Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Weaponizing the Immune System against the Disease Pays Off for Biopharmas of all Sizes

Immunotherapies for cancer have emerged in recent years as a “sweet spot” among researchers, companies, investors, and especially patients. “This represents a potential revenue opportunity for the biopharmaceutical industry in excess of $35 billion by 2023,” Andrew S Baum, global head of healthcare research with Citi, predicted in 2013. “We believe that in 10 years immunotherapy will likely form the backbone of 60% of all developed world cancer management regimes, driven by a paradigm shift in the overall improvement in survival rates in responsive patients.”

So it’s just as well as this first GEN List summarizing cancer immunotherapy activity by drug developers is a “Sweet 16” showcasing companies that have enjoyed the most success in transforming the immune system into a weapon against tumors.

The List highlights two types of companies as being most prevalent: big biopharmas, which have spent recent years scrambling for new blockbusters as older ones have succumbed to the patent cliff; and specialty biotechs that have focused closely on immunotherapies, leveraging their discoveries into often-lucrative collaboration deals.

Also worth noting is that there’s no one route to success. While some of the top cancer immunotherapy developers have built pipelines of compounds, others have succeeded with smaller pipelines and numerous trials aimed at hitching their products to successful combination therapies. And still other companies have focused instead on building collaborations and partnerships rather than bringing products through clinical trials themselves.

And for what it’s worth, to use a military metaphor, first to hit the beach doesn’t always mean winning the war. The first immunotherapy approved for a cancer was Dendreon’s Provenge® (sipuleucel-T) for prostate cancer, which won the FDA’s nod in 2010. But years of business challenges brought Dendreon to Chapter 11 bankruptcy late last year. In February, the company and Provenge were snapped up by Valeant for $400 million.

Below is a list of 16 top cancer immunotherapy developers, listed by marketed products, examples of pipeline therapies in clinical and preclinical phases, and recent collaborations and agreements, many with links to GEN news reports of the deals.
 


AbbVie

Pipeline Highlights

  • ABT-199 (venetoclax or GDC-0199)—Phase III in chronic lymphocytic leukemia (CLL); Phase II in acute muelogenous leukemia and other blood cancers; Phase II in relapsed or refractory CLL; Phase II in relapsed and refractory follicular non-Hodgkin’s lymphoma (NHL; Phase Ib in Acute Myelogenous Leukemia (AML; Phase I in Relapsed/Refractory Multiple Myeloma (MM; Phase I in relapsed or refractory NHL or MM; Phase I in women with systemic lupus erythematosus; Phase I in AML; Phase I in AML; Phase I in relapsed/refractory or previously untreated CLL; Phase I in relapsed/refractory or previously untreated CLL; Phase I in NHL; Phase I in relapsed or refractory NHL. Co-developed with Genentech (Roche).
  • Elotuzumab—(formerly BMS-901608)—Phase III; co-developed with Bristol-Myers Squibb
  • ABT-414—Phase II in squamous cell tumors; Phase I/II in glioblastoma multiforme

Collaborations and Agreements

  • Genentech (Roche)

    • August 2011—Walter and Eliza Hall Institute in Melbourne, Australia says ABT-199, a compound discovered there two decades earlier, has launched clinical trials under co-development by AbbVie predecessor Abbott and Genentech.
  • Bristol-Myers Squibb

    • August 19, 2008—Agreement for global development and commercialization of elotuzumab. Value: Up to $710 million.


Aduro Biotech

Pipeline Highlights

  • CRS-207—Phase II for metastatic pancreatic cancer; Phase Ib for unresectable malignant pleural mesothelioma.
  • ADU-623—Phase I as monotherapy for high-grade glioma.
  • ADU-214—Preclinical; under development by Janssen Biotech
  • ADU-741—Preclinical; under development by Janssen Biotech
  • ADU-S100—Preclinical; under development by Novartis.

