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Immune Design Receives Orphan Drug Designation for G100 Intratumoral Product Candidate

On February 22, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational intratumoral therapy, G100, for the treatment of follicular non-Hodgkin’s lymphoma (Press release, Immune Design, FEB 22, 2017, View Source [SID1234517787]).

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Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to products that treat rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.

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. 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. 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 ensuing induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control in preclinical studies. G100 was evaluated in a Phase 1 study in Merkel cell carcinoma patients and produced a 50% overall response rate per protocol and a favorable safety profile. 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 trial in patients with follicular non-Hodgkin’s lymphoma.

CMB305, Immune Design’s prime-boost cancer immunotherapy product candidate, has previously been designated orphan drug status for soft tissue sarcoma by the FDA, and each of the two agents comprising CMB305 also have both U.S. and European Orphan drug designation for soft tissue sarcoma.

Independent Data Monitoring Committee Recommends Discontinuation of the ADAPT Phase 3 Clinical Trial of Rocapuldencel-T in Metastatic Renal Cell Carcinoma for Futility Following Its Planned Interim Data Review

On February 22, 2017 Argos Therapeutics Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported that the Independent Data Monitoring Committee (IDMC) for the company’s pivotal Phase 3 ADAPT clinical trial of rocapuldencel-T in combination with sunitinib/standard-of-care for the treatment of metastatic renal cell carcinoma (mRCC) has recommended that the study be discontinued for futility based on its planned interim data analysis (Press release, Argos Therapeutics, FEB 22, 2017, View Source [SID1234517784]). The IDMC concluded that the study was unlikely to demonstrate a statistically significant improvement in overall survival in the combination treatment arm, utilizing the intent-to-treat population, the primary endpoint of the study. The IDMC noted that rocapuldencel-T was generally well-tolerated in the trial.

In conjunction with its clinical and scientific advisors, the company is analyzing the preliminary ADAPT trial data set and plans to discuss the data with the U.S. Food and Drug Administration (FDA). The company plans to leave the ADAPT trial open while the company conducts its ongoing data review and discussions with FDA. Based on these analyses and discussions, the company will make a determination as to the next steps for the rocapuldencel-T clinical program.

"We are extremely disappointed with these results, which included seventy-five percent of the targeted events needed to permit the primary analysis and assessment of overall survival in the study," said Jeff Abbey, president and chief executive officer of Argos Therapeutics. "We sincerely appreciate the patients and investigators who have participated in the ADAPT Phase 3 trial, and remain convinced in the ability of precision immunotherapy to improve the lives of patients."

Rocapuldencel-T is an individualized immunotherapy that is designed to capture mutated and variant antigens that are specific to each patient’s tumor and induce an immune response targeting that patient’s tumor antigens. The randomized Phase 3 ADAPT trial evaluating rocapuldencel-T plus sunitinib/standard-of-care therapy versus standard-of-care therapy alone in newly diagnosed mRCC patients was opened in January 2013 and completed enrollment in July 2015. A total of 462 mRCC patients were randomized to the trial. The primary endpoint of the trial is a statistically significant improvement in overall survival.

OXIS BIOTECH ANNOUNCES U.S. PATENT AND TRADEMARK OFFICE NOTIFICATION OF PATENT ISSUANCE FOR OXIS-4235 AS TREATMENT FOR MULTIPLE MYELOMA

On February 21, 2017 Oxis International, Inc. (OTCQB: OXIS) (OXIS.PA) parent company of Oxis Biotech, focused on the development and commercialization of immunotherapy for the treatment of cancer, reported it received notification from the U.S. Patent and Trademark Office a patent will be issued on February 28, 2017 for its drug candidate OXIS-4235 for the treatment of myeloma (Press release, OXIS International, FEB 21, 2017, View Source [SID1234539555]).

The patent clears the way for Oxis Biotech to begin the process of pursuing clinical trials for the new drug.

The drug is a P62-ZZ chemical inhibitor intended for use as a treatment for multiple myeloma. According to the American Cancer Society, more than 30,000 people are expected to be diagnosed with the disease this year and more than 12,000 are expected to die from it.

