On January 8, 2018 Eagle Pharmaceuticals presented Presentation of the Company dated January 2018 (Press release, Eagle Pharmaceuticals, JAN 8, 2018, View Source [SID1234522995]).

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On January 8, 2018 Fibrogen presented its Corporate Presentation (Presentation, FibroGen, JAN 8, 2018, View Source [SID1234523007]).

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On January 8, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported it has received a milestone payment from MedImmune as MEDI0457 (formerly called INO-3112 which MedImmune in-licensed from Inovio) in combination with durvalumab (MEDI4736) satisfactorily completed the phase 1 safety review portion of the study and has advanced to the phase 2 efficacy stage of the trial (Press release, Inovio, JAN 8, 2018, View Source [SID1234523010]). As part of a $700 million 2015 license and collaboration agreement, MedImmune, the global biologics research and development arm of AstraZeneca, is evaluating MEDI0457 in combination with durvalumab, its PD-L1 checkpoint inhibitor, in patients with recurrent/metastatic HPV-associated head and neck squamous cancer (HNSCC) in a clinical trial with an estimated enrollment of 50 patients.

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Under the 2015 agreement, MedImmune acquired exclusive rights to Inovio’s MEDI0457 immunotherapy. MEDI0457 targets cancers caused by human papillomavirus (HPV) types 16 and 18 which are responsible for more than 70 percent of cervical pre-cancers and cancers and are involved in the development of other tumors as well such as HNSCC. Within the broader license and collaboration agreement, MedImmune and Inovio will develop two additional DNA-based cancer therapy products not included in Inovio’s current product pipeline, which MedImmune has exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

Dr. Ildiko Csiki, MD, PhD, Inovio Vice President, Clinical Development said, "We are pleased to see this combination study advance to the efficacy portion of the trial. Published preclinical studies suggest that treatment with HPV targeted immunotherapeutic approach in combination with PD-1/PD-L1 inhibition may be synergistic, and potentially increase efficacy of checkpoint inhibitors."

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "Inovio’s primary goal is to become the global leader in HPV-related disease treatment. Along with MEDI’s development of MEDI0457 for HPV-related cancer, Inovio’s VGX-3100, is currently being tested in global phase 3 pivotal trials for cervical pre-cancer as well as a treatment for vulvar and anal pre-cancers caused by HPV. Overall, these products could be well-positioned to comprehensively treat HPV-related diseases across the continuum of HPV infections from pre-cancerous conditions to cancer in both women and men."

In a phase 1 study of MEDI0457 in 22 HPV-positive patients with HNSCC, Inovio has previously demonstrated that MEDI0457 generated robust antigen-specific CD8+ killer T cell responses in both tumor tissue and peripheral blood. One patient in that trial who initially displayed a slight increase in T cell immune responses developed progressive disease at 11 months into the study and subsequently received a PD-1 checkpoint inhibitor. The patient had a sustained complete response after only four doses of a checkpoint inhibitor, and continues on anti PD-1 therapy with no evidence of disease 18 months after initiation of the checkpoint inhibitor.

About MEDI0457 and VGX-3100

MEDI0457 (formerly called INO-3112 (VGX-3100, plus IL-12) which MedImmune in-licensed from Inovio) is under evaluation by MedImmune to treat HPV-associated cancers. Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (phase 3) and vulva (phase 2). VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes destruction of pre-cancerous cells. In a randomized, double-blind, placebo-controlled phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. The most common side effect was injection site pain, and no serious adverse events were reported. VGX-3100 utilizes the patient’s own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts.

On January 7, 2018 Celgene Corporation (NASDAQ:CELG) and Impact Biomedicines reported the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera (Press release, Celgene, JAN 7, 2018, View Source [SID1234522934]). Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

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Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial (JAKARTA-1) for patients with treatment-naïve myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, these improvements were observed regardless of a patient’s baseline platelet count.

A multi-center, single-arm phase II trial (JAKARTA-2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

As previously reported, JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration (FDA) after potential cases of Wernicke’s encephalopathy (WE) were reported in eight out of 877 patients receiving one or more doses (less than one percent of treated patients). The FDA removed the clinical hold in August 2017.

Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in myelofibrosis are planned beginning in the middle of 2018.

