Monthly Archives - September 2014

Oncology Collaborations

A sampling of recent reports shows just how much immuno oncology continues canada goose outlet to grow. Last month, GrandView Research projected a more than doubling of the global cancer immunotherapy market, from the $58.1 billion it tallied in 2018, to $126.9 billion by 2026. As GEN canada goose outlet black friday noted when it ranked the top immuno oncology startups in February, market projections range from $124.88 billion (Transparency Market Research) to $173 billion (Market Research Engine) by 2024.

Behind the sunny forecasts is the expectation of numerous new treatments reaching market, following a significant increase in clinical activity. The canada goose outlet parka Cancer Research Institute (CRI) in November recorded an approximately 50% year over year increase from 1502 in September 2017 to 2250 in September 2018 for the number of clinical trials evaluating just one category of cancer immunotherapies, programmed death 1 (PD 1) and programmed death ligand 1 (PD L1) immune checkpoint inhibitors. According to CRI, most of the trials (1716) canadian goose jacket were canada goose uk shop evaluating treatment regimens that combine PD L1 immunotherapies with other cancer therapies, with a total 240 targets under study.

However, CRI’s report also presented a more sobering statistic: All the trials it tallied would require 380,900 patient volunteers, up more than 100,000 from the previous year. Yet the recruitment rate for immuno oncology trials has fallen from 2014, when it was 1.15 patients per site per month, to just 0.35 patients per site per month in 2018.

Increasing patient recruitment will be a formidable challenge for cancer immunotherapy developers; yet it is necessary to sustain the momentum generated by biopharmas through their immuno oncology collaborations. The total value of this year’s top 10 immuno oncology collaborations as ranked by GEN is approximately $39.992 billion, up 16% from the canada goose outlet store uk $34.513 billion total for the 10 partnerships on last year A List, and up 52% from the $26.233 billion total for the 10 partnerships ranked in 2017. During canada goose store that period, the No. 10 collaboration has grown in value from a potential $1.5 billion, to $2.1 billion, to $2.6 billion.

Half of the top 10 collaborations were launched since January 2018, including two that were initiated since publication of GEN’s 2018 A List on the topic. Those two partnerships were large enough in value to be ranked third and fourth on this year’s A List and, even more significantly, they included participation by three biopharma giants, reflecting growing interest in immuno oncology by the largest drug developers.

As a result of new and restructured collaborations, three partnerships featured in previous years are no longer ranked:The up to $2.17 billion alliance of Sanofi and Regeneron Pharmaceuticals, launched in 2015 and restructured in January. The FDA approved the lead drug of the alliance, the PD 1 inhibitor Libtayo (cemiplimab rwlc), in September 2018.

Novartis’ up to $2.56 billion partnership to co develop Xencor’s T cell engaging XmAb bispecific antibodies. Novartis will cede XmAb13676 back to Xencor in June, while a Phase I trial (NCT02730312) of XmAb14045 is on a partial clinical hold following the deaths of two patients linked to the candidate.

Below is GEN’s updated A 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 canada goose outlet names, value, and date announced, followed by a summary and updates provided by the companies since their launch announcements.

10. 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

Summary:Celgenereceived options to develop and commercialize jointly cancer immunotherapiesthat included Jounce’s lead candidate JTX 2011, a mAb targeting ICOS (the Inducible T cell CO Stimulator), 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 goose outlet canada an additional option to share JTX 4014, Jounce’s PD 1 product candidate, equally with Jounce. The collaboration has an initial term offouryears, canada goose outlet online which may be extended up to three additional years.

Updates:Jounce plans to present positive JTX 2011 clinical data on April 2 at the 2019 American Association for Cancer Research (AACR) Annual Meeting. Data will come from part of Jounce’s Phase I/II ICONIC trial (NCT02904226), an open label study evaluating JTX 2011 alone and in combination with Bristol Myers Squibb (BMS)’s Opdivo (nivolumab). The trial is also assessing combinations of JTX 2011 with BMS’ Yervoy (ipililumab) and Merck Co.’s Keytruda (pembrolizumab).

Jounce also plans to present a poster detailing a preclinical evaluation of JTX 8064, the company’s lead tumor associated macrophage product cheap canada goose uk candidate targeting Leukocyte Immunoglobulin Like Receptor B2(LILRB2). Jounce expects to file an IND and launch a Phase I trial for JTX 8064 this year.