Collaborations and Agreements

  • Novartis

    • March 30, 2015: Major multiyear alliance to develop new cancer immunotherapies based on Aduro CDNs targeting and activating the STING receptor. Value: Up to $750 million.
  • Johnson & Johnson (Janssen Biotech)

    • October 2014—Second agreement granting an exclusive, worldwide license to develop LADD immunotherapies that include ADU-214, together with an exclusive right to develop LADD strains in lung cancer indications. Value: Up to $817 million.
    • May 2014— Exclusive, worldwide license to develop LADD immunotherapies that include ADU-741. Value: Up to $365 million


Advaxis

Pipeline Highlights

  • ADXS-HPV (ADXS11-001)—Phase III in cervical cancer; Phase II in metastatic cervical cancer; Phase II in persistent or recurrent cervical cancer; Phase II in stage II-IV squamous cell carcinoma of the oropharynx (OPSCC); Phase II in metastatic anal cancer; Phase I/II in advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer; Phase I/II in anal cancer; Phase I/II in persistent, metastatic, or recurrent squamous and non-squamous carcinoma, adenosquamous, or adenocarcinoma of the cervix.
  • ADXS-PSA—Phase I/II in prostate cancer
  • ADSX-HER2—Phase I in HER2 overexpressing tumors

Collaborations and Agreements

  • Incyte

    • February 11, 2015—Clinical trial collaboration agreement to evaluate the combination of Advaxis's ADXS-HPV (ADXS11-001) with Incyte's epacadostat (INCB24360).
  • Merck & Co.

    • August 25, 2014— Clinical trial collaboration agreement to evaluate the combination of Advaxis's ADXS-PSA, with Merck's Keytruda.
  • MedImmune (AstraZeneca)

    • July 22, 2014: Clinical trial collaboration to evaluate MedImmune’s MEDI4736 in combination with Advaxis’ ADXS-HPV in advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and squamous cell carcinoma of the head and neck.
  • University of California, San Francisco (UCSF)

    • March 17, 2014—Evaluation of several new immunotherapy constructs, in addition to ADXS-PSA, each built on the Advaxis proprietary technology by Lawrence Fong, M.D., professor in UCSF’s department of medicine.
       


Amgen

Marketed Treatment

  • Blincyto (blinatumomab)—Indicated for treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Year of first U.S. approval: 2014.

    • Potential additional indications: Phase III in adults with relapsed/refractory acute lymphoblastic leukemia (ALL). Phase II in adults with relapsed/refractory Philadelphia chromosome-positive (Ph+) and minimal residual disease of ALL. Phase II in adults with diffuse large B-cell lymphoma (DLBCL).

Pipeline Highlights

  • Talimogene laherparepvec (T-Vec)—BLA submitted to FDA. PDUFA date: July 28, 2015. Marketing Authorization Application (MAA) submitted to European Medicines Agency. Both agencies are reviewing the compound for the treatment of adults with melanoma that is regionally or distantly metastatic. The compound is also under study for regionally or distantly metastatic melanoma in combination with Keytruda.

Collaborations and Agreements

  • Kite Pharma

    • January 5, 2015–Strategic research collaboration and license agreement to develop and commercialize the next generation of chimeric antigen receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT™) platform and Amgen's array of cancer targets. Value: Up to $1 billion-plus.
  • Merck & Co.

    • February 5, 2014—Clinical trial collaboration to evaluate talimogene laherparepvec combined with MK-3475, an anti-PD-1 immunotherapy.


AstraZeneca (MedImmune)

Pipeline Highlights

  • Selumetinib—Phase III in uveal melanoma; Phase III in differentiated thyroid cancer; Phase III and Phase II in 2nd line KRAS-NSCLC; Phase I in advanced EGFRm non-small cell lung cancer; Phase I in combination with MEDI4736.
  • MEDI4736—Phase III in stage III non-small cell lung cancer (NSCLC); Phase III in third line NSCLC; Phase II in solid tumors; Phase I/II in multiple solid tumors including metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer; Phase I/II in advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer; Phase I in combination with MEDI4736.
  • Tremelimumab—Phase III in mesothelioma; Phase I in NSCLC; Phase I in solid tumors in combination with MEDI6469
  • MEDI0680 (formerly AMP-514)—Phase I in solid tumors; Phase I in solid tumors; Phase I in DLBCL in combination with MEDI-551.

