Welcome back from the Labor Day holiday. Summer is sadly over, but we are excited to be back as this time often marks the start of a rush of biotech news that will play out over the remainder of 2017. Biotech stocks can be quite catalyst driven. As an investor, it helps to know the important dates that might impact companies. These include important medical meetings, clinical trial schedules, and other key events where you can expect to hear news from companies.
To help our investors make sense of it all, we scoured the second quarter earnings releases of companies in the Cancer Immunotherapy ETF (Nasdaq: CNCR) and have listed below their stated immunotherapy catalysts for the remainder of 2017 all in one place. While you can be sure to see a healthy dose of unexpected news as well, the below events should at least give you a snapshot of what the companies are stating as their most important catalysts coming up.
First, it is important to know what medical meetings will be impacting cancer immunotherapy companies throughout the rest of the year. Medical meetings are key to biotech investing because it is at these meetings where companies aim to announce their most important clinical trial results. Be sure to circle these dates as moments where you can expect to hear a lot of news about immunotherapy.
For cancer immunotherapy companies, the most important medical meetings throughout the remainder of 2017 are as follows:
CRI-CIMT-EATI-AACR: September 6-9 | Mainz/Frankfurt, Germany
A consortium of cancer immunotherapy organizations hosts this conference and all of the research presented here will be about immunotherapy. You can expect to see both preclinical (before human testing) and clinical results discussed and presented here.
ESMO 2017: September 8-12 | Madrid, Spain
ESMO is the largest meeting of cancer research held each year in Europe. This is a big one. Even though it has a European flavor, ESMO is a global conference and you can expect that companies from around the world (including many CNCR holdings) will be presenting important clinical trial results here.
SITC 2017: November 8-12 | Washington DC
The Society for Immunotherapy of Cancer will be hosting its 32nd annual meeting in the Washington DC area this year. The conference has turned into somewhat of a central event for immunotherapy research and you can bet that many immunotherapy companies will seek to present data here.
SNO 2017: November 16-19 | San Francisco, CA
The Society for NeuroOncology is one of the most important meetings for presenting brain cancer and spinal tumor research each year. Immunotherapies such as oncolytic viruses, cellular therapies, and others are being researched heavily for brain cancers. Expect to hear news from immunotherapy companies with this focus at SNO.
San Antonio Breast Cancer Symposium: December 5-9 | San Antonio, TX
Celebrating its 40th anniversary, SABCS is always one of the most important conferences for breast cancer research. Immunotherapies are being researched widely for certain types of breast cancer, especially such as triple negative breast cancer, so watch for immunotherapy news to come out of San Antonio this year.
ASH 2107: December 9-12 | Atlanta, GA
ASH stands for the American Society of Hematology and it is the largest conference for blood diseases in the world. Since many cancer immunotherapies approaches like CAR-T are having a big impact on blood cancers, ASH has become one of the top two or three important conferences for immunotherapy. ASH can be make-or-break for certain companies and has often impacted the immunotherapy space a lot in the past so look for it to be newsworthy again in 2017.
All biotech companies often provide in earnings releases and other corporate presentations a snapshot of what they believe are the most important news items and milestones coming up. We scoured the second quarter earnings releases of CNCR held companies and have aggregated this list of their upcoming catalysts for 2017 below.
- Enrollment is ongoing in 9 clinical studies with NY-ESO (in partnership with GSK) and across 12 different tumor indications for Adaptimmune’s wholly-owned assets (MAGE-A4, MAGE-A10, and AFP) with some data to be presented in 2017.