On January 3, Jounce said it completed enrollment in the first cohort for its Phase I dose escalation clinical trial (NCT03790488) of JTX 4014 in patients with solid tumors. JTX 4014 is a fully human IgG4 mAb designed to specifically bind to PD 1 and block its interaction with its ligands, PD L1 and PD L2, to augment antitumor T cell activity.

Date announced:November 17, 2014Updates:The companies have reported three recent clinical setbacks. On March 19, they said they would discontinue the Phase III JAVELINOvarian PARP 100 study(NCT03642132) evaluating chemotherapy followed by maintenance therapy of Bavencio plus Pfizer’s Talzenna (talazoparib), a poly (ADP ribose) polymerase (PARP) inhibitor, in treatment nave patients with locally advanced or metastatic ovarian cancer (Stage III or IV). Pfizer and Merck KGaA blamed factors that included disappointing interim results.

In December 2018, Merck KGaA and Pfizer terminated Canada Goose Parka the canada goose outlet nyc Phase III JAVELIN Ovarian 100 study (NCT02718417) assessing Bavencio with and/or following platinum based chemotherapy in previously untreated patients with ovarian cancer. The companies cited topline results showing Bavencio would not achieve superiority over chemotherapy in the prespecified primary endpoint of progression free survival canada goose outlet uk sale (PFS).

In November 2018, Merck KGaA and Pfizer acknowledged that Bavencio failed the Phase III JAVELIN Ovarian 200 trial (NCT02580058) by missing prespecified primary endpoints of PFS or overall survival (OS) either alone or in combination with pegylated liposomal doxorubicin (PLD) chemotherapy in patients with platinum resistant or refractory ovarian cancer, compared with PLD alone.

Bavencio reached the market in 2017, with indications in metastatic urothelial cancer and Merkel cell carcinoma (MCC) thefirst approved MCC canada goose clearance sale treatment. That year, the FDA granted its Breakthrough Therapy designation for Bavencio in combination with Pfizer’s Inlyta(axitinib) for treatment nave patients with advanced renal cell carcinoma (RCC). The combination showed significant PFS improvement over Pfizer’s Sutent (sunitinib), according to topline results from the Phase III JAVELIN Renal 101 trial (NCT02684006) announced in September 2018.

Summary:The companies are continuing a collaboration launched by Pfizer and Cellectis in 2014, when Pfizer gained exclusive rights to develop and commercialize Chimeric Antigen Receptor T cell (CAR T) cancer immunotherapies directed at 15 targets of its choosing, using Cellectis’ CAR T platform. rights.

Updates: In April 2018, Pfizer contributed UCART19 (plus 16 preclinical CAR T cell candidates licensed from Servier and Cellectis) to Allogene Therapeutics, a startup created with $300 million in Series A financing from a consortium whose members included Pfizer. Allogene assumed Pfizer’s strategic collaboration and official canada goose outlet license agreement with Cellectis, canada goose outlet under which Cellectis is eligible for up to $185 million per product tied to achieving development, regulatory, and commercial milestone payments, plus tiered royalties on net sales of commercialized products.

Pfizer took an approximately 25% stake in Allogene. That stake shrunk to approximately 18% in October 2018, when Allogene carried out an IPO that resulted in canada goose outlet in usa Pfizer’s preferred stock converting into common canada goose uk outlet stock, Pfizer stated in its Form 10 K for 2018. Separately, Pfizer has maintained the approximately 7% ownership stake it took in Cellectis when the collaboration launched.

UCART19 is in a Servier sponsored Phase I program in relapsed/refractory acute lymphoblastic leukemia (r/r ALL), https://www.naslsoccerbowl.com both pediatric (“PALL”, NCT02808442) and adult (“CALM”, NCT02746952). In December 2018, Servier and Allogene announced positive clinical data pooled from canada goose outlet new york city both trials.

On January 28, Allogene announced FDA clearance of an IND for a second CAR T candidate, ALLO 501, with plans to launch buy canada goose jacket the ALPHA Phase I trial in up to 24 patients with relapsed/refractory non Hodgkin lymphoma in the first half of this year.

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