On March 5, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that the company earned a $3.0 million development milestone payment under its worldwide licensing agreement with Merck (known as MSD outside the United States and Canada) for the initiation of a Phase I clinical trial of its anti-CD27 antibody (Press release, Aduro Biotech, MAR 5, 2018, View Source;p=RssLanding&cat=news&id=2336295 [SID1234524377]). The Phase 1 trial is designed to evaluate the safety and pharmacokinetics of the anti-CD27 antibody when administered alone and in combination with pembrolizumab in adults with advanced solid tumors.

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"We are pleased with the strong progress Merck has made in the development of our anti-CD27 antibody," stated Hans van Eenennaam, Ph.D., executive vice president of antibody research and site head, Aduro Biotech Europe. "This marks an important step forward in the advancement of our proprietary B-select monoclonal antibody technology, as the second antibody to enter the clinic."

About CD27 and Aduro’s Anti-CD27 Antibody
CD27 is a co-stimulatory receptor expressed on different immune cells, such as T-lymphocytes and NK (natural killer) cells. It has been recognized as having an important role in priming, enhancing and sustaining a productive anti-cancer (CD8 T-cell) adaptive immune response. In preclinical studies, anti-CD27 activation was shown to enhance T-cell response, which in combination with immune checkpoint inhibition demonstrated the ability to achieve complete tumor eradication.

In 2014, Merck, through certain affiliates, entered into a worldwide license agreement for the development and commercialization of CD27 antibody agonists. Aduro’s anti-CD27 antibody, which was identified with its proprietary B-select monoclonal antibody technology, targets a functional epitope on CD27 demonstrating potent activation of the CD27 co-stimulatory pathway in pre-clinical studies. As a part of the worldwide license agreement, and in addition to payments received, including the $15 million up-front payment, Aduro is eligible to receive future development, commercial and net sales milestone payments. In addition, Aduro is eligible to receive royalties in the mid-single digits to low teens based on any net sales of the product, if it is approved for marketing.

On March 5, 2018 Sangamo Therapeutics, Inc. (Nasdaq: SGMO) reported that Dr. Sandy Macrae, CEO of Sangamo, is scheduled to participate in the following healthcare investor conferences in March (Press release, Sangamo Therapeutics, MAR 5, 2018, View Source [SID1234524396]).

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Cowen 38th Annual Health Care Conference, Boston, MA, March 12-14, 2018
Dr. Macrae is scheduled to present at 1:30 p.m. ET on Monday, March 12th.
Barclays 2018 Global Healthcare Conference, Miami, FL, March 13-15, 2018
Dr. Macrae is scheduled to present at 10:15 a.m. ET on Thursday, March 15th.
Sangamo Therapeutics, Inc. (PRNewsfoto/Sangamo Therapeutics, Inc.)

The presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentations will be archived on the Sangamo website for two weeks after the event.

On March 2, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will be presenting at two upcoming investor conferences (Press release, TG Therapeutics, MAR 2, 2018, View Source [SID1234524343]). Presentation details are as follows:

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The Raymond James & Associates’ 39th Annual Institutional Investors Conference, being held at the JW Marriott Orlando Grande Lakes in Orlando, Florida. The presentation is scheduled to take place on Tuesday March 6, 2018 at 2:50pm ET.
The Cowen 38th Annual Health Care Conference, being held at the Boston Marriott Copley Place in Boston, Massachusetts. The presentation is scheduled to take place on Monday March 12, 2018 at 1:30pm ET.
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com.

Heat Biologics 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, Heat Biologics, 2018, MAR 2, 2018, View Source [SID1234524338]).

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On March 2, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company’s New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA) (Press release, Jazz Pharmaceuticals, MAR 2, 2018, View Source;p=RssLanding&cat=news&id=2335912 [SID1234524340]). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.

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"We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease."

The solriamfetol Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in the treatment of excessive sleepiness in patients with narcolepsy or OSA.

About OSA and Excessive Sleepiness
OSA is a prevalent disease (as high as 14% in men and 5% in women) with excessive sleepiness being a major presenting complaint in many cases.1-2 Excessive sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life. Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep-related airway obstruction, with frequent improvement in excessive sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. It is estimated that excessive sleepiness persists in 13%–65% of people utilizing CPAP for OSA.3-5

About Narcolepsy
Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally.6 It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in early adulthood. It is estimated that more than 50% of patients with narcolepsy have not been diagnosed.7 Studies have shown it may take 10 years or more for people with narcolepsy to receive a correct diagnosis.8 Excessive sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.2 Excessive sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.2,7,9

About Solriamfetol (JZP-110)
Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China and Japan. Solriamfetol has orphan drug designation in the United States for narcolepsy.