On June 2, 2017 NewLink Genetics Corporation (NASDAQ:NLNK) reported the results from a Phase 2 trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer (Press release, NewLink Genetics, JUN 2, 2017, View Source [SID1234519388]).

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Top line data from the study show that the trial did not meet its pre-specified endpoints of a statistically significant difference between the two treatment groups as to progression-free survival, overall survival or objective response rate.

"As demonstrated by multiple studies that have been reported since the start of this clinical trial, breast cancer unfortunately remains a challenging disease in immuno-oncology," said Primary Investigator Hatem Soliman MD, Associate Member Breast, Tumor Biology, and Immunology Departments, Chair Clinical Research Advisory Committee, H. Lee Moffitt Cancer Center and Research Institute, Associate Professor, Division of Oncologic Sciences University of South Florida.

In this study, NLG2101, 169 first line metastatic breast cancer patients were selected to receive either docetaxel or paclitaxel by their treating physicians. Once the choice of backbone chemotherapy was made, patients were then randomized to receive either indoximod or placebo.

"We would like to thank all the patients, families, investigators, and research teams who supported the completion of this trial," said Charles J. Link, Jr., M.D., Chairman and CEO of NewLink Genetics. "Independent of these results, we continue to be highly encouraged by indoximod as an IDO pathway inhibitor and look forward to future opportunities to share data from ongoing trials in multiple cancer types including melanoma, prostate cancer, acute myelogenous leukemia, and pancreatic cancer."

Full results of the trial will be presented at an upcoming academic meeting.

On June 2, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported the presentation of findings in patients with metastatic melanoma in the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada (Press release, Dynavax Technologies, JUN 2, 2017, View Source [SID1234519437]). Results evaluating 19 patients for efficacy and 22 patients for safety were presented in a poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago:

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• In 7 anti-PD-1/L1-naïve patients, SD-101 used in combination with KEYTRUDA resulted in an overall response rate (ORR) of 100%, with a complete response (CR) rate of 29%. This is a meaningful increase over use of KEYTRUDA alone, which has already shown a 33% ORR, with a 6% CR.1

• In 12 patients with advanced (stage IIIc/IV) melanoma who had previously failed on anti-PD-1 treatment, introduction of SD-101 resulted in tumor shrinkage in 42% of patients, with 17% having a partial response (PR), indicating an anti-tumor immune response generated by SD-101.

• The combination of SD-101 and KEYTRUDA in this study, mobilized both innate and adaptive immune response in study participants.

• Tumor shrinkage was observed in non-injected visceral lesions.

"Having 7 out of 7 patients naïve to anti-PD-1/L1 treatment responding is very encouraging," said Antoni Ribas, M.D., Ph.D., of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, and lead investigator. "These results are supported by tumor shrinkage in patients who had previously progressed on anti-PD-1 treatment and by confirmatory laboratory biomarker assessments in tumor biopsies. If these clinical results are sustained in the ongoing trial, this combination, which mobilizes both innate and adaptive immune responses in patients, could represent an important advancement in immuno-oncology."

SD-101 in combination with KEYTRUDA generally was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia. The study also includes biomarker assessments, suggesting that treatment with SD-101 and KEYTRUDA resulted in increased tumor-infiltrating lymphocytes and decreased Th2 in tumor biopsies, consistent with induction of an antitumor immune response.

Keytruda.com View Source

About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIc/IV melanoma. The primary endpoints of the trial are MTD and evaluation of the safety of intratumoral SD-101 in combination with KEYTRUDA. In addition, the trial is investigating response as assessed by the investigator according to RECIST v1.1, biomarker assessments and duration of response. Patients previously treated with anti-PD-1 and other immunotherapies are included.

About SD-101
SD-101 is Dynavax’s proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. SD-101 is being studied for its multiple anti-tumor activities in innate immune cells and activation of plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and provide potent Type 1 interferon induction and maturation of plasmacytoid dendritic cells to antigen-presenting cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its safety and activity.

