On January 8, 2018 Seattle Genetics, Inc. (NASDAQ: SGEN) reported the progress of its pipeline of antibody-drug conjugates (ADCs) at the 36th Annual J.P. Morgan Healthcare Conference (Press release, Seattle Genetics, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325358 [SID1234523020]). Through both internal efforts and that of its collaborators, the company’s ADC technology is being employed in more than 20 programs in clinical trials, including multiple late-state development programs across hematologic malignancies and solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"ADCs continue to advance as an important therapeutic modality, both as single agents and as part of various combination regimens, across hematologic malignancies and solid tumors," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are the industry leader in ADC technology driven by our scientific expertise in monoclonal antibodies, drug payloads and stable linker technologies. Our leadership is further illustrated by the continued clinical and commercial expansion of ADCETRIS (brentuximab vedotin), progress with our late-stage programs enfortumab vedotin and tisotumab vedotin, and the breadth of our pipeline of other ADCs and empowered antibodies. In addition, our collaborators are making significant advances with several programs using our technology. ADCs are an integral part of an evolving cancer treatment paradigm, and we are committed to bringing important new treatments to patients in need."

ADCETRIS, which pioneered a new class of ADCs, is commercially available in 70 countries worldwide and generated more than $600 million in global sales in 2017. On January 2, 2018, the company announced that the FDA accepted for filing a supplemental Biologics License Application (BLA) for ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018. The submission of the supplemental BLA is based on positive results from a phase 3 clinical trial called ECHELON-1. In October 2017, the FDA granted Breakthrough Therapy Designation (BTD) for ADCETRIS in frontline advanced Hodgkin lymphoma based on the ECHELON-1 study results.

In addition to advancing ADCETRIS, Seattle Genetics and its collaborator Astellas have initiated a pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The study is designed to support potential registration under the FDA’s accelerated approval regulations. In addition, Seattle Genetics, in collaboration with its development partner Genmab, plans to initiate a phase 2 clinical trial of tisotumab vedotin for patients with recurrent and/or metastatic cervical cancer. This study is intended to support potential registration under the FDA’s accelerated approval regulations.

Seattle Genetics’ ADC technologies are also empowering several collaborator programs in late-stage clinical trials. These include:

GSK2857916, an ADC being developed by GlaxoSmithKline (GSK) for multiple myeloma. GSK recently reported encouraging data from the program at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017;
Polatuzumab vedotin, an ADC being developed by Genentech/Roche. Positive results were presented at ASH (Free ASH Whitepaper) from a phase 2 trial in advanced-stage diffuse large B-cell lymphoma. A phase 3 trial is underway; and,
Depatuxizumab mafodotin, an ADC for glioblastoma in development by AbbVie. Encouraging data have been reported from this ADC, which is currently in a phase 3 clinical trial.
Polatuzumab vedotin and GSK2857916 have both received BTD from the FDA and PRIority MEDicines (PRIME) designations from the European Medicines Agency. These designations signify the importance of therapies such as these in addressing significant unmet medical need.

"Through our robust internal development efforts and our strong licensing and co-development agreements, we are extending the potential of ADCs globally. We look forward to future results of studies that include Seattle Genetics’ novel technologies both as monotherapies, as well as in combination with checkpoint inhibitors and other agents," said Dr. Siegall.

In 2018, Seattle Genetics anticipates several milestones, including:

Working with FDA towards the May 1 PDUFA action date for ADCETRIS in combination with chemotherapy for frontline treatment of patients with advanced classical Hodgkin lymphoma;
Reporting ECHELON-2 data of ADCETRIS in combination therapy in frontline CD30-expressing mature T-cell lymphoma (MTCL);
Continuing enrollment of the enfortumab vedotin (EV) pivotal trial in locally advanced or metastatic urothelial cancer patients previously treated with a checkpoint inhibitor;
Continuing enrollment of the EV phase 1b trial in combination with checkpoint inhibitors, for patients with locally advanced or metastatic urothelial cancer;
Initiating a phase 2 trial of tisotumab vedotin (TV) in recurrent and/or metastatic cervical cancer to potentially support registration; and,
Initiating a phase 2 trial of TV as part of a combination regimen for first-line cervical cancer and a phase 2 trial of TV in other solid tumor types;
Initiating multiple trials evaluating ladiratuzumab vedotin in combination with checkpoint inhibitors in metastatic triple negative breast cancer, as well as evaluation as a neoadjuvant therapy for early breast cancer as part of the I-SPY consortium.
ADCETRIS is currently not approved for the frontline treatment of MTCL or Hodgkin lymphoma.