- Initiate Phase 1 pLADD (personalized LADD) trial in certain colorectal cancers
- Janssen expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer and determine next steps for ADU-741 in prostate cancer
- Initiate Phase 1b trial of ADU-S100 in combination with anti-PD-1 in collaboration with Novartis
- Report early results from the Phase 2 mesothelioma study evaluating CRS-207 in combination with pembrolizumab
- Report preliminary top-line findings from Phase 1 monotherapy trial of ADU-S100
- File an IND for BION-1301, an anti-APRIL antibody. Initiate Phase 1 multiple myeloma trial with BION-1301, an anti-APRIL antibody
- Advaxis will present two poster presentations on ADXS-PSA and one on biomarkers associated with tumor regression at CRI-CIMT-EATI-AACR in September
- For the axalimogene filolisbac anal cancer program, Advaxis is evaluating whether to continue to the second stage of the monotherapy trial, or to initiate a registrational-quality study in combination with a checkpoint inhibitor in the same patient population later this year
- Present data from the combination trial of axalimogene filolisbac and Imfinzi in cervical and head and neck cancer, likely at SITC
- Advaxis and Amgen are on track to initiate clinical studies of ADXS-NEO later this year. ADXS-NEO is a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with Amgen for the treatment of several metastatic tumor types
- Advaxis plans to file two new IND applications with FDA in the second half of this year for ADXS-HOT. ADXS-HOT leverages Advaxis’ Lm Technology to target public or shared acquired mutations, so-called “hotspots,” in tumor driver genes
- File a marketing application sometime in the second half of 2017 in the EU for axalimogene filolisbac as adjuvant monotherapy to prevent recurrence in high-risk cervical cancer
- Present preliminary data from the ADXS-PSA + Keytruada phase 1/2 study in metastatic prostate cancer
- Present preliminary data from the ADXS-PSA phase 1b monotherapy trial in HER2-postivie metastatic solid tumors
- Launch a phase 2 study in pediatric osteosarcoma with the Children’s Oncology Group.
- AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation and compile safety and pharmacodynamic data
- AGEN2034 (anti-PD-1) Phase 1/2 trial will complete dose-escalation for monotherapy to define the optimal combination dose and collect safety and receptor occupancy data. The company will also recruit patients with second line cervical cancer
- AGEN1884+AGEN2034 Phase 1b trial: commence combination trial
- AutoSynVax (neoantigen vaccine): immunological readouts expected in patients with advanced malignancies. Advance the company’s cell therapy spin off efforts
- Present full date from the phase 3 PACIFIC study of Imfinzi in locally advanced non-small cell lung cancer at ESMO in September
- Submit the regulatory submission for the PACIFIC indication in the second half of 2017
- The phase 3 ARCTIC study of Imfinzi plus or minus tremelimumab in third line PD-L1 low/negative lung cancer patients will read out in the second half of 2017. If positive, a regulatory submission might also be completed by the end of the year.
- Atara expects to initiate two phase 3 studies for ATA129 (an allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy)
- The ATA129 expanded access protocol clinical study for patients with EBV-PTLD and other EBV-positive hematologic and solid tumors is ongoing at more than 10 medical centers. Multicenter data from the EAP clinical study is expected to be presented at appropriate future scientific conferences.
- Present updated Phase 1 monotherapy data of the BGB-A317 PD-1 antibody at ESMO 2017
- Present data from the Phase 1 combination trial of BGB-A317 and BGB-3111 (BTK Inhibitor) in 2017
- Present data from the Phase 1 trial of BGB-A317 in Chinese patients with advanced solid tumors in 2017
- Enrollment in the BP-004 pivotal clinical trials of BPX-501 is ongoing and the company expects to report top-line results in the second half of 2018
- Registrational studies of BPX-501 in adult patients with AML and pediatric non-malignant patients are being designed and more specifics will be disclosed as they are finalized
- Enrollment in a phase 1 trial of Bellicum’s GoCAR-T product BPX-601 is ongoing in patients with nonresectable pancreatic cancer who test positive for PSCA
- Patient dosing in a phase 1 trial of Bellicum’s BPX-701 TCR product with the CaspaCIDe safety switch has been initiated in patients with AML and MDS who test positive for PRAME
- For the bb2121 anti-BCMA CAR-T phase 1 study in multiple myeloma, approximately 6 months of additional follow-up since ASCO on patients treated in the dose-escalation phase and any available early data on patients treated in an expansion cohort will be presented at ASH in December
- An IND will be filed for the next generation anti-BCMA CAR-T product, bb21217.
