On October 31, 2017 Minneapolis-based Humanetics Corporation (Humanetics) reported data at the annual meetings of the American Society for Radiation Oncology (ASTRO) and the Radiation Research Society (RRS) (Press release, Humanetics, OCT 31, 2017, View Source [SID1234521342]). The annual ASTRO meeting was held September 24th through the 27th in San Diego, California and the annual RRS meeting was held October 15th through the 18th in Cancun, Mexico. Dr. Zeljko Vujaskovic, M.D., Ph.D., a professor of radiation oncology at the University of Maryland School of Medicine (UMSOM) and director of the school’s Division of Translational Radiation Sciences, and Michael Kaytor, Ph.D., vice president of research and development at Humanetics, respectively, presented data related to Humanetics’s new drug candidate, BIO 300, which is being evaluated as a potential treatment to prevent erectile dysfunction in patients undergoing radiotherapy for prostate cancer.

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Prostate cancer is the most common non-skin cancer affecting men in the U.S. According to the National Cancer Institute (NCI), nearly 162,000 men will be diagnosed with prostate cancer in the U.S. in 2017, representing approximately 20% of all new cancers in men. While survival rates are high, radiation-induced erectile dysfunction (ED) is a common and lingering side effect associated with prostate radiotherapy. Nearly half of all men undergoing radiation treatment for prostate cancer will experience some level of ED.

Data presented included the results of nonclinical studies that were conducted at UMSOM. These studies demonstrated the potential of BIO 300 to both mitigate radiation-induced ED and also to improve the effectiveness of radiation therapy to kill tumors. “These compelling results show the promise of BIO 300 to enhance a prostate cancer patient’s quality of life, while also directly impacting the ability of radiation therapy to kill the tumor,” said Dr. Vujaskovic. “If this result can be translated to the clinical treatment of prostate cancer, it would represent a breakthrough in prostate cancer treatment outcomes.”

At present, there are no FDA-approved drugs to mitigate radiation-induced ED. “BIO 300’s potential to enhance radiation’s killing effect on the tumor while reducing treatment-related side effects is unparalleled,” said Dr. Kaytor. “These findings support the advancement of BIO 300 into a human efficacy study, which is anticipated to begin in 2018.”

BIO 300 is in development for prevention and mitigation of toxicities associated with radiation exposure for the treatment of multiple cancers and is currently in a Phase Ib/IIa clinical trial in patients with non-small cell lung cancer who are receiving chemoradiotherapy.

On October 31, 2017 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that third quarter 2017 financial results will be released on Tuesday, November 7, 2017 before the market opens (Press release, Cambrex, OCT 31, 2017, View Source [SID1234521350]).

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The Company will host a conference call to discuss the financial results.

Third Quarter 2017 Earnings Conference Call

When: Tuesday, November 7, 2017 at 8:30 a.m. Eastern Time

Dial-in:

1-866-548-4713 for U.S.
1-323-794-2093 for International
Passcode: 1511082
Dial-in Replay:

1-888-203-1112 for U.S.
1-719-457-0820 for International
Passcode: 1511082
Available through Tuesday, November 14, 2017
Webcast: www.cambrex.com

On October 31, 2017 Geron Corporation (Nasdaq:GERN) reported that the United States Food and Drug Administration (FDA) has granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent (ESA) (Press release, Geron, OCT 31, 2017, View Source [SID1234521343]). Imetelstat is a telomerase inhibitor initially developed by Geron and exclusively licensed to Janssen Biotech, Inc. (Janssen) on a worldwide basis. Janssen sponsored the application for Fast Track designation utilizing preliminary data from IMerge, the ongoing clinical trial being conducted by Janssen in lower risk MDS.

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The FDA’s Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and supported by data that demonstrate the potential to address an unmet medical need. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Through the Fast Track Program, a product candidate may be eligible for priority review, if supported by the clinical data, and for the ability to submit completed sections of a New Drug Application (NDA) on a rolling basis as data become available prior to completion of the full application.

Imetelstat Clinical Development in MDS

Imetelstat is being evaluated in an ongoing Phase 2/3 clinical trial (IMerge) in transfusion dependent patients with Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. IMerge is designed in two parts: Part 1 is a Phase 2, open-label, single-arm design and Part 2 is designed to be a Phase 3, randomized, controlled trial.

As previously announced, 32 patients were enrolled in Part 1 of IMerge, of which a subset of 13 patients had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality. As of May 2017, the 13-patient subset showed an increased durability and rate of red blood cell (RBC) transfusion independence (TI) compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%). Based on these data, Part 1 is being expanded to enroll approximately 20 additional patients who are non-del(5q) and naïve to HMA and lenalidomide treatment to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. Janssen has opened the expanded Part 1 for patient enrollment. For more information about IMerge, please visit View Source

Results for the original 32 patients in Part 1 of IMerge, including hematologic improvement and rate of RBC-TI lasting at least 24 weeks, as well as duration of response and safety information, are expected to be presented at an upcoming major medical conference.

About Imetelstat

Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat might have disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Imetelstat has not been approved for marketing by any regulatory authority.

About the Collaboration with Janssen

On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.

On October 31, 2017 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported it will provide third quarter 2017 financial results and corporate highlights on Tuesday, November 7, 2017 after the market closes (Press release, Regulus, OCT 31, 2017, View Source [SID1234521372]).

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Regulus will host a conference call and webcast on November 7, 2017 at 5:00 p.m. Eastern Time to discuss third quarter 2017 financial results and corporate highlights. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 9297128. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 9297128. The webcast and telephone replay will be archived on the Company’s website following the call.

On October 31, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Janssen Biotech, Inc. has initiated the first of three planned Phase 3 clinical trials evaluating a subcutaneous (SC) delivery of Darzalex (daratumumab) with Halozyme’s proprietary ENHANZE technology (Press release, Halozyme, OCT 31, 2017, View Source [SID1234521351]).

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The initial Phase 3 study is in amyloidosis patients, with additional Phase 3 studies in multiple myeloma and smoldering myeloma patients planned for near-term initiation.

The subcutaneous formulation of daratumumab has an estimated administration time of approximately 5 minutes compared to the multi-hour intravenous infusion, potentially offering new benefits to patients, caregivers and health systems. Halozyme’s ENHANZE technology enables the administration of medications with an injection under the skin rather than an infusion into a vein.

“Our goal has been to make the injection of life saving medicines less disruptive to patients using Halozyme’s ENHANZE technology,” said Dr. Helen Torley, president and CEO of Halozyme. “These studies aim to demonstrate the transformative potential of ENHANZE when combined with Darzalex.”

The Phase 3 study follows a Phase 1b clinical trial that demonstrated the safety, pharmacokinetics and anti-tumor activity of the subcutaneous formulation in relapsed or refractory multiple myeloma patients.

Halozyme will receive a $15 million milestone payment from Janssen following dosing of the third patient in a Phase 3 trial.

Darzalex is a human monoclonal antibody that targets CD38 on the surface of cells and is in clinical development by Janssen in a range of cancers and immune diseases.

Halozyme Collaboration with Janssen Biotech, Inc.
In December 2014, Halozyme and Janssen entered into a collaboration and license agreement. Under the terms of the agreement, Halozyme has granted Janssen a worldwide license to develop and commercialize products for up to five targets, combining rHuPH20 with Janssen’s proprietary compounds. CD38, which is targeted by daratumumab, is the first of these five targets. Halozyme is eligible to receive payments upon Janssen’s achievement of specified development, regulatory and sales-based milestones, totaling up to $113 million per target. Halozyme is also entitled to royalty payments based on net sales of products using the ENHANZE technology.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.