On January 8, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) and APEIRON Biologics AG, a company focused on cancer immunotherapy, reported that the companies received the first milestone payment from Sanofi under a 3-party alliance signed in August 2015 (Press release, Evotec, JAN 8, 2018, View Source [SID1234522936]). The milestone payment of EUR 3 m will be split equally between the two biotech companies. The success payment was triggered when the partners successfully advanced an undisclosed, novel immuno-oncology small molecule into late-stage pre-clinical development. Under the alliance, the three companies work together to identify small molecule leads and targets for next-generation therapies in immuno-oncology, which may complement the pre-clinical and clinical profiles of leading checkpoint inhibitors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "The Evotec and APEIRON teams are proud to have achieved our first milestone with Sanofi to discover and develop novel immuno-oncology small molecules therapies. It is a first-in-class approach with tremendous potential in combination with marketed checkpoint inhibitors but also as standalone therapy. The field of immuno-oncology will continue to evolve and at Evotec we will continue to invest in this area."

Dr Hans Loibner, Chief Executive Officer of APEIRON Biologics, said: "We are delighted by the progress made in our collaboration with Evotec and Sanofi. Based on our scientific findings and the mode of action, we jointly agreed to accelerate the research and pre-clinical development of this very promising molecule. The successful achievement of this milestone further demonstrates our abilities to drive innovation in the field of immuno-oncology."

ABOUT THE EVOTEC-APEIRON-SANOFI-ALLIANCE
The strategic collaboration was set up in 2015 to support the long-term pipeline building for Evotec, APEIRON Biologics and Sanofi and has a potential value of over EUR 200 m in milestone payments and significant royalties. The collaboration includes major research and development efforts to advance a first-in-class orally available small molecule approach based on a novel target to treat solid and hematopoietic cancers by enhancing the anti-tumor activity of human immune cells. All three companies are making significant contributions to this collaboration in terms of scientific expertise, technological platforms and resources. The collaboration will further enhance and complement Sanofi’s extensive oncology portfolio and enables Evotec to address the drug discovery area of immuno-oncology. Furthermore, the agreement will substantially support APEIRON’s strategy of focusing on novel and innovative checkpoint inhibiting approaches.

On January 9, 2018 Amgen Astellas BioPharma K.K. (Headquarters Tokyo; President and Representative Director Steve Sugino "Amgen Astellas BioPharma") and Astellas Pharma Inc. (Headquarters Tokyo; President and CEO Yoshihiko Hatanaka "Astellas") reported that an application was submitted in Japan for the marketing authorization for bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct blinatumomab (Genetically Recombination) (generic name, development code: AMG 103, "blinatumomab") to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) (Press release, Astellas, JAN 8, 2018, View Source [SID1234522970]). In Japan, blinatumomab is jointly developed by Amgen Astellas BioPharma and Astellas.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ALL affects approximately 5,000 patients in Japan1, out of which an estimated 670 per year have relapsed or refractory ALL2,3,4. There are several limitations to current treatment options, including their limited efficacy in adult and pediatric patients with relapsed or refractory ALL and dependency on a limited number of drugs with similar mechanisms of action. Improved outcomes for relapsed or refractory ALL patients calls for the development of drugs such as blinatumomab which demonstrate efficacy as a monotherapy and have mechanisms of action dissimilar to cytotoxic agents.

The submission of application for marketing approval in Japan was based on the results from multiple global clinical studies including the Phase 3 randomized study (TOWER study), and the Japanese Phase 1b/2 study. In the TOWER study, blinatumomab was shown to extend overall survival compared to standard-of-care (SOC) chemotherapy in adult patients with relapsed or refractory ALL. Blinatumomab is considered to have the potential to address the serious unmet medical needs of ALL patients.

Blinatumomab received Orphan Drug designation from the Ministry of Health, Labour and Welfare effective September 29, 2017.

About Blinatumomab

Blinatumomab (genetically recombinant antibody) is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. Blinatumomab was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration, and is now approved in the U.S. for the treatment of relapsed or refractory B-cell precursor ALL in adult and pediatric patients. In November 2015, the EU granted conditional marketing authorization for blinatumomab for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. AmgenInc. is seeking to gain approval for blinatumomab in countries around the world.