- An FDA decision for Opdivo in 2nd line (previously treated) hepatocellular carcinoma is due by September 24th
- Data from the Checkmate-459 study of Opdivo in first line hepatocellular cancer is expected in the second half of 2017
- An interim look at the Checkmate-227 combination trial of Opdivo and Yervoy in first line advanced lung cancer is expected late in 2017
- Enrollment recently completed in the phase 2 METRIC study of glembatumumab vedotin in triple negative breast cancer. Data is expected in the second quarter of 2018
- A phase 2 study in checkpoint-refractory metastatic melanoma includes a glembatumumab vedotin and varlilumab combination arm, and data from this portion of the study are expected in the fall of 2017
- A phase 1 dose escalation study of CDX-0158 (a humanized monoclonal antibody designed to inhibit KIT) continues to enroll patients with advanced refractory gastrointestinal stromal tumors and other KIT-positive tumors. This study is designed to determine the maximum tolerated dose, recommend a dose for further study, and characterize the safety profile of CDX-0158. Data from the study continue to be expected by year-end 2017
- Celldex has finalized plans for an open-label Phase 2 study of CDX-3379 (a human monoclonal antibody designed to block the activity of ErbB3) in patients with recurrent/ metastatic head and neck squamous cell cancer who are refractory to Erbitux. The company anticipates initiating this study in the fourth quarter of 2017
- Enrollment is ongoing in Phase 1 study of CDX-014 (a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen). This study in advanced renal cell carcinoma is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017
- Patient dosing is ongoing with the UCART123 product candidate in patients with AML and BPDCN. Enrollment and dose escalation should progress throughout 2017
- An IND has been cleared for Servier and Pfizer to proceed with UCART19 in phase 1 clinical trials in the US in patients with relapsed/refractory ALL. This trial should dose patients throughout 2017
- UCART19 phase I clinical trials in pediatric and adult ALL patients are ongoing at University College London and Kings College London in the UK
- A poster presentation for CA-170 (PDLA/VISTA antognist) will take place at the ESMO Conference in September.
- CytomX will complete enrollment in the monotherapy dose escalation arm of the study evaluating CX-072 (a probody PD-L1) in patients with advanced unresectable solids tumors or lymphomas in the second half of 2017
- A combination arm of the study evaluating a concomitant schedule for CX-072 plus ipilimumab in patients with advanced unresectable solids tumors or lymphomas is currently enrolling
- A combination arm of the study evaluating CX-072 plus vemurafenib in patients with V600E BRAF-positive melanoma is currently enrolling
- The PROCLAIM-CX-2009 study, a Phase 1/2 clinical trial evaluating CX-2009 (a probody drug conjugate targeting CD166) as monotherapy in a subset of CD166-positive cancers, is currently enrolling
- A phase 2 portion of a study evaluating the safety and efficacy of SD-101 (TLR9 agonist) and pembrolizumab in advanced melanoma and squamous cell carcinoma of the head and neck is currently enrolling
- A clinical study combining SD-101 and MK-1966, a monoclonal antibody against IL-10, in patients with advanced malignancies is currently enrolling
- A final FDA decision is expected on Dynavax’s marketing application for the HEPLISAV-B hepatitis B vaccine by November 10. This is not a cancer immunotherapy program but will have a significant impact on the company
Five Prime Therapeutics
- For the phase 1a/1b combination study of cabiralizumab (CSF1R inhibitor) and Opdivo, Five Prime has completed enrollment in some of the Phase 1b cohorts and expects to complete enrollment in all the cohorts in the second half of 2017. Five Prime and Bristol-Myers Squibb also expect to present initial clinical trial data at the Society for Immunotherapy of Cancer (SITC) meeting in November
- For the ongoing Phase 1/2 trial of cabiralizumab in patients with PVNS, Five Prime plans to enroll additional patients in the Phase 2 portion of the trial to refine the dosing schedule and to optimize the therapeutic index of cabiralizumab in this chronic disease setting. These additional data are intended to support a pivotal trial for cabiralizumab in PVNS
- Enrollment continues in the expansion portion of the phase 1 monotherapy trial of FPA144 (FGFR2b antibody) evaluating the safety, PK and efficacy of biweekly 15 mg/kg infusions of FPA144 in patients with gastric cancer whose tumors overexpress FGFR2b
