On May 16, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that data from its ongoing Phase 1/2 ICONIC trial, an adaptive design, open label trial evaluating JTX-2011 monotherapy and in combination with nivolumab, will be the subject of an oral presentation at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1-5, 2018 (Press release, Jounce Therapeutics, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349498 [SID1234526705]). The abstract published today online reflects data as of January 27, 2018 and updated results will be presented on June 2, 2018.

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Jounce has met its target enrollment for the Phase 1/2 ICONIC trial in its combination cohorts across four solid tumor types: gastric cancer, triple negative breast cancer (TNBC), head and neck squamous cell cancer (HNSCC) and non-small cell lung cancer (NSCLC), with most patients completing at least one efficacy assessment. Updated results, including preliminary efficacy data on all evaluable patients in the trial, will be presented at ASCO (Free ASCO Whitepaper).

"The preliminary data from patients across multiple solid tumor types enrolled in the ICONIC trial show that JTX-2011 is well-tolerated alone and in combination with nivolumab and has demonstrated evidence of biologic activity and tumor reductions in heavily pre-treated patients who have failed all available therapies. In addition, a potential surrogate biomarker of response has been identified that may help to guide JTX-2011 development," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "We look forward to continuing clinical development of JTX-2011."

Details of the Oral Presentation

Title: ICONIC: Biologic and clinical activity of first in class ICOS agonist antibody JTX-2011 +/- nivolumab (nivo) in patients (pts) with advanced cancers

Session: Developmental Therapeutics – Immunotherapy
Date and Time: Saturday, June 2, 2018, 3:00 – 3:12 p.m. CT (4:00 – 4:12 p.m. ET)
Abstract Number: 3000
Location: Hall B1
Presenter: Timothy A. Yap, MBBS, PhD, MRCP, BS, The University of Texas MD Anderson Cancer Center

Full session details and data presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.asco.org.

ASCO Abstract and Presentation
The ASCO (Free ASCO Whitepaper) abstract includes preliminary efficacy data from Phase 1 and 2 patients with gastric cancer and TNBC; pharmacodynamic data from Phase 1 that supported Phase 2 dose selection; and safety data from all Phase 2 subjects.

At the presentation, Jounce will provide longer-term follow-up from patients included in the abstract as well as preliminary efficacy data on all evaluable patients in the trial as of an April 4, 2018 cut-off date. This includes data from tumor specific cohorts in gastric cancer, TNBC, HNSCC, NSCLC and other solid tumors. Phase 1 and 2 monotherapy and combination safety data in all patients will be presented, as well as biomarker information on ICOS expression including the emergence of an ICOS high peripheral blood T cell population. Initial Phase 1 safety, PK and PD were previously reported at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting.

Jounce Therapeutics to Host Event and Webcast
Jounce Therapeutics will host an investor and analyst event beginning at 6:30 p.m. CT (7:30 pm ET) and live webcast beginning at 7:00 p.m. CT (8:00 p.m. ET), both on Monday, June 4, 2018. To access the live webcast, please visit the "Events & Presentations" page in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

On May 16, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer reported positive data from the FORWARD II trial evaluating mirvetuximab soravtansine in multiple combination cohorts in patients with folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 16, 2018, View Source [SID1234526704]). Results from the cohort assessing mirvetuximab in combination with Avastin (bevacizumab) in patients with platinum-resistant disease will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 1-5 in Chicago, IL. In addition, ImmunoGen reported updated data from the dose-escalation cohort evaluating mirvetuximab in combination with carboplatin in patients with recurrent platinum-sensitive ovarian cancer.

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"Building upon the encouraging data generated with mirvetuximab monotherapy, we have looked to expand our addressable patient population through combination regimens with both currently approved and experimental agents in ovarian cancer. In dose escalation, we have demonstrated that full dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin, or Keytruda, with encouraging preliminary clinical activity," said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen. "The promising new data reported in the FORWARD II Avastin and carboplatin arms support the potential of mirvetuximab combinations in earlier lines of therapy. Together, these results have informed the triplet combination study with mirvetuximab plus carboplatin and Avastin, which we initiated last quarter."

Berkenblit continued, "In addition, we plan to present initial data from the Keytruda expansion cohort later this year, building upon the dose escalation data recently presented at SGO. The totality of these data from FORWARD II will guide the next stages of development of mirvetuximab and support a path to registration for combination regimens."

DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN
Mirvetuximab soravtansine in combination with Avastin in patients with platinum-resistant ovarian cancer has demonstrated anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to three prior lines of therapy and have medium or high levels of FRα expression. This is the population being studied in the FORWARD I Phase 3 registration trial.