Dr. Sean Xie of Pittsburgh, Pa., developed the drug. The drug is intended to stop the growth of multiple myeloma cells without harming healthy cells. In addition to shrinking the tumors, the dual purpose drug is also intended to increase bone density, a second benefit of the technology.

Oxis Biotech, through its licensing agreement with Dr. Xie, holds the exclusive worldwide rights to commercialize this technology.

"Bone density shrinkage is one of the biggest problems of multiple myeloma. Bones wither away. This dual action drug is extremely promising," said Oxis CEO Anthony Cataldo. "We have always had great confidence in Dr. Xie’s work related to multiple myeloma. The issuance of this patent points out the unique and novel technology Dr. Xie has developed. We are incredibly happy to add it to our pipeline."

The USPTO indicated it will issue Patent No. 9,580,382 for the technology on February 28, 2017.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Exact Sciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Exact Sciences, 2018, FEB 21, 2017, View Source [SID1234524344]).

OncoGenex Pharmaceuticals, Inc. Announces Phase 2 Apatorsen Data for Two Clinical Trials Presented at the American Society of Clinical Oncology (ASCO) 2017 Genitourinary Cancers Symposium

On February 21, 2017 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported that apatorsen results from two randomized Phase 2 clinical trials were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Genitourinary Cancers Symposium, held February 16th- 18th in Orlando (Press release, OncoGenex Pharmaceuticals, FEB 21, 2017, View Source [SID1234517811]). Clinical data from trials in bladder and prostate cancers demonstrated apatorsen was well-tolerated and improved patient outcomes when administered in combination with standard-of-care treatments.

Bladder Cancer Trial
The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The primary endpoint analysis met the superiority test for overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.

Patients who received apatorsen treatment experienced a 20% reduction in risk of death, compared to patients receiving docetaxel alone (overall survival hazard ratio (HR)=0.80; 80% CI: 0.65-0.98; p=0.078).
Partial or complete responses occurred in 16.2% patients receiving apatorsen plus docetaxel compared to 10.9% patients receiving docetaxel alone with median response durations of 6.2 months versus 4.4 months, respectively.
Higher baseline serum Hsp27 levels were significantly prognostic for indicating an almost 2-fold higher risk of death (HR= 1.96; p=0.0001). In an exploratory analysis on a subset of patients (20% of total) who completed at least two treatment cycles and had either a decrease in serum Hsp27 levels from baseline or had only a 20.5% increase in serum Hsp27 levels from baseline, the reduction in risk of death with apatorsen treatment was 71% (HR= 0.29: 80% CI: 0.18-0.48; interaction p=0.0727).
Apatorsen was well tolerated in combination with docetaxel with a median treatment of 2 cycles.
The Borealis-2 trial was an investigator-sponsored trial conducted by the Hoosier Cancer Research Network at 28 sites across the United States.
Prostate Cancer Trial
The Pacific trial evaluated the ability of apatorsen, when added to Zytiga (abiraterone acetate), to reverse or delay treatment resistance in 72 men who were experiencing a rising PSA on Zytiga alone. The primary endpoint evaluated the proportion of patients who were progression free (clinical and radiologic) at study day 60 with apatorsen added to Zytiga, compared to continuing Zytiga alone.

In men receiving apatorsen, 33% were progression free at study day 60 compared to 17% for those men receiving Zytiga alone.
For patients with ≥5 circulating tumor cells (CTCs) at baseline, 22% vs 11% of patients had a CTC reduction to less than 5 CTCs when apatorsen was added to Zytiga vs Zytiga alone, respectively.
Apatorsen was well tolerated in combination with Zytiga with a median duration of 106 days.
The Pacific trial was an investigator-sponsored trial conducted by the Hoosier Cancer Research Network at sites in Canada and the United States.
"These data further reinforce our belief that by targeting heat shock protein 27 (Hsp27), apatorsen can improve outcomes of exisiting cancer therapies across various mechanisms of action, as demonstrated here with cytotoxic and hormonal treatments," said Scott Cormack, President and CEO of OncoGenex. "Given the biologic rationale for combining apatorsen with checkpoint inhibitors and other immune modulators, we are engaging in partnering discussions to further explore these development opportunities."