Category Archives: Biotech Companies Infectious Diseases

ExeVir Bio Announces Exceptional Virus Neutralization Potency of its Variant-proof XVR013m Antibody Against the SARS-CoV-2 Variant JN.1

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Developed to provide protection for millions of immunocompromised and elderly individuals who are most vulnerable to COVID-19

GHENT, Belgium, June 04, 2024 (GLOBE NEWSWIRE) — ExeVir Bio, a biotech company developing robust heavy chain-only antibody therapies for broad protection against infectious diseases, today announced new data demonstrating that its antibodies are exceptionally potent in neutralizing the SARS-CoV-2 variant JN.1, the parental strain of the currently most dominantly circulating variants worldwide.

ExeVir’s COVID-19 program focuses on addressing the high unmet medical need to protect and treat immunocompromised and elderly individuals that account for respectively 4% and 10% of the global population. Despite the availability of effective vaccines, the immunocompromised and elderly remain at a higher risk for severe COVID-19 as they are often not able to elicit an adequate immune response to vaccination and therefore would strongly benefit from additional protection in the form of antibody therapeutics.

ExeVir’s variant-proof lead clinical candidate XVR013m is a heavy chain-only antibody that targets a unique membrane-proximal epitope in the S2 subunit of the spike protein. This binding region remains completely unmutated across all variants of concern, variants of interest and variants under monitoring that have circulated to date. XVR013m demonstrates exceptional neutralization potency against JN.1, the parental strain of the currently most dominantly circulating variants worldwide, with an IC50 of 2.8 ng/mL in a pseudovirus neutralization assay, unchanged compared to all previously tested variants. The activity against new circulating variants under monitoring is continually being tested.

ExeVir is currently gearing up to start the clinical development of the variant-proof XVR013m in 2025 as a solution for the prevention of COVID-19 in the target populations of immunocompromised and elderly individuals.

Jeanne Bolger, interim CEO of ExeVir, said: “COVID-19 is here to stay and is still the most important respiratory infectious disease causing substantially more hospitalizations and deaths compared to influenza and RSV. Today, no real seasonality is observed for COVID-19, in sharp contrast to influenza and RSV. Our antibody XVR013m is differentiated by targeting a unique and highly conserved epitope in the S2 subunit of the SARS-CoV-2 spike protein that makes it virtually variant-proof.”

Viki Bockstal, CSO of ExeVir, said: “XVR013m not only demonstrates exceptional virus neutralization potency against all variants tested to date, it is also anticipated to maintain its activity against future variants because of the unique nature of the epitope. There is still a strong and urgent medical need for novel antibodies that work against both the newest as well as future SARS-CoV-2 variants, and these new data again demonstrate that XVR013m has the potential to become a durable therapeutic solution to protect the most vulnerable patients from this serious infectious disease.”

About ExeVir Bio

ExeVir Bio is a clinical stage biotechnology company developing heavy-chain only antibody therapies focusing on infectious diseases. The company is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases. ExeVir’s initial focus is on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, hematological malignancies, AIDS patients, and for the elderly, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches.

ExeVir has demonstrated it can progress its candidates from research to the clinic in under one year, execute on Phase 1a and Phase 1b studies, and conduct scale-up manufacturing. Leveraging this extensive experience, its XVR013m asset is being developed to start a First in Human clinical trial in 2025.

VHHs are smaller in size than whole antibodies, giving them access to hidden epitopes that traditional monoclonal antibodies are unable to reach with potential for deeper tissue penetration and simpler, more cost-effective manufacturing. VHHs can be linked together like building blocks into single multispecific molecules to tackle different epitopes or act through different mechanisms of actions at once, to address the “arms race” in more complex and co-evolving infectious diseases.

ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors including Fund+, which led the series A of EUR 42 million, together with an international consortium including UCB Ventures, SFPIM, V-Bio Ventures, VIB, Wallonie Entreprendre, Noshaq, Vives IUF and SambrInvest. ExeVir has received support from VLAIO, the SPW-Recherche and the European Union, leading to a total of EUR 18 million in non-dilutive funding. In 2023, ExeVir secured an option for EUR 25 million venture debt financing from the European Investment Bank.

References

1. Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational population-based INFORM study, Evans et al, The Lancet, 2023.
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762%2823%2900166-7/fulltext.

2. World population above 65 years old: Population ages 65 and above, total | Data (worldbank.org)

For more information contact:

ExeVir Bio
Veronique Vandevoorde
vvandevoorde@exevir.com

Scius Communications (for media)
Katja Stout
+44 778 943 5990
katja@sciuscommunications.com

Daniel Gooch
+44 774 787 5479
daniel@sciuscommunications.com

Find out more on ExeVir’s LinkedIn or on ExeVir’s website

Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

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Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

  • Agreement provides patients with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards
  • Accelerates potential for development of a novel flu-COVID-19 combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering patients enhanced convenience and protection

Paris and Gaithersburg, Md., United States. May 10, 2024. As part of Sanofi’s commitment to developing a diverse portfolio of best-in-class vaccines, the company has entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US.

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

Jean-Francois Toussaint
Global Head of Vaccines R&D
“With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses. We’re excited by the prospect of combining Novavax’s adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines that have demonstrated superior protection against flu and its serious complications. Improved tolerability and thermostability, without compromise on efficacy, are what regulators, recommending bodies, and patients will demand.”

John Jacobs
CEO, Novavax

“This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix™ adjuvant, and R&D expertise with Sanofi’s world-class leadership in launching and commercializing innovative vaccines. Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide. Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.” 

Under the terms of the licensing agreement:

  • Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and launch milestones, up to $1.2 billion in total.
  • Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses.
  • Novavax will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines.
  • Sanofi will be solely responsible for development and commercialization of any novel flu-COVID-19 combination vaccine containing a Sanofi flu vaccine.
  • Outside of the collaboration, each party may develop and commercialize their own flu-COVID-19 vaccines and adjuvanted products at their own cost.
  • Novavax is entitled to additional launch and sales milestones opportunities of up to $200 million plus mid-single digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology.
  • In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine, and its pipeline includes CIC and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering INNA-051, a First-in-Class Antiviral Innate Immunomodulator

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MELBOURNE, Australia, May 08, 2024 (GLOBE NEWSWIRE) — ENA Respiratory, a clinical-stage pharmaceutical company developing innate immune modulators for the prevention of complications associated with respiratory viral infections in at-risk populations, announces today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application US 18/112091 entitled “Novel molecules” covering claims for its lead program, INNA-051 and its composition.

A virus-agnostic intranasal antiviral host defence immunomodulator, INNA-051 is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognizing pathogens and triggering the innate immune response.

This USPTO allowance further strengthens ENA Respiratory’s strong IP portfolio related to INNA-051, with 30 granted patents and allowed applications in the major markets, including the US, Europe, the United Kingdom, Japan and China. The portfolio covers seven distinct patent families, with claims directed to the composition of matter for INNA-051 and various backup molecules, formulations and method of use protection, as part of a comprehensive lifecycle management strategy. ENA Respiratory has an additional 39 pending applications in various jurisdictions.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “Our IP portfolio provides robust and long-lasting protection with potential exclusivity for INNA-051 out to at least 2042 and likely for five years post that date. This gives us great confidence in the future global commercial value of our innate immune modulators as we continue to drive forwards in clinical development.”

Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences for INNA-051 in a Phase IIa proof-of-principle study using a liquid formulation in an influenza-challenge model, ENA Respiratory has developed an improved dry powder formulation to take into further clinical development. This formulation recently received FDA IND clearance and the Company has submitted ethics approval for a Phase 1b study in Australia. This study is expected to be initiated in mid-2024 with the aim to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of the dry powder formulation of INNA-051 in older adults.

