gene therapies in the Novartis pipeline. We are excited about the possibility of adding the significant experience of CellforCure to our existing leadership in pioneering research, development and supply of cell and gene therapies."

The transaction is subject to usual and customary closing conditions, including employee consultation process and necessary regulatory approvals. If approved, the transaction is expected to be funded through available cash and close in the first half of 2019.

CellforCure is an LFB group company specializing in innovative therapy drugs. CellforCure`s industrial platform located in Les Ulis, near Paris is one of the first and largest in Europe for the production of cell and gene therapy drugs. Established as a pharmaceutical company since 2013, CellforCure operates a Contract Development and Manufacturing Organization. The company obtained two Good Manufacturing Practice (GMP) certificates from the French Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) in 2016 for the production of innovative experimental and commercial therapy drugs.

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 AskAt reported that it received a notice of allowance dated December 11, 2018 from Canadian Intellectual Property Office (CIPO) in connection with the Application No. 3,000,237, Use of EP4 receptor antagonists for the treatment of NASH-associated liver cancer (Press release, AskAt, DEC 20, 2018, View Source [SID1234535042]).

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