SAN DIEGO, Sept. 27, 2017 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged in the discovery and development of immunology-based therapeutics, harnessing new pathway insights from human Physiocrine proteins, to treat patients suffering from severe, rare immune-mediated diseases, as well as various cancers, today announced participation in the upcoming 22nd International Annual Congress of the World Muscle Society (WMS) being held October 3 - 7, 2017 in Saint Malo, France.
Poster Presentation: Thursday October 5, 2017 from 15:30 – 17:00 (CEST)
In this exploratory, open-label study, Resolaris was generally well tolerated at doses up to 3.0 mg/kg once weekly in patients aged 16 to 20 years with early-onset FSHD. 63% of patients (5 of 8) had increases from baseline in their Manual Muscle Test (MMT), a validated assessment tool that measures muscle strength, with a mean change from baseline of +3.8%. In addition, 67% of patients measured (4 of 6) had improvement in their Individualized Neuromuscular Quality of Life (INQoL) score, a validated patient reported outcome measuring a patient’s level of disease burden. On average, patients did not have a worsening of their disease burden as measured by INQoL. No signs of general immunosuppression were observed, and low-level ADA signals did not result in clinical symptoms.
aTyr believes these data are supportive of further advancement of Resolaris.
About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients using its knowledge of Physiocrine biology, a newly discovered set of immunological and physiological pathways. To date, aTyr has generated three innovative therapeutic programs with three different biologic modalities based on its knowledge of the Resokine pathway to treat patients suffering from severe, rare immune-mediated diseases, as well as various cancers. The Resolaris and iMod.Fc programs are agonists of the Resokine pathway designed to temper immune system engagement in diseases characterized by excessive immune cell involvement. aTyr’s third program, ORCA, represents a novel, proprietary pathway in immuno-oncology that utilizes antibody approaches to block the Resokine pathway and ‘release multiple brakes’ on the immune system in the tumor cell environment. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 220 issued patents or allowed patent applications that are owned or exclusively licensed, including over 300 potential Physiocrine-based protein compositions. For more information, please visit http://www.atyrpharma.com .
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act. Forward-looking statements are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by such safe harbor provisions for forward-looking statements and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the potential and potential therapeutic benefits of Resolaris, the ability of the Company to successfully advance its pipeline or product candidates, undertake certain development activities and accomplish certain development goals, and the scope and strength of our intellectual property portfolio, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the discovery, development and regulation of our Physiocrine-based product candidates, as well as those set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2016 and in our other SEC filings. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Sr. Director, Investor Relations
SAN CARLOS, Calif., Dec. 13, 2017 (GLOBE NEWSWIRE) -- Allakos Inc., a private, clinical-stage biopharmaceutical company focused on the development of antibodies for the treatment of allergic, inflammatory and proliferative diseases, today announced the successful completion of a $100 million Series B equity financing. The Series B was led by New Enterprise Associates (NEA) and included Redmile Group, Partner Fund Management, Rock Springs Capital, LifeSci Venture Partners, Samsara BioCapital, and a large institutional investor, as well as existing investors Alta Partners, RiverVest Venture Partners, Roche Venture Fund, and 3X5 Partners. Paul Walker, a Partner at NEA, will join the Company’s Board of Directors.
Proceeds from the financing will be used to advance Allakos’s development programs including the Company’s lead clinical candidate, AK002, which is being evaluated in patients with eosinophilic gastritis, indolent systemic mastocytosis (ISM), urticaria and severe allergic conjunctivitis. This investment also will support Allakos’s preclinical programs.
“We are excited to welcome a distinguished group of new investors to Allakos and appreciate the support of our existing investors,” said Robert Alexander, Ph.D., and Chief Executive Officer of Allakos. “The Allakos team is committed to developing antibodies to potentially treat a broad range of conditions for which there are no approved therapies or where treatment options come with undesirable side effects. We have made tremendous progress during 2017 and, with this financing, we look forward to continuing the development of AK002 and our preclinical programs.”
