On August 29, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) and Seattle Genetics, Inc. (Nasdaq: SGEN) reported that Seattle Genetics, Inc. has exercised its option to co-develop tisotumab vedotin (Press release, Genmab, AUG 29, 2017, View Source [SID1234520327]). The companies originally entered into a commercial license and collaboration agreement in October 2011 under which Seattle Genetics had the right to exercise a co-development option for tisotumab vedotin at the end of Phase I clinical development. Tisotumab vedotin, an antibody-drug conjugate (ADC) targeting tissue factor, is currently being evaluated in Phase I/II clinical studies in solid tumors. Going forward, Genmab and Seattle Genetics will co-develop and share all future costs and profits for tisotumab vedotin on a 50:50 basis.

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"The combination of Genmab’s differentiated HuMax-TF antibody and Seattle Genetics’ clinically-validated antibody-drug conjugate (ADC) technology has resulted in encouraging preliminary data for tisotumab vedotin in selected solid tumors. We very much look forward to working with Seattle Genetics to further develop this exciting first-in-class ADC product," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

"Our ADC partnership with Genmab has generated promising Phase I/II data for tisotumab vedotin in patients with recurrent cervical cancer. As Seattle Genetics opts into co-development of this clinical program, we add another potential product to our strong pipeline," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Together with Genmab, we look forward to advancing tisotumab vedotin for the treatment of solid tumors."

Preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701) were announced in June 2017, demonstrating antitumor activity and manageable safety in recurrent cervical cancer patients. This announcement can be found here. Updated preliminary data from the Phase I/II study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid (Spain), September 8-12, 2017.

Today’s news does not impact the 2017 financial guidance issued by Genmab on May 10, 2017.

About the collaboration
In October 2011, Genmab and Seattle Genetics, Inc. entered into a commercial license and collaboration agreement for ADCs. Under the agreement, Genmab was granted rights to utilize Seattle Genetics ADC technology with its HuMax-TF antibody. Seattle Genetics was granted rights to exercise a co-development and co-commercialization option at the end of Phase I clinical development for tisotumab vedotin. With today’s news Seattle Genetics exercises its option to co-develop tisotumab vedotin and the companies will share all future costs and profits for the product on a 50:50 basis. Seattle Genetics will be responsible for commercialization activities in the US, Canada, and Mexico, while Genmab will be responsible for commercialization activities in all other territories. Each party has the option to co-promote by employing up to 40 percent of the sales effort in the other party’s territories.
About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human antibody that binds to tissue factor (TF) and Seattle Genetics’ ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is in Phase I/II clinical studies for solid tumors.

On August 29, 2017 Eli Lilly and Company (NYSE: LLY) reported it will showcase new data across six different tumor types at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain, September 8-12, 2017 (Press release, Eli Lilly, AUG 29, 2017, View Source [SID1234520326]). Notably, results from Phase 3 studies of abemaciclib and ramucirumab have been selected for oral presentation during a Presidential Symposium, which features groundbreaking research that is potentially practice-changing, on September 10.

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"In line with this year’s theme of ‘integrating science into oncology for a better patient outcome,’ the data being presented at ESMO (Free ESMO Whitepaper) demonstrate how we are further developing our foundational medicines – each rooted in the biology of cancer – to deliver innovative breakthrough medicines that will make a meaningful difference to patients and doctors," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We are excited to share new data that shows our progress on bringing forward abemaciclib as a potential new treatment option for advanced breast cancer and investigating the use of ramucirumab in additional tumor types such as advanced or metastatic urothelial carcinoma."

For the first time, two Lilly molecules will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium, with data from its MONARCH 3 and RANGE studies in advanced breast cancer and platinum-refractory urothelial cancer, respectively. MONARCH 3 is a global Phase 3, double-blind, placebo-controlled study, which evaluated the efficacy and safety of abemaciclib in combination with a nonsteroidal aromatase inhibitor (letrozole or anastrozole) as initial endocrine-based therapy for postmenopausal women with advanced breast cancer who have had no prior systemic treatment for advanced disease. RANGE is a global Phase 3 randomized, double-blind study evaluating the safety and efficacy of ramucirumab and docetaxel compared to placebo and docetaxel in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.

