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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}

  • The numbers keep rising for immuno-oncology, starting with the size of the market.

    Last time GEN visited the topic in September, the most generous forecast for the future size of the cancer immunotherapy market was $34 billion in 2024 (GlobalData). Six months later, the rosiest of market growth projections has nearly quadrupled to $119.39 billion by 2021 (MarketsandMarkets), or merely more-than-doubled to $75.8 billion by 2022 (GBI Research).

    Behind the climbing numbers is the expectation of rising sales as new immuno-oncology drugs win approvals, and as established treatments gain new indications. Already, the top three best-selling cancer immunotherapies have all generated billion-dollar-plus “blockbuster” sales, and generated a combined $6.388 billion last year, more than double the $2.634 billion made in 2015.

    The top cancer immunotherapy accounted for more than half the total—Bristol-Myers Squibb (BMS)’s marketed Opdivo® (nivolumab) racked up $3.774 billion in 2016. Next came Merck & Co.’s Keytruda® (pembrolizumab) at $1.402 billion, followed by BMS’ Yervoy® (ipilimumab) at $1.053 billion.

    Below is GEN’s updated list of the top 10 immuno-oncology collaborations, ranked by dollar value as disclosed by the companies in regulatory filings, press announcements, and other public statements. Each collaboration is listed by partner names, value, and date announced, followed by a summary and updates provided by the companies since their launch announcements.

    The total value of all 10 ranked collaborations is approximately $26.233 billion, up 6% from $24.687 billion six months ago, thanks to a significant expansion of last year’s No. 10 ranked collaboration (announced March 20) which zoomed as a result to No. 2 on this year’s list. Another reflection of the rising value of partnerships: While last year’s No. 10 collaboration was worth up to $1.242 billion, this year’s No. 10 partnership was worth potentially 21% more, up to $1.5 billion. This year’s list also shows a shift in immuno-oncology from the creation and announcement of billion-dollar partnerships, to more clinical activity within those alliances.

    Not included on this list are collaborations that combine immuno-oncology and other areas; that would include Amgen and Xencor’s up-to-$1.7 billion alliance disclosed in 2015 to develop six candidates in cancer immunotherapy and inflammation, since the companies’ announcement did not break down how many programs were in each area.

    Also not included are collaborations whose full total potential value was not disclosed. For example, on November 16, 2016, BMS agreed to pay $30 million upfront in a partnership with Enterome to discover and develop microbiome-derived biomarkers, drug targets, and bioactive molecules; no other financial terms were disclosed. And on September 21, 2016, BioNTech said it was launching a collaboration with Roche subsidiary Genentech to develop individualized messenger RNA (mRNA)-based, individualized cancer vaccines, through a collaboration whose value includes $310 million in upfront and near-term payments tied to achieving unspecified milestones.

  • #10. Shire (Baxalta) and Symphogen

    Value: Up to €1.4 billion ($1.5 billion) for Symphogen

    Date announced: January 4, 2016

    Summary: Companies agreed to develop Symphogen’s portfolio of early-stage immuno-oncology programs. Companies agreed to advance new treatments against six undisclosed checkpoint targets, with the first program to enter clinical studies in 2017.

    Updates: On June 3, Baxalta became an indirect wholly-owned subsidiary of Shire following completion of the companies’ $32 billion merger. In its Form 10-K Annual Report for 2016, filed February 22, Shire disclosed that it has options under the collaboration to obtain exclusive licensing rights for four specified proteins in development for the treatment of immuno-oncology diseases, as well as two additional unspecified proteins that may be selected at a later date. Each option is exercisable for a period of 90 days when each protein is ready for Phase II clinical trials. Symphogen is responsible for development costs for each protein until option exercise, at which point Shire would become responsible for development costs.

  • #9. Shire (Baxalta) and Precision BioSciences

    Value: Up to $1.7 billion for Precision, including $105 million upfront

    Date announced: February 25, 2016

    Summary: Companies agreed to develop allogeneic chimeric antigen receptor T cell (CAR-T) therapies, by bringing together immuno-oncology candidates of Baxalta (since acquired by Shire) with Precision’s ARCUS genome-editing platform technology.

    Baxalta and Precision agreed to develop CAR-T therapies for up to six undisclosed targets addressing areas of major unmet need in multiple unspecified cancers. Precision agreed to oversee early-stage research activities up to Phase II, after which Baxalta has the exclusive right to opt in for late-stage development and commercialization. However, Precision also has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the U.S.

    Updates: Baxalta became an indirect wholly-owned subsidiary of Shire on June 3 following completion of the companies’ $32 billion merger. In its Form 10-K Annual Report for 2016, filed February 22, Shire restated that the first development program created through the collaboration is expected to enter clinical studies in late 2017.

  • #8. Bristol-Myers Squibb (BMS) and Five Prime Therapeutics

    Value: Up to $1.74 billion for Five Prime, including $350 million upfront

    Date announced: October 15, 2015

    Summary: BMS agreed to co-develop and co-commercialize Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, led by the Phase I cancer/immunology compound cabiralizumab (FPA008). BMS agreed to oversee development and manufacturing of cabiralizumab for all indications, subject to an option by Five Prime to conduct and pay for future studies to support approval of cabiralizumab in pigmented villonodular synovitis (PVNS), and cabiralizumab in combination with Five Prime’s internal pipeline assets in immuno-oncology.

    Updates: On February 23, Five Prime said it expects to complete enrollment of the Phase II trial of cabiralizumab in PVNS in the first half of 2017. Five Prime is evaluating response rate, pain, and range of motion in approximately 30 PVNS patients. Five Prime plans to disclose clinical data from the trial at the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting.

    In October 2016, Five Prime launched the Phase Ib portion of a trial evaluating the combination of cabiralizumab with BMS’ Opdivo® (nivolumab). Five Prime and BMS are evaluating the safety, tolerability, and preliminary efficacy of the combination in advanced solid tumors, including non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma, and ovarian cancer. Five Prime expects to complete enrollment in the current Phase Ib trial cohorts in the second half of 2017.

  • #7. Servier and Pieris Pharmaceuticals

    Value: Up to €1.7 billion ($1.8 billion) for Pieris, including €30 million ($32 million) upfront

    Date announced: January 5, 2017

    Summary: Servier will partner with Pieris to co-develop Pieris’ PRS-332 and up to seven other immuno-oncology bispecific drug candidates. Companies agreed to initially pursue five bispecific therapeutic programs. These are led by the preclinical bispecific checkpoint inhibitor PRS-332, a programmed cell death protein 1 (PD-1)-targeting therapy, and include four immuno-oncology bispecific drug candidates that may combine antibodies from the Servier portfolio with one or more of Pieris’ Anticalin® proteins. Pieris retains all U.S. commercial rights, with Servier having commercial rights elsewhere in the world. Servier and Pieris also agreed to allow for expansion of their collaboration by up to three additional therapeutic programs.

    Updates: In reporting fourth-quarter and full-year 2016 results on March 22, Pieris said it expected this year to advance preclinical evaluation of PRS-332 with Servier, “with IND-enabling activities planned for later in 2017.”

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