“Allakos’s highly differentiated approach has the potential to deliver first-in-class treatments for serious illnesses affecting both large and rare disease populations,” said Paul Walker. “I welcome the opportunity to work with the experienced leadership team at Allakos as they conduct clinical trials in several important disease indications.”
Allakos is a privately held clinical-stage company developing antibodies that target immunomodulatory receptors present on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, AK002, targets Siglec-8, an inhibitory receptor expressed on the surface of mast cells and eosinophils. AK002 has completed two Phase 1 studies, one in healthy volunteers and a single ascending dose study in patients with ISM. In addition, patients with ISM are currently being treated with AK002 for up to 12 months in a repeat dose study. In these studies, AK002 was well tolerated and demonstrated pharmacological activity on objective measures as well as patient reported symptoms.
For more information, please visit the Company's website at http://www.allakos.com/
Source: Allakos, Inc.
It may be time to give millennials the nickname, “The Now Generation”, because we seem to have, do, and want it all now. With just your mobile phone, you can get just about anything delivered right to your door, be picked up and dropped off, and source any piece of information your mind wonders about.
The latest convenience app that can save you time is in the healthcare space. When you are sick, the last thing you want to do is get in your car, sit in traffic, and interact with more people than absolutely necessary while you wait in a crowded waiting room.
A New Way To Get Well
DispatchHealth is a relatively new service that is bringing the health care to your door. “DispatchHealth is an on-demand, in-home, care delivery platform designed to address the healthcare needs of the on-demand consumer, as well as the needs of the consumer that struggles with access to care,” said Mark Prather, CEO of DispatchHealth.
While the service doesn’t cover something as serious as a broken arm, it does cover most common illnesses that would be an expensive use of an emergency room or urgent care.
“Consumers can access the service via an app on their mobile phones, the DispatchHealth website or simply call directly to request medical care,” said Prather. “Using its proprietary risk-stratification technology, patients are screened to make sure it is appropriate to assign a medical team. Once cleared, board-certified, ER-trained professionals are then dispatched to the home, senior care facility or workplace.”
Millennials Want Convenient Health Care
Some busy millennials may find it easier to have a medical professional meet them at their workplace instead of home, because they need to see someone as soon as possible, but can’t afford to stay home for the day.
An important piece about DispatchHealth is that the service is also great for senior citizens who have difficulty getting to the doctor when they are sick. For millennials though, the convenience factor is key.
According to a recent survey by The Capital Group , millennials consider health insurance to be one of their top three “must have” benefits, signaling the importance of having available and affordable health care when they need it. This priority translates into on demand services for health care too.
“We live in an on-demand culture,” said Prather. “We all want the right care at the right price at the right time. Our service aligns well with millennial expectations and the shift toward consumer-directed healthcare. DispatchHealth's Net Promotor Score (NPS) has never dropped below 90, indicating the high customer satisfaction and loyalty that millennials are known to be so fond of. Far above the healthcare industry average of 30.”
Millennials Can’t Afford An Emergency Room Visit
Another major perk of DispatchHealth when it comes to millennial preference is cost. Millennials know all too well how expensive it is to be an adult, especially with the rising cost of health care.
“The providers have the ability to perform procedures such as laceration repair, rapid infectious disease testing and even deliver IV fluids and medications,” shared Prather. “They also have access to their own on-scene laboratory and mobile imaging. The average cost of an emergency room visit can run $2200, while a DispatchHealth visit can cost approximately a tenth of that.”
Speaking from experience as a millennial parent, I know how expensive an emergency room bill can be when bringing my child in for care. Since most new parents are now millennials, they will be more cost conscious where possible when it comes to health care and this gives them another choice for themselves and their children.
The cost is usually cheaper for this type of in home care, compared to an emergency room. Another area that is a benefit is the comfort factor. Have you ever felt stuffy in a doctor’s office from the smells, sounds, and sights?
