On May 31, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of fimepinostat (formerly CUDC-907) in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy (Press release, Curis, MAY 31, 2018, View Source [SID1234526990]). Previously reported results from Phase 1 and Phase 2 clinical studies demonstrated that treatment with fimepinostat resulted in a complete or partial response in approximately one out of every four patients with R/R DLBCL with MYC alterations. The median duration of response for all responding patients in these studies was over one year.

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!

"We are pleased with this Fast Track designation, which will enable us to accelerate the development of fimepinostat for patients with R/R DLBCL, including patients whose tumors have MYC alterations," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "Patients with this disease have a very poor prognosis and we are encouraged by the FDA’s recognition of the unmet need that may be addressed by fimepinostat, as well as the potential durable benefit that fimepinostat can provide for these patients. We expect to re-initiate enrollment this year as part of a pivotal study to assess fimepinostat’s efficacy in this patient population. As we work toward the start of this study, we are also continuing to lay the groundwork for potential registration of fimepinostat, which involves coordination with commercial product manufacturers as well as a potential diagnostic test."

The FDA Fast Track process is designed to facilitate the development and expedite review of drugs used to treat serious conditions and fill an unmet medical need. Fast Track designation provides Curis with more frequent meetings and written communications with the FDA regarding fimepinostat’s development plan, trial design and data collection to support the drug’s approval. Fast Track designation also provides eligibility for Accelerated Approval and Priority Review, if the relevant criteria are met, as well as Rolling Review with regards to the submission of the completed sections of the NDA for review by the FDA.

On May 31, 2018 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will present at the Jefferies 2018 Healthcare Conference in New York on Thursday, June 7, 2018 at 9:30 a.m. Eastern Time (Press release, AVEO, MAY 31, 2018, View Source;p=RssLanding&cat=news&id=2352456 [SID1234526988]).

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!

A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On May 31, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Dr. Brian Schwartz, Chief Medical Officer and Head of Research and Development, will present at the Jefferies 2018 Healthcare Conference on June 7, 2018, at 3:00 p.m. ET at the Grand Hyatt, New York, New York (Press release, ArQule, MAY 31, 2018, View Source [SID1234526986]).

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!

You can access the live webcast of the presentation via the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On May 31, 2018 Amgen (NASDAQ:AMGN) and The University of Texas MD Anderson Cancer Center reported two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen’s early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies (Press release, Amgen, MAY 31, 2018, View Source;p=RssLanding&cat=news&id=2352602 [SID1234526985]). The agreements combine Amgen therapies nearing clinical development or those that have already begun the process with MD Anderson’s translational medicine capabilities.

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 collaborations will focus on Amgen’s bispecific T cell engager (BiTE), chimeric antigen receptor (CAR) T cell and small molecule programs. Amgen is advancing both types of T cell therapies against different targets and, in some cases, the same target. BiTE antibody constructs and CAR T cell therapies differ in their approach, though they share the same goal – activating a patient’s immune system to eradicate cancer. BiTE antibody constructs work by bridging T cells to tumor cells, enabling them to attack tumor cells, while CAR T cell therapies reengineer a patient’s own T cells to recognize tumor-specific antigens, inciting an immune system attack against cancer cells.

"These agreements build on a long history of collaboration between Amgen and MD Anderson, including a number of different efforts which helped to enable the advancement and regulatory approval of Amgen’s first bispecific T cell engager," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "We are pleased to work with MD Anderson to accelerate the translation of several of our early-stage oncology programs from the laboratory to the clinic."

The five-year collaboration will begin with Phase 1 clinical studies for BiTE antibody constructs and CAR T cell therapies for multiple myeloma and small cell lung cancer. The second agreement spans four years and will study BiTE antibody constructs, CAR T and small molecule treatments in leukemia and myelodysplastic syndromes. The collaboration includes multi-institutional pre-clinical and clinical trials, some of which will be led by MD Anderson, which may offer the potential for identifying new biomarkers.

"The field of immuno-oncology is rapidly evolving and combining resources from both organizations could be important in answering key scientific questions," said Patrick Hwu, M.D., division head of Cancer Medicine at MD Anderson. "The collaboration allows MD Anderson to study up to 16 different oncology treatments which we hope will lead to rapid development and advancement of important therapies into clinical practice."

About BiTE Technology
Bispecific T cell engager (BiTE) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to bridge T cells to tumor cells, using the patient’s own immune system to eradicate cancer. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

About CAR T Cell Therapy
CAR T cell therapy is an evolving area of personalized medicine in which a patient’s own T cells (a type of white blood cell) are engineered to recognize tumor-specific antigens and incite an immune system attack against the cancer cells. Amgen is exploring the application of CAR T cell therapy across hematologic and solid tumor malignancies. Amgen and Kite Pharma, a subsidiary of Gilead Sciences Inc., are collaborating on engineering and commercializing CAR T cell therapies.

On May 31, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the upcoming release of financial results for the six months ended April 30, 2018, to take place on Thursday, June 7, 2018 (Press release, Advaxis, MAY 31, 2018, View Source [SID1234526984]).

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!

Advaxis’ senior management will host a conference call to review its financial results and provide a business update. The conference call and live audio webcast will begin at 11:00 a.m. Eastern time on Thursday, June 7, 2018.

Conference Call & Webcast Information

WHEN: Thursday, June 7, 2018 at 11:00 a.m. Eastern time.
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 8975538
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning June 7, two hours after the close of the conference call. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 8975538. In addition, the audio webcast will be archived on the Company’s website for a period of time at ir.advaxis.com/events-presentations.