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling serious respiratory viral infections through the development of host defence immune modulators which locally prime and boost the body’s innate immune response – the natural first line of defence. Being virus-agnostic, immune modulators are complementary to often virus-specific vaccines and existing direct-acting antivirals.

The company’s lead product, INNA-051, is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and triggering the innate immune response. With a safe profile supporting prophylaxis use, it has demonstrated accelerated viral clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using an influenza-challenge model. INNA-051 is being developed as a convenient, once-a-week nasal dry powder product to prevent complications associated with respiratory viral infections in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel).

Headquartered in Melbourne, Australia, the company has raised US$26M (AU$44million) in equity financing from Brandon Capital, The Minderoo Foundation and Uniseed. It is partnered with the COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$8.18million contract from the U.S. Department of Defence. It is a member BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen potential solutions for future pandemics.

For more information, please visit https://enarespiratory.com

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Karius Raises $100M Co-Led by Khosla Ventures, 5AM Ventures and Gilde Healthcare, to Expand Access to Advanced Genomic Diagnostics in Infectious Disease, Addressing Antimicrobial Resistance Crisis

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New Board Members Appointed to Support Expansion

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Karius®, Inc., a world leader in genomic diagnostics for infectious disease, today announced it has secured $100 million in Series C funding. The round was co-led by Khosla Ventures and new investors 5AM Ventures and Gilde Healthcare. Also investing was new investor Seventure Partners, and existing investors Softbank Vision Fund 2, General Catalyst, HBM Healthcare Investments, Blue Water Life Sciences, Innovation Endeavors, Waycross Ventures, and others.

This investment will enable Karius to extend its reach beyond the 400 U.S. hospitals currently using the Karius Test®, an infectious disease diagnostic test that utilizes genomic analysis and artificial intelligence to detect over 1,000 pathogens from a single blood sample. The funding enables Karius to address increasing demand from healthcare providers to expand access to the Karius Test beyond the hospital setting. Additionally, it will support research into the broader health implications of Karius’ microbial cell-free DNA technology beyond infectious diseases.

“Every minute in the U.S., five cancer patients are admitted to the hospital due to infections—conditions that are often overshadowed by their primary diagnosis but are equally lethal, leading to nearly 1,000 deaths daily,” said Alec Ford, CEO of Karius. “This worrying reality emphasizes a critical and frequently overlooked gap in our healthcare system: the urgent need for faster diagnostic solutions. At Karius, we confront this challenge head-on. The Karius Test can reduce the time required to identify the cause of infections, as every minute counts for cancer patient survival. This additional $100 million will significantly enhance our capacity to deliver rapid diagnostic testing to more patients, where faster treatment saves more lives and significant healthcare resources.”

New Board Appointments

Karius also announced the appointment of three new board members joining recent additions, Dr. Norman Sharpless M.D., former National Cancer Institute Head, and Elizabeth O’Farrell, former Eli Lilly executive:

  • Alex Morgan, M.D., Ph.D., Partner at Khosla Ventures
  • Joep Muijrers, Ph.D., General Partner at Gilde Healthcare
  • Andrew Booth, Venture Advisor to 5AM Ventures, and CFO of AbCellera Biologics

“Investing in Karius addresses critical gaps in healthcare diagnostics,” stated Alex Morgan, Partner at Khosla Ventures. “Traditional methods can be slow and can contribute to overuse of antibiotics, particularly risky for immunocompromised patients and fueling Antimicrobial Resistance (AMR). Precisely identifying pathogens allows for targeted treatment, minimizing the use of broad-spectrum antibiotics and reducing the risk of AMR proliferation. This investment aligns with our commitment to advancing technologies for better public health outcomes.”

“We are thrilled to partner with Karius and to support the company in its journey to help deliver better care at lower cost to some of the most vulnerable patients out there,” added Joep Muijrers, General Partner at Gilde Healthcare.