“We have had mothers write to tell us how their children had a laceration repaired on the kitchen table and never even cried,” said Prather. “There is just something different about care in the home. The patients are more comfortable and the providers have an insight into the social circumstances of a patient’s life. We believe that this insight gives us a better chance at producing a care plan that truly works for our patients.”
If you are reading this with a stuffed nose, headache, or other common ailment and want to give it a test run, make sure to check their covered cities. They are currently active in Phoenix, AZ, Richmond, VA, Denver, CO, and Colorado Springs, CO.
The good news is that DispatchHealth will be spreading throughout the United States soon, as they have received a $30.8 million Series A investment, which will allow them to expand. Clearly on demand health care is a valuable resource that millennials and others alike will use.
DispatchHealth has begun to disrupt the health care industry, much like other emerging companies have upended the norm in their own niche. Millennials are likely to get behind their mission as they look to craft their lives from convenience and the ability to save money.See original article here .
Using Crispr gene-editing technology, EGenesis overcame a major hurdle on the path to animal-to-human organ transplantation, removing 62 viruses that humans are susceptible to from 40 pig embryos.
I’m on a mission to create a world where there are no organ shortages. In the U.S., over 100,000 people are on a waiting list, and only about 20 percent to 30 percent will get one.
The idea of xenotransplantation, or cross-species transplantation, has been around for decades. In the 1990s, there was a huge failure to overcome the compatibility issues that arise with trying to put a pig organ in a human body. Because of public health concerns, the WHO and USDA shut down all clinical trials, and the field has been silent.
There are two major barriers to xenotransplantation using pigs. One is viruses known as PERVs. PERVs reside in the pig genome and can integrate into the human genome. In 2015 we showed that we could use Crispr gene editing to eradicate 62 PERVs in pig cells. But one of the biggest questions was whether the PERVs played a crucial function in the pig. For the first time, in 2017, we answered the question: They’re dispensable.
It took hundreds of trials to get to a viable, “PERV-inactive” pig. Too many edits to a pig’s cells will stress out the cells, leading them to essentially commit suicide. We created a chemical cocktail to tell the cell, “It’s OK, don’t worry.” The first pig was born in China in March. We’re testing them to see if they have normal physiology and can produce offspring that preserve the genetic modification.
The other barrier is that, even though we know how to remove PERVs, there’s still the possibility that a human host could reject a pig organ. It’s still early days. We’re talking with the FDA about how to test our organs’ compatibility. We’ve just finished raising a $38 million Series A, and while we don’t have a clear path to market, we always keep our goal in mind: to deliver an organ. We’re not doing science for intellectual purposes.
—As told to Caroline Chen
Read full article here
Trevena, Inc. (NASDAQ:TRVN) today announced that it has recently submitted its New Drug Application (NDA) for OLINVO™ (oliceridine injection) to the U.S. Food and Drug Administration (FDA). OLINVO is the first G protein biased ligand of the mu opioid receptor, a new class of opioid receptor modulator, and the first pain program to receive Breakthrough Therapy designation from the FDA.
The submission includes data showing that intravenous OLINVO demonstrated analgesic efficacy in all three dosing regimens tested in the two Phase 3 APOLLO pivotal efficacy studies. These trials were designed to support an indication for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted.
The filing also includes safety and tolerability data for over 1,100 patients administered OLINVO across Phase 2 and Phase 3 studies, including the ATHENA open label safety study. Additional pharmacokinetic data, clinical pharmacology data, and results from five randomized controlled trials with head to head comparisons to morphine support potential differentiation of OLINVO.
“OLINVO was designed to fill a major gap in the set of medicines available for managing moderate to severe pain in the hospital,” said Maxine Gowen, Ph.D., chief executive officer. “Despite availability of non-opioid analgesics and advances in multimodal analgesia, tens of millions of patients still require IV opioids following surgery, during severe illness, or after trauma. Millions of these patients remain at risk for opioid-related adverse events, including respiratory depression or postoperative vomiting. We look forward to working with the FDA during the review process and to a potential NDA approval of OLINVO in 2018.”