TOWER Study

The TOWER study was a Phase 3 randomized study investigating the efficacy of blinatumomab versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL. The study enrolled a difficult-to-treat patient population, which included patients from several stages of relapse. In the blinatumomab arm, this included 35% of patients that had relapsed post-allogenic hematopoietic stem cell transplant (alloHSCT), and excluded those with late first relapse (≥ 12 months after initial remission). Patients were randomized in a 2:1 ratio to receive blinatumomab (n = 271) or one treatment with investigator’s choice out of 4 types of SOC chemotherapy regimens (n = 134). The determination of efficacy was based on overall survival. Per the recommendation of the data monitoring committee, the study was ended early for evidence of superior OS in the blinatumomab arm vs SOC chemotherapy from the pre-specified interim analysis.

These results are published in the New England Journal of Medicine.5

About BiTE Technology

Bispecific T cell engager (BiTE) antibody constructs are being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers. For more information, visit www.biteantibodies.com.

About Amgen’s Commitment to Oncology

Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

On January 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, reported that Christopher O’Brien, M.D., Chief Medical Officer, has notified the Company he plans to retire in February 2018, after a transition period with his successor (Press release, Neurocrine Biosciences, JAN 7, 2018, View Source;p=RssLanding&cat=news&id=2325239 [SID1234522940]). Dr. O’Brien joined Neurocrine in 2005, and has led the clinical development and medical affairs activities for more than 12 years. Dr. O’Brien will remain as an exclusive consultant for Neurocrine.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"On behalf of the board, shareholders and our employees, I want to thank Chris for his tremendous contributions as Chief Medical Officer of Neurocrine," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With his considerable expertise and leadership, we successfully developed and obtained FDA approval of INGREZZA capsules for the treatment of adults with tardive dyskinesia and advanced our clinical development programs for Tourette syndrome, Parkinson’s disease, endometriosis and congenital adrenal hyperplasia. I am very pleased that Chris will continue to be a part of the Neurocrine team for the foreseeable future."

Eiry W. Roberts, M.D., will join the company as Chief Medical Officer, effective January 8, 2018.

"We are very pleased to welcome Eiry to Neurocrine as she brings extensive senior leadership and pharmaceutical management experience to the team," Dr. Gorman said. "Eiry’s strong background in implementing strategic clinical development programs and navigating the regulatory approvals process across phases of drug development from research to commercialization in multiple therapeutic areas, including neuroscience, will be valuable as we execute on our commercialization and clinical plans and advance our pipeline in support of our commitment to relieve patient suffering and enhance lives."

Dr. Roberts has over 25 years of research and development experience in the pharmaceutical industry across all phases of drug development from research through commercialization in multiple therapeutic areas, including neuroscience, inflammation, oncology and metabolic diseases. She joins Neurocrine from Eli Lilly and Company where she held various positions during her tenure, including Vice President, Clinical Pharmacology and Vice President of R&D, BioMedicines Business Unit.

Dr. Roberts was the Chair of the Medical Review Committee, where she was responsible for review and approval of all the integrated clinical plans for molecules in the Lilly portfolio. She was also a member of Lilly’s Corporate Portfolio Management Committee and Lilly Ventures Steering Committee. Dr. Roberts was accountable for early clinical development programs across all therapeutic areas within Lilly, as well as registration for new chemical entities and biproducts in Phase III development. During her time at Lilly, Dr. Roberts established a new therapeutic area, which resulted in the development of five potential novel medicines from Phase I through to approval, with two of them successfully receiving regulatory approval. Dr. Roberts also has extensive leadership and business development experience, including the management of strategic alliances, business partnerships and venture capital collaborations.

Dr. Roberts is a physician who trained in pharmacology and medicine in the UK, qualifying from the University of London in 1987. Her post-graduate clinical training was in clinical pharmacology and cardiology at St. Bartholomew’s Hospital and the Royal London Hospital.

Neurocrine also announced the grant of an inducement award to Dr. Roberts pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. In connection with her employment by Neurocrine, Dr. Roberts will be granted an inducement award consisting of a stock option to purchase 70,000 shares of Neurocrine common stock. The stock option will vest over a period of four years, with 25% vesting on the first anniversary of its grant date and the balance vesting each month over the remaining three years. Dr. Roberts also received 20,000 restricted stock units which vest in equal increments over four years, with 25% vesting each year. These awards are subject to the terms and conditions of Neurocrine’s Inducement Plan, and will be effective on January 8, 2018. The stock option grant will have an exercise price equal to the closing price of Neurocrine’s common stock on the NASDAQ Global Select Market on that date. These awards were granted as an inducement material to Dr. Roberts’ employment pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.