Collaborations and Agreements

  • Johnson & Johnson (Janssen) and Pharmacyclics

    • November 4, 2014: Clinical trial collaboration to evaluate MEDI4736, co-developed by Pharmacyclics and Janssen, as a treatment for patients with hematological cancers including diffuse large B-cell lymphoma and follicular lymphoma.
  • Advaxis

    • July 22, 2014: Clinical trial collaboration to evaluate MedImmune’s MEDI4736 in advanced, recurrent or refractory HPV-associated cervical cancer and squamous cell carcinoma of the head and neck.
  • Incyte

    • May 14, 2014— Clinical study collaboration to evaluate MedImmune’s MEDI4736.
  • The University of Texas MD Anderson Cancer Center

    • March 13, 2014—Translational and clinical research collaboration to advance cancer immunotherapy via MD Anderson’s Moon Shots Program immunotherapy platform.
  • Immunocore

    • January 8, 2014—Oncology research collaboration and licensing agreement to research and develop novel cancer therapies using Immunocore’s Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology. Value: $320 million per compound developed.
  • Amplimmune

    • August 26, 2013—Acquired by AstraZeneca; pipeline includes cancer compounds AMP-224, partnered with GlaxoSmithKline, and the unpartnered AMP-514. Value: Up to $500 million


Bristol-Myers Squibb (BMS)

Marketed Treatments

  •  Opdivo® (nivolumab)—Indications: Unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor ; Metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Year of first U.S. approval: 2014
  • Yervoy® (ipilimumab)—Indications: Unresectable or metastatic melanoma. Year of first U.S. approval: 2011

Pipeline Highlights

  • Elotuzumab (formerly BMS-901608)—Phase III; co-developed with AbbVie
  • Prostvac+—Phase III  
  • Anti-CD137 Urelumab—Phase I
  • Anti-KIR Lirilumab—Phase I
  • Anti-LAG3—Phase I
  • F001287—Preclinical; Lead small molecule IDO1-inhibitor of Flexus Biosciences, to be acquired by BMS; targeted for IND filing in the second half of 2015
  • Cancer immunotherapy program 1, targeting indoleamine 2,3-dioxygenase (IDO)—Preclinical
  • Cancer immunotherapy program 2, target not disclosed—Preclinical
  • Cancer immunotherapy program 3, target not disclosed—Preclinical

Collaborations and Agreements

  • Rigel Pharmaceuticals

    • February 23, 2015—Collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel’s portfolio of small molecule TGF beta receptor kinase inhibitors. Value: Up to $339 million, plus royalties.
  • Flexus Biosciences

    • February 23, 2015—Acquisition of cancer immunotherapeutics developer. Deal gave BMS full rights to F001287, Flexus’ lead preclinical small molecule IDO1-inhibitor targeted for IND filing in the second half of 2015. BMS will also acquire Flexus’ indoleamine 2,3-dioxygenase (IDO) and tryptophan 2,3-dioxygenase (TDO) discovery programs, which include its IDO-selective, IDO/TDO dual, and TDO-selective compound libraries. Value: Up to $1.25 billion.
  • Five Prime Therapeutics

    • November 24, 2014: Exclusive clinical collaboration agreement  to evaluate the safety, tolerability, and preliminary efficacy of combining Opdivo (nivolumab) with Five Prime’s FPA008, through a Phase Ia/Ib study in six types of tumors. Value: $30 million-plus.
    • March 17, 2014: Collaboration agreement for the discovery, development, and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime’s target discovery platform. Value: Up to $350 million-plus.
  • Johnson & Johnson (Janssen) and Pharmacyclics

    • October 13, 2014–Clinical trial collaboration agreement to evaluate the safety, tolerability, and preliminary efficacy of Opdivo (nivolumab) in combination with Imbruvica® (ibrutinib), co-developed and co-marketed by Pharmacyclics and Janssen in Phase I/II study.
  • Incyte

    • o May 27, 2014—Clinical trial collaboration to evaluate combination regimen of BMS’ Opdivo (nivolumab) and Incyte’s INCB24360.
  • AbbVie

    • August 19, 2008—Agreement for global development and commercialization of elotuzumab. Value: Up to $710 million.


GlaxoSmithKline (GSK)

Pipeline Highlights

  • MAGE-A3—Phase III in melanoma; Phase III in NSCLC halted April 2014 after vaccine missed its third co-primary endpoint.
  • AMP-224—Phase I in metastatic Colorectal cancer, in combination with stereotactic body radiation therapy; co-developed with Amplimmune, now owned by AstraZeneca.
  • NY-ESO TCR—Phase I/II in synovial sarcoma; Phase I/II in multiple myeloma (both with and without auto-SCT); Heading for Phase I/II in ovarian cancer, melanoma, and esophageal cancer; Preclinical in non-small cell lung cancer. Co-developed with Adaptimmune.