For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

On June 2, 2017 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) reported the schedule of presentations featuring TG-1101 and TGR-1202 at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held this week, June 2 – 6, 2017, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, JUN 2, 2017, View Source [SID1234519352]).

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Know more, wherever you are:
Latest on Cancer Drug Development at ASCO (Free ASCO Whitepaper), book your free 1stOncology demo here.

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
– Date & Time: Saturday, June 3, 2017 3:00 PM – 6:00 PM CT
– Presentation Time: 4:12 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

Abstracts are available online and can be accessed at www.asco.org. 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.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will host a reception on Monday, June 5, 2017 beginning at 7:00pm CT, with featured presentations now beginning promptly at 7:05pm CT. The event will take place at the Peninsula Chicago Hotel in the Avenues Ballroom. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics June 2017 Investor & Analyst Event.

On June 1, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the first patient was dosed in its Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (Press release, Lion Biotechnologies, JUN 1, 2017, View Source;p=irol-newsArticle&ID=2278256 [SID1234519425]).

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"We are pleased to have dosed our first patient in this trial evaluating LN-145 for the treatment of head and neck cancer. While some patients benefit from the few options available for the treatment of metastatic squamous cell carcinoma of the head and neck, there remains an unmet medical need for those who progress through such therapies," said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Lion Biotechnologies. "With this important milestone, patient dosing is now ongoing in two of our three Lion sponsored Phase 2 programs. We look forward to reporting data from these trials."

LN-145 is an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL manufacturing process as originally developed by the National Cancer Institute. This Phase 2, multicenter, single-arm, open-label interventional study will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.

Additional information on this study is available at www.clinicaltrials.gov.

On June 1, 2017 OBI Pharma, Inc., a Taiwan biopharma company (TPex: 4174), reported an agreement with Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) to acquire TH-3424, a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1c3 (AKR1C3) (Press release, OBI Pharma, JUN 1, 2017, View Source [SID1234525559]). The product will be renamed OBI-3424 effective immediately.

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OBI-3424 is a first-in-class prodrug that selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult to treat cancers. For example, hepatocellular carcinomas (HCC), which highly overexpress AKR1C3 in the majority of patients. OBI-3424 has demonstrated potent activities in preclinical models of HCC, including a model resistant to the standard of care treatment, sorafenib. AKR1C3 is adaptively upregulated in response to castration; therefore, castrate-resistant prostate cancer is another logical unmet need population where OBI-3424 will be tested. In addition, the US National Cancer Institute is performing preclinical evaluations of OBI-3424 for the potential treatment of T-cell acute lymphoblastic leukemia (T-ALL).

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed to identify patients with other tumor types most likely to respond to treatment with OBI-3424, thereby offering the possibility for a streamlined clinical development strategy.

Under the terms of the agreement, Threshold will transfer to OBI Pharma its ownership rights as well as preclinical and manufacturing data for OBI-3424 in exchange for an undisclosed, upfront one-time payment. No further payments or future royalties are required. OBI Pharma will obtain Threshold’s global intellectual property as well as the commercial, developmental, and manufacturing rights to OBI-3424, except in certain specified countries in Asia (see footnote 1).

"OBI-3424 is an innovative anticancer drug that can preferentially deliver its payload to cancers that overexpress the activating enzyme, AKR1C3. AKR1C3 is highly overexpressed in a number of cancers that represent unmet medical needs, including hepatocellular carcinoma, castrate-resistant prostate cancer, and T-cell acute lymphoblastic leukemia. OBI-3424 offers the possibility of early efficacy read outs based on objective response rates in well-defined resistant patient populations," said Tillman Pearce, M.D., Threshold’s Chief Medical Officer.

"We will continue the pre-clinical work and hope that OBI-3424 develops into a solid treatment option for patients with cancers that express AKR1C3," said Amy Huang, General Manager of OBI Pharma, Inc. "This novel cancer therapeutic enhances our pipeline and moves us another step towards becoming a global cancer biopharma company. "

OBI Pharma plans to accelerate the development of OBI-3424, with an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration (FDA) planned for early 2018.

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(1) OBI obtains worldwide rights with the exception of the following countries: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey and India.