“Karius’ strong revenue and growth illustrates how impactful the Karius Test is to clinical care. We are proud to co-lead the company’s Series C as Karius expands into new markets and moves to profitability,” added Andrew Booth, Venture Advisor, at 5AM Ventures.

“Over the years, we’ve witnessed firsthand the repeat impact Karius has made on patient management across numerous clinical settings,” added Vali Barsan, M.D., Karius Board Member and investor for SoftBank Investment Advisers. “Alongside our new as well as existing investors, we’re proud to extend our partnership with the Karius team as they continue to scale precision metagenomics for more rapid and definitive diagnostics that enable better patient outcomes.”

Karius’ Series C financing coincides with the positive results from the PICKUP1 trial, a landmark multi-center study enrolling 257 hospitalized adults with pneumonia and active hematologic malignancies across 10 leading medical centers, including Duke University Health, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and University of California, San Francisco Medical Center. When added to the standard of care workup, the Karius Test detected 40% (21/52) more infections with a potential to change medical management for 81% (17/21) of these cases, demonstrating a significant additive diagnostic value in patients with blood cancers or bone marrow transplants. This first-of-its-kind study underscores the Karius Test’s potential to transform the diagnostic journey and patient care.

“We’ve done extensive due diligence, and the value that Karius brings to patients and the healthcare system at large is abundantly clear,” said Isabelle De Cremoux, CEO and Managing Partner of Seventure Partners. “The clinical evidence clearly shows its potential to help more patients. We’re excited to join Karius at such a key strategic time for the company as they grow to support the wider commercialization of the Karius Test.”

Learn more about Karius’ solutions for infectious disease diagnostics by visiting kariusdx.com.

About Karius

Karius Inc., a global leader in liquid biopsy for infectious diseases, harnesses metagenomics, next-generation sequencing, and artificial intelligence (AI) to help enhance the precision and speed of pathogen diagnosis. The Karius Test®, used in over 400 healthcare institutions–including 90+ transplant centers and 40+ children’s hospitals across the United States–identifies more than 1,000 pathogens, including viruses, bacteria, fungi, and parasites from a single blood draw typically within a day of sample receipt.

A landmark study in the Journal of Clinical Microbiology found that the Karius Test detected 701 unique microbial taxa across a cohort of 15,000 patients, making it the largest study of its kind, demonstrating the capability of the Karius Test in pathogen identification. The Karius Test also has been incorporated into the diagnostics recommendations in the 2023 Duke-ISCVID Criteria for Infective Endocarditis.

References:

  1. Bergin SP, et al. Clinical Infectious Diseases. October 2023

 

Contacts

Media Contact
Consort Partners for Karius

kariusdx@consortpartners.com

Ocedurenone: A Novel Therapy for Uncontrolled Hypertension in Advanced Chronic Kidney Disease

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EMJ Nephrology interviewed two World-renowned experts in nephrology and cardiology, George Bakris and Faiez Zannad, regarding the challenges of treating uncontrolled hypertension (uHTN) in patients with advanced chronic kidney disease (CKD), a large unmet need for safe, effective therapies, and the potential of one therapy, Ocedurenone, to address this need.

Original article: EMJ-8.1-2023-1.pdf (emg-health.com)

Large Unmet Need

Patients with advanced CKD have a high burden of disease, compounded by serious comorbidities, most commonly hypertension. Controlling hypertension is vital in these patients to reduce the associated risks of morbidity and mortality, as well as reducing cardiorenal risk, but treatment options are limited due to safety concerns with the use of existing agents.

Current Options

Bakris:”The PATHWAY-2 trial showed that in people with resistant hypertension without advanced CKD, spironolactone produced a greater reduction in blood pressure than a β-blocker and an α-blocker. However, it presents safety risks to patients when administered.”

“Then there is eplerenone, given twice a day, while safe, has a much weaker effect on blood pressure reduction than spironolactone. That’s all we’ve got, so that’s what people use.”

