Pyxis Oncology Presents Preclinical Data and Details on Antibody-Drug Conjugate Candidates Supporting Therapeutic Potential

— Pyxis Oncology to host webcast with Key Opinion Leaders (KOLs) on April 27, 2021 at 1:00pm ET —

CAMBRIDGE, Mass., April 27, 2021 Pyxis Oncology (“Pyxis” or the “Company”) today announced the targets of its three antibody-drug conjugate (ADC) candidates along with additional details and preclinical data supporting the potential of its ADC platform. The Company will host a webcast with KOLs to further discuss the potential of Pyxis’ ADCs to improve the lives of patients with difficult-to-treat cancers.

“ADCs represent a promising therapeutic modality, but historically their advancement has been limited due to on and off-target toxicities,” said Ronald Herbst, Ph.D., Chief Scientific Officer of Pyxis. “Our ADC assets have been specifically designed and developed using site-specific conjugation chemistry to combine new and established targets, linkers and payloads. All three candidates are potent with highly stable linker-payload conjugation – characteristics that have led to superior therapeutic indexes. We believe our ADCs may apply to a broad patient population as single agents and in combination with immunotherapies to further improve the outcome for patients with difficult-to-treat cancers.”

ADC candidate highlights:

  • PYX-201 is a first-in-class non-internalizing ADC that targets extra domain-B (EDB) of fibronectin. EDB is an oncofetal splice variant of fibronectin, a key component of the tumor extracellular matrix that is highly expressed across several solid tumors, including non-small cell lung cancer, ovarian, breast and pancreatic cancers. PYX-201 is designed to release an auristatin payload with bystander activity into the extracellular space to induce immunogenic cell death to kill tumor cells and their supporting infrastructure.
  • PYX-202 is a first-in-class internalizing ADC targeting delta-like 1 homolog (DLK-1), a tumor antigen that is restricted in normal tissues but expressed in a range of solid tumors, including small cell lung cancer, soft tissue sarcoma, hepatocellular carcinoma and neuroblastoma. PYX-202 utilizes a well-understood toxic agent, monomethyl auristatin payload (MMAE) and a beta-glucuronide cleavable linker designed to increase stability in circulation and reduce off-target toxicities.
  • PYX-203 is a best-in-class internalizing ADC targeting CD123, a clinically validated target primarily expressed in several high need hematologic malignancies, including acute myeloid leukemia (AML), myelodysplastic syndromes and others. PYX-203 utilizes a lysosomal cleavable linker and a highly potent cyclopropylpyrroloindole (CPI) DNA-damaging payload that may reduce the drug concentration needed to achieve positive treatment outcomes while limiting unwanted side effects. A larger patient population may benefit from PYX-203, including patients who otherwise would not respond to the standard of care.

Lara Sullivan, M.D., Chief Executive Officer of Pyxis, added, “We believe that our ADCs have the potential to overcome the challenges of difficult-to-treat cancers and help patients in need who currently do not respond to standard of care. Our expert team has incorporated a comprehensive understanding of ADC chemistry and cancer biology to identify the most promising therapeutic candidates that we expect will demonstrate improved activity, potency and stability. We look forward to progressing our ADC candidates to IND submissions next year.”

Pyxis Oncology Webcast:
Title: Next-Generation ADCs: A Conversation With Key Opinion Leaders
Date: April 27, 2021
Time: 1:00 – 2:00 pm ET
Presenters:

  • Jeremy Barton, M.D., strategic oncology drug development consultant
  • Rakesh Dixit, Ph.D., DABT, President and Chief Executive Officer of Bionavigen

To register, click here. A replay of the event will be available here.

About PYX-201
PYX-201 is a first-in-class non-internalizing ADC that uniquely targets the oncofetal EDB isoform of fibronectin, a key component of the tumor extracellular matrix. As a non-internalizing ADC, PYX-201 binds to EDB and releases auristatin, a potent toxin, into the extracellular space after its linker is cleaved by cathepsin B to effectively kill tumor and tumor-associated cells. Through its unique mechanism of action, PYX-201 has significant potential as a single agent and in combination with immuno-oncology agents.

