Kleo Pharmaceuticals Secures $21 Million to Advance Novel Small Molecule Cancer Immunotherapies

New Haven, CT, November 13, 2018 – Kleo Pharmaceuticals Inc., an immuno-oncology company pioneering a new class of bi-specific, small molecule compounds designed to emulate or enhance biologics against cancer, announced today the closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020. The financing was led by the company’s development partner, PeptiDream, Inc., (TOKYO:4587), with participation from current strategic investor Biohaven Pharmaceuticals Inc. (NYSE:BHVN).

Kleo’s lead candidates are based on the Company’s modular Antibody Recruiting Molecules (ARMs) technology, which enables Kleo’s compounds to bind at one end to specific targets on cancer cells and to the body’s endogenous antibodies. This unique approach redirects the activity of any ARM-bound antibody against the cancer cells without inhibiting the antibody’s native function. In parallel, Kleo is continuing to advance its two additional immuno-oncology therapy platforms, including its Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs).

Douglas Manion, CEO of Kleo Pharmaceuticals, said, “Successful completion of this financing represents an important step in the translation of our groundbreaking approach into therapies that may improve patients’ lives. Having improved the modularity of our platforms and expanded the applicability of our ARMs to recruit antibodies to target cancer cells, we are now well funded to advance our first next-generation candidates into human clinical studies. We are excited to welcome our development partner PeptiDream to our community of investors, and we’re humbled by the continued support of our founding investor Biohaven.”

Patrick Reid, CEO of PeptiDream, stated, “We have worked with Kleo since July 2017 and we are impressed by the scientific progress they have made in validating their technology platforms. We are enthusiastic about the robust pipeline they are building from all three of their unique immunotherapy platforms and we are very happy to be a part of it, both as a strategic partner and now as an investor. We believe Kleo’s clinical candidates represent a paradigm shift in immuno-oncology development that elegantly delivers the therapeutic power of highly complex bi-specific antibodies, but in a more simple, less costly, and potentially more beneficial manner. When combined with PeptiDream’s robust discovery platform, we expect Kleo to generate many novel drug franchises that can bring incredible value for patients suffering from cancer.”

About Kleo Pharmaceuticals Inc. 
Kleo Pharmaceuticals is an immuno-oncology company pioneering a new class of bi-specific, small molecule compounds designed to emulate or enhance biologics against cancer. Similar to complex biologic drugs, Kleo’s compounds engage the body’s immune system to target cancer cells, but unlike biologics, Kleo’s compounds are non-immunogenic, highly stable, and much faster and less costly to design and produce, particularly against novel targets. The company is advancing several drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against certain cancers, or enhance the properties of existing immunotherapies. These include Antibody Recruiting Molecules (ARMs), Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs). The company was formed to advance technologies developed at Yale University and founded by Dr. David Spiegel and Roy Prieb. For more information visit http://kleopharmaceuticals.com.

About PeptiDream
PeptiDream Inc. is a public (Tokyo Stock Exchange 1st Section 4587) biopharmaceutical company founded in 2006 employing our proprietary Peptide Discovery Platform System(PDPS), a state-of-the-art highly versatile discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based, small molecule-based, or peptide-drug-conjugate-based therapeutics. PeptiDream aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide. Further information regarding PeptiDream can be found at: http://peptidream.com.

About Biohaven
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation, and myeloperoxidase inhibitor platforms. Biohaven's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


CONTACT INFORMATION
Tiberend Strategic Advisors, Inc.

Joshua Drumm, Ph.D. (Investors)
(212) 375-2664
jdrumm@tiberend.com

Janine McCargo (Media)
(646) 604-5150
jmccargo@tiberend.com

Kleo Pharmaceuticals Selected to Present at Biotech Innovation Conference

NEW HAVEN, Conn., April 5, 2018 /PRNewswire/ -- Kleo Pharmaceuticals, a biopharmaceutical company developing innovative small molecule immunotherapies, announced today that CEO Doug Manion, M.D. FRCP (C) will be presenting at Biotech Innovations Conference in New York, NY on Monday, April 9th from 1:30-2:00PM. Bloomberg Intelligence and Mass Innovation Labs are co-hosting the event focusing on the exciting and evolving landscape of the biotech industry and will feature company presentations that focus on private and recently public biotech firms who are pioneers in immuno-oncology, cell therapy, and gene therapy fields.