Dr Bakris also mentioned two existing nonsteroidal MRAs, esaxerenone which is “approved exclusively in Japan, for which there are no placebo-controlled comparisons”, and Finerenone which “reduces blood pressure (placebo subtracted) variously from 3 mmHg (ARTS-DN, FIGARO-DKD, and FIDELIO-DKD studies) to approximately 8 mmHg (subset analysis from ARTS-DN study, eGFR of approximately 68, though office blood pressure from the same study showed around 3 mmHg reduction)”.

Future Option – Ocedurenone

Bakris:”Now, Ocedurenone, a non-steroidal MRA, shows clear promise in patients whose standard of care includes two, three, or more drugs. Ocedurenone is the only drug that has consistently steadied resistant hypertension in people with advanced CKD.”

In the first dedicated study of patients with uncontrolled hypertension and advanced CKD (BLOCK-CKD), Ocedurenone demonstrated efficacy in lowering blood pressure, together with a favorable safety profile. The experts were optimistic that it could provide a much-needed treatment option for these patients, with the added potential for reduction in the risk of cardiorenal outcomes.

“This study showed that Ocedurenone reduces SBP by 11 mmHg (placebo-subtracted), a reduction that could lead to potential approval. No other agent to date has steadied blood pressure as well in this group of patients. And the point is that these are the patients who need the most help.”

Zannad reinforced the importance of the hyperkalemia data for the clinical safety of Ocedurenone:”With Ocedurenone, we may for the first time have an MRA that is both safe and efficacious.”

Bakris added:”A Phase 3 study (CLARION-CKD) of Ocedurenone in a similar patient population is ongoing. I remain optimistic that the signal seen in the BLOCK-CKD study will be seen in this larger study.”

“I remain excited about Ocedurenone. Its tolerability and efficacy in lowering blood pressure in a very high-risk group will have a significant impact on morbidity.”

“Mineralocorticoid receptors are so ubiquitous which may allow for indications beyond CKD and cardiovascular conditions. This is likely just the beginning for Ocedurenone.”

About Ocedurenone (KBP-5074)

KBP Biosciences is a global, clinical-stage biotechnology company, headquartered in Princeton, NJ, focused on discovering, developing, and commercializing innovative small-molecule therapeutics for the treatment of serious cardiorenal and infectious diseases with large unmet medical needs.

Ocedurenone (KBP-5074) is a non-steroidal MRA discovered and developed by KBP Biosciences. At present, the Phase 3 clinical trial of the first indication for Ocedurenone, advanced CKD and uncontrolled hypertension, is underway.

About KBP Biosciences, please visit https://www.kbpbiosciences.com/.

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

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Autophagy is a catabolic process which degrades a cellular own component through the lysosomal machinery. The lysosome, at the heart of the autophagy sytem is important in various processes (cancer, infection…).

Genoscience Pharma - new approaches disrupting cancer cell lysosomal functions

In Cancer, they are required in tumor cells for cellular adhesion, motility and signaling, exocytosis, angiogenesis and overall survival, growth, aggressiveness, metastatic potential and drug resistance. Because of their high metabolic rates, rapidly dividing and invasive cancer cells require increased new biomass production to survive. The lysosome is also important for adaptation to nutrient stress as it contains hydrolytic enzymes that play a major role in the degradation of intracellular macromolecules and catabolic (such as autophagy) and anabolic growth. This busy lysosomal behavior leads to alterations in lysosomal structure and function, which, paradoxically, renders cancer cells more sensitive to lysosomal destabilization. In addition, lysosomal enzyme activity is elevated in many tumors compared to adjacent normal tissue, and several reports suggest that lysosomes in tumor cells are more fragile than normal lysosomes. Therefore, lysosome seems to be a target of interest in the fight against cancers. Targeting lysosomes triggers apoptotic and lysosomal cell death pathways.

