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GlycoMimetics Doses First Patient in Phase 1 Clinical Trial of Drug Candidate GMI-1271 for Multiple Myeloma

On September 14, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported it has dosed its first patient in a Phase 1 clinical trial of its novel E-selectin antagonist, GMI-1271, combined with bortezomib-based chemotherapy, for multiple myeloma (Press release, GlycoMimetics, SEP 14, 2016, View Source [SID:SID1234515148]). The trial marks a second application for GMI-1271, which already is undergoing clinical study as a potential treatment for acute myeloid leukemia (AML).

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The newly initiated multi-center, open-label dose escalation trial, which has begun in Ireland, will measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with chemotherapy among patients who have been diagnosed with multiple myeloma and have not responded well to standard chemotherapy. The company anticipates enrolling 24 participants in the trial.

"This new clinical trial provides an opportunity to evaluate GMI-1271’s ability to treat hematological cancers beyond AML," said Dr. John Quinn, Consultant Haematologist, Beaumont Hospital, Dublin, Ireland. "Preclinical studies showed promise for E-selectin antagonists against other types of cancers, so this pilot study in multiple myeloma may determine if GMI-1271 may become part of a bortezomib rescue treatment for patients not responding to standard regimens." Beaumont Hospital is one of a number of Blood Cancer Network Ireland (BCNI) sites participating in this study.

In preclinical studies, mice with multiple myeloma that were treated with GMI-1271 and bortezomib showed improvement in survival compared to those treated with bortezomib alone. Furthermore, in mice with myeloma resistant to treatment with bortezomib, addition of GMI-1271 restored bortezomib sensitivity. In addition, blood samples from individuals with multiple myeloma showed increases in cell surface expression of E-selectin carbohydrate ligands when cancer had relapsed, indicating E-selectin as a promising target for reducing drug resistance in certain groups of patients who have the disease.

Multiple myeloma is a neoplastic proliferation of plasma cells derived from bone marrow. The cells ultimately infiltrate a number of organs and lead to bone marrow destruction and failure. It is the most common tumor in the bone and the second most-common blood cancer in the US and Europe. According to EU data from 2012, 39,000 new diagnoses were made for multiple myeloma, and 24,000 people died from the disease there. Most patients currently ultimately relapse from chemotherapy, and the disease is not considered curable using current approaches.

In the Phase 1 study, participants will include individuals who have been diagnosed with multiple myeloma and undergone bortezomib-based therapy with inadequate responses. The patients will receive one of four doses of GMI-1271 in combination with bortezomib, intravenously concurrently with bortezomib treatment. They will be followed after treatment to measure safety endpoints and efficacy.

About GMI-1271

GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug’s potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper), GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.

Immune Design Announces Proposed Public Offering of Common Stock

On September 14, 2016 Immune Design Corp. (Nasdaq:IMDZ) reported that it plans to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by Immune Design (Press release, Immune Design, SEP 14, 2016, View Source [SID:SID1234515147]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

Jefferies LLC, Leerink Partners LLC and Wells Fargo Securities, LLC are acting as joint book-running managers for the offering. In connection with the offering, Immune Design intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

Immune Design plans to use the net proceeds of the offering to fund further clinical development of its Antigen Specific and Antigen Agnostic approaches, including CMB305, G100, ZVexNeo and ZVex2.0, continue developing the manufacturing process and scale up of its product candidates, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Jefferies LLC Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, telephone: (877) 547-6340, e-mail: [email protected]; Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: (800) 808-7525, ext. 6142, email: [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, telephone: (800) 326-5897, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Levi Garraway, M.D., Ph.D., to become Senior Vice President of Global Oncology at Lilly, Succeeding Richard Gaynor, M.D., Who is Retiring after a Distinguished Career

On September 14, 2016 Eli Lilly and Company (NYSE: LLY) reported that Levi Garraway, M.D., Ph.D., a world leader in the analysis of cancer genomics and resistance to targeted therapies, will join Lilly as senior vice president, Global Development & Medical Affairs, for Lilly’s Oncology business on January 1, 2017 (Press release, Eli Lilly, SEP 14, 2016, View Source [SID:SID1234515146]). He will succeed Richard Gaynor, M.D., who will retire after a distinguished career at Lilly.