All key studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract Title: MONARCH 3: Abemaciclib as initial therapy for patients with HR+/HER2- advanced breast cancer
Abstract #236O_PR; Presidential Symposium II: Sunday, September 10, 2017; 16:30-16:45 CEST
Author/Speaker: Angelo Di Leo, M.D., Hospital of Prato, Instituto Toscano Tumori
Location: Madrid Auditorium

Abstract Title: Efficacy and Safety of Abemaciclib Combined with LY3023414 or Pembrolizumab in Stage IV NSCLC
Abstract #1363P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Pilar Garrido Lopez, M.D., Hospital Universitario Ramón y Cajal
Location: Hall 8

Abstract Title: Analysis of overall survival by tumor response in MONARCH 1, a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, in women with HR+/HER2- metastatic breast cancer (MBC) after chemotherapy for advanced disease
Abstract #249P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Javier Cortés, M.D., Vall d’Hebron University Hospital
Location: Hall 8

Abstract Title: Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer – an exploratory analysis of MONARCH 2
Abstract #253P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Peter Kaufman, M.D., Dartmouth-Hitchcock Medical Center
Location: Hall 8
Ramucirumab

Abstract Title: RANGE: a randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma
Abstract #LBA4; Presidential Symposium II: Sunday, September 10, 2017; 17:30-17:45 CEST
Author/Speaker: Daniel Petrylak, M.D., Yale Cancer Center
Location: Madrid Auditorium

Abstract Title: Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab
Abstract #1592P; Poster Session: Sunday, September 10, 2017; 13:15-14:15 CEST
Author/Speaker: Dirk Arnold, M.D., Klinik für Tumorbiologie
Location: Hall 8

Abstract Title: A Dose-Response Study of Ramucirumab Treatment in Patients with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: Primary Results of 4 Dosing Regimens in the Phase 2 Trial I4T-MC-JVDB
Abstract #698P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Jaffer Ajani, M.D., MD Anderson Cancer Center
Location: Hall 8

Abstract Title: Analysis of Angiogenesis Biomarkers for Ramucirumab (RAM) Efficacy in Patients with Metastatic Colorectal Cancer (mCRC) from RAISE, a Global, Randomized, Double-Blind, Phase 3 Study
Abstract #555P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST
Author/Speaker: Josep Tabernero, M.D., Vall d’Hebron University Hospital
Location: Hall 8
Sarcoma

Abstract Title: The Sarcoma Policy Checklist – focusing policy efforts on sarcoma
Abstract #1493P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST
Author/Speaker: Bernd Kasper, M.D., Universitätsmedizin Mannheim
Location: Hall 8

On August 29, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and ImmunoGen, Inc. (Nasdaq: IMGN) reported that the companies have entered into a collaboration and option agreement granting Jazz Pharmaceuticals exclusive, worldwide rights to opt into development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well as an additional program to be designated during the term of the agreement (Press release, ImmunoGen, AUG 29, 2017, View SourceJazz-Pharmaceuticals-ImmunoGen-Announce-Strategic-Collaboration-Option/?feedref=JjAwJuNHiystnCoBq_hl-Q2avtREEUtW02Sy35VP1Jgh2AeBni2PXJ_Baqm56MONnkvYMqDDYxFrLs-oQ2BHQ2rAcstzsNUxXKGrEYTNy5oMAQjA1BPjLiRY4AHvKLse85mKl9fT46bVvfOgDdqKag==" target="_blank" title="View SourceJazz-Pharmaceuticals-ImmunoGen-Announce-Strategic-Collaboration-Option/?feedref=JjAwJuNHiystnCoBq_hl-Q2avtREEUtW02Sy35VP1Jgh2AeBni2PXJ_Baqm56MONnkvYMqDDYxFrLs-oQ2BHQ2rAcstzsNUxXKGrEYTNy5oMAQjA1BPjLiRY4AHvKLse85mKl9fT46bVvfOgDdqKag==" rel="nofollow">View Source [SID1234520325]). The programs covered under the agreement include IMGN779, a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies expected to enter clinical testing before the end of the year.

