PharmAkea Announces Successful Completion of a Phase 1 Trial in Healthy Subjects For Its Novel LOXL2 Inhibitor, PAT-1251

SAN DIEGO, CA, Aug. 22, 2017 /PRNewswire/ – PharmAkea, Inc. announced that it has successfully completed a Phase 1 single and multiple ascending dose (SAD/MAD) clinical study with PAT-1251, its novel, small-molecule LOXL2 inhibitor being developed for the treatment of IPF and other fibrotic diseases.

The study results indicate that PAT-1251 was generally well tolerated and a maximum tolerated dose (MTD) was achieved. A proprietary target engagement assay was used successfully to demonstrate that PAT-1251 binds the LOXL2 enzyme in plasma. After successful completion of the 6- and 9-month toxicology studies in Q4 2017, PAT-1251 will be ready to enter Phase 2 clinical development in early 2018.

"Based on its unique mechanism of action, PharmAkea's LOXL2 inhibitor, PAT-1251, has the potential to improve lung function in patients suffering from IPF, a debilitating lung disorder in which novel agents with improved tolerability, efficacy, and long-term safety profiles are needed," said Robert Williamson, CEO of PharmAkea."

The aim of the completed study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ascending doses of PAT-1251 in healthy subjects. The data from these studies will inform the dose selection and study design for a subsequent Phase 2 proof-of-concept study in IPF.

PharmAkea will be presenting a poster on this program at the IPF Summit, on Tuesday, August 22, 2017 in Boston MA.

About PharmAkea Inc.

PharmAkea is a privately held San Diego-based clinical-stage pharmaceutical company developing novel small molecules against protein targets involved in fibroproliferative diseases. The company has a diversified portfolio, including PAT-1251, a Phase 2 ready LOXL2 inhibitor, for the treatment of IPF, as well as liver and kidney fibrosis, and PAT-409, a Phase 1 ready autotaxin inhibitor for IPF, NASH (nonalcoholic steatohepatitis), PBC (primary biliary cholangitis), scleroderma and chronic kidney disease. For more information, please visit the Company's website at www.pharmakea.com.

Forward-Looking Statements

This press release contains "forward-looking" statements (which are identified by words like "believe," "anticipate," "could," "should," "estimate," "expect," "intend," "plan," "project," "will," "forecast," "budget," "pro forma," and similar terms) that are based on the Company's management's beliefs and assumptions and on information currently available to management. These forward-looking statements include, among others, statements regarding the possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of competition. The Company cautions you that these statements are based on the Company's projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause the Company's actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ.

Contacts:

PharmAkea, Inc.
Vanessa L. Jacoby, Vice President, Finance
858-764-3879
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Professor Andrew Tager, M.D.

It was with great sadness that we learned of the passing of Professor Andrew Tager on August 11, 2017. He was a remarkable man, a true gentleman and a wonderful collaborator. Andy’s brilliant scientific contributions have significantly helped progress the search for a treatment for pulmonary fibrosis and PharmAkea has certainly benefitted from his insights. Andy will be sorely missed by his family, friends and colleagues – he was one of the best.

http://www.legacy.com/obituaries/bostonglobe/obituary.aspx?pid=186369719

 


 

PharmAkea Extends Collaboration with Celgene Corporation

Extension Allows Anti-Fibrotic Programs to Further Mature and Build Value

SAN DIEGO, CA, November 18, 2016 – PharmAkea Inc. announced the extension of their strategic collaboration with Celgene Corporation which was established to leverage PharmAkea's proprietary drug discovery platform and novel small-molecule therapies targeting fibrotic diseases.

Under the terms of the agreement, Celgene Corporation committed $9 million to PharmAkea to extend the collaboration for 9 months. PharmAkea announced the original 3-year collaboration with Celgene in October of 2013.  PharmAkea is currently conducting a Phase 1 SAD and MAD trial, as well as toxicology studies that will enable Phase 2 trials on its lead program, a small molecule LOXL2 inhibitor. The Company is also conducting IND-enabling studies in preparation for a Phase 1 trial on its second program, an Autotaxin inhibitor.

"We have been very impressed with the progress the team at PharmAkea has made over the past three years," said Rupert Vessey, President of Research and Early Development at Celgene. "This extension allows the company to further realize the potential of their programs and to complete some key activities."

"Our relationship with Celgene has been extremely collaborative," said Robert Williamson, CEO of PharmAkea. "This extension is a validation and endorsement of our work to date.  We look forward to continuing our work with Celgene."

About PharmAkea Inc.