A live webcast and replay will be available on the Bloomberg Terminal on the LIVE<Go> function for subscribers. Kleo will provide access to a video of the presentation on its website when it becomes available.

About Kleo Pharmaceuticals Inc. 
Kleo Pharmaceuticals Inc. is a biopharmaceutical company founded to develop and advance the pioneering technology that originated in the laboratory of co-founder David Spiegel, M.D., Ph.D. at Yale University. Initially funded by Biohaven Pharmaceuticals Holding Ltd (NYSE: BHVN) and Connecticut Innovations, Kleo is focused on developing small molecule-based immunotherapies that emulate biologics. Our 2 novel platforms—Antibody Recruiting Molecules (ARMs™) and Synthetic Antibody Mimics (SyAMs™)— are designed to direct a patient's immune system to fight specific disease-causing cells. For more information, please visit: www.kleopharmaceuticals.com

CONTACT INFORMATION

Contact: 
Roy Prieb
Kleo Pharmaceuticals Inc. 
203-691-6961 ext. 202
email: pr@kleopharmaceuticals.com 
website: www.kleopharmaceuticals.com

 

SOURCE Kleo Pharmaceuticals Inc.

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http://www.kleopharmaceuticals.com

Kleo Pharmaceuticals Inc. Appoints Luca Rastelli, PhD as Chief Scientific Officer

New Haven, CT—April 2, 2018

Kleo Pharmaceuticals Inc., a biotechnology company pioneering a new class of immunotherapies utilizing small molecules to activate an individual’s own immune system to fight against cancers and other diseases, announced today the appointment of Luca Rastelli PhD, as Chief Scientific Officer, effective immediately and reporting to Doug Manion, CEO.  Dr. Rastelli will lead all aspects of R&D for the company and serve as the scientific external face of Kleo Pharmaceuticals to the investor, scientific, medical and patient communities.

"We welcome Luca to the Kleo Pharmaceuticals executive team," said Kleo's Chief Executive Officer, Doug Manion, M.D., FRCP(C). "He brings more than 20 years of drug discovery and development experience and a wealth of expertise in oncology and, more specifically, immuno-oncology. Luca is the ideal leader to drive the next phase of Kleo’s evolution as we complete platform validation for our various small-molecule immunotherapeutic programs and select clinical candidates for upcoming IND-enabling activities."

“We are delighted to welcome Luca to Kleo.  His considerable expertise and scientific acumen are perfectly suited to the cutting-edge science being done at Kleo.  I am confident that Luca will continue to build on the already very strong scientific team at Kleo as well as partner effectively with scientific experts the world over”, said David Spiegel M.D., Ph.D., Founder and Chief Scientific Advisor, Kleo Pharmaceuticals.

“I am excited to join Kleo Pharmaceuticals at this very important time.  I look forward to working with Doug, David and the rest of the Kleo team to accelerate this innovative science to the clinic and then to patients as expeditiously as possible.  Kleo Pharmaceuticals is poised to become a major player in the immunotherapy landscape and I am proud to be a part of it.” said Luca Rastelli, Ph.D.

Dr. Rastelli has more than 20 years of oncology drug discovery, development, and business development experience ranging from startups to large pharmaceutical companies. Most recently, he was Vice President, for Oncology at BioXcel Therapeutics which just completed a successful IPO. Luca has held multiple preclinical and clinical project leadership positions at Boston Scientifics, CuraGen, Sopherion and EMD Serono (Merck Serono). He discovered the target and led the initial development of CR011, an antibody drug conjugate agent undergoing a registrational trial in triple negative metastatic breast cancer. He was also part of the initial development of the novel immuno-oncology antibody Avelumab, a PDL-1 inhibitor. He received the American Brain Tumor Association's 25th Anniversary Translational grant for his work on Medulloblastoma tumors at the Department of Neuro-Oncology, MD Anderson Cancer Center. He is a named inventor on more than 10 issued patents and holds a Ph.D. in Molecular Biology from the University of Geneva.

About Kleo Pharmaceuticals Inc.

Kleo Pharmaceuticals Inc. is a biopharmaceutical company founded to develop and advance the pioneering technology that originated in the laboratory of co-founder David Spiegel, M.D., Ph.D. at Yale University. Initially funded by Biohaven Pharmaceuticals Holding Ltd (NYSE: BHVN) and Connecticut Innovations, Kleo is focused on developing small molecule-based immunotherapies that emulate biologics. Our 2 novel platforms—Antibody Recruiting Molecules (ARMs™) and Synthetic Antibody Mimics (SyAMs™)— are designed to direct a patient’s immune system to fight specific disease-causing cells. For more information, please visit: www.kleopharmaceuticals.com.