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This Smart News Release features multimedia. View the full release here: View Source

Under the terms of the agreement, ImmunoGen will be responsible for the development of the three ADC programs prior to any potential opt-in by Jazz. Following any opt-in, Jazz would be responsible for any further development as well as for potential regulatory submissions and commercialization.

As part of the agreement, Jazz will pay ImmunoGen an upfront payment of $75 million. Additionally, Jazz will pay ImmunoGen up to $100 million in development funding over seven years to support the three ADC programs. For each program, Jazz may exercise its opt-in right at any time prior to a pivotal study or any time prior to a biologics license application (BLA) upon payment of an option exercise fee of mid-double digit millions or low triple digit millions, respectively. For each program to which Jazz elects to opt-in, ImmunoGen would be eligible to receive milestone payments based on receiving regulatory approval of the applicable product, plus tiered royalties as a percentage of commercial sales by Jazz, which depending upon sales levels and the stage of development at the time of opt-in, range from mid- to high single digits in the lowest tier to low 10’s to low 20’s in the highest tier. After opt-in, Jazz and ImmunoGen would share costs associated with developing and obtaining regulatory approvals of the applicable product in the United States (U.S.) and the European Union. ImmunoGen has the right to co-commercialize in the U.S. one product (or two products, under certain limited circumstances) with U.S. profit sharing in lieu of Jazz’s payment of the U.S. milestone and royalties to ImmunoGen.

"We are pleased to enter into this collaboration with ImmunoGen, a well-known leader in the field of ADC technology, with demonstrated success in creating ADC molecules, including the only FDA-approved ADC product to treat metastatic breast cancer. This investment supports our long-term commitment to expand our hematology/oncology portfolio with the potential addition of multiple innovative antibody drug conjugates," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We look forward to the advancement of these ADC programs and the potential synergy of these compounds with our current products and pipeline, as new therapeutic options for cancer patients are urgently needed."

"This strategic partnership with Jazz significantly advances our goal of accelerating the development of our early-stage novel ADC assets. This deal joins us with a global partner, provides us with substantial funding to support these programs, and preserves the right to co-commercialize one of these assets," said Mark Enyedy, president and chief executive officer of ImmunoGen. "Jazz has demonstrated the ability to bring innovative compounds to patients and will make an ideal partner to help develop and commercialize our novel ADC assets targeting AML, and more broadly, in the area of hematology/oncology. In addition, this partnership significantly strengthens our financial position and moves us closer to delivering upon our mission of bringing ADC therapies to patients."

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells1,2. IMGN779 is in Phase 1 clinical testing for the treatment of AML. IMGN632 is a preclinical stage humanized anti-CD123 antibody-based ADC that is a potential treatment for AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), myelodysplastic syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive malignancies. IMGN632 uses a novel payload, linker, and antibody technology and in AML xenograft models has demonstrated a large therapeutic index3. ImmunoGen expects to file an investigational new drug application (IND) for IMGN632 this quarter and enroll the first patient in a Phase 1 study before the end of the year.

On August 28, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) reported that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash (Press release, Gilead Sciences, AUG 28, 2017, View Source [SID1234520786]). The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.