Key findings in 59 patients with platinum-resistant ovarian cancer include:

In the subset of 23 patients evaluable for response with medium or high FRα expression levels who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 48 percent (95% CI 27,69), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.6,14.5) and a median duration of response (DOR) of 10.6 months (95% CI 3.3,12.0).
For the 54 patients evaluable for response, the confirmed ORR was 43 percent (95% CI 29,57), with a median PFS of 7.8 months (95% CI 5.6,10.2); patients in this cohort had received a median of 3 prior lines of systemic therapy, with 58 percent of patients having received prior bevacizumab.
The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.
"The mirvetuximab and Avastin combination has demonstrated very encouraging initial clinical activity in ovarian cancer patients and a consistently favorable safety profile," stated David O’Malley, M.D., Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Investigator. "There is a significant need for new therapeutic options to improve outcomes and tolerability for this difficult-to-treat patient population, and I believe these results support further clinical evaluation of this combination regimen."

ASCO PRESENTATION DETAILS
Title: Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: maturing safety and activity profile from the FORWARD II Phase 1b study
Presenter: David M. O’Malley, MD, The Ohio State University College of Medicine
Day/Time: Monday, June 4, 1:15-4:45 pm CDT
Location: Hall A
Abstract: 5549

Additional information, can be found at www.asco.org.

UPDATED DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH CARBOPLATIN
Initial findings from a dose escalation cohort of mirvetuximab in combination with carboplatin were presented at ASCO (Free ASCO Whitepaper) 2017. The data have matured and updated findings in heavily pre-treated patients with platinum-sensitive ovarian cancer include:

In the subset of 10 patients with medium or high FRα expression levels, the confirmed ORR was 80 percent (95% CI 44,98), with a median PFS of 15 months (95% CI 9.9,-), and with median DOR not reached.
For all 17 evaluable patients, the confirmed ORR was 71 percent (95% CI 44,90), with a median PFS of 15 months (95% CI 9.9, -), and with median DOR not reached; 50 percent of patients in this cohort had received 3 or more prior lines of systemic therapy.
The combination continues to display a favorable safety profile in-line with the known profiles of each agent, with no new safety signals identified.
Based on the findings from the carboplatin and Avastin cohorts, ImmunoGen recently initiated an additional cohort assessing a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer as part of the FORWARD II trial.

DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH KEYTRUDA
Additionally, ImmunoGen recently announced encouraging activity and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with platinum-resistant ovarian cancer at the Society of Gynecologic Oncology Annual Meeting. Based on these data, ImmunoGen is completing enrollment in an expansion cohort that includes an additional 35 patients with medium or high FRα expression levels. ImmunoGen plans to report initial findings from this cohort in the second half of this year.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on Thursday, May 17 at 8:00am ET to discuss new data from the FORWARD II trial. To access the live call by phone, dial 323-794-2423; the conference ID is 5718620. The call may also be accessed through the "Investors" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 7, 2018.

ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 16, 2018 Galera Therapeutics, Inc., a clinical-stage biotechnology company developing drugs targeting oxygen metabolic pathways with the potential to transform cancer radiotherapy, reported that data from its Phase 2b clinical trial of GC4419 for severe oral mucositis in patients with head and neck cancer will be presented during an oral abstract session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 1-5, 2018 in Chicago (Press release, Galera Therapeutics, MAY 16, 2018, View Source [SID1234526703]). GC4419 is a highly selective and potent small molecule dismutase mimetic that rapidly converts superoxide to hydrogen peroxide and oxygen.

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Presentation details are as follows:

Title: Results of a randomized, placebo (PBO) controlled, double-blind P2b trial of GC4419 (avasopasem manganese) to reduce duration, incidence and severity and delay onset of severe radiation-related oral mucositis (SOM) in patients (pts) with locally advanced squamous cell cancer of the oral cavity (OC) or oropharynx (OP)

Abstract Number: 6006

Oral Abstract Session: Head and Neck Cancer

Date / Time / Location: June 3, 2018 / 10-10:12 a.m. CDT / McCormick Place E451

Presenter: Carryn M. Anderson, MD, Radiation Oncologist, University of Iowa Hospitals and Clinics

The abstract has also been selected for inclusion in the 2018 Best of ASCO (Free ASCO Whitepaper) program, which aims to increase global access to cutting-edge science by condensing highlights from ASCO (Free ASCO Whitepaper)’s Annual Meeting into a two-day program to be held this summer.

For information about the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit View Source

About GC4419

GC4419 is a highly selective and potent small molecule dismutase mimetic that closely mimics the activity of human superoxide dismutase enzymes. GC4419 works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Left untreated, elevated superoxide can damage noncancerous tissues and lead to debilitating side effects, including oral mucositis (OM), which can limit the anti-tumor efficacy of radiation therapy. Conversion of elevated superoxide to hydrogen peroxide, which is selectively more toxic to cancer cells, can also enhance the effect of radiation on tumors, particularly with stereotactic body radiation therapy (SBRT), which produces high levels of superoxide.