CONTACT INFORMATION

Contact:
Roy Prieb
Kleo Pharmaceuticals Inc.
203-691-6961 ext. 202
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

PeptiDream and Kleo Pharmaceuticals Announce Collaboration Agreement to Develop Novel Immunotherapies for Oncology

New Haven, CT – July 18, 2017

PeptiDream Inc., a public Tokyo-based biopharmaceutical company (“PeptiDream”)(TOKYO:4587) and Kleo Pharmaceuticals Inc., a New Haven-based company using its proprietary Antibody Recruiting Molecule (“ARM”) and Synthetic Antibody Mimic (“SyAM”) platform technologies to develop small molecule immunotherapies (“Kleo”), announced today a collaboration agreement to co-develop proprietary immune-oncology products in multiple indications.  

Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (“PDPS”) technology to identify macrocyclic/constrained peptides against multiple oncology targets of interest selected by Kleo, and to optimize hit peptides into optimized binders that will be engineered by Kleo into novel ARM and SyAM products. Kleo will receive an upfront payment and will have the right to develop and commercialize all compounds resulting from the collaboration. PeptiDream is eligible to receive a tiered share of proceeds from any products that arise from the collaboration based on degree to which PeptiDream funds development of the product. Specific financial terms were not disclosed.

“We are very excited to enter into this collaboration agreement with PeptiDream ,” said Douglas Manion, MD, CEO of Kleo. “We think combining PeptiDream’s PDPS technology with Kleo’s ARM and SyAM platform represents a truly potent partnership that will generate many more effective targeted treatments for patients. We are looking forward to advancing this new paradigm of small molecule immunotherapies into the clinic.”

“PeptiDream has long been on the forefront of transforming PDPS-identified peptides into peptide therapeutics, small molecule drugs, and peptide drug conjugates (PDCs),” said Keiichi Kubota, CEO of PeptiDream. “We greatly look forward to working with innovative leaders like Kleo to leverage our capabilities to develop the next generation of first-in-class and best-in-class immunotherapies.”

About Kleo Pharmaceuticals Inc.  

Kleo Pharmaceuticals Inc. is a biotechnology company initially formed on the basis of intellectual property from the Spiegel Lab at Yale University and funded by a series A round led by Biohaven Pharmaceuticals Holding Ltd (NYSE: BHVN) . The company was founded by Dr. David Spiegel and Roy Prieb and is focused on developing a new class of targeted immunotherapies. The company is based in New Haven, CT. Further information regarding Kleo can be found at: http://kleopharmaceuticals.com.

About PeptiDream

PeptiDream Inc. is a public (Tokyo Stock Exchange 1st Section 4587) biopharmaceutical company founded in 2006 employing our proprietary Peptide Discovery Platform System(PDPS), a state-of-the-art highly versatile discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based, small molecule-based, or peptide-drug-conjugate-based therapeutics. PeptiDream aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide. Further information regarding PeptiDream can be found at: http://peptidream.com

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

Contact:
Roy Prieb
Kleo Pharmaceuticals Inc.
203-691-6961
E: rprieb@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

Kleo Pharmaceuticals Inc. Appoints Douglas J. Manion, MD as Chief Executive Officer

New Haven, CT—June 9, 2017

Kleo Pharmaceuticals Inc., a biotechnology company pioneering a new class of immunotherapies utilizing small molecules to activate an individual’s own immune system to fight against cancers and infectious diseases, announced today the appointment of Douglas J. Manion M.D. FRCP(C) as Chief Executive Officer, effective immediately. Dr. David Spiegel M.D., Ph.D., co-founder of Kleo, takes the role of President, Kleo Laboratories.  Dr. Manion will also serve on the company’s Board of Directors.  Dr. Manion has had senior leadership roles in advancing therapies for a wide range of therapeutic areas including oncology, infectious diseases, autoimmunity, cardiology, metabolic diseases, genetically-defined diseases and fibrosis.  He has been involved with the initial approval or life-cycle expansion of over 20 major brands, 10 of which reached blockbuster status globally.