Collaborations and Agreements

  • Adaptimmune

    • June 2, 2014–Strategic collaboration and licensing agreement for development and commercialization of Adaptimmune’s lead clinical cancer program, NY-ESO-1. Value: More than $350 million.
  • The University of Texas MD Anderson Cancer Center

    • April 8, 2014—Research alliance to advance cancer immunotherapy via MD Anderson’s Moon Shots Program immunotherapy platform. Value: Not disclosed.
    • December 10, 2012—Research collaboration and license agreement to develop new therapeutic antibodies that activate OX40 on the surface of T cells. Value: $335 million plus royalties.
  • Merck & Co.

    • December 18, 2013—Clinical trial collaboration to assess the combination of Merck’s Keytruda (then called MK-3475) and GlaxoSmithKline’s Votrient® (pazopanib) in advanced renal cell carcinoma.
  • Amplimmune

    • August 4, 2010: Global strategic alliance to further develop PD-1 targeting therapies for cancer and other diseases. GSK obtains exclusive worldwide rights to AMP-224. Value: Up to $508 million plus royalties.


Incyte

Pipeline Highlights

  • Epacadostat (INCB24360)—Phase I/II in select advanced solid tumors and lymphomas including melanoma (MEL), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL), in combination with BMS’s Opdivo (nivolumab); Phase I/II in several different advanced or metastatic solid tumors [Phase I] and in NSCLC only [Phase II], in combination with Merck & Co.’s Keytruda; Phase I/II in selected advanced solid tumors, in combination with AstraZeneca’s MEDI4736; Phase I in locally advanced or metastatic non-small cell lung cancer (NSCLC) that have been previously treated with platinum-based chemotherapy, in combination with Roche’s MPDL3280A;

Collaborations and Agreements

  • Advaxis

    • February 11, 2015—Clinical trial collaboration to evaluate the combination of Advaxis's ADXS-HPV (ADXS11-001) with Incyte's epacadostat (INCB24360).
  • Agenus

    • January 9, 2015—Global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ Retrocyte Display™ antibody discovery platform. Value: Up to $410 million.
  • Bristol-Myers Squibb

    • May 27, 2014—Clinical trial collaboration to evaluate the combination regimen of BMS’ Opdivo (nivolumab) and Incyte’s INCB24360.
  • AstraZeneca (MedImmune)

    • May 14, 2014— Clinical study collaboration to evaluate MedImmune’s MEDI4736, in combination with Incyte’s INCB24360.
  • Merck & Co.

    • February 5, 2014—Clinical trial collaboration to evaluate Incyte’s INCB24360 and Merck’s Keytruda (then called MK-3475).


Johnson & Johnson (Janssen Biotech)

Collaborations and Agreements

  • AstraZeneca (MedImmune) and Pharmacyclics

    • November 4, 2014: Clinical trial collaboration to evaluate MEDI4736, co-developed by Pharmacyclics and Janssen, as a treatment for patients with hematological cancers including diffuse large B-cell lymphoma and follicular lymphoma.
  • Bristol-Myers Squibb (BMS) and Pharmacyclics

    • October 13, 2014—Clinical trial collaboration agreement to evaluate efficacy of BMS’ Opdivo (nivolumab), co-developed and co-marketed by Janssen and Pharmacyclics, in Phase I/II study.
  • Aduro Biotech

    • October 16, 2014—Second agreement granting an exclusive, worldwide license to develop LADD immunotherapies that include ADU-214, together with an exclusive right to develop LADD strains in lung cancer indications. Value: Up to $817 million.
    • May 29, 2014—Exclusive, worldwide license to develop LADD immunotherapies that include ADU-741. Value: Up to $365 million
  • Dana-Farber Cancer Institute

    • June 24, 2014—Collaboration with Dana-Farber and its Dana-Farber Cancer Institute and its Belfer Institute for Applied Cancer Science to determine which lung cancer patients are most likely to benefit from a new generation of immunotherapies and to determine which combination of such therapies promise to be the most effective.
  • The University of Texas MD Anderson Cancer Center

    • January 21, 2014—Collaboration to develop immunology-based cancer treatments through the MD Anderson Moon Shots Program immunotherapy platform.
  • ImmuNext

    • September 5, 2012—Agreement to develop immunotherapies for cancer. ImmuNext granted Janssen a worldwide, exclusive license to develop and commercialize therapeutics that antagonize the V-region immunoglobulin-containing suppressor of T-cell activation (VISTA) signaling pathway. Value: More than $150 million.
       