About PYX-202
PYX-202 is a first-in-class ADC targeting DLK-1, a tumor antigen that is restricted in normal tissues but expressed in a range of solid tumors. PYX-202 is designed to reduce toxicity by using a highly selective linker and a well-understood toxic agent, MMAE. PYX-202 uses a potent monoclonal antibody that has high affinity for DLK-1 and that drives efficient internalization of the ADC into tumor cells. PYX-202 utilizes a cleavable beta-glucuronide linker designed to increase stability in circulation. The linker is cleaved by an enzyme that is often overexpressed in a range of solid tumors, allowing for an added level of specificity that may further limit potential off-target activity. PYX-202 has significant potential as a monotherapy in tumors expressing high levels of DLK-1 and as a combination therapy with immunotherapies.

About PYX-203
PYX-203 is an ADC targeting CD123, an antigen primarily expressed in several high need hematologic malignancies and a clinically validated target being studied across multiple therapeutic modalities. Previous studies have found that CD123 is expressed on leukemic blasts as well as on AML stem cells, a critical population of cancer cells linked to disease relapse. Clinical evidence has found that CD123 expression is associated with poor outcomes, further supporting its potential role in disease progression. PYX-203’s DNA-damaging toxin, CPI, is a key component of the ADC, since its potency and specificity may lead to greater efficacy while limiting unwanted side effects even in patients who do not respond to standard of care.

About Pyxis Oncology
Founded by Longwood Fund, Pyxis Oncology is building a differentiated portfolio of biologics, including antibody-drug conjugates (ADCs) and immunotherapies, to improve the lives of patients with difficult-to-treat cancers. Pyxis is employing site-specific conjugation technology to develop highly stable ADCs with superior therapeutic indexes. Pyxis is also advancing a diverse portfolio of immunotherapies that target broad immune regulators as well as novel immune checkpoints identified through its immuno-oncology and cold tumor platforms. For additional information, visit www.pyxisoncology.com.

Contacts
Investor Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com

Media Contact
Jason Braco, Ph.D.
LifeSci Communications
jbraco@lifescicomms.com

Pamela Connealy, M.B.A.

Chief Financial Officer

Pamela Yanchik Connealy, M.B.A. joined Pyxis in July 2021 as the Chief Financial Officer with responsibility for finance, legal and human resources. Pam has over 25 years of finance and business operations experience and prior to joining Pyxis Pam was the CFO, Chief HR Officer of Immunovant with additional responsibilities for legal, IT and facilities. Ms. Connealy also served as the Chief Financial Officer and Chief Operating Officer of Kiva, a San Francisco based nonprofit organization. From April 2014 to June 2018, Ms. Connealy served as Global Head of Talent at the Bill & Melinda Gates Foundation, focusing on talent management, compensation, benefits, and global mobility. From March 2012 to November 2013, she served as Vice President of Business Operations at Salesforce, and from March 2002 to April 2010, Ms. Connealy served as a Vice President and Corporate Officer at Genentech, with roles including Chief Financial Officer of Research & Development and Global Head of Procurement.

Ms. Connealy earned a B.S. in Chemistry from Gannon University and an M.B.A. in Finance from the University of St. Thomas in Houston, Texas.

Mark Chin

Director

Mark is an experienced venture capital investor, with significant experience as a board director of both private and public biotech companies in the US and Europe. He is currently a managing director at Arix Bioscience and a board director of Harpoon Therapeutics (Nasdaq: HARP), Imara (Nasdaq: IMRA), Iterum Therapeutics (Nasdaq: ITRM), and a number of privately held biotechnology companies.

Prior to Arix, Mark was a principal at Longitude Capital, where he focused on investments in biotechnology and medical technology companies. Prior to Longitude, he was a consultant at the Boston Consulting Group, where he was responsible for strategy and corporate development projects for pharmaceutical and biotechnology companies. Before BCG, he worked in corporate development at Gilead Sciences and market planning at Genentech. He has an MBA from The Wharton School at the University of Pennsylvania, an MS in Biotechnology from the University of Pennsylvania, and a BS in Management Science from the University of California at San Diego.

Christopher O’Donnell, Ph.D.

Director

Christopher O’Donnell, Ph.D. is a Partner at Pfizer Ventures and Executive Director, Pfizer Worldwide Research, Development & Medical. Chris has over 20 years of scientific leadership at Pfizer and a strong track record of delivering clinical candidates across multiple disease areas and modalities. Prior to Pfizer Ventures, Chris built and led the Applied Synthesis Technologies group within Pfizer Worldwide Research & Development organization to accelerate the delivery of Pfizer’s small molecule portfolio. Prior to that, Chris built and led Pfizer’s Antibody Drug Conjugate Oncology Medicinal Chemistry group which delivered new linker, payload and conjugation methods resulting in 7 conjugates entering clinical development for many different cancer indications and this technology is at the foundation of PYX-201 and PYX-203. Chris started his career in the Neuroscience Medicinal Chemistry group where he invented and helped deliver numerous clinical candidates, with the most advanced being the AMPA positive allosteric modulator in Phase II that was licensed to Biogen. Chris has co-authored 60 peer reviewed manuscripts and is the inventor/co-inventor on 25 patents.

