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ALLSCHWIL, Switzerland, Dec. 11, 2020 (GLOBE NEWSWIRE) — Polyphor AG (SIX: POLN) today announced the extension of its existing grant agreement with CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global partnership led by Boston University dedicated to supporting the development of antibacterial products to diagnose, prevent and treat drug-resistant infections. The grant will support the development of Polyphor’s novel OMPTA (Outer Membrane Protein Targeting Antibiotics) BamA program. The OMPTA-BamA program addresses the deadliest and most resistant Gram-negative bacterial pathogens, potentially active against all three critical priority 1 pathogens in the World Health Organization (WHO) list.

Under the extension of the 2019 agreement, CARB-X is committing to Polyphor additional funding of up to USD 2.3 million, bringing potential funding for this contractual stage to USD 5.1 million. Polyphor may also receive up to USD 13 million in future option stages that could take the program through a first-in-human program if certain project milestones are met.

“We are delighted to extend our partnership with CARB-X on our OMPTA-BamA program, which has the potential to be a major breakthrough in addressing carbapenem resistance potentially covering all WHO priority 1 pathogens”, said Gokhan Batur, Chief Executive Officer of Polyphor. “This is another important endorsement of Polyphor’s OMPTA program, following the award by CARB-X in October for our OMPTA Thanatin Derivatives program.”

Polyphor’s novel OMPTA antibiotics target the highest priority Gram-negative ESKAPE pathogens (Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa), which are the leading cause of severe and often deadly infections throughout the world, such as bloodstream infections, urinary tract infections and pneumonia. Importantly, this new class of antibiotics is active against strains which have become resistant to most commonly used antibiotics including the “last resort workhorse” carbapenems.

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About Polyphor
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.

Disclaimer

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.

Research reported in

this news release

is supported by CARB-X. CARB-X’s funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The content is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders.

Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly

• Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
• Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
• Companies plan a Phase 2b study with an improved antigen formulation
• With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorized COVID-19 vaccine
• Product availability now expected in Q4 2021 pending successful completion of the development plan  

PARIS and LONDON – December 11, 2020 – Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

A recent challenge study in non-human primates performed with an improved antigen formulation demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs, within 2 to 4 days. These results increase the Companies confidence in the capacity of the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults.

Sanofi’s recombinant technology and GSK’s pandemic adjuvant are established vaccine platforms that have proven successful against influenza. The recombinant technology offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission.

“We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to further optimize our candidate to achieve this goal,” said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”

Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile. It is also clear that multiple vaccines will be needed to contain the pandemic. Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”

The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) under contract W15QKN-16-9-1002. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.

Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by U.S. government’s Operation Warp Speed in order to accelerate its development and manufacturing.

The Companies have updated Governments and the European Commission where a contractual commitment to purchase the vaccine has been made.

Phase 1/2 study

The interim Phase 1/2 results showed a level of neutralizing antibody titers after two doses comparable to sera from patients who recovered from COVID-19, a balanced cellular response in adults aged 18 to 49 years, but insufficient neutralizing antibody titers in adults over the age of 50. The candidate showed transient but higher than expected levels of reactogenicity likely due to the suboptimal antigen formulation, with no serious adverse events related to the vaccine candidate. The most favorable results were observed in the group which tested the highest antigen concentration, combined with the GSK adjuvant, showing neutralization titers in 88% of participants. Seroconversion was observed in 89.6% of the 18 to 49 age group; 85% in the >50 age group; and 62.5% in the >60 age group.

The Phase 1/2 clinical study is a randomized, double blind and placebo-controlled study designed to evaluate the safety, reactogenicity and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 441 healthy adults participated in the study, across 10 investigational sites in the United States. The participants received one or two doses of the vaccine candidate, or placebo at 21 days apart.

Full results of the Phase 1/2 study will be published as soon as all data are available, following peer-reviewed publication process.

Latest preclinical results

A recent preclinical study using a highly virulent challenge in non-human primates, showed high ability for the vaccine to protect against lung pathology and reduce virus in the nose and lungs within 2 to 4 days. Results from this pre-clinical study confirm strong ability of the vaccine candidate to stop the replication of the virus with an optimal antigen formulation.

These data are being prepared for submission to a peer-reviewed publication.