Juno Therapeutics

Pipeline Highlights

  • JCAR014—Phase I/II in 27 disorders that include forms of leukemia and lymphoma, as well as post-transplant lymphoproliferative disorder, recurrent adult grade III lymphomatoid granulomatosis, and Waldenstrom macroglobulinemia
  • JTCR016—Phase I/II in nine disorders including acute myeloid leukemia arising from previous myelodysplastic syndrome, as well as other forms of leukemia and myelodysplastic syndrome
  • JCAR017—Phase I/II in CD19+ acute leukemia
  • JCAR015—Phase I in acute lymphoblastic leukemia; Phase I in Relapsed and Refractory Aggressive B Cell Non-Hodgkin’s Lymphoma
  • L1CAM (CD171)—Preclinical
  • MUC-16 / IL-12—Preclinical
  • ROR-1 product candidate—Preclinical


Merck & Co.

Marketed Treatments

  • Keytruda® (pembrolizumab; formerly MK-3475 or lambrolizumab) —Indications: Unresectable or metastatic melanoma. Year of first U.S. approval: 2014

    • Additional potential indications: Under review in Europe in advanced melanoma; Phase III in bladder cancer; Phase III in head and neck cancer; Phase III in non-small cell lung cancer; Phase II in gastric cancer.

Pipeline Highlights

  • Numerous collaborations assessing combinations of Keytruda with partners’ products (see below):

Collaborations and Agreements

  • Syndax Pharmaceuticals

    • March 31, 2015—Collaboration to assess the safety and efficacy of combining Syndax’s entinostat, an epigenetic therapy, with Merck’s Keytruda.
  • Eli Lilly

    • January 13, 2015—Collaboration to evaluate the safety, tolerability and efficacy of Keytruda in combination with Lilly compounds in multiple clinical trials.
  • Pfizer

    • August 26, 2014—Collaboration to explore the therapeutic potential of Merck’s Keytruda (then called MK-3475) with Xalkori (crizotinib) in Phase Ib clinical study in ALK-positive advanced or metastatic cases of non-small cell lung cancer.
    • February 5, 2014—Collaboration to explore the therapeutic potential of Merck’s Keytruda (then called MK-3475) in separate studies assessing combinations with two Pfizer oncology assets: Inlyta® (axitinib) in renal cell carcinoma; and PF-05082566 (PF-2566) in multiple cancer types. 
  • Advaxis

    • August 25, 2014—Collaboration agreement to evaluate the combination of Advaxis's ADXS-PSA, with Merck's pembrolizumab.
  • Agenus

    • April 28, 2014—Collaboration and license agreement for the discovery and development of therapeutic antibodies to immune checkpoints for the treatment of cancer. Value: Approximately up to $100 million, plus royalties.
  • Amgen

    • February 5, 2014—Collaboration to evaluate talimogene laherparepvec combined with MK-3475, an investigational anti-PD-1 immunotherapy.
  • Incyte

    • February 5, 2014—Clinical trial collaboration to evaluate Incyte’s INCB24360 and Merck’s Keytruda (then called MK-3475).
  • Ablynx

    • February 3, 2014—Research collaboration and licensing agreement focused on the discovery and development of several predefined Nanobody candidates directed toward immune checkpoint modulators. Value: Up to €1.7 billion ($2.3 billion at the time; $1.8 billion now).
  • GlaxoSmithKline (GSK)

    • December 18, 2013—Collaboration to assess the combination of Merck’s Keytruda (then called MK-3475) and GlaxoSmithKline’s Votrient® (pazopanib) in advanced renal cell carcinoma.
       


