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Phase III trial patient enrollment for balixafortide completed in Q4 2020 despite COVID-19. Results expected for ORR and PFS in Q2 and Q4 2021 respectively
Exclusive licensing agreement for balixafortide in China with Fosun Pharma
Clinical Trial Authorization (CTA) granted by MHRA to initiate Phase I trial for inhaled murepavadin. Patient enrollment expected in Q3 2021
Grants for the antibiotics pipeline from CARB-X and CF Foundation enabling pipeline progression with non-dilutive financing
Research efforts for new CXCR4 lead candidate in hematologic malignancies and balixafortide in SARS-CoV-2 provide incremental pipeline expansion opportunity
Cash on hand of CHF 34.3 million as of December 31, 2020 is expected to finance operations into Q3 2021
ALLSCHWIL, Switzerland, March 05, 2021 (GLOBE NEWSWIRE) -- Polyphor AG (SIX: POLN) a research driven clinical stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance today announced its financial results for the full-year of 2020 and provided a business update.
“Polyphor achieved significant progress in 2020 despite the unprecedented challenges of the COVID-19 pandemic. We have successfully completed the enrollment in our Phase III balixafortide (FORTRESS) trial in 2020 and the expected data readout in 2021 will be an important milestone and key priority for our company,” says Gökhan Batur, CEO of Polyphor: “Beyond our Phase III program with balixafortide in advanced cancer, we are rapidly progressing our R&D efforts in oncology and antibiotics. These additional efforts in progressing our mid-term pipeline can bring substantial benefit to patients and high value to our company and our shareholders.”
Balixafortide – FORTRESS Phase III trial enrollment closed with results expected for ORR and PFS in Q2 and Q4 2021 respectively
Polyphor's FORTRESS study, a pivotal Phase III study evaluating balixafortide (POL6326) in combination with eribulin for the treatment of patients with HER2 negative, locally recurrent or metastatic breast cancer, had randomized 432 patients in November 2020, when enrollment was closed. The independent Data Safety Monitoring Board (DSMB) has completed the first, second and third pre-specified interim analyses of safety outcomes for the 193, 284 and 401 randomized patients respectively, and recommended that the study should continue without any modifications.
Data on the key primary endpoint, progression free survival (PFS), are expected in Q4 2021 to serve as basis for a regular submission of a New Drug Application (NDA) and Marketing Authorization Application in the U.S., where fast track review has been granted, and for a Marketing Authorization Application in the European Union (EU). Data on the first coprimary endpoint, objective response rate (ORR), is expected in Q2 2021, and could potentially lead to an accelerated approval in the U.S. Completion of the dossier for the NDA filing is on track to support potential breakthrough designation.
In August 2020, Polyphor entered into an exclusive licensing agreement for balixafortide in China with Fosun Pharma, one of the leading Chinese healthcare companies with a global footprint. This agreement represents an important milestone for the development and commercialization of balixafortide in one of the largest markets in oncology. Under the terms of the agreement, Polyphor received a USD 15 million upfront payment, and is eligible for additional development milestone payments of up to USD 19 million, sales milestones of up to USD 148 million and royalties on net sales in the territory, which start in the low double digits and increase to the mid-teens based on net sales achieved.
Polyphor is steadily conducting preclinical experiments for balixafortide in different combinations and tumors and plans to initiate a Phase Ib/II trial in earlier lines of metastatic breast cancer in combination with nab-paclitaxel. The start of the study is planned in Q3 2021, dependent on the COVID-19 situation. Beyond balixafortide, the company has identified another CXCR4 lead candidate to be explored in liquid cancers based on promising data in preclinical models. This lead candidate is a potent, specific, and highly selective antagonist of the chemokine receptor CXCR4.
Balixafortide - novel non-oncology indication
In a research collaboration with the University of Basel, Department of Biomedicine, balixafortide has demonstrated in a pre-clinical experiment using a CPE (cytopathic effect) assay a strong and robust activity against SARS-CoV-2 (COVID-19) infection at clinically relevant concentrations with no adverse cytotoxic effects. Based on this strong anti-viral effect in addition to the potential anticipated beneficial effects on disease progression of CXCR4 inhibitors (mitigation of cytokine storm, effects on vascular pathology, acute respiratory distress, and prevention of lung fibrosis), Polyphor plans to further investigate the profile of balixafortide against COVID-19 in non-clinical pharmacology studies. Given the non-clinical safety and toxicology program of balixafortide has been largely completed, Polyphor is currently evaluating the feasibility of a Phase II clinical proof of concept study in patients with confirmed COVID-19 infections.
Inhaled murepavadin – moved to Phase I clinical development
In December 2020, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted a Clinical Trial Authorization (CTA) to start the first-in-human Phase I study of Polyphor’s novel class antibiotic murepavadin, delivered via the oral inhalation route. The start of patient enrollment in the Phase I study, evaluating safety, tolerability, and pharmacokinetic profile by using eFlow® Technology nebulizer (PARI Pharma GmbH) to administer murepavadin Inhalation Solution (MIS) in healthy volunteers, is expected in Q3 2021, to further optimize primary packaging providing better stability for later stages of development.
