On May 17, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 2 – 6, 2017, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, MAY 17, 2017, View Source [SID1234519202]). Abstracts are now available online and can be accessed at www.asco.org. Details of the data presentations are outlined below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Oral Presentation:

Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
° Abstract Number: 7504
° Presentation Date & Time: Saturday, June 3, 2017 3:00 PM – 6:00 PM CT
° Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
° Presenter: Jeffrey P. Sharman, MD
Poster Discussion Presentation:

Title: Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL
° Abstract Number: 7511
° Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT (Poster Viewing); 1:15 PM-2:30 PM CT (Poster Discussion)
° Session Title: Poster Discussion Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
° Presenter: Loretta Nastoupil, MD
Trials in Progress Poster Presentation:

Title: KI intolerance study: A phase 2 study to assess the safety and efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy
° Abstract Number: TPS7569
° Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT
° Session Title: Poster Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
° Presenter: Colleen Dorsey, BSN, RN
Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

On May 17, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported new clinical and biomarker data today from CMB305 and G100 monotherapy studies (Press release, Immune Design, MAY 17, 2017, View Source [SID1234519200]). The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) is publishing three abstracts today relating to these new data. A broader set of data will be presented at the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting, providing further clinical validation of the company’s lead product candidates and discovery platforms.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CMB305 Monotherapy in Patients with Soft Tissue Sarcoma

Most recent patient survival data meaningfully exceed published survival outcomes for standard of care therapy in comparable soft tissue sarcoma (STS) patients with recurrent metastatic disease.
With a median follow up exceeding 18 and 11 months for LV305 and CMB305, respectively, median overall survival (mOS) has not yet been reached in recurrent metastatic STS patients.
Durable disease control was observed in more than half of STS patients, including durable tumor growth arrest in patients who had evidence of disease progression prior to CMB305 therapy.
CMB305’s safety profile consisted mostly of mild to moderate adverse events, with therapy being well tolerated by patients.
Anti-NY-ESO-1 immune biomarkers identify cancer patients who may be more likely to have prolonged survival following therapy with CMB305
Anti-NY-ESO-1 immune responses were observed in more than half of the patients who received CMB305 therapy.
Induction of anti-NY-ESO-1 immunity in patients treated with CMB305 or LV305 was associated with better clinical outcomes, including survival.
Immune biomarkers pre-treatment may guide regulatory strategy via the selection of patients more likely to respond to CMB305 therapy.
G100 Intratumoral Monotherapy with Radiation in Patients with Low-grade Follicular NHL (FL)

More than 40% of the FL patients experienced objective responses based on WHO criteria (at least a 50% tumor reduction), including substantial tumor shrinkage in untreated, unirradiated distal (abscopal) lesions.
Safety profile remains favorable at higher doses than those previously reported in Merkel cell carcinoma patients.
G100 resulted in favorable tumor microenvironment changes.
An increased intratumoral expression of inflammatory cytokines/chemokines, T cell infiltration, and an increased frequency of clonal tumor infiltrating lymphocytes, were observed.
"The ability to identify patients who are likely to benefit from antigen-targeted immunotherapy has been an elusive goal. We believe the results highlighted here should be considered as we aim to maximize the chance of success of these novel modalities, including CMB305 and future product candidates from our ZVex platform." said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "During the second half of the year, we hope to have the opportunity to build on these positive clinical and biomarker data for CMB305 and G100 monotherapy with the results from ongoing trials evaluating each agent in combination with anti-PD-1/PD-L1 inhibitors."

Presentations at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Data underlying the topline releases above were published online today by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in abstracts accepted for presentation at ASCO (Free ASCO Whitepaper)’s 2017 Annual Meeting in June (presentation information set forth below). The abstracts reflect an analysis performed on or before February 2017; additional data will be presented at the Annual Meeting.

ORAL PRESENTATION

Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS)

Abstract # 11006
Session Title: Sarcoma
Date: Friday, June 2, 2017
Time: 3 p.m. — 6 p.m. CT (oral session)
Location: S100bc
Presenter: Neeta Somaiah, M.D., Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center
POSTER PRESENTATIONS

The Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival in recurrent cancer patients

Abstract # 3090
Session Title: Developmental Therapeutics—Immunotherapy
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT
Location: Hall A
Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center
Intratumoral G100 to induce systemic immune responses and abscopal tumor regression in patients with follicular lymphoma

Abstract # 7537
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT
Location: Hall A
Presenter: Christopher Flowers, M.D., Department of Hematology and Medical Oncology, Emory University School of Medicine
About CMB305

CMB305 is a prime-boost vaccine approach against NY-ESO-1-expressing tumors, designed to generate an integrated, anti-NY-ESO-1 immune response in vivo via a targeted, specific interaction with dendritic cells, a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in STS patients in ongoing Phase 1 monotherapy and 2 combination studies with the anti-PD-L1 antibody, Tecentriq (atezolizumab), pursuant to a collaboration with Genentech. Immune Design has received Orphan Drug Designation for CMB305 from the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma, as well as from the FDA and European Medicines Agency for each of the components of CMB305 for the treatment of soft tissue sarcoma.