SAN DIEGO, Nov. 01, 2017 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged in the discovery and development of immunology-based protein therapeutics to treat patients suffering from severe, rare immune-mediated diseases, as well as various cancers, announced that today Sanjay Shukla, M.D., M.S., who joined aTyr Pharma as Chief Medical Officer in March 2016, will succeed John Mendlein, Ph.D., as President and Chief Executive Officer. Dr. Shukla will also join aTyr’s Board of Directors. Dr. Mendlein, who has served as Chief Executive Officer since September 2011 and as a member of the Board of Directors since July 2010, will continue to serve on the Board of Directors of aTyr Pharma.
“This is an excellent time for aTyr as we are well-positioned for future growth with strong leadership to drive forward our shared vision to develop meaningful medicines for patients with rare muscle and lung diseases, as well as to serve cancer patients with products based on our new immuno-oncology platform, ORCA,” said John Mendlein, outgoing-CEO of aTyr Pharma. “After six incredible years as CEO, I am very pleased to pass the leadership torch to Sanjay and continue to advise him as a board member. Having worked extensively with Sanjay, I am confident he will continue to elevate aTyr to greater heights for patients and all stakeholders alike. I would like to express my immense gratitude to all our amazing employees, board, patients, and investors for all that we have accomplished so far at aTyr.”
“We are truly grateful for John’s leadership in guiding aTyr through several key milestones, including bringing the first Physiocrine-based therapeutic into the clinic, building a well-capitalized, NASDAQ-traded company, growing a robust pipeline of three biologic programs and solidifying aTyr’s intellectual property estate for an entire new class of proteins,” said John Clarke, chairman of aTyr Pharma’s board. “We thank John for his leadership and accomplishments at aTyr and wish him well in all his future endeavors. Looking forward, we are excited about this transition and confident that under Sanjay’s leadership, aTyr will continue to grow and successfully deliver upon its important mission.”
Dr. Shukla will continue aTyr’s mission to develop innovative new protein therapeutics based on its knowledge of Physiocrine biology. Dr. Shukla served as aTyr’s Chief Medical Officer since March 2016and has over twenty years of leadership experience in both large pharma and biotech companies. Since joining aTyr, Dr. Shukla led the completion of three Phase 1b/2 Resolaris™ clinical trials and two long-term safety extension studies for the treatment of rare muscular dystrophies and has advanced the iMod.Fc program for the treatment of interstitial lung diseases towards the clinic with a Phase 1 trial expected to commence this quarter.
“I am excited for the opportunity to lead aTyr at such a productive time for the company,” said Sanjay Shukla, President and CEO of aTyr Pharma. “Our team has made tremendous progress in elucidating the biology and laying the groundwork for the potential therapeutic applications of this groundbreaking new science, under John’s leadership. I am ready to lead our team forward to continue to build on this strong foundation of success. Our mission remains steadfast and during this quarter we intend to bring a second Physiocrine-based therapeutic candidate into the clinic with an iMod.Fc Phase 1 trial and select an antibody to develop as an IND candidate from our ORCA program.”
NEWARK, Calif., Oct. 31, 2017 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need, today announced the appointment of Sujal Shah as its President and Chief Executive Officer, effective November 1, 2017. Mr. Shah has been serving as the Interim President and Chief Executive Officer since March 2017.
“I am delighted to announce the appointment of Sujal as Chief Executive Officer,” said Robert Wills, Ph.D., Chairman of the Board of Directors. “Sujal has the vision and leadership needed to guide CymaBay through its next stage of growth. During his tenure as CFO, and over the last six months as interim CEO, he has played a key role in strategy, finance and operations at the company, and I believe he is uniquely qualified to lead CymaBay.”