The Phase I study is part of the clinical development plan exploring the inhaled formulation of murepavadin to treat Pseudomonas aeruginosa infections in people with cystic fibrosis (CF), including resistant bacterial strains and is largely funded by the European Innovative Medicines Initiative (IMI). A Phase Ib/IIa trial in adults with CF, assessing safety and tolerability of ascending doses of inhaled murepavadin, is planned following completion of the Phase I study. In November 2020, Polyphor received an award of up to USD 3.3 million from the Cystic Fibrosis Foundation to help fund the planned Phase Ib/IIa study.
CARB-X awards fuel early antibiotics pipeline
Polyphor is pioneering a new class of antibiotics, OMPTAs (Outer Membrane Protein Targeting Antibiotic), that has the potential to offer new treatment options for patients with difficult-to-treat infections caused by Gram-negative pathogens, including resistant strains. The company’s two early-stage antibiotics programs, OMPTA-BamA and Thanatin Derivatives, focus exclusively on WHO Priority 1 pathogens and are planned to enter into clinical development over the next few years.
In October 2020, Polyphor received an award from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership led by Boston University, to support the development of its thanatin-derivative antibiotics program. CARB-X will provide Polyphor with initial funding of up to USD 2.62 million to complete the hit-to-lead stage and up to USD 15.82 million if certain project milestones are met.
In December 2020, Polyphor extended an earlier funding agreement from 2019 with CARB-X to support the development of the company’s novel OMPTA-BamA program. CARB-X has committed to Polyphor additional funding of up to USD 2.3 million, bringing potential funding for this contractual stage to USD 5.1 million. The company may also receive up to USD 13 million in future option stages that could take the program through a first-in-human study if certain project milestones are met.
New member of the Board proposed
On its next Annual General Meeting, Polyphor will propose Hugh O’Dowd for election to the board of directors. Hugh O’Dowd currently serves as independent Non-executive Chairman on the Board of ONK Therapeutics, an innovative natural killer (NK) cell therapy company and as Non-executive Director on the Board of Puma Biotechnology, Inc (NASDAQ: PBYI), an oncology company. Until its acquisition by BioNTech SE in May 2020, he served for four years as President, Chief Executive Officer, and a member of the Board of Directors of Neon Therapeutics, Inc., a clinical-stage immuno-oncology company that developed neoantigen-based therapeutics.
Prior to Neon Therapeutics, Hugh O’Dowd spent more than 20 years in a variety of senior leadership roles at Novartis Pharmaceuticals Corporation including his role as Chief Commercial Officer of Novartis Oncology from 2011 to 2015. During this time, he was responsible for the oncology portfolio strategy for the world’s then second-largest oncology/hematology organization, including global brand leadership, business development/licensing, and commercialization.
Polyphor started 2020 with a solid financial position, a renewed strategy and organizational restructuring. This has allowed the company to allocate the majority of the cash position to the balixafortide program, while cystic fibrosis and antibiotics drug candidates have been largely externally funded.
In the full year of 2020, the total loss was CHF 44.9 million. R&D costs were primarily driven by the balixafortide trial and amounted to CHF 52.3 million, resulting in a 14% decrease compared to the CHF 60.7 million spent in 2019. The R&D expenditures are expected to decrease in 2021 following the closure of patient enrollment in late 2020. The company has received a USD 15 million upfront payment as part of the partnering agreement with Fosun Pharma. This brings the total cash position to CHF 34.3 million (cash and cash equivalents) as of December 31, 2020, which is expected to finance the operations into Q3 2021.
On June 4, 2020, Polyphor’s shareholders approved all proposals of the Board of Directors at the 23rd Annual General Meeting with a significant majority. This includes approval of the renewal of authorized share capital and the creation of conditional share capital for bonds and similar debt instruments. Based on these resolutions, Polyphor has entered into an equity-linked financing arrangement with the French company IRIS to raise a gross amount of up to CHF 19.3 million until June 2022. The equity-linked financing arrangement with IRIS allows for additional flexibility to further extend the cash outlook if needed.
Full-year 2020 results conference call at 14.00 CET on March 05, 2021
Gökhan Batur (CEO), Hernan Levett (CFO), Frank Weber (CMDO), Daniel Obrecht (CSO) and Johann Zimmermann (Head of Oncology Research) will provide a business and financial update, followed by a Q&A session.
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Profit and Loss1
Research and development expenses
Average net cash burn2
Cash on hand
1) based on the consolidated IFRS financial statements
2) represents the average monthly cash used in operating and investing activities
The annual report 2020 is available for download on our website: https://www.polyphor.com/investor-relations/reporting/
22 March 2021 – Annual General Meeting, Information call
06 April 2021 – Annual General Meeting
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+41 44 447 12 21
Polyphor is a research driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-in-class molecules in oncology and antimicrobial resistance leveraging the company’s leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company’s lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor’s results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.