On the front lines in the fight against COVID-19

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in Q1 2021, with earliest potential approval in the second half of 2021.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information please visit www.gsk.com

Attachment

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  Innate
  
  
  will
  
  
  no longer
  
  
  pursue Lumoxiti
  
  
  commercialization
  
  
  activities
  
  
  in US or E
  
  
  U
  
  
  ;
  
  
  Company
  
  
  to
  
  
  re
  
  
  -focus
  
  
  investments
  
  
  in
  
  
  its
  
  
  R&D p
  
  
  ortfolio 

  
  

• 
  Companies
  
  
  will
  
  
  develop
  
  
  a
  
  
  transition
  
  
  plan
  
  
  with the goal of returning full commercialization
  
  
  responsibilities
  
  
  to
  
  
  AstraZeneca
  
  
  in
  
  
  2021
  

• 
  C
  
  
  ompanies
  
  
  will
  
  
  ensure availability of Lumoxiti to patients
  
  
  during transition period
  

• 
  C
  
  
  onference call to be held
  
  
  today
  
  
  at
  
  
  2 pm CET
  
  
  / 8 am ET
  

MARSEILLE, France, Dec. 11, 2020 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that it will return the US and EU commercialization rights of Lumoxiti (moxetumomab pasudotox-tdfk) to AstraZeneca¹. Innate licensed the US and EU rights to AstraZeneca’s FDA-approved Lumoxiti for certain patients with relapsed or refractory hairy cell leukemia in October 2018.

The companies will develop a transition plan, including costs and transfer of the US marketing authorization and distribution of Lumoxiti back to AstraZeneca in 2021. AstraZeneca will remain the marketing authorization applicant for the EU filing.

“Since in-licensing Lumoxiti from AstraZeneca, we have been committed to delivering this medicine to patients and healthcare professionals in the US, and moving towards commercialization in the EU.
However,
we’ve determined that there is low
strategic value
for us
in
main
taining
Lumoxiti in our portfolio
due to
lower than anticipated
product
sales
,
further compounded by the
ongoing
COVID-19 pandemic
. This
has
led
us to
ma
k
e the
decision to
re-
prioritize our investments in our R&D portfolio,”
s
aid
Mondher Mahjoubi, Chief Executive Officer of Innate Pharma
. 
“
W
e will
continue to embed a commercial mindset into our R&D programs,
which
is a key success factor
for
the development
and future commercialization
of our
pipeline
assets
.”

As part of this decision, Innate will immediately begin to reduce its US commercial operations; however, it will maintain the appropriate patient and customer support services, as well as product supply, during this transition period. In the EU, Innate will no longer progress Lumoxiti regulatory or commercial activities.   

The accounting impacts will be presented in the December 31, 2020 financial statements. As a reminder, the net book value of Lumoxiti intangible assets amounted to €45.2 million, as of June 30, 2020.  

All other agreements with AstraZeneca remain unchanged. 

About
Lumoxiti (moxetumomab pasudotox-tdfk):

Lumoxiti is a CD22-directed immunotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death. Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of r/r HCL. AstraZeneca is the marketing authorization applicant for the EU filing.

About Innate Pharma:
Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.

Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.

Innate has been a pioneer in the understanding of natural killer cell biology and has expanded its expertise in the tumor microenvironment and tumor-antigens, as well as antibody engineering. This innovative approach has resulted in a diversified proprietary portfolio and major alliances with leaders in the biopharmaceutical industry including Bristol-Myers Squibb, Novo Nordisk A/S, Sanofi, and a multi-products collaboration with AstraZeneca.

Based in Marseille, France, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com

Information about Innate Pharma shares:

Disclaimer on forward-looking information and risk factors
:

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995.The use of certain words, including “believe,” “potential,” “expect” and “will” and similar expressions, is intended to identify forward-looking statements. Although the company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s commercialization efforts, the Company’s continued ability to raise capital to fund its development and the overall impact of the COVID-19 outbreak on the global healthcare system as well as the Company’s business, financial condition and results of operations. For an additional discussion of risks and uncertainties which could cause the company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2019, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

For additional information, please contact:

¹ Lumoxiti is licensed from MedImmune, a subsidiary of AstraZeneca.