- Five Prime plans to begin dosing patients in a Phase 1 clinical trial to test the safety of ascending doses of FPA144 in combination with chemotherapy by the end of 2017. This safety trial will support the start of the global Phase 3 clinical trial
- Five Prime plans to advance the Phase 1 monotherapy trial of FPA144 in patients with bladder cancer
- Clinical data from the phase 1b trial of FP-1039 (a protein drug designed to block FGF signaling) in mesothelioma have been accepted as an oral presentation at the European Society for Medical Oncology (ESMO) 2017 Congress in September
- Five Prime will file an IND for FPA150 (anti-B7-H4) in the fourth quarter of 2017. B7-H4 is overexpressed in breast, ovarian, and endometrial cancers
- FPA150 was selected for an oral poster discussion during the ESMO 2017 Congress in September
- Incyte and Merck will present updated data from the ECHO-202/Keynote-037 phase 2 clinical trial of the combination of epacadostat and Keytruda in first line metastatic melanoma
- Phase 3 studies of the IDO1 inhibitor epacadostat in combination with Keytruda will begin in non-small cell lung, renal, bladder, and head and neck cancer
- Phase 3 studies of the IDO1 inhibitor epacadostat in combination with Opdivo will begin in non-small cell lung and head and neck cancer
- Inovio is on track to open at least 50 sites by the end of the year for its phase 3 trial to evaluate the efficacy of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV)
- INO-5401 glioblastoma multiforme (brain cancer) phase 1/2 combination study with Regeneron will initiate in the second half of 2017
- INO-5401 bladder cancer phase 1/2 combination study with Genentech will initiate in the second half of 2017
- INO-5150 prostate cancer study (phase 1) will report data in the 3rd quarter of 2017
- Data will be presented at the upcoming ESMO congress demonstrating phenotypic and functional characterization of TIL grown from lymphoma tumors
- Patient dosing in the second cohort of its ongoing Phase 2 trial investigating LN-144 for the treatment of patients with metastatic melanoma is ongoing
- Patient dosing for the phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck is ongoing
- Iovance is actively screening patients in the Phase 2 trial for LN-145 in cervical cancer and patient dosing should begin shortly
- Enrollment is ongoing in the phase 2 part C monotherapy portion of the ICONIC study of JTX- 2011 (ICOS agonist) in at least six solid tumor types
- Enrollment is also ongoing in the Phase 2 part D combination study of JTX-2011 and nivolumab in at least six tumor types
- Initiate the pivotal study of JCAR017 in DLBCL
- Initiate a second trial of anti-BCMA CAR-T in multiple myeloma
- Eleven product candidates are in clinical trials against eight different targets, including five solid organ tumor targets
- An IL13RA2 program in glioblastoma is planned for 2017 or 2018
- Report various clinical trial updates at ASH in December
- A decision by FDA is expected on Kite’s marketing application for axicabtagene ciloleucel (axi- cel) by November 29th
- Commence the commercial launch of axi-cel in the United States, if approved
- Data from a one-year follow-up of the ZUMA-1 study of axi-cel in patients with aggressive NHL is expected in the second half of 2017
- Preliminary data from ZUMA-6 combination study of axi-cel and atezolizumab (PD-L1 checkpoint inhibitor) in refractory DLBCL is expected in the second half of 2017
- Preliminary follow-up phase 1 data from the ZUMA-3 and ZUMA-4 studies of pediatric and adult ALL are expected in the second half of 2017
- The ZUMA-3 and ZUMA-4 studies will be advanced into phase 2
- A phase 1 trial of KITE-585 (anti-BCMA CAR-T) will be initiated in multiple myeloma
- MacroGenics expects to complete enrollment of the phase 2 gastric cancer study of margetuximab (Fc-optimized monoclonal antibody that targets HER2) in 2017
- MacroGenics expects to use the phase 1 trial of MGD009 (DART molecule targeting B7-H3 and CD3) to establish the dose and schedule for this asset as well as initiate expansion cohorts in multiple tumor types in 2017
- The company’s PD-1 asset MGA012 is enrolling patients in a dose escalation segment of a phase 1 clinical study and expects to define a target dose and schedule soon. The company expects to initiate the first study of MGA012 in combination with another internal program by the end of 2017
- FDA cleared the IND for MGD013 (a DART molecule that co-blocks PD-1 and LAG-3) and enrollment should progress throughout 2017
- An abstract from a Phase 1 first-in-human study of flotetuzumab, a CD123 x CD3 bispecific DART molecule, in AML/MDS had been accepted for oral presentation at ESMO 2017
- An FDA decision for Keytruda for the treatment of third line gastric cancer is scheduled by September 22