“I am honored to be named Chief Executive Officer and to have the opportunity to lead such a talented team as the company enters one of the most important periods in its history,” said Sujal Shah, President and Chief Executive Officer of CymaBay. “Our lead candidate seladelpar has the potential to significantly advance the treatment of patients with primary biliary cholangitis, or PBC, and nonalcoholic steatohepatitis, or NASH. Just last week, positive interim results from a phase 2 study in PBC were presented as an oral, late-breaking presentation at the Liver Meeting® 2017. Our goals for 2018 are to initiate a phase 3 study in PBC as well as a phase 2 study in NASH. All of us here at CymaBay are focused on improving the lives of patients with liver disease, and I feel fortunate to be part of that effort.”
Sujal Shah joined CymaBay as Chief Financial Officer in December of 2013. Prior to that he served as a consultant and acting Chief Financial Officer since June 2012. From 2010 to 2012, Mr. Shah served as Director, Health Care Investment Banking Group for Citigroup, where he was responsible for managing client relationships and executing strategic and financing related transactions for clients focused in life sciences. From 2004 to 2010, Mr. Shah was employed with Credit-Suisse, last serving as Vice President, Health Care Investment Banking Group. Mr. Shah received a MBA from Carnegie Mellon University Tepper School of Business and B.S. and M.S. degrees in biomedical engineering from Northwestern University. Mr. Shah currently serves on the Executive Advisory Board of the Chemistry of Life Processes Institute at Northwestern University.
IRVINE, Calif.--(BUSINESS WIRE)-- Aerie Pharmaceuticals, Inc. (NASDAQ: AERI ), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today announced the appointment of John Maltman, Ph.D., as Vice President of Medical Affairs, reporting to Theresa Heah, M.D., M.B.A., Aerie's Vice President of Clinical Research and Medical Affairs. Dr. Maltman will be responsible for leading the strategic efforts of Aerie's Medical Affairs Department across a broad spectrum of product-related activities. He previously held several related positions at Allergan, Inc.
In connection with his acceptance of the position as Vice President of Medical Affairs, Dr. Maltman will receive awards totaling 46,500 stock options and 4,000 shares of restricted stock. The stock options will vest over 4 years, with 25% vesting on the first anniversary of the hire date and the remainder vesting ratably on each of the subsequent 36 monthly anniversaries of the hire date; the restricted stock will vest over a period of 4 years in four equal annual installments on each anniversary of the hire date. This award was made outside of Aerie's stockholder-approved equity incentive plan and was approved by the Company's independent directors as an inducement material to Dr. Maltman entering into employment with the Company in reliance on NASDAQ Listing Rule 5635(c)(4), which requires this public announcement.
Prolacta Bioscience, the pioneer in human milk-based neonatal nutritional products for premature infants, will participate in the 2017 Infant Health Policy Summit
, hosted by the National Coalition for Infant Health
and the Institute for Patient Access
, on Oct. 26, 2017, in Washington, D.C.
The Summit, titled “Diversity & Disparity: Breaking Down Access Barriers,” provides a collaborative platform for health care providers, patient advocates, parents and policymakers to discuss patient access issues facing vulnerable premature infants and their families. The panel on “Milk Matters: Diversity, Quality & Safety,” will include:
“The National Coalition for Infant Health’s agenda is to make exclusive human milk the standard of care for all infants, and especially those born weighing less than 1,500 grams (3 pounds 5 ounces),” Goldstein said. “We are simultaneously raising awareness on this issue and working to ensure access to an exclusive human milk diet for low-income families through Medicaid reimbursement.”
“Prolacta is proud to support the 2017 Infant Health Policy Summit, as we share a mutual commitment to making an exclusive human milk diet accessible to all vulnerable premature infants in the NICU,” Eaker said.
Now in its third year, the Policy Summit also explores issues related to maternal nutrition; nutritional practices in the neonatal intensive care unit (NICU), including infant tube feeding safety; respiratory health; and the potential risk of Hepatitis C transmission. The annual event draws attendees including individual health care providers, congressional leaders and staff, representatives from national nursing and physician organizations and national and regional preemie parent organizations.