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April 03, 2017

Top 10 Immuno-Oncology Collaborations

Biopharmas Continue to Ramp Up Cancer Immunotherapy Spending

Top 10 Immuno-Oncology Collaborations

From the overall market size to the value of deals, the numbers keep climbing when it comes to the top immuno-oncology collaborations. [laflor/Getty Images}

  • #6. Sanofi and Regeneron

    Value: Up to $2.17 billion for Regeneron, including $640 million upfront

    Date announced: July 28, 2015

    Summary: Sanofi and Regeneron agreed to jointly develop REGN2810, a programmed cell death protein 1 (PD-1) inhibitor then in Phase I, and launch clinical trials in 2016 with new therapeutic candidates based on ongoing preclinical programs. The partners committed to spend $325 million each toward developing REGN2810.

    Updates: In releasing fourth-quarter 2016 results on February 9, Regeneron said REGN2810 was the subject of a Phase II “potentially pivotal” study for the treatment of advanced cutaneous squamous cell carcinoma that was launched in the second quarter of 2016, as well as various Phase I studies, all of which continue to enroll patients. REGN2810 is also being studied in combination with other antibodies and treatments, the company said in its Form 10-K Annual Report for 2016. In 2017, Regeneron said that Phase II studies of REGN2810 will be initiated in non-small cell lung cancer (NSCLC) and in basal cell carcinoma.

  • #5. Celgene and Jounce Therapeutics

    Value: Up to $2.6 billion-plus for Jounce, including $225 million upfront, and a $36 million equity investment by Celgene

    Date announced: July 19, 2016

    Summary: Celgene received options to develop and commercialize jointly cancer immunotherapies that include Jounce’s lead candidate JTX-2011, a monoclonal antibody (mAb) expected to enter clinical trials by year’s end, and other cancer immunotherapies. Celgene gained options from Jounce for up to four of its early-stage programs to be selected from a defined pool of B cell-, regulatory T cell-, and tumor-associated macrophage targets emerging from the Jounce Translational Science Platform; and an additional option to share JTX-4014, Jounce’s PD-1 product candidate, equally with Jounce. The collaboration agreement has an initial term of four years, which may be extended up to three additional years.

    Update: On March 10, Jounce said it expects to report data this year from the Phase I/II ICONIC study of JTX-2011. Data includes safety and PK/PD data from the Phase I portion of the study, expected in the first half of 2017, followed in the second half by preliminary efficacy data in both a monotherapy setting and combination therapy setting with Bristol-Myers Squibb’s anti-PD-1 antibody Opdivo® (nivolumab). The combination will be assessed “in patients with NSCLC, HNSCC, triple negative breast cancer (TNBC), melanoma, stomach cancer, and additional niche indications identified through our Translational Science Platform,” Jounce said in its Form 10-K Annual Report for 2016.

  • #4. Merck KGaA and Pfizer

    Value: Up to $2.85 billion for Merck KGaA, including $895 million upfront

    Date announced: November 17, 2014

    Summary: Merck KGaA agreed to jointly develop and commercialize its PD-L1 checkpoint inhibitor MSB0010718C [since renamed Bavencio® (avelumab) and also known as PF-06834635] with Pfizer, both as a single agent and in various combinations with the companies’ oncology therapies.

    Update: On March 23, Merck KGaA entity EMD Serono and Pfizer announced FDA approval for Bavencio Injection 20 mg/mL, for intravenous use, for adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC)—the first treatment approved for the rare, aggressive form of skin cancer. Bavencio’s Biologics License Application (BLA) was accepted for review in November under the FDA’s Priority Review status, which shortened the agency’s expected review time from 10 months. Also in November, Pfizer said it will collaborate with the National Cancer Institute’s Center for Cancer Research to assess Bavencio and two other immunotherapy candidates by arranging and conducting clinical and preclinical trials.