About G100

G100 contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. It leverages the activation of both innate and adaptive immunity, including dendritic cells, in the tumor microenvironment to create an immune response against the tumor’s preexisting diverse set of antigens. G100 is being evaluated as both a monotherapy (with XRT) and in combination with Merck’s anti-PD-1 agent, Keytruda (pembrolizumab), pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin’s lymphoma. The FDA has granted Orphan Drug Designation for G100 for the treatment of follicular non-Hodgkin’s lymphoma.

On May 17, 2017 Halozyme Therapeutics (NASDAQ: HALO) reported that results from a Phase 2 randomized, multi-center clinical trial in pancreas cancer patients of its targeted investigational therapy, PEGPH20, will be presented in an oral presentation on June 4 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual conference (Press release, Halozyme, MAY 17, 2017, View Source [SID1234519199]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Principal Investigator Sunil R. Hingorani, M.D., Ph.D., a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine will present the HALO-202 results, which include the study meeting its primary and key secondary endpoints.

"The HALO-202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment," said Dr. Hingorani. "The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study."

The study demonstrated that PEGPH20 plus standard chemotherapy of ABRAXANE (nab-paclitaxel) and gemcitabine improved median progression-free survival (mPFS) by 77 percent over chemotherapy alone in stage IV pancreas cancer patients with high levels of hyaluronan (HA-High). Halozyme is currently enrolling HA-High patients in a global Phase 3 clinical trial.

In a subanalysis of patients who received uninterrupted therapy with PEGPH20 plus chemotherapy (Stage 2 patients), a 91 percent improvement in mPFS and a 4-month benefit in overall survival were observed.

Dr. Helen Torley, president and chief executive officer of Halozyme said, "The results in the HA-High patient cohort are particularly encouraging given that we are using this biomarker and recruiting this specific patient population in our ongoing global Phase 3 study, HALO-301. We believe that HALO-301 is the first targeted or biomarker driven Phase 3 study to date in this highly lethal cancer type."

Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.

About HALO-301 and HALO-202
HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.

HALO-202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival.

About PEGPH20
PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

On May 17, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that study investigators will present larotrectinib (LOXO-101) interim clinical data across the RECIST-evaluable TRK fusion clinical trial database from all three ongoing clinical trials in a late breaking oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting being held on June 2 – 6, 2017 in Chicago, IL (Press release, Loxo Oncology, MAY 17, 2017, View Source [SID1234519197]). This presentation was also selected for inclusion in the ASCO (Free ASCO Whitepaper) Press Program. In addition, the larotrectinib interim pediatric Phase I clinical data will be highlighted in a separate oral presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The schedule for the presentations is as follows:

Late Breaking Presentation Date & Time: Saturday, June, 3, 2017, 1:15 – 4:15PM CT
Title: The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers.
Abstract Number: LBA2501
Session Title: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Location: E450ab
Presenter: David Michael Hyman, M.D.

Presentation Date & Time: Monday, June, 5, 2017, 8:00 – 11:00AM CT
Title: A pediatric phase I study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family.
Abstract Number: 10510
Session Title: Pediatric Oncology II
Location: S504
Presenter: Theodore Willis Laetsch, M.D.

Conference Call and Webcast Information
Loxo Oncology will host a conference call and live webcast with slides and Q&A on Sunday, June 4, 2017 at 5:30PM CT to discuss the larotrectinib data presented at ASCO (Free ASCO Whitepaper). To participate in the conference call, please dial (877) 930-8065 or (253) 336-8041 and refer to 14447513. A live webcast of the presentation will be available at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the company’s website for 90 days following the call.

About Larotrectinib (LOXO-101)
Larotrectinib (LOXO-101) is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, larotrectinib has demonstrated encouraging preliminary efficacy. Larotrectinib is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1/2 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. Larotrectinib has been granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation by the U.S. FDA. For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.

On May 17, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported an update regarding the Company’s diverse oncology portfolio, including the acceptance of a wide selection of abstracts across a broad range of cancers for oral or poster presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6 in Chicago (Press release, Astellas, MAY 17, 2017, View Source [SID1234519195]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Astellas is presenting a record number of abstracts at ASCO (Free ASCO Whitepaper), including data for gilteritinib in acute myeloid leukemia, enfortumab vedotin in urothelial cancer, and IMAB362 from the recently acquired Ganymed. A number of XTANDI (enzalutamide) abstracts accepted for presentation also speak to the comprehensive clinical trial program in metastatic CRPC and other prostate cancer populations. In just over a decade, Astellas has built a leadership position and substantial Oncology pipeline through a thoughtful blend of investments in organic R&D, strategic business development and strong collaborative partnerships with some of the most renowned institutions around the world.

"We are thrilled to announce our largest presence to date at this year’s ASCO (Free ASCO Whitepaper) meeting," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We believe these data reflect significant progress in our pursuit to create innovative treatment options for some of the most difficult-to-treat cancers and further underscore our ongoing commitment to becoming a world-class oncology company focusing on patients with cancer."

Additionally, the Company announced today the joint decision with Pfizer to discontinue the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. The companies have also decided that based on the enzalutamide data from the Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time.

About XTANDI (enzalutamide) capsules
XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown.

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide is not approved for use in patients with breast cancer.