Merck KGaA (EMD Serono)

Pipeline Highlights

  • Avelumab (MSB 0010718C)—Phase II in Merkel cell skin carcinoma; Phase I for solid tumors. Under joint development with Pfizer—both as monotherapy and in combination with the companies’ approved and investigational cancer therapies
  • MSB 0010445 (NHS-IL2)—Phase II in melanoma
  • MSB 0010360N (NHS-IL12)—Phase I in solid tumors; study sponsored by the NIH’s National Cancer Institute

Collaborations and Agreements

  • Intrexon

    • March 30, 2015—Collaboration and license agreement to develop and commercialize chimeric antigen receptor T-cell (CAR-T) cancer therapies, using Intrexon’s cell engineering techniques and RheoSwitch® platform. Value: Up to $941 million.
  • Pfizer

    • April 7, 2015–Agreement to co-promote Pfizer’s marketed Xalkori® (crizotinib).
    • November 17, 2014—Global strategic alliance to jointly develop and commercialize MSB0010718C; collaborate on up to 20 immuno-oncology clinical development programs. These programs include up to six Phase II or III trials. Value: Up to $2.85 billion.
  • Oncothyreon

    • September 12, 2014—Clinical development of Oncothyreon’s tecemotide (L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC) discontinued, including two Phase III studies.
  • MorphoSys

    • June 12, 2014—Collaboration to discover and develop therapeutic antibodies against undisclosed immune checkpoints, using Ylanthia® antibody phage library and technology platform.
  • PDS Biotechnology

    • July 9, 2012—Licensing agreement for use of PDS Biotechnology’s Versamune™ nanotechnology platform in two Merck KGaA (Merck Serono) investigational antigen-specific cancer immunotherapies in preclinical development.


MorphoSys

Pipeline Highlights

  • MOR208 (also called XmAb5574)—Phase II in B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin’s lymphoma; co-developed with Xencor.
  • MOR202—Phase I/IIa in relapsed or refractory multiple myeloma patients, in combination with Celgene products Revlimid® (lenalidomide) and Pomalyst® (pomalidomide). 
  • MOR209/ES414—Phase I in metastatic, castration-resistant prostate cancer (mCRPC). Co-developed with Emergent BioSolutions.

Collaborations and Agreements

  • Celgene

    • March 27, 2015—Termination of co-development and co-promotion agreement for MOR202, the subject of a MorphoSys-sponsored Phase I/IIa trial in relapsed or refractory multiple myeloma patients, in combination with Celgene products Revlimid® (lenalidomide) and Pomalyst® (pomalidomide). Value: Up to $818 million.
  • Emergent BioSolutions

    • August 20, 2014—Agreement for joint development and commercialization of MOR209/ES414, developed by Emergent using its ADAPTIRplatform. Value: Up to $183 million.
  • Merck KGaA (Merck Serono)

    • June 12, 2014—Strategic collaboration to discover and develop therapeutic antibodies against undisclosed immune checkpoints, using Ylanthia® antibody phage library and technology platform.
  • Xencor

    • June 27, 2010—Collaboration providing MorphoSys with worldwide exclusive license to develop MOR208 for cancer and other indications, using Xencor’s XmAb Fc enhancement technology. Value: $13 million upfront.


Novartis

Pipeline Highlights

  • CTL019 (CART-19)—Phase II in children with B-cell acute lymphoblastic leukemia (ALL), who are chemo-refractory, relapsed after allogeneic stem cell therapy, or are otherwise ineligible for allogeneic stem cell transplant; Phase II in adult patients with r/r B-cell ALL; Phase II in non-Hodgkins Lymphoma (NHL); Regulatory filings planned for 2016.
  • Checkpoint inhibitor targeting PD-1, LAG3, TIM3—Three programs in preclinical phase; Development program acquired from CoStim

Collaborations and Agreements

  • Aduro Biotech

    • March 30, 2015: Develop new cancer immunotherapies based on Aduro’s cyclic dinucleotides (CDNs), synthetic small molecule immune modulators that are designed to target and activate the Stimulator of Interferon Genes (STING) receptor. Value: Up to $750 million.
  • Bristol-Myers Squibb (BMS)

    • October 6, 2014: Clinical collaboration to evaluate three Novartis products—the marketed drug Zykadia™ (ceritinib), and compounds INC280 [licensed from Incyte] and EGF816—in combination with BMS’ Opdivo.
  • CoStim Pharmaceuticals

    • February 17, 2014: Cancer immunotherapy developer acquired by Novartis. Deal includes late discovery stage immunotherapy programs directed to several targets, including PD-1.
  • University of Pennsylvania

    • August 6, 2012: Exclusive global research and licensing agreement to further study and commercialize novel cellular immunotherapies using chimeric antigen receptor (CAR) technologies. The deal gives Novartis exclusive rights to UPenn’s CART-19 immunotherapy. 


