On May 16, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that five abstracts have been selected for poster presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 1-5, 2018 in Chicago (Press release, Verastem, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349503 [SID1234526720]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, as well as defactinib, its oral small molecule inhibitor of Focal Adhesion Kinase (FAK). The poster presentations will highlight the latest findings from the Company’s ongoing clinical trials for duvelisib, the Phase 3 DUO study crossover extension in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), in addition to a Phase 1 study of defactinib in combination with pembrolizumab and gemcitabine in patients with relapsed/refractory pancreatic cancer.

A poster will also be presented on PRIMO, a Phase II study that Verastem Oncology has initiated to evaluate duvelisib monotherapy in peripheral T-cell lymphoma (PTCL), one of the most aggressive forms of non-Hodgkin lymphoma (NHL). The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy. This study was initiated based on promising activity observed with duvelisib monotherapy in T-cell lymphomas in the Phase I study. In addition, posters on biomarker measurements in the DUOTM and DYNAMOTM studies, as well as in a treatment naive follicular lymphoma study, will be presented.

"In the crossover extension trial of the Phase 3 DUO study, patients treated with duvelisib following confirmed disease progression on prior ofatumumab therapy exhibited a 73% overall response rate (ORR), compared to a 28% ORR with ofatumumab in the DUO study. These results were consistent with the ORR of patients originally initiated on duvelisib. This response rate was accompanied by a longer median progression-free survival (mPFS), with duvelisib-treated patients achieving 15-month mPFS, compared to 9 months when they were treated with ofatumumab," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology.

Dr. Le added, "For our lead FAK inhibitor defactinib, Dr. Andrea Wang-Gillam will describe initial results from the ongoing Phase 1 study evaluating defactinib in combination with pembrolizumab and gemcitabine in patients with advanced pancreatic cancer. In addition to defining a recommended Phase 2 dose, the combination regimen has been well tolerated with promising signs of clinical activity, including one confirmed partial response in a pancreatic cancer patient and stable disease in additional pancreatic patients."

"Data presented at this year’s ASCO (Free ASCO Whitepaper) meeting by Verastem Oncology and collaborative researchers also directly demonstrate inhibition of both PI3K-delta and PI3K-gamma in patients treated with duvelisib," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, biomarker changes observed in duvelisib-treated patients indicate targeting of malignant B-cells directly along with targeting of the supportive tumor microenvironment."

Details for the ASCO (Free ASCO Whitepaper) 2018 presentations are as follows:

Duvelisib

Title: The efficacy of duvelisib monotherapy following disease progression on ofatumumab monotherapy in patients with relapsed/refractory CLL or SLL in the DUO crossover extension study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 170
Abstract #: 7533
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 216
Abstract #: 7579
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The PRIMO study: A phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral t-cell lymphoma (PTCL)
Lead author: Dr. Steven Horwitz, Memorial Sloan Kettering Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 222b
Abstract #: TPS7590
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study)
Lead author: Dr. David Weaver, Verastem Oncology
Session: Tumor Biology
Poster #: 161
Abstract #: 12048
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 1:15 – 4:45 p.m. CT

Defactinib

Title: Phase I study of defactinib combined with pembrolizumab and gemcitabine in patients with advanced cancer
Lead author: Dr. Andrea Wang-Gillam, Washington University School of Medicine in St. Louis
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster #: 387
Abstract #: 2561
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib

Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov

On May 16, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that a poster with data from the Peter MacCallum Cancer Centre will be presented on Endocyte’s lead investigational therapy at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, June 2, 2018 (Press release, Endocyte, MAY 16, 2018, View Source [SID1234526737]). Updated data from the phase 2 study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC), including data from an additional 20 patient expansion cohort, will be highlighted by the poster.

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"We are very pleased that we continue to see high rates of PSA response, even in heavily pre-treated patients," said Mike Sherman, president and CEO of Endocyte. "In the 50 patients receiving 177Lu-PSMA-617, 62% had a greater than 50% reduction in their PSA levels. Further, 44% of patients had a PSA reduction of 80% or greater. We look forward to sharing more information on this phase 2 trial at ASCO (Free ASCO Whitepaper). We recently reported median overall survival of 13.5 months for the first cohort of 30 patients enrolled. The median overall survival in the total 50 patients is not yet meaningful as follow-up in the second cohort of 20 patients is between 6 and 9 months at the time of cutoff. Updated survival metrics will be presented at a future medical conference as that data matures."