- Primary completion of the Keynote-189 Keytruda plus chemotherapy combination trial in first line non-small cell lung cancer is scheduled for the second half of 2017. djuvant melanoma, Keynote-061 in second line gastric cancer, Keynote-180 in third line non-small cell lung cancer is scheduled for the second half of 2017
- Other Keytruda studies with primary completions dates by the end of 2017 include Keynote-054 in adjuvant melanoma, Keynote-061 in second line gastric cancer, Keynote-180 in third line esophageal cancer, Keynote-224 in second line hepatocellular carcinoma, Keynote-164 in colorectal cancer, and Keynote-048 in first line head and neck cancer
- A phase 2 clinical study of the company’s aNK cell therapy is currently ongoing in Merkel cell carcinoma
- FDA authorized the IND for a study of the NANT Pancreatic Cancer Vaccine combination immunotherapy phase 1b/2 study in subjects with pancreatic cancer who have progressed on or after standard-of-care-therapy and this study might be open for recruitment in the coming months
- A phase 1b/2 study combination immunotherapy study with the NANT Melanoma Vaccine in subjects who have progressed on or after chemotherapy and PD-1/PD-L1 therapy might open for recruitment in the coming months
- Novartis will file for approval of CTL019 for the treatment of pediatric ALL in the EU in the second half of 2017
- Full results of the CTL019 JULIET study in DLBCL will be presented at a medical meeting in the second half of 2017
- Novartis will file for approval for CLT019 for the treatment of DLBCL in the US and EU in the fourth quarter of 2017
- Enrollment in the PD-1 refractory non-small cell lung cancer cohort of the ENCORE 601 trial of entinostat (HDAC inhibitor) is expected to be completed in the fourth quarter of 2017
- A determination on whether PD-1 naïve non-small cell lung cancer cohort of the ENCORE 601 trial of entinostat has satisfied the pre-specified efficacy criteria for advancing is expected by the end of 2017
- Enrollment in the ENCORE 601 cohort enrolling microsatellite stable colorectal cancer (CRC) patients is ongoing
- Syndax expects to present data from stage one of the NSCLC cohorts, as well as biomarker data from the melanoma cohort, of the ENCORE 601 trial at the SITC Annual Meeting
- A Phase 1b/2 combination study of entinostat and Genentech’s PD-L1 inhibitor Tecentriq in patients with triple negative breast cancers is expected to complete enrollment in the phase 2 portion by the end of 2017
- Syndax expects to present data from the phase 1 single ascending dose study of SNDX-6352 (SCF-1R antibody) at a scientific congress in the fourth quarter of 2017
- An investigational new drug application filing for XmAb18087, a somatostatin receptor 2 (SSTR2) x CD3 bispecific antibody for the treatment of neuroendocrine tumors, is expected in 2017
- A phase 1 trial of XmAb14045, a CD123 x CD3 bispecific antibody for the treatment of AML, is currently ongoing and initial data is expected in 2018, pending alignment on timing with Novartis
- A phase 1 trial of XmAb13676, a CD20 x CD3 bispecific antibody for the treatment of B-cell tumors, is currently ongoing and initial data is expected in 2018, pending alignment on timing with Novartis
- Initiate a pivotal clinical trial for the IL-12 RheoSwitch program in recurrent glioblastoma
- Initiate a combination study of the IL-12 RheoSwitch program with an anti-PD1 for recurrent glioblastoma
- Initiate a phase 1 study of the IL-12 RheoSwitch program for the treatment of brain tumors in children
- Provide a program update at the Society of Neuro-Oncology Annual Meeting in November
- Continue the company’s clinical study of the second generation CD19 specific CAR-T, enrolling patients under a shortened manufacturing protocol
- A first patient in Ziopharm’s phase I trial for the CD33-specific CAR-T cell therapy for relapsed or refractory AML will dose in the third quarter of 2017
- Initiate a Phase 1 study of off-the-shelf NK cells for elderly patients with AML not eligible for standard intensive chemotherapy
Thank you for reading our preview of cancer immunotherapy catalysts remaining for 2017. While we aim to arm our investors with as much information as possible about the immunotherapy space, it is our pleasure to do this research on your behalf and provide you with a consolidated way of investing in the theme of immunotherapy. Have a great rest of the year!
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Opinions expressed are those of the author or Funds and are subject to change, are not intended to be a forecast of future events, a guarantee of future results, nor investment advice.