On October 19, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation for G100, Immune Design’s investigational intratumoral therapy, for the treatment of follicular non-Hodgkin’s lymphoma (Press release, Immune Design, OCT 19, 2017, View Source [SID1234521040]).

The EMA orphan drug designation is assigned to products targeting the treatment of rare diseases, which are defined as having a prevalence of not more than 5 in 10,000 people in the European Union (EU). This designation provides the sponsor with certain benefits, including protocol assistance, reduced fees for regulatory activities and up to 10 years of market exclusivity in the EU upon marketing approval for the designated indication.

G100 has also been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of follicular non-Hodgkin’s lymphoma.

G100 is a product candidate from Immune Design’s GLAAS discovery platform. It 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. G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The induction of local and systemic immune responses has been shown in preclinical studies to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. Currently, G100 is being evaluated as both a monotherapy (with local radiation) and in combination with Merck’s anti-PD-1 agent, pembrolizumab, pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 clinical trial in patients with follicular non-Hodgkin’s lymphoma.

On October 19, 2019 INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), reported that it will release its third quarter 2017 financial results on Thursday, Nov. 2, before the U.S. financial markets open(Press release, Insys Therapeutics, OCT 19, 2017, View Source [SID1234521027]).

Following the release of the financial results, Saeed Motahari, president and chief executive officer, and Andrew Long, chief financial officer, will host a conference call at 8:30 a.m. Eastern Daylight Time.

Investors, analysts and members of the media interested in listening to the live presentation are encouraged to join a webcast of the call available on the company’s website at View Source Interested parties may also participate in the call by dialing (844) 263-8304 (from inside the U.S.) or (213) 358-0958 (from outside the U.S.). A webcasted replay of the conference call will be available a few hours after the event through the INVESTORS section, under the NEWS & EVENTS tab for “Presentations.”

Halozyme Therapeutics, Inc. will webcast its Quarterly Update Conference Call for the third quarter 2017 on Tues., Nov. 7 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, OCT 19, 2017, View Source [SID1234521026]).

The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 19320711.

On October 19, 2017 Esanex, Inc., a clinical stage company developing Heat Shock Protein inhibitors for the treatment of cancer, reported the first patient has been dosed in an open-label study of SNX-5422 added to ibrutinib in chronic lymphocytic leukemia (CLL) subjects with residual disease (clinicaltrials.gov ID#NCT02973399) (Press release, Esanex, OCT 19, 2017, View Source [SID1234521024]).

“Resistance to ibrutinib is a serious concern in CLL,” says Dr. Jennifer A. Woyach, M.D., The Ohio State University. “SNX-5422 is designed to attack cancer cells by a different, complementary mechanism, making their escape from cell death much harder. There is a critical need to develop drugs and drug combinations for the patients suffering from this life-threatening disease.”

The study is designed to investigate the safety of combining SNX-5422 and ibrutinib and provide information on whether the addition of SNX-5422 to an established dose of ibrutinib will provide clinical benefit in subjects who have stable, residual disease on ibrutinib alone. In each cycle, subjects will receive SNX-5422 (56 mg/m2) in the morning once every other day for 21 days (11 doses), followed by a 7-day period without SNX-5422 treatment. Subjects will continue to receive daily oral ibrutinib at their established dose level in the afternoon.

“The initiation of this clinical trial marks a major milestone for our Company,” said Steve Hall, Ph.D., president and CEO of Esanex. “The new mechanistic understanding of SNX-5422 that Esanex has uncovered, which differentiates our compound from other Hsp90 inhibitors, has enabled us to rationally approach monotherapy and select combination therapies for distinct indications. We believe we are only beginning to see the potential of SNX-5422 and Hsp90 inhibition as a treatment for cancer and possibly other diseases.”

About SNX-5422
SNX-5422 is a chemically unique, orally active Hsp90 inhibitor that has provided durable clinical responses in open label trials in non-small cell lung cancer (NSCLC) and neuroendocrine tumors (NET). The potential of SNX-5422 in hematologic cancers is currently being explored in a chronic lymphocytic leukemia (CLL) clinical trial. With approximately 200 patients treated to date, SNX-5422 has a well-established safety profile that supports studying it in combination with existing approved drugs in a variety of clinical settings.

On October 19, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported initiation of dosing in a phase 1B dose escalation clinical trial of its investigational inhaled toll-like receptor 9 (TLR9) agonist, DV281, in patients with non-small cell lung cancer (NSCLC) (Press release, Dynavax Technologies, OCT 19, 2017, View Source [SID1234521023]). This multi-center, open label trial is designed to evaluate safety and identify the optimal dose for a potential expansion phase of the study. The dose escalation study is expected to enroll approximately 24 patients in 5 cohorts with advanced NSCLC that has progressed on previous therapy. Dynavax engineered DV281 specifically for inhalation to facilitate local administration of a TLR9 agonist to lung tumors which are not easily accessible for intratumoral injection. NSCLC is the third tumor type, in addition to melanoma and squamous cell carcinoma of the head and neck, where Dynavax is studying aTLR9 agonist in combination with an anti-PD-1 therapy.

Edward Garon, M.D., Associate Professor of Medicine at the David Geffen School of Medicine at UCLA is the primary investigator on the study.

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an aerosol. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.