Chris earned his BS in Chemistry from the University of Illinois-Urbana/Champaign and his Ph.D. in Chemistry from the University of Wisconsin-Madison and joined Pfizer after his post-doctoral research studies as an American Cancer Society Fellow at the University of California – Irvine.

Within Pfizer Ventures Chris is responsible for identifying, evaluating, making and managing equity investments aligned with the future directions of Pfizer. He currently serves on the boards of Adapsyn Biosciences, ARKUDA Therapeutics, Pyxis Oncology, Storm Therapeutics (UK) and Strata Oncology. Chris previously served on the boards of Kymera Therapeutics (KYMR) and was a board observer of BioAtla Inc. (BCAB), Mitokinin, Morphic Therapeutic (MORF) and Petra Therapeutics.

Gotham Makker, M.D.

Director

Gotham Makker, M.D., serves as head of Strategic Investments at RTW Investments, LP (“RTW”). Gotham has more than 17 years of healthcare industry experience. Prior to joining RTW, Gotham served as CEO of Simran Investment Group, LLC, a privately held equity investment fund. Before Simran, Gotham was a healthcare portfolio manager and principal at Citadel Investment Group LLC, a position he held from 2002 to 2005. Prior to joining Citadel, Gotham served in various analyst roles at Oracle Partners LP, covering biotechnology and medical device sectors. He began his career on the life sciences investment banking team at Hambrecht & Quist.

Gotham serves on the board of directors of Rocket Pharmaceuticals.

Gotham received his MD from the University of Nebraska Medical School, and he completed the Sarnoff cardiovascular research fellowship at Columbia University, College of Physicians & Surgeons and at Harvard Medical School, Brigham & Women’s Hospital.

Christian Schetter, Ph.D.

Director

Christian has over 20 years’ experience in the life science industry. He is Executive Chairman of STipe Therapeutics, Chairman of Twelve Bio and a Non-Executive Director of Atox Bio, all Arix portfolio companies. Prior to joining Arix he was for four years CEO of Rigontec GmbH, a German Biotech start-up company in the immune oncology space. Christian lead Rigontec to a successful acquisition mid 2017 by MSD valuing EUR 115 MM in upfront payment and additional EUR 349 million in potential milestones. Between 2008 and 2014 Christian was President and CEO of Neovii Biotech, previously Fresenius Biotech. During his tenure one antibody product was brought to market and the indication for another product expanded. Christian was instrumental in selling Fresenius Biotech to the Neopharm Group, Israel, to form Neovii Biotech and positioning it as a successful standalone business. Before joining Fresenius, Christian was Senior Vice President, European Operations of Coley Pharmaceutical Group, Inc, a pioneer in the development of immunostimulatory oligonucleotides, and served as Managing Director of Coley GmbH. He was part of the leadership team which built Coley Pharmaceuticals from inception through multiple financing rounds, a NASDAQ IPO and, following a number of significant pharma deals, to a trade sale to Pfizer in 2007.

Before entering the life science industry Christian was successfully performing academic research at the Max Planck Institute in Martinsried, Germany. He received his undergraduate degree and PhD from the University of Cologne and did postdoctoral research in oncology and virology at the Scripps Research Institute in La Jolla, California.

John Flavin

Co-founder, Founding Chairman and Independent Director

John is co-founder and an independent Director of Pyxis Oncology, where he was founding Chairman. He is also the Founder and CEO of Portal Innovations, a life sciences venture development engine.  A seasoned life sciences executive and entrepreneur with over 20 years of experience in finance, operations, and innovation, John has co-founded and scaled several life sciences companies as President and CFO such as Advanced Life Sciences and MediChem Life Sciences. Mr. Flavin has also co-founded and led transformative life sciences incubators including MATTER and the Polsky Center for Entrepreneurship and Innovation at the University of Chicago. He has completed numerous public and private capital financings totaling over $300 million including 2 NASDAQ IPOs and has raised over $135 million in philanthropic and corporate funding to support university technology commercialization and venture start-up activities.  He received his B.S. in Business Administration from Marquette University and his M.B.A. in Finance from Lewis University. 