PharmAkea Inc. is a privately held San Diego-based biopharmaceutical company whose focus is to discover and develop small molecule therapeutics directed at cancer and fibrotic diseases. For more information, please visit the Company's website at www.pharmakea.com.

Contacts:

PharmAkea Therapeutics, Inc.
Vanessa L. Jacoby, Executive Director, Finance
858-764-3879
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PharmAkea, Celgene Corporation and Bay City Capital Collaborate to Advance Innovative Oral Therapies to Benefit Patients with Cancer and Fibrotic Disease

Partnership Highlights New Paradigm that Advances High-Potential Science Programs with Goal to Improve Patient Outcomes

SAN DIEGO, CA, October 4, 2013 – PharmAkea Therapeutics, Inc. and Bay City Capital, LLC, today announced a strategic collaboration with Celgene Corporation designed to leverage PharmAkea’s proprietary drug discovery platform to generate and advance novel small-molecule therapies targeting cancer and fibrotic diseases.

Under terms of the agreement, Celgene Corporation will commit $35 million to PharmAkea during an initial three-year alliance term, with an option to extend the collaboration with additional funding. Bay City Capital has invested $10 million in a Series A equity financing. In addition, Celgene will also take an equity stake in PharmAkea and will retain an exclusive option to acquire the company. PharmAkea was founded in 2012 with seed funding from Celgene, which was used to secure the initial scientific team, initiate operations and commence identification of clinical candidates against selected targets.

PharmAkea was co-founded by three highly-experienced early-drug developers, John Hutchinson, Ph.D., Jilly Evans, Ph.D., and Kevin Holme, Ph.D., all three of whom previously worked together at Amira Pharmaceuticals, which was sold to Bristol-Myers Squibb. Joining PharmAkea as Chief Executive Officer will be Robert F. Williamson, III. Mr. Williamson brings with him extensive industry experience, having held key management and leadership positions at venture backed and public life science companies, and was previously a partner with The Boston Consulting Group, Inc.

"The very strong team at PharmAkea is led by drug hunting professionals with a proven track record of delivering important medicines to patients," said Tom Daniel, M.D., Executive Vice President and President of Research and Early Development at Celgene. "As our commitment to immune & inflammatory diseases expands, this investment partnered with Bay City Capital represents an extension of our commitment to develop innovative approaches and complementary strategic assets for high therapeutic impact."

"We are excited to be working with Celgene and Bay City Capital on moving our fibrosis and oncology focused programs forward," said Dr. Hutchinson. "We see tremendous potential to leverage our expertise in the emerging biological understanding of connective tissue disorders to develop new therapeutics for these grave diseases, which carry high morbidity and mortality and affect a significant portion of the population."

"We are pleased to be collaborating with Celgene Corporation again, and look forward to helping build PharmAkea and advance their mission. PharmAkea brings together people from within all of our networks to form a team with a track record of effective collaboration and success," said Carl Goldfischer, Managing Director of Bay City Capital. "This kind of collaboration exemplifies an innovative way that venture firms, entrepreneurs, and industry can come together to support and foster progress in the life sciences."

Merv Turner, former Chief Strategy Officer of Merck & Co. and an advisor to Bay City Capital, will be joining PharmAkea's board along with Tom Daniel, Carl Goldfischer and Rob Williamson.

About PharmAkea Therapeutics, Inc.

PharmAkea Inc. is a privately held San Diego-based biopharmaceutical company whose focus is to discover and develop small molecule therapeutics directed at cancer and fibrotic diseases. For more information, please visit the Company's website at www.pharmakea.com.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.

About Bay City Capital, LLC

Bay City Capital is a life sciences venture capital firm investing in opportunities across the various life sciences sectors in companies at all stages of development. Established in 1997, the firm has managed eight venture capital funds representing over $1.6 billion in capital commitments. Bay City Capital has invested in over 100 life sciences companies globally, including Epizyme, Epocrates, GenturaDx, Hyperion Therapeutics, Idev Technologies, Ion Torrent Systems, Lexicon, MAP Pharmaceuticals, Medarex, Nabsys, NextWave Pharmaceuticals, Oculex Pharmaceuticals, Pharmion, Reliant Pharmaceuticals, and Sunesis Pharmaceuticals.

For more information, visit www.baycitycapital.com.

Contacts:

PharmAkea Therapeutics, Inc.
Vanessa L. Jacoby, Executive Director, Finance
858-764-3879
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Bay City Capital, LLC
Stacey Leanos, Senior Director Marketing and Investor Relations
415-835-9394
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Media:
Argot Partners
Eliza F. Schleifstein
973-361-1546
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