On October 15, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) and Quantum Leap Healthcare Collaborative (QLHC) reported that the immunotherapy combination of Dynavax’s proprietary investigational compound SD-101 and KEYTRUDA (pembrolizumab) will be evaluated in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, Dynavax Technologies, OCT 15, 2018, View Source [SID1234530123]).

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SD-101 is an intratumoral TLR9 agonist that modulates the tumor microenvironment and optimally primes T cells to generate a systemic anti-tumor response. SD-101 is expected to augment responses to anti-PD-1 therapy as has been reflected in early clinical studies of other tumor types. The combination will be added to standard of care in a new I-SPY 2 TRIAL treatment arm.

"The I-SPY TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add SD-101 into I-SPY 2, and combine it with pembrolizumab with the goal of extending responses previously observed with pembrolizumab alone," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.

"We are excited SD-101 has been chosen to be included in the I-SPY 2 trial and see this as an excellent opportunity to potentially expand its use into the emerging field of neoadjuvant immunotherapy," stated Eddie Gray, chief executive officer of Dynavax.

The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). Dynavax will provide funding and SD-101; Merck will provide pembrolizumab. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit www.quantumleaphealth.org.

About SD-101
SD-101, Dynavax’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On October 15, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, Nov. 5, 2018 (Press release, Neurocrine Biosciences, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371705 [SID1234530025]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9176 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On October 15, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the addition of six major cancers in the United States that have adopted the amended trial protocol for the company’s registration trial in ocular melanoma liver metastases (Press release, Delcath Systems, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371612 [SID1234529999]). These centers join Stanford Medical Center in initiating enrollment in the amended trial, giving the company wide geographic coverage in the United States. Joining Stanford Medical Center are:

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Moffitt Cancer Center – Tampa, FL Center 1
Thomas Jefferson University Hospital – Philadelphia, PA
Emory University Hospital, Atlanta, GA
Methodist University Hospital, Memphis, TN
The University of Arizona Medical Center, Tucson, AZ
Ohio State University Cancer Care Center – Columbus, OH
The trial, A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma (The FOCUS Trial), is enrolling a minimum of 80 patients with ocular melanoma metastatic to the liver. The Company expects approximately 30 leading cancer centers in the U.S. and Europe to participate in the amended FOCUS Trial.

"Our team has been working diligently with participating medical centers to expedite the adoption of the new single-arm protocol," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "These additional centers provide greater geographic coverage for this trial, which will help improve patient access. We look forward to the adoption of the amended protocol by additional centers in both the United States and Europe in the coming weeks and are working hard to achieve our goal of completing trial enrollment by the end of the first half of 2019."

On October 15, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that preliminary results of pilot studies in China in which patients received T-cell receptor affinity enhancing specific T-cell therapy ("TAEST") showed encouraging positive clinical signals in terms of efficacy and safety (Press release, Athenex, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371574 [SID1234529935]).

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The pilot studies are being conducted in China by Xiangxue Life Sciences ("XLifeSc"), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147). In July 2018, XLifeSc and Athenex entered into an agreement to establish a new joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights), and in this territory Axis Therapeutics is leading the research, development and commercialization efforts of T-cell receptor-engineered T cells (TCR-T, including the TAEST technology), a form of cancer immunotherapy.

The pilot studies are focused on the testing of TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A*02:01 restricted. Preliminary results of TAEST technology generated T-cell therapy studied in nine end-stage cancer patients who failed all standard treatments showed the following: In the first three patients, dose escalation in one patient and full dose in two patients were tested. All three patients showed an acceptable safety profile. Two of the patients showed stable disease with survival of 6 and 10 months, respectively. One patient with lung cancer showed a small tumor reduction, and a reduction in pain and softening of the subcutaneous metastasis following treatment. Lymphodepletion was added to the protocol in patients 4 through 9. Treatment was well tolerated with fever (n=5), chills (n=4), weakness (n=4), and mild skin rash (n=3) observed. Two patients (one breast cancer, one synovial sarcoma) had more than 40% reduction in tumor size, as measured by CT scans. The patient with breast cancer also had healing of two skin metastatic ulcers. Two other patients (one liver cancer patient with retroperitoneal recurrence after resection, one with thyroid cancer) showed stable disease. Both of these patients showed significant tumor necrosis shortly after the treatment, resulting in the formation of cavitation in the middle of the tumors. Clinically, there was also symptomatic relief of local pain reported during the period of radiologic evidence of increased tumor necrosis. The remaining two patients with lung cancer had stable disease for more than 60 days after treatment. This study also observed the expected cytokine response, detection of TCR-expression on T-cells, and persistence of the introduced TCR-gene in all patients during therapy.