"Myelofibrosis is a disease with high unmet medical need as the number of patients who are ineligible for or become resistant to existing therapy continues to increase," said Nadim Ahmed, President, Hematology and Oncology for Celgene. "We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets."

"We launched Impact Biomedicines and based on our thorough review of the data, fedratinib presents a compelling risk benefit profile in both treatment-naïve patients and patients who are resistant or intolerant to other JAK2 therapies," said Dr. John Hood, Chief Executive Officer of Impact. "We believe Celgene is the ideal organization to follow through on our mission of maximizing fedratinib’s potential for patients with myelofibrosis."

Deal Terms

Under the terms of the agreement, Celgene will make an upfront cash payment of approximately $1.1 billion. In addition, Impact Biomedicines’ shareholders are eligible to receive contingent payments based on regulatory approval and sales-based milestones. The maximum aggregate amount payable for regulatory approval milestones is $1.4 billion relating to approvals for myelofibrosis and other indications. Starting from global annual net sales of $1.0 billion, aggregate tiered sales-based milestone payments could total a maximum of $4.5 billion if global annual net sales exceed $5.0 billion.

Credit Suisse acted as financial advisor and Hogan Lovells acted as legal counsel to Celgene on the transaction. PJT Partners acted as exclusive financial advisor and Latham & Watkins acted as exclusive legal counsel to Impact Biomedicines on the transaction. The acquisition is subject to customary closing conditions and applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act. The transaction is expected to close in the first quarter of 2018.

On January 7, 2018 Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 Oncology reported the signing of new development, manufacturing, and supply agreements with plans to complete a new cGMP manufacturing facility in Shenzhen in support of large scale lentivirus contract manufacturing (Press release, EXUMA Biotechnology, JAN 7, 2018, View Source [SID1234619679]). The new facility, Shenzhen Biowit, which will expand from the current clinical production staff and site in Shenzhen, is scheduled for completion in 2018 and will utilize F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology and processes. The Shenzhen Biowit facility, in collaboration with F1 Oncology’s Hong Kong affiliate, will support future China gene therapy markets with clinical and commercial cGMP lentivirus for CAR-T and other gene therapies.

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The new collaboration agreements between F1 Oncology’s international affiliates and Sinobioway Sunterra Biotechnology will facilitate clinical development and commercialization of F1 Oncology’s CCT3-based conditionally active biologic chimeric antigen receptor T cell (CAB-CAR-T) products in China, Hong Kong, Macau, and Taiwan. F1 Oncology retains rights to CCT3 products in all other territories and exclusive responsibility for global manufacturing and supply of certain product classes.

Upon SSSB’s closing of certain financing activities, SSSB will issue to F1 Oncology 20% equity plus 5% warrants. F1 Oncology will be responsible for lead generation, preclinical safety assessment and clinical virus manufacturing costs. Sinobioway Sunterra Biotechnology will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialization in the defined territories.

The agreement provides for certain licensing fees to be paid by SSSB upon nomination of new CAR-T products with preclinical packages delivered to SSSB for commercialization. The agreement further provides for processing of raw materials provided by F1 Oncology’s international affiliates and production to supply commercial products to the China markets.

"Biowit, a subsidiary of SSSB, has been providing the majority of cell therapy research institutions in China with virus products service over the past 7 years. Today, the introduction of F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology marks a new stage of China clinical virus manufacturing. Through our one year-old collaboration, Sunterra is leveraging the value of F1 Oncology’s CAB-CAR-T technology and proprietary industrial manufacturing processes to begin novel CAR-T clinical trials in China. We are confident that F1 Oncology’s differentiating technologies will allow us to stand out from other players in the CAR-T solid tumor space." Stated Mr. Wu Zili, Board Director and founder of SSSB.

"Reliable supply of viral gene vectors for cell and gene therapy programs is a current and growing challenge for the commercial biotechnology industry, and generally requires a different facility configuration to those used for traditional biologics" stated Tim Mayall, Ph.D. Head of Process Development at F1 Oncology. "Our early investments in the generation of serum-free well-characterized cell substrates capable of suspension-based lentivirus production supports a scalability that we believe will be beneficial from first in human through commercialization."