GC4419 has been studied in patients with head and neck cancer, GC4419’s lead indication, for its ability to reduce the duration, incidence and severity of radiation-induced severe oral mucositis (SOM). Results from Galera’s 223-patient, double blind, randomized, placebo-controlled Phase 2b clinical trial demonstrated GC4419’s ability to dramatically reduce the duration of SOM from 19 days to 1.5 days (92 percent), the incidence of SOM through completion of radiation by 34 percent and the severity of patients’ OM by 47 percent, while demonstrating acceptable safety when added to a standard radiotherapy regimen. In addition, in multiple preclinical studies, GC4419 demonstrated an increased tumor response to radiation therapy while preventing toxicity in normal tissue.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. The FDA also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.

On May 16, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that seven abstracts highlighting progress in the Rubraca preclinical research and clinical development program will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 1-5 in Chicago (Press release, Clovis Oncology, MAY 16, 2018, View Source [SID1234526702]).

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The accepted abstracts include additional data from the phase 3 ARIEL3 clinical trial, as well as summaries of ongoing preclinical research and multiple clinical trials in which Rubraca is being studied as monotherapy and in combination in cancer types including ovarian, bladder, prostate and breast cancers.

"Rubraca has demonstrated its ability to reduce the risk of disease progression following platinum-based chemotherapy for women with advanced ovarian cancer, and our team is dedicated to fully exploring the potential of this molecule as a new treatment option for patients being treated for other cancer types where PARP inhibitors have shown encouraging results," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing updates on the progress of our clinical development program at ASCO (Free ASCO Whitepaper) 2018."

The four Clovis Oncology-sponsored abstracts accepted for presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting comprise:

Abstract TPS4592 (Poster 415a) – ATLAS: A phase 2, open-label study of rucaparib in patients (pts) with locally advanced or metastatic urothelial carcinoma (mUC).

Presenter: Petros Grivas, MD, PhD, University of Washington
Session: Genitourinary (Nonprostate) Cancer
Date/Time: Saturday, June 2, 8:00 -11:30 a.m. CT
Location: Hall A
Abstract 5537 (Poster 264) – Evaluation of rucaparib in platinum-sensitive recurrent ovarian carcinoma (rOC) in patients (pts) with or without residual bulky disease at baseline in the ARIEL3 study.

Presenter: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5545 (Poster 272) – Exploratory analysis of percentage of genomic loss of heterozygosity (LOH) in patients with platinum-sensitive recurrent ovarian carcinoma (rOC) in ARIEL3.

Presenter: Ana Oaknin, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO)
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Abstract 5582 (Poster 309) – Efficacy and immune modulation of the tumor microenvironment with the combination of the PARP inhibitor rucaparib and CD122-biased agonist NKTR-214.

Presenter: Andrew Simmons, PhD, Clovis Oncology
Session: Gynecologic Cancer
Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
Location: Hall A
Additionally, three additional collaborator and investigator sponsored abstracts investigating Rubraca in metastatic breast and prostate cancers are also being presented:

Abstract TPS1112 (Poster 187a) – An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2- metastatic breast cancer patients with high genomic loss of heterozygosity.

Presenter: Anne Patsouris, Institute of West Cancerology Paul Papin
Session: Breast Cancer – Metastatic
Date/Time: Saturday, June 2, 8:00-11:30 a.m. CT
Location: Hall A
Abstract TPS5095 (Poster 317b) – Phase II trial of rucaparib (without ADT) in patients with metastatic hormone-sensitive prostate cancer harboring germline DNA repair gene mutations (TRIUMPH).

Presenter: Mark Christopher Markowski, MD, PhD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Session: Genitourinary (Prostate) Cancer
Date/Time: Saturday, June 2, 1:15-4:45 p.m. CT
Location: Hall A
Abstract TPS3126 (Poster 327b) – An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).

Presenter: Karim Fizazi, MD, PhD, Gustave Roussy
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00-11:30 a.m. CT
Location: Hall A
Clovis Oncology’s Rubraca posters will be available online at View Source as of the time they are presented at the meeting.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S.

On May 16, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that two abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago (Press release, Celldex Therapeutics, MAY 16, 2018, View Source [SID1234526701]).

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The schedule for the presentations is as follows:

Abstract TPS6091: "A phase 2, multicenter, open-label study to evaluate the efficacy and safety of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC)" (Bauman, et al)

Poster Session: Head and Neck Cancer
Date and Time: Saturday, June 2, 2018, 1:15 – 4:15 p.m. CDT
Location: Hall A
Abstract 3001: "Anti-CD27 agonist antibody varlilumab with nivolumab for colorectal and ovarian cancer: Phase 1/2 clinical trial results" (Sanborn, et al)

Oral Abstract Session: Developmental Therapeutics—Immunotherapy
Date and Time: Saturday, June 2, 2018, 3:12 – 3:24 p.m. CDT
Location: Hall B1