Lucio Iannone, Ph.D.

Director

Lucio Iannone is an investor at Leaps by Bayer, the investment arm of the global life sciences company Bayer. Lucio is responsible for developing investment cases and deal execution. He is also involved in the sourcing, screening, and mentoring of companies with game-changing science. As an investor, Lucio is also serving as board member for Khloris Biosciences, Vesigen Therapeutics , Immunitas Therapeutics, eGenesis, Azitra, Kojin Therapeutics and Axxam. Before joining Leaps by Bayer, he had several senior roles in biotechnology companies and venture capital firms. He has experience with molecular biology, cell & gene therapy technologies and their application in oncology and other therapeutic fields. Lucio obtained his Ph.D. in Medicine at the Imperial College of London.

David Steinberg

Founding CEO and Chairman

David is co-founder and Chairman of Pyxis Oncology, where he was founding CEO, and serves as a General Partner at Longwood Fund. Previously, David was co-founder and Chief Innovation Officer at PureTech Health, (LSE: PRTC), where he focused on biotech venture creation and investing. David has co-founded and served as CEO and founder of several biotech companies, including Vor Biopharma (NASDAQ:VOR) Be Biopharma, Vedanta Biosciences, Endra Life Sciences Inc. (NASDAQ: NDRA), and Entrega Biosciences, and co-founded ResTORbio (NASDAQ: TORC). Prior to that David worked in biopharma strategy consulting at Boston Consulting Group and Vertex Partners, and in R&D at P&G Pharmaceuticals. He received his M.B.A. from the University of Chicago Booth School of Business and holds a B.A. in biology from Cornell University.

Ritu Shah, PMP

Chief Operating Officer

Ritu is the Chief Operating Officer at Pyxis Oncology. Ritu has over 20 years of experience in the pharmaceutical and biotech industry specializing in portfolio management and strategic planning. Prior to joining Pyxis, Ritu served as the Vice President of Business Operations and Program Management of Levo Therapeutics where she led the operations for the Phase 3 trial of Prader-Willi syndrome, a rare disease. Prior to Levo, Ritu was the Chief of Staff to the CEO and Vice President of Program Management for AveXis, a biotech gene therapy company focusing on SMA, and led the integration following the $8.7B acquisition by Novartis. Prior to AveXis, Ritu spent 8 years at Baxter, Baxalta, and Shire in various executive roles leading patient advocacy, commercial, research and development, supply chain, and global operations. Ritu started her career at Accenture where she spent over a decade in management consulting focusing on R&D and supply chain projects across manufacturers, wholesalers, and retailers.

Ritu earned her B.Sc. from University of Notre Dame in the Department of Chemical Engineering and graduated summa cum laude. Ritu is certified as a Project Management Professional, PMP. Ritu is also involved in her community and serves as a Board member of an entrepreneurial incubator program.

Steve Monks

Chief Technical Officer

Steve is the Chief Technical Officer at Pyxis Oncology. Prior to joining Pyxis, Steve was an independent consultant advising small to medium biotech companies in the oncology, vaccine, and tissue repair spaces on CMC (chemistry, manufacturing, and controls), Quality, and Regulatory strategies. Prior to this, Steve served as Senior Vice President of Development at Aura Biosciences where he spearheaded all product technical development efforts for their Virus-Like drug conjugate AU-011. Prior to Aura, Steve was a member of the executive leadership team at Agenus, where he was responsible for internal and external cGMP manufacturing, warehousing and distribution, and the analytical and process development functions across the entire Agenus pipeline.

Steve received his Ph.D. from The University of Melbourne and a BSc with first-class honors in Zoology from the University of Queensland, Australia.

James Mutamba, Ph.D.

Vice President of Business and Corporate Development

Dr. James Mutamba is the Vice President of Business and Corporate Development at Pyxis Oncology. Prior to joining Pyxis, Dr. Mutamba was a Principal at Longwood Fund, where he was responsible for building and supporting portfolio companies, including Pyxis Oncology. Prior to Longwood he was a Senior Associate at PureTech Health where he co-founded Commense, Inc., a microbiome-based maternal and childhood health company. Dr. Mutamba was also a co-founder and inventor in Glyph Biosciences, an immune-focused company targeting novel lymphatic system biology, and Calix Biopharma, a company developing engineered exosomes for novel drug delivery applications. Prior to joining PureTech, Dr. Mutamba was a strategy consultant at ClearView Healthcare Partners and played multiple roles in research and product development at Pathogenica, Inc., a biotech startup out of Harvard University. 