  • #3. Pfizer, Cellectis, and Servier

    Value: Up to $2.885 billion for Cellectis, including $80 million upfront

    Date announced: June 18, 2014

    Summary: Pfizer and Cellectis agreed to develop Chimeric Antigen Receptor T-cell (CAR-T) cancer immunotherapies directed at select targets using the French biotech’s CAR-T platform technology. Pfizer has exclusive rights to develop and commercialize CAR-T cancer therapies directed at a total of 15 targets of its choosing. Both companies agreed to work together on preclinical research for four of 12 additional targets to be selected by Cellectis, with Pfizer having the right of first refusal to the four. In return, Pfizer agreed to fund R&D costs for the 15 targets, and a portion of R&D costs associated with four other Cellectis-selected targets. Cellectis is eligible for payments tied to achieving development, regulatory, and commercial milestone payments of up to $185 million per product resulting from the Pfizer-selected targets, and tiered royalties on net sales of any products commercialized by Pfizer.

    In November 2015, Servier acquired exclusive rights from Cellectis for UCART19, for up to $338 million-plus. Servier then granted exclusive rights to Pfizer to develop and commercialize UCART19 in the U.S.—in a deal whose value has not been disclosed—while retaining rights elsewhere in the world.

    Updates: On March 9, Servier and Pfizer announced that the FDA granted Servier an IND clearance to proceed in the U.S. with clinical development of UCART19 for relapsed/refractory acute lymphoblastic leukemia. UCART19 is an allogeneic CAR-T cell candidate for CD19-expressing blood malignancies, gene-edited with Thermo Fisher Scientific’s TALEN® technology and co-developed by Servier and Pfizer. Servier is sponsoring the CALM Phase I study on UCART19, which was launched in the U.K. in August 2016. The study is assessing UCART19 in patients with CD19-positive B-cell relapsed/refractory acute lymphoblastic leukemia.

    Pfizer owned approximately 8% of Cellectis’ outstanding shares as of November 30, 2016.

  • #2. Bristol-Myers Squibb (BMS) and CytomX Therapeutics

    Value: Up to $2.888 billion for CytomX, including $200 million upfront (1)

    Date announced: March 20, 2017

    Summary: In expansion of up-to-$1.242 billion, up-to-four-target cancer immunotherapy collaboration announced May 27, 2014, BMS and CytomX agreed to discover up to eight additional targets—six oncology targets, two non-oncology—using CytomX’s Probody™ drug discovery platform. CytomX granted BMS exclusive worldwide rights to develop and commercialize the eight targets. In return, BMS agreed to pay CytomX $200 million upfront, plus research funding, and up to $448 million per candidate tied to achieving development, regulatory and sales milestones, plus tiered royalties from the mid-single digits to low-double digits on net sales of each product commercialized by BMS.

    Update: In announcing the expanded collaboration March 20, BMS and CytomX said the four oncology targets called for under the original agreement had been selected by BMS, with a CTLA-4 Probody therapeutic progressing to IND-enabling studies, and the three other programs remaining in the lead discovery and optimization phase.

  • #1. Merck & Co. and Ablynx

    Value: €5.78 billion ($6.4 billion)

    Date announced: July 22, 2015

    Summary: In an up-to-€4.08 billion (about $4.5 billion) expansion of an up-to-€1.7 billion ($2.3 billion) immuno-oncology collaboration to address additional checkpoint modulator targets, announced February 3, 2014, the companies agreed to discover and develop up to 12 additional cancer drugs based on single-domain antibody fragments, or Nanobodies®, through preclinical proof-of-concept. After that, Merck & Co. will have the option to advance specific lead candidates. Merck will also oversee clinical development, manufacturing, and commercialization of any products resulting from the collaboration, which grew to 17 Nanobodies programs.

    Updates: On February 23, Ablynx included among its “significant clinical and regulatory catalysts anticipated for 2017” the initiation of the first clinical trial of a Nanobody developed through the collaboration. On October 12, Ablynx announced a second extension of the collaboration, which it said entailed developing and commercializing Nanobody candidates toward an undisclosed voltage gated ion channel. Ablynx said the extension resulted in a payment to the company by Merck & Co. of €1 million (about $1.1 million), and a commitment by Merck & Co. to extend funding of the research collaboration to September 2018.

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