ASCO Presentation Details:

Abstract #: 5040 (Poster Board: #267)
Title: Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase II trial.
When: Saturday, June 2, 2018 at 1:15 p.m. – 4:45 p.m. CDT
Session Title: Genitourinary (Prostate) Cancer
Location: Hall A

Webcast Investor Event and 177Lu-PSMA-617 Panel Discussion:

The Company will host a reception and webcast panel discussing 177Lu-PSMA-617 for investors and analysts on Monday, June 4, 2018 from 6:00 p.m.- 8:00 p.m. CDT. Panelists scheduled to participate at the event include:

Alison Armour, M.B., Ch.B., B.Sc, M.Sc, M.D., F.R.C.P., F.R.C.R., Chief Medical Officer, Endocyte
Johann S de Bono, M.D., M.Sc, Ph.D, F.R.C.P., Regius Professor of Cancer Research; Professor, The Royal Marsden NHS Foundation Trust (UK)
Oliver Sartor, M.D., C.E. & Bernadine Laborde Professor for Cancer Research; Medical Director, Tulane Cancer Center
A live audio webcast of the event can be accessed by visiting "Events & Presentations" under the Investors & News section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event, and a replay will be available on the Company’s website for at least 90 days following the event.

Website Information:

Endocyte routinely posts important information intended for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in legal compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following the company’s press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, the Endocyte website is not incorporated by reference into, and is not a part of, this document.

On May 16, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported that the U.S. Food and Drug Administration (FDA) has granted final approval for Eagle’s ready-to-dilute (RTD) bendamustine hydrochloride (HCl) solution in a 500ml admixture for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen (Press release, Eagle Pharmaceuticals, MAY 16, 2018, View Source [SID1234526686]). Eagle’s bendamustine HCl injection does not require reconstitution and is administered as a 500ml admixture over 30 or 60 minutes.

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"This approval expands our bendamustine product offering, is complementary to BENDEKA, and enables us to provide value to a cost-conscious segment of the market that we are uniquely positioned to fill. We intend to launch our ready-to-dilute product with our internal sales force. Based upon our view of the market, we anticipate over time achieving up to a 12% market share, increasing our overall profitability," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Eagle has 13 U.S. patents covering different bendamustine formulations and methods.

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 Turnstone Biologics reported it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug Application (IND) for MG1-HPV for the treatment of patients with human papillomavirus (HPV) positive solid tumors (Press release, Turnstone Biologics, MAY 16, 2018, View Source [SID1234526721]). Additionally, Turnstone reported that it has entered into a clinical supply agreement with F. Hoffmann-La Roche Ltd ("Roche") under which Roche will provide atezolizumab (Tecentriq), its anti-PDL1 antibody, for use in combination with Turnstone’s Maraba virus immunotherapy platform, MG1.

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Turnstone will investigate the safety and efficacy of MG1-HPV therapy in combination with atezolizumab across a range of HPV positive tumors in a Phase I/II clinical study expected to commence in the second quarter of 2018.

"We are committed to helping patients in need of a safe and effective treatment for HPV positive cancers. Following FDA clearance of our IND, we look forward to advancing this promising combination of therapies into the clinic," said Mike Burgess, MD, Ph.D., president of Research and Development at Turnstone. "We are excited to have the support of Roche in evaluating our novel MG1 platform in combination with atezolizumab, and believe the promise of our technology to unleash the power of T cells to treat a range of solid tumors is reinforced by this relationship."

Turnstone’s MG1 virus is the first immunotherapy engineered to function as both a selective tumor-destroying oncolytic virus and an immune stimulating T cell vaccine. MG1 directly attacks cancer cells and modifies the microenvironment to make tumor sites throughout the body susceptible to targeted killer T cell responses, also induced by the virus. Building off of recently published scientific data, Turnstone will investigate MG1-HPV (MG1 expressing four different HPV viral antigens) as a safe and effective treatment option for patients with advanced metastatic cervical, oropharyngeal, and other HPV positive solid tumors.