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Jazz Pharmaceuticals and ImmunoGen, Inc. Announce a Strategic Collaboration and Option Agreement to Develop and Commercialize Antibody-Drug Conjugate Products

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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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.

FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients

On August 28, 2018 the U.S. Food and Drug Administration reported that it took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California (Press release, US FDA, AUG 28, 2017, View Source [SID1234526938]). On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.

"Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures," said FDA Commissioner Scott Gottlieb, M.D. "The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse."

The seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.

Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.

"I’ve directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb added. "I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch."

Health care professionals and consumers should report any adverse events related to treatments received at California Stem Cell Treatment Center to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The U.S. Department of Justice filed the seizure complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Gilead Sciences to Acquire Kite Pharma for $11.9 Billion

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.

GlobeImmune Provides Update on Recent Clinical Trial Developments

On August 28, 2017 GlobeImmune, Inc. reported a number of developments in its clinical programs and licensing and manufacturing activities. The Company previously announced that NantCell, Inc., a member of the ecosystem of NantWorks companies, has acquired a controlling interest in GlobeImmune. Through this relationship, a number of programs have now advanced into multiple trials.

NantCell has licensed exclusive worldwide rights to the Company’s GI-4000 program, which targets the mutated Ras oncogene product, and which had previously completed phase 2 trials in resected pancreas cancer, non-small cell lung cancer (NSCLC) and colorectal cancer. GI-4000 will now be evaluated in combination with multiple additional agents in patients with metastatic pancreas cancer, triple negative breast cancer (TNBC), ovarian cancer, urothelial cancer, head and neck squamous cell cancer, metastatic colorectal cancer and NSCLC, whose tumors express mutations in the Ras oncogene product.

NantCell has also now acquired exclusive rights to develop, manufacture and commercialize the Company’s GI-6207 program which targets the CEA protein expressed in a number of solid tumors and the Company’s GI-6301 program targeting the Brachyury protein. In addition, NantCell has exercised an option to license the Company’s preclinical GI-6100 program targeting the MUC1 protein. GI-6207 and GI-6301 will be combined with GI-4000 and other agents in a number of the above described trials. More details on these trials can be found at www.clinicaltrials.gov by searching for "QUILT" trials.

Under the terms of each of these agreements with NantCell, GlobeImmune is entitled to receive payments on the achievement of certain product development and commercialization milestones and royalties based on net sales of products by NantCell or its affiliates or sublicensees.

In preparation for clinical trials of these products, the Company has re-started manufacturing activities at its Louisville Colorado facility and will be providing GMP product under a supply agreement with NantCell to support these trials.

"We are delighted at these developments," stated Jeffrey Dekker, the Company’s president. "They demonstrate the progress we anticipated with our new relationship with NantCell and will allow us to continue to explore the potential of the Tarmogen platform."

Dr. Patrick Soon-Shiong, Founder and CEO of NantCell noted, "Our goal has continued to focus on the most comprehensive path to activating the innate and adaptive immune system and through our partnership with GlobeImmune, we are able to increase the number of molecular immunotherapy options we currently have available for patients. We’re looking forward to the continued work we’re doing with this innovative company and are excited to learn from the results of the clinical trials."

Daiichi Sankyo Enters Worldwide Licensing Agreement with Boston Pharmaceuticals for a Highly Selective RET Inhibitorfor Solid Tumors

On August 28, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Boston Pharmaceuticals, Inc. (hereafter, Boston Pharmaceuticals) reported they have entered into a worldwide licensing agreement for Daiichi Sankyo’s novel RET inhibitor, DS-5010 (Press release, Daiichi Sankyo, AUG 28, 2017, View Source [SID1234520324]).

DS-5010 is a highly selective and potent RET (ret proto-oncogene) kinase inhibitor in late preclinical development. RET rearrangements and activating mutations are associated with several types of cancer, including non-small cell lung cancer, colorectal cancer and thyroid cancer.1,2,3

Under the terms of the agreement, Daiichi Sankyo grants Boston Pharmaceuticals worldwide rights for the research, development, manufacturing and commercialization of DS-5010. Daiichi Sankyo will collaborate with Boston Pharmaceuticals to complete preclinical studies to support an Investigational New Drug Application to regulatory authorities and initiation of the clinical program, after which Boston Pharmaceuticals will be responsible for all activities related to DS-5010. Daiichi Sankyo will receive an upfront payment and is eligible for clinical, regulatory and sales milestone payments, as well as royalties on net sales worldwide. Financial terms of the agreement were not disclosed.

"We continue to actively prioritize and manage our growing oncology portfolio to ensure that promising compounds are supported with appropriate resources, either within Daiichi Sankyo Cancer Enterprise or through strategic licensing agreements and partnerships," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "It’s our obligation to bring innovative compounds to patients with cancer as quickly as possible, and we believe this agreement with an innovative U.S. partner will rapidly advance the development of this novel compound and potentially its availability to patients. Boston Pharmaceuticals has worked hard to develop a model that works for potential partners. We congratulate them on this success and look forward to continuing to explore similar collaborations in the future."

"The acquisition of DS-5010, now the fifth candidate in our pipeline, demonstrates our commitment to identifying and developing novel and differentiated therapeutic agents through strategic partnerships for the ultimate benefit of patients," said Robert Armstrong, PhD, Chief Executive Officer and Co-Founder of Boston Pharmaceuticals. "This agreement, with such an innovative partner as Daiichi Sankyo, marks a significant step in our plan to assemble a diverse portfolio of clinical candidates across a broad range of mechanisms and therapeutic targets."