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 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris "GTBP.PA" or the "Company")), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, has reported that it expects to file the Investigational New Drug Application ("IND") for OXS-3550, the Company’s most advanced Tri-specific Killer Engager ("TriKE") product candidate, in mid-2018 (Press release, GT Biopharma , MAY 16, 2018, View Source [SID1234539530]).

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GT Biopharma is working in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Deputy Director. Dr. Miller is a recognized leader in the field of Natural Killer ("NK") cell and IL-15 biology and their therapeutic potential.

"The expected filing of the IND for our first TriKE product candidate in mid-2018 is representative of the overall progress we are making as a company," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "We look forward to updating our shareholders on our progress throughout 2018 as we continue to execute on our objectives."

The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. Before the IND was transferred to the Company in October 2017, the FDA requested that additional preclinical toxicology be conducted prior to initiating clinical trials. The FDA also requested additional information and clarifications on the manufacturing (CMC) and clinical packages. The Company has reported that the requested additional information and clarifications have been completed and are being incorporated into the IND in eCTD format and that it expects to file the IND in mid-2018.

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.