“Doug brings an incredible wealth of drug discovery and development expertise and experience to the Kleo team.  Without a doubt, the addition of Doug will further accelerate Kleo’s place as a leader in the field of immunotherapy be it in cancer, infectious diseases or other areas of high unmet medical need,” said Declan Doogan, M.D., Chairman of the Board, Kleo Pharmaceuticals.

“We are delighted to welcome Doug to Kleo.  It was clear from day one that Doug shared our passion for bringing innovative immunotherapy solutions to patients in need.  His extensive experience and broad connections to the pharmaceutical and investor communities will be invaluable as Kleo Pharmaceuticals evolves into an industry leader”, said David Spiegel.

“I am thrilled to join Kleo Pharmaceuticals as it accelerates its quest to provide novel immunotherapies for patients with high unmet medical need.  The science is so compelling.  I look forward to partnering with the scientists at Kleo led by David Spiegel and the rest of the team, in advancing a truly innovative approach to enlist patients’ own immune systems to fight serious disease,” said Doug Manion.

Doug is a drug discovery and development leader with over 20 years of experience including Dupont Pharmaceuticals, GlaxoSmithKline and, most recently, Bristol-Myers Squibb.  He earned a B.A.Sc. in Civil Engineering prior to his Medical Degree both from the University of Ottawa, Canada.  He completed training in Internal Medicine and Infectious Diseases in Ottawa and a post-doctoral fellowship in bench and clinical research in HIV/AIDS at the Massachusetts General Hospital, Harvard Medical School in Boston.  He is currently a non-executive Board Member for Celleron Therapeutics in Oxford, UK.

About Kleo Pharmaceuticals Inc.  

Kleo Pharmaceuticals Inc. is a biotechnology company initially formed on the basis of intellectual property from the Spiegel Lab at Yale University. The company was founded by Dr. David Spiegel and Roy Prieb and is focused on developing a new class of targeted immunotherapies. The company is based in New Haven, CT. Further information regarding Kleo can be found at: http://kleopharmaceuticals.com.

 About Biohaven

Biohaven (NYSE: BHVN) provided the initial Series A funding to Kleo Pharmaceuticals, Inc. and entered into a master services agreement to provide clinical development support to help advance Kleo’s small molecule, immune based therapeutics called Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMS).  Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has licensed intellectual property from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC, Rutgers and Massachusetts General Hospital. Biohaven is a company organized under the laws of the British Virgin Islands and its United States operations are based in New Haven, Connecticut. 

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

Contact:
Roy Prieb
Kleo Pharmaceuticals Inc.
203-691-6961
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

Kleo Pharmaceuticals Inc. Appoints Roy Prieb as Chief Operating Officer and Chief Financial Officer

New Haven, CT—September 19, 2016

Kleo Pharmaceuticals Inc., a biotechnology company pioneering a new class of immunotherapies utilizing small molecules to activate an individual’s own immune system to fight against cancers and infectious diseases, announced today the appointment of Roy Prieb as Chief Operating Officer and Chief Financial Officer effective immediately. Mr. Prieb will also serve on the company’s Board of Directors. He is a co-founder of Kleo Pharmaceuticals and the entrepreneur who secured its technology license from Yale University and organized the company’s series A financing, which was led by Biohaven Pharmaceuticals.

“Roy’s strategic insight and leadership have been key to putting Kleo on the path to success. He was one of the first people to recognize and articulate the value of our platform and has been a tremendous advocate for the company among investors and partners. We are excited to have him on board to help us execute our vision and lead this company to the next level,” said David Spiegel, M.D. Ph.D., Chief Executive Officer at Kleo Pharmaceuticals.

“Kleo has the opportunity to reshape the field of immunotherapy and transform the lives of so many patients. We are looking forward to bringing together the right people and partners to advance our small molecule immunotherapies into the clinic. It will be an exciting journey and I am thrilled to be part of the team that will meet its challenges and deliver its successes,” said Roy Prieb.

Roy Prieb is a technology entrepreneur with over 15 years of experience in business strategy, development, and operations. He has helped launch, fund, and grow several digital ventures including Saaspire, Kellogg Media Group, Qiosk.com, and JibJab.com. Earlier in his career, Mr. Prieb was a consultant with The Boston Consulting Group. He received his B.A. from Harvard University and M.B.A. from Wharton Business School.

About Kleo Pharmaceuticals Inc.  

Kleo Pharmaceuticals Inc. is a biotechnology company initially formed on the basis of intellectual property from the Spiegel Lab at Yale University. The company was founded by Dr. David Spiegel and Roy Prieb is focused on developing a new class of targeted immunotherapies. The company is based in New Haven, CT. Further information regarding Kleo can be found at: http://kleopharmaceuticals.com.

About Biohaven Pharmaceuticals

Biohaven recently provided Series A funding to Kleo Pharmaceuticals, Inc. and entered into a master services agreement to provide clinical development support to help advance Kleo’s small molecule, immune based therapeutics called Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMS). Biohaven is a privately-held biopharmaceutical company with expertise in late stage clinical development and has a portfolio of multiple late stage drug assets. Biohaven has licensed intellectual property from Yale University, Catalent, ALS Biopharma LLC, and Massachusetts General Hospital. The company has advanced multiple candidates into the clinic and plans on pivotal trials beginning late 2016. Biohaven is owned by a group of investors including Yale University, Portage Biotech Inc. (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), John W. Childs and other private investors. Further information regarding Biohaven can be found at: http://biohavenpharma.com.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

Contact:
Roy Prieb
Kleo Pharmaceuticals Inc.
(203) -428-4596
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

 

Kleo Pharmaceuticals Inc. Appoints David A. Spiegel as Chief Executive Officer

New Haven, CT—September 19, 2016

Kleo Pharmaceuticals Inc., a biotechnology company pioneering a new class of immunotherapies utilizing small molecules to activate an individual’s own immune system to fight against cancers and infectious diseases, announced today the appointment of David A. Spiegel, M.D. Ph.D., as Chief Executive Officer effective immediately. Dr. Spiegel will also serve on the company’s Board of Directors. He is a co-founder of Kleo Pharmaceuticals and the scientist who discovered and developed Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs) in his laboratory at Yale University.

“Because the ARM and SyAM platforms are unique technologies with such tremendous potential for expanding the field of immunotherapy, we felt it was absolutely key for us to have David’s mind and leadership at the helm of the company that will champion this approach in the clinic. We are looking forward to contributing our development and commercial experience and expertise to transform David’s vision into a life-changing reality for patients,” said Declan Doogan, M.D., Chairman of the Board for Biohaven Pharmaceuticals, which led Kleo’s series A financing.

“This is a golden age for immunotherapies and I am very grateful to be a part of this revolution in patient treatment options,” said Dr. Spiegel. “Small molecule immunotherapies have so many unique and potentially advantageous characteristics when compared to biologics that it will be exciting to see where our platforms will ultimately be best deployed in the fight against disease.”

Dr. Spiegel is a Professor of Chemistry and Pharmacology at Yale University where he heads the Spiegel Research Group. During his time as a faculty member, he has led research efforts in a number of successful directions, ranging from the development of antibody-recruiting molecules to fundamental studies of advanced glycation end-products. He has co-authored over 40 peer-reviewed publications and is an inventor with over a dozen patents. He has consulted to International Flavors and Fragrances, Novartis Institute for Biomedical Research, Bristol-Myers Squibb, and Allied-Bristol Life Sciences. He has been recognized with various awards and honors, including the NIH Director’s New Innovator Award, the Department of Defense Era of Hope Scholar Award, the Ellison Medical Foundation New Scholar Award in Aging Research, the Novartis Early Career Award in Organic Chemistry, the Bill and Melinda Gates Foundation Grand Challenges Explorations Award, an Alfred P. Sloan Foundation Fellowship, an Arthur C. Cope Early Career Scholars Award, and others.

About Kleo Pharmaceuticals Inc.  

Kleo Pharmaceuticals Inc. is a biotechnology company initially formed on the basis of intellectual property from the Spiegel Lab at Yale University. The company was founded by Dr. David Spiegel and Roy Prieb is focused on developing a new class of targeted immunotherapies. The company is based in New Haven, CT. Further information regarding Kleo can be found at: http://kleopharmaceuticals.com.

About Biohaven Pharmaceuticals

Biohaven recently provided Series A funding to Kleo Pharmaceuticals, Inc. and entered into a master services agreement to provide clinical development support to help advance Kleo’s small molecule, immune based therapeutics called Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMS). Biohaven is a privately-held biopharmaceutical company with expertise in late stage clinical development and has a portfolio of multiple late stage drug assets. Biohaven has licensed intellectual property from Yale University, Catalent, ALS Biopharma LLC, and Massachusetts General Hospital. The company has advanced multiple candidates into the clinic and plans on pivotal trials beginning late 2016. Biohaven is owned by a group of investors including Yale University, Portage Biotech Inc. (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), John W. Childs and other private investors. Further information regarding Biohaven can be found at: http://biohavenpharma.com.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the U.S. federal and Canadian securities laws. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "estimate," "project," "intend," "expect," "believe," "anticipate," "will,” "plan," "could," "may" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements including receipt of regulatory approvals and market conditions. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT INFORMATION

Contact:
Roy Prieb
Kleo Pharmaceuticals Inc.
(203) - 691 - 6332
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

Kleo Pharmaceuticals Inc. Secures Series A Funding to Advance the Development of Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs)

ARMs and SyAMs represent a new class of targeted immunotherapies utilizing small molecules to fight cancer and infectious disease

New Haven, CT - September 1, 2016

Kleo Pharmaceuticals Inc., a biotechnology company pioneering a new class of immunotherapies utilizing small molecules to activate an individual’s own immune system to fight against cancers and infectious diseases, announced today it has completed its Series A funding. The Series A round is being led by Biohaven Pharmaceutical Holding Company, Ltd. (Biohaven) and will support the company’s development platform of Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs).

ARMs are bifunctional or ‘two-headed’ chemical structures designed such that one head interacts with disease-relevant molecular targets (such as cancers), while the other head interacts directly with antibodies already present in a person’s bloodstream. SyAMs are novel synthetic molecules that possess both the targeting and effector cell activating functions of antibodies. The new drugs being developed by Kleo recruit the immune system to target and kill disease specific cells.

Kleo Pharmaceuticals was founded on the research of David A. Spiegel, MD PhD, a professor of Chemistry and Pharmacology at Yale University. “Biologics have been the gold standard for immunotherapies. With ARMs and SyAMs, we have the opportunity to raise that bar,” said Dr. Spiegel. ”Our ability to rationally design and synthesize small molecules that emulate the functionality of biologics represents a great advancement in the field. Our molecules are hundreds of times lighter than their biological counterparts and thus may infiltrate tissue more efficiently than large proteins. These small molecules are easier to produce, more tractable to engineer, and non-immunogenic.  It’s a tremendously exciting time.”

“Kleo’s groundbreaking technology opens up exciting new paths in the development of innovative immunotherapies,” said Declan Doogan, M.D., Chairman of Biohaven Pharmaceuticals. “We were drawn to this opportunity by both the strength of the technology and the ambitious vision Dr. Spiegel has for applying it to advance treatment options for patients across a wide range of indications. In addition to our investment, we look forward to partnering with Kleo’s team to help drive clinical development of its ARM and SyAM platform technologies.” 

About Kleo Pharmaceuticals, Inc.  

Kleo Pharmaceuticals Inc. is a biotech company initially formed on the basis of intellectual property from the Spiegel Lab at Yale University. The company was founded by Dr. David Spiegel and Roy Prieb and is focused on developing a new class of targeted immunotherapies. Further information regarding Kleo Pharmaceuticals can be found at: http://kleopharmaceuticals.com

About Biohaven

Biohaven is a privately-held biopharmaceutical company with particular expertise in late stage clinical development and has portfolio of multiple late stage drug assets. Biohaven has licensed intellectual property from Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Further information regarding Biohaven can be found at: http://biohavenpharma.com

 

Contact:
Roy Prieb
Kleo Pharmaceuticals, Inc.
(203) 691-6332
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

Kleo Pharmaceuticals Inc. Licenses Intellectual Property from Yale University Related to Targeted Immunotherapies

Proprietary platform technology covering Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs) represent two novel classes of small molecules targeting the immune system

New Haven, CT—September 1, 2016

Kleo Pharmaceuticals Inc.  announced today that it has entered into a definitive agreement with Yale University to license world-wide intellectual property rights related to Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Molecules (SyAMs) originally developed in the laboratory of David A. Spiegel, MD, PhD.

This new class of drugs discovered by Dr. Spiegel are bifunctional small molecules that can recruit the immune system to target and kill specific disease cells. These molecules combine the advantages of biologics with those of traditional small molecules. The technology promises to further expand the already large, growing market for immunotherapies by improving overall treatment efficacy, safety and accessibility.

Dr. Spiegel commented,  ”This technology emerged from years of research that began as an exploration of using small molecules to manipulate the body’s natural capabilities in fighting disease. Initial proof of concept experiments in animals successfully demonstrate the safety and efficacy of ARMs and SyAMs as immunomodulatory drugs. I’m very excited to see how they will perform in clinical development.“

Kleo received support to launch the platform from the Office of Cooperative Research (OCR) which guides the commercialization process for Yale faculty and researchers. The intellectual property technology and lead molecules licensed from Yale includes all  aspects of the ARM and SyAM platform with the exception of a single target (PSMA) that was previously licensed from Yale University to Allied-Bristol Life Sciences (ABLS) last year.

“We see tremendous opportunities to leverage Dr. Spiegel’s research in the development of novel treatments for a wide range of diseases,” said Roy Prieb, co-founder at Kleo Pharmaceuticals. “We are excited to bring to bear the necessary resources and industry talent to translate his success in the lab into advances in clinical development. It’s been an absolute pleasure working with Yale and Dr. Spiegel to form this partnership and we look forward to building a long, fruitful collaboration.”

Jon Soderstrom, PhD, Managing Director of OCR said “Dr. Spiegel and the OCR team have worked together to cultivate the intellectual property, solidify the business opportunity and build relationships with investors to make the founding of Kleo a reality. I think he’s a fantastic example of how entrepreneurship is flourishing in our academic community. We look forward to seeing the technology make its way into new, effective treatments for patients. “  

About the Yale Office of Cooperative Research

Since its founding in 1982, the Yale Office of Cooperative Research (OCR) has built a significant portfolio of inventions and patents and has grown into an engine of regional economic development. Its mission is to facilitate the translation of research from Yale’s labs into products and services that benefit society. OCR is recognized as a leading force for catalyzing economic growth by identifying, counseling and nurturing early-stage technologies and guiding the transition into robust companies. Learn more at: ocr.yale.edu.

About Kleo Pharmaceuticals Inc.

Kleo Pharmaceuticals Inc. is creating a new class of drugs utilizing small molecules as targeted immunotherapies. The molecules, called Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs) are bifunctional small molecules that can recruit the immune system to target and kill specific disease-causing cells. The company’s technology is built on the research of Dr. David Spiegel, MD, PhD of Yale University and has primary application in oncology indications as well as potential in infectious disease.

Contact:
Roy Prieb
Kleo Pharmaceuticals, Inc.
(203) 691-6332
email: pr@kleopharmaceuticals.com
website: www.kleopharmaceuticals.com

Kleo Pharmaceuticals Awarded $50K Innovation Prize By Boehringer Ingelheim and Boehringer Ingelheim Venture Fund

Kleo Pharmaceuticals was awarded the inaugural $50K Innovation Prize sponsored by Boehringer Ingelheim and Boehringer Ingelheim Venture Fund as recognition of its work in developing small molecule immunotherapies.

New Haven, CT - December 31, 2015

Kleo Pharmaceuticals Inc (Kleo). a biotechnology company pioneering a new class of small molecule immunotherapies, won the inaugural $50K Innovation Prize at the partnering day event hosted at Massachusetts Biotechnology Council (MassBio), and sponsored by Boehringer Ingelheim (BI) and Boehringer Ingelhiem Venture Fund (BIVF). Kleo was one of 15 early stage companies selected to present and compete at the event, which was attended by more than 200 industry and academic innovators in the life sciences. Attendees voted to determine the top five companies with the most technologies and the winner was selected from that group by a panel of BI and BIVF professionals. 

"We are thrilled to be part of such a vibrant biotech community," said Dr. David Spiegel,  Kleo's founder, "It's a great honor to be recognized by BI and BIVF for the work that has been done and what we are setting out to do with small molecule immunotherapies. We look forward to advancing our technology to the clinic and building a collaborative relationship with the industry. Many thanks to all who participated." 

About Kleo Pharmaceuticals

Kleo Pharmaceuticals Inc. is creating a new class of drugs utilizing small molecules as targeted immunotherapies. The molecules, called Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Mimics (SyAMs) are bifunctional small molecules that can recruit the immune system to target and kill specific disease-causing cells. The company's technology is built on the research of Dr. David Spiegel, MD, PhD of Yale University and has primary application in oncology indications as well as potential in infectious diseases.

Additional Information:

Boehringer Ingelheim Newsletter - December 2015 

Contact Information

Roy Prieb
Kleo Pharmaceuticals, Inc.
(203) 691-6332
email: pr@kleopharmaceuticals.com
website: www.kleopharmacuticals.com