Dr. Mutamba earned his Ph.D. from MIT in the Department of Biological Engineering and completed coursework at the MIT Sloan School of Management. He received his BS in Biochemistry from UNCG where he graduated summa cum laude and Phi Beta Kappa. 

Ronald Herbst, Ph.D.

Chief Scientific Officer

Dr. Ronald Herbst is the Chief Scientific Officer of Pyxis Oncology. Prior to joining Pyxis, Dr. Herbst was Vice President, Research & Development and Head of Oncology Research at MedImmune, the global biologics research and development arm of AstraZeneca, where he served as Chair of the Oncology Research Committee and as member of the MedImmune Research Leadership Team. Under his leadership, the oncology group brought 10 novel targets to the clinic in the areas of immunotherapy and antibody drug conjugates. Prior to that, Ronald focused on the company’s respiratory, inflammation and autoimmunity efforts, where he led the advancement of 4 novel molecules into the clinic, including one that is now approved by the US Food and Drug Administration. 

Before joining MedImmune, Ronald was Senior Principal Investigator in oncology at DNAX, a Schering Plough biotechnology subsidiary. 

Ronald conducted his postdoctoral research in the Department of Biology at Stanford University.  He obtained his Ph.D. at the Ludwig-Maximilian University of Munich, with research conducted at the Max-Planck Institute of Biochemistry in Axel Ullrich’s Laboratory. Ronald has (co)-authored more than 100 publications and is co-inventor on 17 pending or granted patents. 

Robert Crane

Chief Financial Officer

Robert Crane is the Chief Financial Officer of Pyxis Oncology. Mr. Crane has 30 years of experience in the life sciences industry, including therapeutics, medical devices, and diagnostics. Mr. Crane has been involved with public and private firms in the U.S., Europe, and Asia, serving as chief financial officer at six U.S. public companies. He has listed companies on NASDAQ as well as the Australian Stock Exchange.

Mr. Crane has served as Chief Financial Officer plus stepping in to run manufacturing, quality, and business development when required. Mr. Crane has been responsible for several IPOs and numerous public and private financings with proceeds of over $1 billion plus partnerships and collaborations. He has also been responsible for the sale of multiple companies. Mr. Crane’s involvement includes growth-stage companies and turnarounds. Companies where Mr. Crane has been CFO include Sirtris Pharmaceuticals, Inc., which was acquired by GlaxoSmithKline Plc; I-STAT Corporation, Inc., which was acquired by Abbott Laboratories; Taris Biomedical, which was acquired by Allergan and Johnson & Johnson; InKine Pharmaceutical Company, Inc., which was acquired by Salix, Inc.; Olivo Laboratories which was acquired by Shiseido; Seragen, Inc., which was acquired by Ligand Pharmaceuticals, Inc.

Mr. Crane was previously a partner in the venture capital firm, Montgomery Ventures which invested in emerging healthcare and technology companies. He was also chairman of the American Bicycle Group, a premier manufacturer of high-end bicycles with brands including Litespeed, Merlin, and Quintana Roo.

Mr. Crane holds a Bachelor of Science in mechanical engineering from the Massachusetts Institute of Technology and a Masters of Business Administration from Stanford University.

Lara S. Sullivan, M.D.

Chief Executive Officer

Dr. Lara S. Sullivan is the Chief Executive Officer of Pyxis Oncology. Prior to joining Pyxis, Lara was Founder and President of SpringWorks Therapeutics (NASDAQ: SWTX), a clinical stage biopharmaceutical company spun-out from Pfizer. While at Pfizer, Lara led strategy, competitive intelligence and portfolio operations for the company’s early-stage R&D pipeline. Prior to joining Pfizer, Lara was an associate partner at McKinsey & Company, where she specialized in biopharmaceutical R&D productivity and efficiency. Lara also served as a principal at Paul Capital Partners, where she led due diligence for healthcare investments, and earlier in her career worked in healthcare equity research and healthcare municipal finance at Credit Suisse First Boston.

Lara holds an M.D. from the University of Pennsylvania School of Medicine, an M.B.A. from The Wharton School at the University of Pennsylvania, and a B.A. in Comparative Literature from Cornell University.