Dr. Garraway is currently associate professor of medicine in the Department of Medical Oncology at the Dana-Farber Cancer Institute and Harvard Medical School, an associate physician at the Brigham and Women’s Hospital, an Institute Member of the Broad Institute of MIT and Harvard, and an investigator of the Howard Hughes Medical Institute. He will report to Sue Mahony, Ph.D., Lilly senior vice president and president of Lilly Oncology. "We are pleased and honored to have Dr. Garraway join us at Lilly," Mahony said. "He has made a tremendous impact in his career and is recognized around the world as a leader in oncology.

"We know he will provide keen insight and expertise—and will continue to advance Lilly’s work in developing innovative new medicines to truly make life better for people with cancer around the world."

Mahony praised Dr. Gaynor for his significant contributions to the discovery and development of cancer medicines. "Richard is known for scientific rigor and deep expertise in drug development, coupled with a personal warmth and care for patients that is truly inspiring," she said. "He is leaving a remarkable legacy at Lilly through his impact on the pipeline, people and patients."

About Levi Garraway, M.D., Ph.D.
A graduate of Harvard Medical School, Garraway is director of the Joint Center for Cancer Precision Medicine, which spans Harvard teaching hospitals: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Boston Children’s Hospital, and the Broad Institute of MIT and Harvard. He is also co-leader of the Cancer Genetics Program at the Dana-Farber/Harvard Cancer Center.

In addition to his work at Harvard, Dr. Garraway is on the boards of major cancer centers, including Sloan Kettering, MD Anderson and Ohio State, and he is chairman of several major National Institutes of Health (NIH) committees. He also serves on the American Association for Cancer Research (AACR) (Free AACR Whitepaper) board of directors and was elected president of the American Society of Clinical Investigation–one of the highest honors for academic clinician scientists.

He is the author of nearly 200 peer-reviewed scientific articles and has received many awards, including the Paul Marks Prize for Cancer Research, the Jane Cooke Wright Award from AACR (Free AACR Whitepaper), the New Innovator Award from the NIH, and an Outstanding Investigator Award from the National Cancer Institute.

Dr. Garraway’s industry activities also include being a founder of Foundation Medicine, a leading company in cancer genomics diagnostics.

FDA Advisory Committee Votes that Qapzola™ (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo

On September 14, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC) (Press release, Spectrum Pharmaceuticals, SEP 14, 2016, View Source [SID:SID1234515145]).

The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is December 11, 2016.

Heat Biologics Resumes Enrollment in its Non-Small Cell Lung Cancer Trial Evaluating HS-110 in Combination with Anti-PD-1 Checkpoint Inhibitor

On September 14, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported that the company has resumed enrollment in its Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer (NSCLC) (Press release, Heat Biologics, SEP 14, 2016, View Source [SID:SID1234515136]). The decision to resume trial enrollment was based on the positive data reported in June, including two clinical responses in "cold tumor" patients, and enabled by additional company funding through the exercise of warrants, as reported in the latest company financial and corporate update.

"We are pleased to resume enrollment in this trial, especially following the three case studies we reported earlier this year in June, where two out of the three patients showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 plus nivolumab," stated Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "These early data suggest that HS-110 in combination with nivolumab may improve response rates for patients with ‘cold tumors’ who typically have lower response rates to checkpoint inhibitor monotherapy."

The anti-PD-1 combination trial is designed to evaluate whether HS-110 expands the proportion of NSCLC patients responsive to PD-1 blockade, particularly in the estimated 50% of patients lacking an anti-tumor immune response. There are currently eight patients enrolled and the company expects to report topline 6-month data for these patients in the fourth quarter of this year. Heat intends to complete enrollment of each of the two 9-patient cohorts consistent with the original design of the trial, with the potential to expand each cohort up to 30 patients. The topline data for additional patients enrolled in the trial are anticipated within the next twelve months.

"It is important to note that the trial is structured as a Phase 1b/Phase 2 with pre-specified thresholds in place to expand the trial to a full Phase 2. We believe that we are close to fulfilling these thresholds given the positive clinical responses we have already reported," added Dr. Schreiber.