Pfizer

Marketed Treatment

  • Ibrance (palbociclib, formerly PD-0332991)—Indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Year of first U.S. approval: 2015 (February 3).

    • Additional potential indications: Phase III in 1st Line advanced breast cancer [Europe]; Phase III in recurrent advanced breast cancer; Phase III in high-risk early breast cancer; Phase III in renal cell carcinoma adjuvant.

Pipeline highlights:

  • Avelumab (MSB 0010718C)—Phase II study for Merkel cell skin carcinoma; Phase I for solid tumors. Under joint development with Merck KGaA.
  • PF-05082566—Phase Ib in solid tumors in combination with Merck’s Keytruda; Phase I in solid tumors or b-cell lymphomas, and in CD20 positive Non-Hodgkin's Lymphoma (NHL).

Collaborations and Agreements

  • iTeos Therapeutics

    • December 8, 2014—Collaboration under which iTeos licensed to Pfizer rights to preclinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2). Companies also will collaborate to discover and validate new targets that play key roles in the ability of tumors to evade immune responses. Value: €24 million ($26 million) upfront.
  • Merck KGaA (EMD Serono)

    • April 7, 2015—Agreement to co-promote Pfizer’s marketed Xalkori® (crizotinib).
    • November 17, 2014—Alliance to jointly develop and commercialize MSB0010718C; collaborate on up to 20 high-priority immuno-oncology clinical development programs expected to commence in 2015. These clinical development programs include up to six Phase II or III trials. Value: Up to $2.85 billion.
  • Merck & Co.

    • August 26, 2014—Collaboration to explore the therapeutic potential of Merck’s Keytruda (then called MK-3475) with Xalkori (crizotinib) in Phase Ib clinical study in ALK-positive advanced or metastatic cases of non-small cell lung cancer.
    • February 5, 2014—Collaboration to explore the therapeutic potential of Merck’s Keytruda (then called MK-3475) in separate studies assessing combinations with two Pfizer oncology assets: Axitinib (Inlyta®) in renal cell carcinoma; and PF-05082566 (PF-2566) in multiple cancer types. Value: Not disclosed.
  • Cellectis

    • June 18, 2014—Collaboration to develop chimeric antigen receptor T-cell (CAR-T) immunotherapies in oncology directed at select targets, using Cellectis’ CAR-T platform technology. Pfizer has exclusive rights to pursue development and commercialization of CAR-T therapies in oncology, directed at up to 15 targets selected by Pfizer. Value: Up to more than $2.885 billion.
  • The University of Texas MD Anderson Cancer Center

    • January 6, 2014—Alliance to accelerate and improve the development of immune-based approaches to cancer treatment via MD Anderson’s Moon Shots Program immunotherapy platform.
       


Roche (Genentech)

Pipeline Highlights

  • MPDL3280A (RG7446)—Phase III in 2nd line non-small cell lung cancer; Phase III in 2nd line urothelial bladder cancer; Phase III studies in additional tumor types to be launched this year; Phase II in renal cell cancer; Phase II in metastatic urothelial bladder cancer; Phase II in metastatic non-small cell lung cancer; Phase I in solid tumors; Phase I in solid tumors ; Phase I in locally advanced or metastatic solid tumors; Phase I in in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL; Phase I in non-small cell lung cancer with EGFR-activating mutations; Phase I in metastatic melanoma; Phase I in locally advanced or metastatic solid tumors.
  • Venetoclax or GDC-0199 (also ABT-199)—See ABT-199 under Abbott
  • INO-5150—Phase I in prostate cancer. Co-developed with Inovio.

Collaborations and Agreements

  • Immatics

    • November 13, 2013—Strategic research and development collaboration covering multiple immunotherapeutics and cancer vaccines targeting primarily gastric, prostate and non-small cell lung cancer. Value: More than $1 billion.
  • Inovio

    • September 10, 2013— Exclusive worldwide license agreement to research, develop and commercialize Inovio's DNA immunotherapies INO-5150 (targeting prostate cancer) and INO-1800 (targeting hepatitis B) as well as the use of Inovio's CELLECTRA® electroporation technology for delivery of the vaccines. Value: Up to $422.5 million.
  • Abbott (now AbbVie)

    • Details Under Abbott.
       


























 

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