Kite is an industry leader in the emerging field of cell therapy, which uses a patient’s own immune cells to fight cancer. The company has developed engineered cell therapies that express either a chimeric antigen receptor (CAR) or an engineered T cell receptor (TCR), depending on the type of cancer. Kite’s most advanced therapy candidate, axicabtagene ciloleucel (axi-cel), is a CAR T therapy currently under priority review by the U.S. Food and Drug Administration (FDA). It is expected to be the first to market as a treatment for refractory aggressive non-Hodgkin lymphoma, which includes diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA). A marketing authorization application (MAA) has also been filed for axi-cel for the treatment of relapsed/refractory DLBCL, TFL and PMBCL with the European Medicines Agency (EMA), representing the first submission in Europe for a CAR T therapy. Approval in Europe is expected in 2018. Kite has additional candidates in clinical trials in both hematologic cancers and solid tumors, including KITE-585, a CAR T therapy candidate that targets BCMA expressed in multiple myeloma.

“The acquisition of Kite establishes Gilead as a leader in cellular therapy and provides a foundation from which to drive continued innovation for people with advanced cancers,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients. We are greatly impressed with the Kite team and what they have accomplished, and share their belief that cell therapy will be the cornerstone of treating cancer. Our similar cultures and histories of driving rapid innovation in order to bring more effective and safer products to as many patients as possible make this an excellent strategic fit.”

Research and development as well as the commercialization operations for Kite will remain based in Santa Monica, California, with product manufacturing remaining in El Segundo, California.

“From the release of our pivotal data for axi-cel, to our potential approval by the FDA, this is a year of milestones. Each and every accomplishment is a reflection of the talent that is unique to Kite. We are excited that Gilead, one of the most innovative companies in the industry, recognized this value and shares our passion for developing cutting-edge and potentially curative therapies for patients,” said Arie Belldegrun, MD, FACS, Chairman, President and Chief Executive Officer of Kite. “CAR T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers. With Gilead’s expertise and support, we hope to fulfill that potential by rapidly accelerating our robust pipeline and next-generation research and manufacturing technologies for the benefit of patients around the world.”

Benefits of the Transaction

Near-term Product Opportunity

Axi-cel approval for refractory aggressive non-Hodgkin lymphoma is expected in Q4 2017 in the United States and in 2018 in Europe
U.S. commercial launch and manufacturing preparations complete
Building infrastructure in Europe
Robust Pipeline and Technology Platform to Drive Future Growth

Multiple development programs ongoing to broaden axi-cel utilization in earlier lines of therapy in aggressive NHL and other B-cell malignancies
Advancing additional CAR Ts to treat multiple myeloma and acute myeloid leukemia
Progressing TCRs for potential use in solid tumors
Positions Gilead to be a Global Leader in Oncology and Cell Therapy

Cell therapy has generated compelling clinical data in patients for whom all other treatments have failed
Axi-cel, coupled with Kite’s leading manufacturing capabilities and its portfolio of next-generation technologies and therapy candidates, will serve as a foundation for Gilead’s efforts to build an industry-leading cell therapy franchise
Leverages Gilead’s Core Capabilities to Maximize the Value of Kite’s Portfolio

Ability to drive continuous scientific and medical innovation that improves or replaces existing products
Demonstrated ability to scale complicated manufacturing processes to meet patient demand
Rapid design and execution of clinical development programs that shorten development timelines
Successful track record of launching innovative, specialty medicines
Transaction Terms

Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Kite’s common stock at a price of $180.00 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.

The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Kite shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act, and other customary conditions.

Gilead plans to finance the transaction with a combination of cash on hand, bank debt and senior unsecured notes. The tender offer is not subject to a financing condition.

The $180.00 per share acquisition price represents a 29 percent premium to Kite’s closing on Friday, August 25, and a 50 percent premium to the company’s 30-day volume weighted average stock price.

BofA Merrill Lynch and Lazard are acting as financial advisors to Gilead. Centerview Partners is acting as exclusive financial advisor to Kite. Jefferies LLC and Cowen and Company, LLC also provided advice to Kite. Skadden, Arps, Slate, Meagher & Flom is serving as legal counsel to Gilead and Sullivan & Cromwell LLP and Cooley LLP are serving as legal counsel to Kite.