An abstract with more detailed data will be submitted for presentation at an international scientific meeting.

Dr. Yi Li, Chief Scientific Officer of Axis Therapeutics and XLifeSc, stated, "We believe our TAEST technology has four distinct advantages: first, our engineered TCR has an improved binding affinity; second, our engineered TCR has excellent expression level on the engineered T-cells; third, we have demonstrated in this pilot study that our engineered TCR genes persisted in these patients; and finally, we have developed other HLA subtypes and we will be able to treat more patients with different HLA subtypes in the near future."

Dr. Johnson Lau, Vice Chairman and CEO of Axis Therapeutics and Chairman and CEO of Athenex, said, "We are excited by the positive clinical signal observed in this group of patients. The safety profile is within expectations and within acceptable limits of cancer therapy. The observation of clinical signal in these patients, with tumor reduction of more than 40% in two patients and significant tumor necrosis after treatment in two others, indicates that this approach showed anti-tumor activity even in late stage cancer patients. We have also followed the circulating level of the engineered T-cells and inserted gene expression and so far, their persistence in the patients’ circulation suggested that this approach can have the desired effect of having a consistent anti-tumor immune response for at least a moderate amount of time. More work will be done soon to define the best treatment protocol to advance this program. We are very grateful to Perceptive Advisors for their support and confidence in our team which made this joint venture possible."

Mr. YongHui Wang, Chairman of Axis Therapeutics and Chairman and CEO of Xiangxue Pharmaceutical, stated, "We are very impressed by the scientific and management skills that Athenex team contributes to this joint venture. We are excited to see these encouraging preliminary clinical data. We have full confidence in our collaboration and strongly believe that we will make a meaningful contribution to the arsenal of cancer treatment options for patients worldwide."

Axis Therapeutics is also announcing the line-up of the management team, with Mr. YongHui Wang as the Chairman of the Board, Dr. Johnson Lau as Vice-Chairman and CEO, Dr. Yi Li as Chief Scientific Officer, Dr. WingKai Chan as Chief Medical Officer, and Ms. Jacqueline Li as the Chief Financial Officer.

On October 15, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that in conjunction with the two Proffered Papers Sessions (oral presentations) highlighting data from ongoing clinical trials of sitravatinib, the Company will conduct an investor conference call during the 2018 Annual Meeting of the European Society for Medical Oncology in Munich, Germany, on October 22nd at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT (Press release, Mirati, OCT 15, 2018, View Source [SID1234529931]).

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The Proffered Papers (Oral Presentations) Details:

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018, at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.

The data being presented in this oral presentation will feature data from the ongoing Phase 1b trial of sitravatinib monotherapy in patients with certain genetic alterations.

Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018, at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

The data being presented in this oral presentation comprise updated clinical data from the ongoing Phase 2 trial of sitravatinib in combination with OPDIVO (nivolumab) for the treatment of non-small cell lung cancer (NSCLC) patients who have progressed on prior immune checkpoint inhibitor therapy.

Investor Call and Webcast Information
In conjunction with the oral presentations, Mirati will host a live conference call and webcast, led by Dr. Charles Baum, on Monday, October 22, 2018, at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT. The live call can be accessed by dialing (866) 324-3683 (toll free) or (509) 844-0959 (international) and then using passcode 3890724. A telephone replay will be made available by dialing (855) 859-2056 (toll free) or (404) 537-3406 (international) using conference replay ID 3890724.

The call will also be webcast live through the "Investors" section of the Mirati corporate website at View Source A replay of the webcast will be available on the Mirati website shortly after the conclusion of the event.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL kinase. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations