Amgen to Acquire Rodeo Therapeutics Corporation

  • Preclinical Program Targeting 15-PGDH has Potential use in a Broad Range of Therapeutic Applications Including Inflammatory Disease Indications

THOUSAND OAKS, Calif. and SEATTLE, March 30, 2021 /PRNewswire/ — Amgen Inc. (NASDAQ:AMGN) and Rodeo Therapeutics Corporation (Rodeo) today announced an agreement under which Amgen will acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo’s 15-PGDH program is a strong strategic fit with Amgen’s inflammation portfolio and efforts to develop first-in-class therapeutics for patients.

Under terms of the agreement, Amgen will acquire all outstanding shares of Rodeo in exchange for a $55 million upfront payment as well as future contingent milestone payments potentially worth up to an additional $666 million in cash. The transaction has been approved by the shareholders and the Board of Directors of Rodeo.

Rodeo is focused on developing first-in-class, orally available modulators of prostaglandin biology that play an important role in tissue regeneration and repair. Rodeo’s lead 15-prostaglandin dehydrogenase (15-PGDH) modulators have generated compelling data in extensive preclinical studies and have clinical potential in multiple indications.

“The enzyme 15-PGDH plays a key role in many disease-relevant processes such as stem cell self-renewal and epithelial barrier repair. Given the encouraging preclinical data to date, we are excited about the opportunity to develop a novel therapy with potential in a range of important inflammatory disease indications,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen.

Thong Q. Le, president and chief executive officer of Rodeo commented, “We are thrilled that Amgen recognizes the potential value and differentiated profile of our 15-PGDH inhibitor program. With decades of experience in developing, manufacturing and commercializing innovative therapies for patients suffering from a broad range of immunologic diseases and conditions, Amgen is ideally positioned to rapidly advance our program into the clinic.”

Cooley LLP acted as legal advisor to Rodeo and Gunderson Dettmer LLP acted as legal advisor to Amgen on this transaction.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Rodeo Therapeutics
Rodeo Therapeutics (Rodeo) was founded in July 2017 by Accelerator Life Science Partners (ALSP), a venture capital firm that catalyzes the creation of high-quality, cutting edge life science companies.  Rodeo focuses on developing small-molecule therapies that increase tissue levels of prostaglandin PGE2.  Preclinical studies have shown that increasing PGE2 through modulation of a prostaglandin-degrading enzyme (15-PGDH) protects against colitis and idiopathic pulmonary fibrosis (IPF), accelerates hematopoietic stem cell reconstitution following bone marrow transplant, and promotes liver regeneration in a variety of animal models.  Since its founding, Rodeo has been exclusively managed by ALSP, validating the firm’s ability to identify, nurture, and efficiently manage ground-breaking start-up companies that address unmet medical needs and advance patient care and outcomes.  For more information, please visit: www.rodeotherapeutics.com and www.acceleratorlsp.com.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the integration of Otezla® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Rodeo Therapeutics acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen’s business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen’s results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen’s products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen’s business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen’s business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgenmay fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen’s manufacturing activities, the distribution of Amgen’s products, the commercialization of Amgen’s product candidates, and Amgen’s clinical trial operations, and any such events may have a material adverse effect on Amgen’s product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect Amgen’s business. Amgen’s business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

The scientific information discussed in this news release related to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for Amgen’s products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

CONTACT:

Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)

Rodeo Therapeutics Corporation, Seattle, Washington
Jessica Burback, 206-234-6481, jburback@acceleratorlsp.com  (media and investors)


Proniras Corporation Announces National Institute on Drug Abuse (NIDA) Grant Award to Pursue Treatment for Opioid Withdrawal

SEATTLE, WA — September 17, 2020 —Proniras Corporation, a biotechnology company committed to the development of life saving therapeutic products, today announced that the company and its collaborator, Indiana University (IU) School of Medicine, have received a $12.3 million grant from the National Institute on Drug Abuse (NIDA) to support development of the company’s proprietary molecule, tezampanel, as a treatment for opioid withdrawal syndrome. Tezampanel, a novel antagonist of glutamate receptors, is a small molecule parenteral compound that has been evaluated as a potential therapy for acute migraine in more than 400 human subjects and has demonstrated positive results in a variety of preclinical models of seizure disorder. Proniras licensed exclusive global rights to tezampanel (LY-293,558) from Eli Lilly and Company in 2017.

The grant, titled “AMPA-antagonism: A Novel Pharmacology for Launching Recovery from Opioid Addiction,” will initially support the laboratory characterization of tezampanel in the context of various preclinical models of opioid withdrawal and in combination with opioid and benzodiazepine drugs commonly associated with opioid addictions and lethal overdoses. If the preclinical work supports further advancement of the development program, the grant also provides funding for human clinical trials of tezampanel in individuals with opioid addiction.

“This grant award underscores the urgent unmet need for safe and effective opioid withdrawal therapies, which are critical for addressing the U.S. opioid addiction crisis,” said Christopher Toombs, PhD, DABT co-founder and chief scientific officer of Proniras. “The tezampanel data generated to date suggest that this proprietary glutamate receptor antagonist may have significant clinical utility in treating opioid withdrawal syndrome and other co-morbid psychiatric conditions. We very much look forward to working closely with R. Andrew Chambers, MD, and the rest of the team in the Department of Psychiatry at the IU School of Medicine to bring tezampanel into clinical trials as soon as possible for the benefit of patients fighting opioid addiction.”

The investment syndicate supporting Proniras, an Accelerator Life Science Partners (ALSP) portfolio company, include Alexandria Venture Investments, ARCH Venture Partners, Eli Lilly and Company, Johnson & Johnson Innovation – JJDC, Inc., Watson Fund, L.P., and WRF Capital.

“Alexandria Venture Investments is pleased to support Proniras in its efforts to end the scourge that is opioid addiction,” said Joel S. Marcus, executive chairman and founder of Alexandria Real Estate Equities, Inc. and Alexandria Venture Investments. “Alexandria has exemplified its deep commitment to the treatment of opioid disorders via its investment in the design and development of OneFifteen, a

“The progress that Proniras has made in the three years since its founding is important both for the company and for the field of addiction therapy. Such progress is emblematic of the types of companies that ALSP seeks to support,” said David M. Schubert chief operating officer at Proniras and operating partner of ALSP. “This non-dilutive grant augments the historical support of Proniras’ top tier syndicate state-of-the-art campus located in Dayton, Ohio, which focuses on the treatment and rehabilitation of people addicted to opioids. We are excited about the potential application of tezampanel for the treatment of opioid withdrawal syndrome.”

of venture capital and big pharma investors and provides additional validation of tezampanel’s potential. The U.S. opioid epidemic rages on and is likely worsening as millions of people throughout the country struggle to navigate the unprecedented economic and psychological challenges of the COVID-19 pandemic. New treatment modalities that allow more patients to overcome their opioid addiction are urgently needed to address this clear and present threat to individuals and communities with high rates of opioid abuse.”

About Proniras Corporation

Proniras Corporation is a Seattle-based biotechnology company focused on developing tezampanel as a potential treatment for opioid withdrawal and related disorders of addiction. Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs. By alleviating symptoms associated with opioid withdrawal, Proniras hopes to help patients complete their discontinuation of opioids and facilitate successful treatment. The development of tezampanel for opioid withdrawal is supported by federal funding from the National Institute on Drug Abuse (NIDA), under Grant No. 1UG3DA050923-01. Proniras was founded in 2017 by Accelerator Life Science Partners and Christopher Toombs, PhD, DABT. For more information, please visit www.proniras.com.

About IU School of Medicine

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.


Accelerator Life Science Partners Expands its Team of Advisors

  • Joining the Assembly are Renowned Pharmaceutical R&D Experts, Experienced Company-Builders and First-Rate Drug Developers

SEATTLE, WA – September 9, 2020 — Accelerator Life Science Partners (ALSP), a leading early-stage life science management and venture capital firm, announced today the expansion of its world-class advisory teams with the addition of several renowned leaders in the life science industry. Kevin Chow, Ph.D. and Melissa A. Yeager, J.D., have been named as Operating Partners; Scott Brun, M.D. and David I. Hirsh, Ph.D., have been appointed to the Clinical and Scientific Advisory Board; Jan M. Lundberg, Ph.D. has been appointed to the Clinical and Scientific Advisory Board and will serve as a Senior Advisor; and Eugene (Gene) Yeo, Ph.D., MBA will serve as a Senior Advisor.

Dr. Chow and Ms. Yeager will join a top-tier group of Operating Partners to assist with the evaluation of new business opportunities, support current (and future) ALSP portfolio companies and serve in a variety of operating and advisory roles. Adding their expertise in international regulatory affairs, global operations, business development and corporate strategy will be an invaluable toolset for ALSP’s portfolio of companies.

  • Kevin Chow, Ph.D. – Dr. Chow has over two decades of experience leading business development and corporate strategy in both large and small biopharmaceutical companies. Dr. Chow was Co- founder, President and CEO of Vitaeris (acquired by CSL Behring) and held senior positions in business development at Alder Biopharmaceuticals, Gilead Sciences, Corus Pharma (acquired by Gilead Sciences) and Diversa Corporation.
  • Melissa A. Yeager, J.D. – Ms. Yeager has served in executive management for over 25 years in biopharmaceutical and medical device companies with responsibility for international regulatory affairs and operation activities. Ms. Yeager has held senior positions in global corporations such as Gilead Sciences and Becton Dickinson, and start-up entities including Breath Therapeutics, Corus Pharma (acquired by Gilead Sciences) and PathoGenesis. Ms. Yeager was also co-founder of Cardeas Pharma, a venture capital company.

“After working closely with Melissa and Kevin over many years, I am confident that their wealth of experience and leadership skills will add immediate value to our therapeutic and drug discovery portfolio companies,” said Thong Q. Le, senior managing partner and CEO of Accelerator Life Science Partners. “Their expertise combined with that of the other new ALSP advisors provides us with one of the most knowledgeable teams in the industry, further enhancing our ability to identify and support innovative companies with unique potential to provide unparalleled value for investors and patients.”

The Clinical and Scientific Advisory Board (CSAB) will add three new advisors from leading global pharmaceutical companies and universities, including AbbVie, AstraZeneca, Eli Lilly and Columbia University, bringing with them their expertise in drug discovery, drug development and R&D leadership.

Joining the CSAB are:

  • Scott Brun, M.D. – Dr. Brun served in various scientific & leadership roles for over 20 years at Abbott and AbbVie, which rank among the largest global biopharmaceutical companies. Dr. Brun oversaw a global development organization with responsibilities for AbbVie’s entire portfolio of early and late stage clinical preregistration pipeline compounds as well as marketed compounds within oncology, neurology, immunology, renal, infectious disease, and women’s and men’s health therapeutic areas.
  • David I. Hirsh, Ph.D. – Dr. Hirsh has served in academic, entrepreneurial and executive roles for over 50 years. Dr. Hirsh is a professor in the Department of Biochemistry and Molecular Biophysics in the College of Physicians and Surgeons of Columbia University, where he also served as department chairman and subsequently was appointed Columbia University’s first executive vice president for research.
  • Jan M. Lundberg, Ph.D. – Dr. Lundberg has over two decades as head of research at AstraZeneca and head of research and development at Eli Lilly. He has guided more than 200 candidate drugs to the clinic and 25 products to the market, several becoming blockbuster drugs. Dr. Lundberg was professor of Pharmacology at Karolinska Institute and he was a cofounder of Aerocrine AB. Currently, Dr. Lundberg sits on six boards.

“Our clinical and scientific advisors support the complete spectrum of product development activities, providing critical insights into preclinical research, clinical trial design and strategy and regulatory pathways,” said Kendall Mohler, Ph.D., chief development officer and chairman of the CSAB. “Drs. Brun, Lundberg and Hirsh bring extensive knowledge in identifying and leading cutting-edge research and development programs. We are looking forward to working closely with them on Accelerator programs.”

Gene Yeo, Ph.D., MBA and Dr. Lundberg will join ALSP’s Senior Advisory Board (SAB) to provide high-level advice and strategic guidance regarding its R&D activities and portfolio investments.

  • Eugene (Gene) Yeo, Ph.D., MBA – Dr. Yeo has served in academic and entrepreneurial roles for over 20 years with a focus on neurodegeneration, RNA processing, computational biology and stem cell technologies. Dr. Yeo is currently a Professor of Cellular and Molecular Medicine at the University of California San Diego. He is a co-founder of multiple biotech companies and serves as a scientific advisor on the boards of corporate and non-profit organizations.

“We are honored to have Drs. Yeo and Lundberg join the senior advisory board”, said Mr. Le. “Their insights and expertise will help facilitate our efforts as we work to close our second fund, ALSP II, which will operate out of our Seattle, New York and San Diego bases as well as a new international site”.

 

About Accelerator Life Science Partners
Accelerator Life Science Partners catalyzes the development and commercialization of breakthrough biotechnology innovations. Accelerator is a trusted partner that provides the complete business, scientific and financial toolkit necessary for successfully establishing and operating early-stage biotechnology companies. Accelerator nurtures its companies across all stages and in all facets of development, setting them on a path that offers the greatest chance for long-term success. Among these key resources are committed investment capital, experienced start-up management, unique access to world-class scientific expertise and state-of-the-art laboratories and shared facilities.

The company is uniquely positioned to provide this unprecedented collection of capabilities and resources through its partnership with top-tier investors, seasoned executive managers and world-class research institutions. The value of these collective resources has been validated over more than a decade of successful investing in life science companies that are helping to shape the rapidly evolving future of medicine and healthcare.

For more information, please visit www.acceleratorlsp.com

 

Media Contacts:
Accelerator Life Science Partners
Jessica Burback – jburback@acceleratorlsp.com T: 206-234-6481


Rodeo Therapeutics Nominates First-in-Class Oral Development Candidate for Inflammatory Bowel Disease

Rodeo Therapeutics nominates Candidate RTX-1688, a first-in-class oral small molecule therapy for tissue regeneration and repair, with inflammatory bowel disease as the initial indication and platform potential in other disease settings

SEATTLE, WA – August 31, 2020 – Rodeo Therapeutics Corporation, a company developing small-molecule therapies designed to promote regeneration and repair of multiple tissue types, announced today that it has selected development candidate, RTX-1688, for its inflammatory bowel disease (IBD) program. RTX-1688 is a first-in-class, orally available, small molecule inhibitor of 15- prostaglandin dehydrogenase (15-PGDH) that has proven to be highly efficacious and safe in extensive preclinical studies. With the nomination of RTX-1688 as the development candidate, Rodeo Therapeutics is well-positioned for IND-enabling studies, clinical planning, and partnering activities.

“We are delighted to announce that Rodeo Therapeutics has achieved our preclinical target product profile of a first-in-class oral therapy and nominated RTX-1688 as our development candidate. With a differentiated mechanism of action and favorable drug characteristics, RTX-1688 can potentially offer an attractive treatment option for patients. We look forward to advancing RTX-1688 into the clinic and exploring partnering options.” said Kendall Mohler, Ph.D., chief development officer of Rodeo Therapeutics.

Inflammatory bowel disease is a substantial unmet medical need, with anti-inflammatory and other immune-modulating therapies dominating the current treatment landscape. RTX-1688 has demonstrated marked monotherapy efficacy in injury-induced IBD model and favorable in vitro and in vivo characteristics. With its unique and orthogonal mechanism of barrier repair, we believe RTX- 1688 warrants clinical exploration as a single-agent and in combination with existing anti-inflammatory therapies.

“RTX-1688 represents a new and exciting treatment strategy for IBD. This novel approach has the potential to enhance intestinal mucosal healing and repair which is essential in maintaining remission.” said Tadataka Yamada, MD, board member of Rodeo Therapeutics.

Given the unique mechanism and substantial efficacy observed in numerous preclinical models across different indications, we believe Rodeo Therapeutics compounds can provide benefits in additional disease settings where tissue repair is crucial.

About Rodeo Therapeutics
Rodeo Therapeutics is focused on developing small-molecule therapies that increase tissue levels of prostaglandin PGE2. Preclinical studies have shown that increasing PGE2 through inhibition of a prostaglandin-degrading enzyme (15-PGDH) protects against colitis and idiopathic pulmonary fibrosis (IPF), accelerates hematopoietic stem cell reconstitution following bone marrow transplant, and promotes liver regeneration in a variety of animal models. The company focuses on developing 15-PGDH inhibitors for the treatment of inflammatory bowel disease as its initial development program. Rodeo Therapeutics was formed in 2017 as a portfolio company under Accelerator Life Science Partners. For more information, please visit: www.rodeotherapeutics.com


Lodo Therapeutics Acquires Conifer Point Pharmaceuticals

  • Expands AI/ML Capabilities and Gains Exclusive Rights to Leading Suite of Cheminformatics Technologies
  • Conifer Point’s Technologies Enable Expansion of Lodo’s P4 PlatformTM to Include Therapeutic Target-Based De Novo Drug Discovery
  • Represents Major Advance in Lodo’s Reinvention of Natural Product Drug Discovery
  • Lodo to Present at 2020 Wedbush PacGrow Healthcare Virtual Conference

New York, NY – August 7, 2020 – Lodo Therapeutics Corp. (Lodo), a biotechnology company reinventing natural product drug discovery by applying its informatics-enabled technology platform to previously undruggable disease targets, today announced that it has completed the acquisition of Conifer Point Pharmaceuticals, LLC (Conifer Point). Conifer Point has proprietary tools and deep expertise in computational structural biology and cheminformatics. Lodo will integrate Conifer Point’s technology and know-how to enhance its artificial intelligence/machine learning (AI/ML) capabilities and expand its P4 PlatformTM for the in-silico discovery of novel drug leads from biosynthetic gene clusters (BGCs) in microbial DNA.

Dale Pfost, PhD, Chairman and CEO of Lodo, noted, “This is the first of our targeted strategic acquisitions designed to accelerate Lodo’s goal of reinventing natural product drug discovery. Conifer Point and its predecessor company, BioLeap, have pioneered the application of advanced cheminformatics and structural biology to drug discovery. Its molecular modeling technologies and algorithms have been tested and refined for more than a decade in real-world use with biopharmaceutical partners. Lodo’s initiative to adapt these capabilities to the domain of biosynthetically-produced molecules is a breakthrough that for the first time makes the possibility of de novo natural product drug discovery a reality.”

Dr. Pfost continued, “Our existing P4 Platform allows Lodo to access the vast chemical space of drug-like molecules encoded in microbial DNA starting from known, data-supported drug scaffolds, thereby unlocking a rich new source of lead candidates and analogs. The addition of Conifer Point’s technology allows de novo discovery starting from a disease target of interest, rather than a known drug scaffold. This makes it possible for Lodo to discover, enrich and prioritize large numbers of biologically and pathway-relevant molecules addressing hard-to-drug disease targets in silico, with unprecedented gains in predictive power and significantly enhanced efficiency.”

Conifer Point’s integrated cheminformatic and structural biology modeling platform creates an in-silico map of where, and with what relative affinity, molecules and their fragments bind to target proteins. The technology includes a variety of advanced tools and software for assessing the engagement of natural product molecules and their docking to targets of interest, greatly facilitating the ability of drug researchers to enumerate, select and prioritize potential leads in silico.

The company’s proprietary tools include the Grand Canonical Monte Carlo Fragment Simulator for generating chemical fragment binding maps. It is among the industry’s highest performing protein-fragment simulation software in terms of speed and accuracy and is the only platform with the demonstrated ability to produce hundreds of thousands of accurate binding maps on an industrial scale. Associated software incorporates 3D molecular visualization and extensive capabilities for managing and searching the very large binding data sets produced by the Simulator.

Lodo will house Conifer Point’s technology at its New York City-based facilities. John Kulp Jr., PhD, Chief Technology Officer at Conifer Point and an inventor of its technology, is joining Lodo as Vice President, Cheminformatics. Conifer Point founder and CEO, John Kulp lll, PhD, will serve as a consultant to Lodo.

Dr. John Kulp, lll commented, “The sophisticated drug discovery tools and technologies first developed at BioLeap and advanced by Conifer Point have demonstrated their utility for improving drug discovery efficiency and effectiveness across chemical classes and therapeutic areas. We are delighted to join forces with Lodo, whose commitment to applying informatics, genomics and synthetic biology to reinvent natural product drug discovery is fully aligned with our vision. We see Lodo as well situated to extend the full potential of our unique technology to the domain of natural product therapeutics. I look forward to serving as a consultant to help the Lodo team make optimal use of these powerful tools.”

Dr. John Kulp, Jr. has decades of experience developing and applying AI/ML and other advanced computational technologies to biopharmaceutical uses. At the Sarnoff Corporation (now Stanford Research International), Dr. Kulp established the large-scale biophysical simulation team and served as Vice President. At Sarnoff he helped form Locus Pharmaceuticals before founding BioLeap, a leader in computational fragment-based molecular design. Dr. Kulp served as founding CEO of BioLeap and was directly involved in the coding and application of BioLeap’s Grand Canonical Monte Carlo simulation program with pharmaceutical and biotechnology company partners. Its assets were acquired by Conifer Point in 2015. Dr. Kulp earned BS and MS degrees in Electrical Engineering and Computer Science and a PhD in Electrical Science from the Massachusetts Institute of Technology.

Further financial details were not disclosed.

Separately, Lodo announced that Dale Pfost will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020 at 8:35 am ET. A live webcast of the presentation will be available at http://wsw.com/webcast/wedbush36/lodo/2229562. A replay of the webcast will be available for 90 days following the presentation.

About Lodo Therapeutics
Lodo is reinventing natural product drug discovery with its technology enabled P4 PlatformTM and ClusterTechTM suite of informatics tools. Our DNA-first approach taps the structurally diverse, biologically relevant drug-like molecules encoded in microbial DNA. Lodo integrates breakthroughs in next-generation sequencing, artificial intelligence/machine learning and synthetic biology to identify, characterize and prioritize lead molecules in silico. Lodo uses synthetic biology to boost production and enhance candidate molecules’ pharmacologic properties, including their ability to engage challenging targets. Together, these integrated technologies increase the scalability, efficiency and productivity of the discovery process by orders of magnitude. We view our ability to efficiently access, annotate and prioritize large numbers of natural product drug-like molecules in silico as a historic breakthrough. Following successful initial collaborations with two leading global partners, Lodo is developing a pipeline of oncology drugs and seeking additional partners in a range of indications. Lodo is headquartered in New York City and is supported by top tier investors, including Arch Venture Partners, Alexandria Venture Investments, Pfizer, AbbVie and Lilly. For more information, visit lodotherapeutics.com.

Contact:

Lodo Therapeutics

Barbara Lindheim
Strategic Communications & Investor Relations
blindheim@lodotherapeutics.com
(917) 355-9234


Lodo Therapeutics Names Serial Biotech Entrepreneur Dale Pfost as CEO and Adds Top Industry Veterans to Leadership Team

  • Lodo’s Unique Platform Integrates Next-Generation Sequencing, AI/ML and Synthetic Biology to Reinvent Environmentally-Sourced, Natural Product Drug Discovery
  • This Platform Allows Lodo to Identify and Prioritize Novel Drug Leads Directly from the Millions of Undiscovered Molecules Encoded in Environmental Microbial DNA
  • Validation of Platform in Projects with Global Partners Sets the Stage for Expanded Industry Collaborations and Advancement of Lodo’s Internal Pipeline

New York, NY – December 20, 2019 – Lodo Therapeutics Corp., a biotechnology company applying its proprietary platform to reinvent environmentally-sourced, natural product drug discovery, today announced the appointment of Dale Pfost, PhD, as Chairman and Chief Executive Officer. Dr. Pfost has more than 25 years of experience as a life science entrepreneur, senior executive and venture investor. He has served as CEO of five biotechnology companies, three of which became publicly traded with valuations exceeding two billion dollars. Dr. Pfost has successfully completed dozens of financings, overseen numerous M&A transactions and served as a director at multiple public and private life science firms.

The company also announced the addition of four members to the senior leadership team: Steve Colletti, PhD, Senior Vice President of R&D; Anthony Colasin, Senior Vice President of Business Development; Barbara Lindheim, Consulting Vice President of Strategic Communications and Investor Relations; and Sarajane Mackenzie, Consulting Vice President of Human Resources and Organization Development.

Accelerator Life Science Partners’ chief executive, Thong Q. Le, served as Lodo’s initial CEO and remains a Lodo director. Mr. Le noted, “Lodo is one of the shining stars of our New York City-based portfolio companies. It is leveraging the pioneering metagenomic research of Dr. Sean Brady at Rockefeller University to tackle a big challenge—revolutionizing the field of environmentally-sourced, natural product drug discovery. Lodo has demonstrated that its technology-enabled platform can identify wholly novel molecules directly from environmental DNA with the potential to address currently undruggable targets. Dale brings Lodo a wealth of experience in growing cutting-edge enterprises and is supported by the expert scientific and business talent joining the Lodo team. We are thrilled he is taking the reins at this exciting time in the company’s development.”

Lodo’s technology reinvents and reinvigorates environmentally-sourced, natural product drug discovery. The company’s platform uniquely integrates next-generation sequencing (NGS), artificial intelligence/machine learning (AI/ML), synthetic biology and automation to access undiscovered molecules directly from biosynthetic gene clusters encoded in the microbial DNA present throughout nature. The molecules produced by these microbes exhibit extensive chemical diversity and are biologically relevant. Honed by a billion years of evolution, their functions and activities include signaling, regulating growth, immunomodulation, antiproliferative, and modulating intra and intercellular interactions. The Lodo platform is designed to capture data on these functions at the level of the encoded DNA, thereby obviating the need to first culture the microbe and assay the metabolites. This greatly accelerates the discovery process while significantly decreasing costs.

Pharmaceuticals derived from natural sources, while representing more than half of the most widely used drugs, were developed from the tiny fraction of microbes that can be readily cultured in the laboratory (estimated at less than 1%). By extracting, analyzing and prioritizing microbial DNA directly from the environment, Lodo is able to efficiently access an entire universe of chemically diverse, drug-like compounds created by this microbial treasure trove, and it does so initially using DNA data, prior to working with the compounds themselves.

Lodo is applying its platform to discover novel anti-infective agents for two global partners while building an internal pipeline of oncology drug candidates. The company expects to establish additional partnerships and expand its own programs in other therapeutic areas.

Dr. Pfost commented, “Pharmaceuticals derived from nature have been among the richest sources of important drugs. But productivity declined as the limitations and costs of conventional technology restricted researchers to a small pool of candidates. Lodo’s platform is a game changer. It uniquely integrates advanced technologies including NGS and AI/ML to leapfrog those limitations, providing us a historic opportunity to reinvent environmentally-sourced drug discovery.”

Dr. Pfost continued, “We are the only company that can broadly access microbial DNA encoding such highly diverse collections of drug-like molecules, and we can also analyze, prioritize and enrich these molecules in silico, with orders of magnitude improvements in efficiency and speed. Our scientists combine deep knowledge of molecular and biological targets with computer-aided structure activity relationship data to bridge from the DNA to assessments of the encoded molecule’s ability to bind to its target. This represents a quantum leap in capability compared to the laborious and costly laboratory methods required for conventional natural product drug research. I welcome the opportunity to work with our exceptional team, top-tier partners and investors to further advance our platform and address major unmet medical needs.”

Lodo director Steven Gillis, PhD, is a Managing Director of Arch Venture Partners and a renowned biotechnology inventor, entrepreneur and investor. Dr. Gillis said, “Dale Pfost and the newly appointed senior team are an excellent choice to lead Lodo, which has developed a unique platform incorporating advances in both life sciences tools and computational technologies. It enables researchers for the first time to rapidly and efficiently access the 99% of undiscovered microbial DNA-encoded molecules that may have potential as novel drugs. This promising approach could help reinvigorate the lagging productivity of conventional drug discovery and produce innovative medicines for several diseases that remain poorly treated.”

Dr. Pfost previously was General Partner at venture capital firm Advent Life Sciences and acting CEO of MicroBiome Therapeutics, which he co-founded. Dr. Pfost was founding CEO of Acuity Pharmaceuticals, which merged to form OPKO Health. He was the founding CEO of Oxford GlycoSciences and genomics pioneer Orchid BioSciences. Dr. Pfost was CEO at anti-cancer company Receptor BioLogix, where he led its successful acquisition by Symphogen. His first company, which he started in graduate school, was acquired by SmithKline Beckman and produced the Biomek, still a leading laboratory automation system today. Dr. Pfost is the co-author of 10 scientific papers and an inventor on 10 patents. He earned a BS degree from the University of California Santa Barbara and a PhD in physics from Brown University.

Dr. Colletti brings 24 years of experience at Merck Research Laboratories in small molecule, natural products, RNA therapeutic and fusion protein drugs. Starting as a medicinal chemist, Dr. Colletti assumed positions of increasing responsibility at Merck. Most recently, he was Executive Director and Head of Therapeutic Modalities, responsible for overseeing 200 scientists. Dr. Colletti was a core member of development teams that discovered and advanced more than a dozen preclinical candidates across multiple therapeutic areas. He is an inventor, author and co-author of over 125 publications and patents. Dr. Colletti completed a BS degree at Loyola University Chicago, received a PhD in chemistry from Boston University, and was an NIH Postdoctoral Research Fellow in chemistry at the Scripps Research Institute.

Anthony Colasin has over 20 years of leadership experience in strategy and corporate and business development at large and emerging biotechnology firms. He has an extensive track record in creating and implementing business and partnering strategies, with deal transactions valued at more than $3 billion. Mr. Colasin most recently co-founded microbiome-based drug developer Bloom Science. Previously, he was the Chief Business Officer for neurological drug developer Bionomics and Vice President of Business Development for Ironwood Pharmaceuticals. Mr. Colasin began his career at Amgen and ICOS. He has an MBA from the Anderson School at the University of California, Los Angeles and a BS degree in economics magna cum laude from the University of Southern California, and also served in the U.S. Marine Corps.

Barbara Lindheim provides strategic communications services to the biotechnology and life sciences industries. Her more than 25 years of experience spans public relations, strategic positioning, corporate and product communications, investor relations, crisis communications and social media. She is a Principal at BLL Partners, LLC, and previously held senior communications, marketing and strategy roles at Orchid BioSciences, Edelman Public Relations, BioCom Partners, Noonan/Russo Communications, Glaxo SmithKline, Pfizer and Sanofi. An honors graduate of Cornell University, Ms. Lindheim earned an MBA with Distinction from Harvard Business School and a master’s degree in public policy from Princeton University. She lectures on biomedical industry strategy at leading business schools.

Sarajane Mackenzie has over 25 years’ global and cross-cultural experience in executive human resource positions in the biotech, pharmaceutical, consumer healthcare and information technology industries. She headed the human resource function at Novo Nordisk, Orchid Biosciences, Johnson & Johnson and Tata Consultancy Services. Ms. Mackenzie has helped transform businesses and manage rapid expansions. She is also President of The Mackenzie Consulting Group, LLC, which provides interim HR executives and does HR executive search at small and emerging life science companies She holds an undergraduate degree inpsychology from the University of California at Santa Cruz and a master’s degree in organization development from the University of San Francisco.

About Lodo Therapeutics
Lodo discovers and develops novel therapeutics addressing undruggable targets by applying its proprietary platform to tap the vast collections of undiscovered molecules encoded in environmental microbial DNA. These evolutionarily optimized leads include structurally diverse molecules with drug-like properties that have been largely inaccessible until now. The Lodo platform leverages breakthroughs in next-generation sequencing, artificial intelligence/machine learning and synthetic biology to increase speed and efficiency by orders of magnitude. Following successful initial collaborations with two global partners, Lodo is developing an internal pipeline of oncology drugs and expanding its partnering activities in a range of indications. Lodo is an Accelerator Life Science Partners-backed entity headquartered in New York City. For more information, visit lodotherapeutics.com.

Contact:
Lodo Therapeutics
Barbara Lindheim
Strategic Communications & Investor Relations
blindheim@lodotherapeutics.com
(917) 355-9234