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

In virology, It has been shown that autophagy is activated during virus and bacterial infection and that some viruses can use the autophagy system to facilitate their own replication . Some viruses, such as Coronaviruses are single stranded, positive sense RNA viruses, which induce the rearrangement of cellular membranes upon infection of a host cell. This provides the virus with a platform for the assembly of viral replication complexes, improving efficiency of RNA synthesis. Genoscience Pharma focuses on new approaches disrupting cancer cell lysosomal functions.

Genoscience Pharma was founded in 2001 by Pr Philippe Halfon, a world renowned medical expert on viral diseases, especially on Human Immunodeficient Virus (HIV) and Hepatitis C Virus (HCV). The company was initially focused on the development of anti-HCV agents. Two protease inhibitors were thus developed and out-licensed to BioLineRX. A new scientific direction was taken in 2012 after the discovery of a new chemical family: autophagy inhibitors. Following promising preliminary in vitro and in vivo results from these small molecules, including against cancer stem cells, Genoscience Pharma has decided to take the opportunity to make the difference in Oncology, especially in cancers where medical needs are still unmet. Now, Genoscience Pharma is a clinical stage biopharmaceutical company focused on translating novel scientific insights into medicines for patients with cancer.

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

More info: https://www.genosciencepharma.com/

Keywords : lysosomal functions , cancer, oncology , Genoscience Pharma , lysosomes , infectious diseases  , virus , Covid19, leukemia , pancreatic cancer , hepatocarcinoma , small molecules

Biophytis – therapeutics to slow down the degenerative processes associated with aging

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Biophytis is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratoy failure in patients suffering from COVID-19.

Biophytis - therapeutics to slow down the degenerative processes associated with aging

Biophytis SA, founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, Biophytis has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical needs. Specifically, the company is advancing two proprietary drug candidates into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The business model of BIOPHYTIS is to ensure the conduct of the project until clinical activity in the patient is proven, then to license the technologies in order to continue the development in partnership with a pharmaceutical laboratory. The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and collaborates with scientists at the Institute of Myology, and the Vision Institute

Its lead drug candidate, Sarconeos (BIO101), is an orally administered small molecule in development for the treatment of neuromuscular diseases, including sarcopenia and Duchenne muscular dystrophy (DMD). Our second drug candidate, Macuneos (BIO201), is an orally administered small molecule in development for the treatment of retinal diseases, including dry AMD and Stargardt disease.

Biophytis also has preclinical efficacy data for Sarconeos (BIO101) in Spinal Muscular Atrophy (SMA), a rare neuromuscular disease. Spinal Muscular Atrophy is a rare progressive neurodegenerative disease that robs an individual of the ability to walk, eat and breathe. SMA is the leading genetic cause of death in infants. Symptoms may appear in the first 6 months of life (type 1, the most severe and common), in infancy (types 2 and 3) or in adulthood (type 4, the least common form). SMA affects 1 in 11,000 births in the United States each year, and about 1 in 50 Americans is a genetic carrier.

More info : www.biophytis.com

Keywords for Biophytis :

neuromuscular diseases, dry age-related macular degeneration, AMD, ophthalmology, infectious diseases, COVID19, Asthma, COPD, small molecule, sarcopenia, Stargardt disease, Duchenne muscular dystrophy , DMD, preclinical stage pharma company, clinical stage pharma company , Spinal Muscular Atrophy , rare diseases , aging

Bavarian Nordic – poxviral-based vaccine

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Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.

Bavarian Nordic – poxviral-based vaccine

Bavarian Nordic has built its foundation around two poxviral-based vaccine platform technologies, Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) and Vaccinia-Fowlpox-TRICOM (VF-TRICOM) that have the potential to support a broad product pipeline in both infectious diseases and cancer immunotherapies. Both technologies can be manufactured at commercial scale at Bavarian Nordic’s own facility, which was recently expanded to accommodate the production of multiple products. Bavarian Nordic focuses on developing product candidates to address cancer and infectious diseases by leveraging several core strengths:

  • Extensive R&D expertise in vaccines and immunotherapy
  • Broadly applicable platform technology
  • Multiple clinical stage development programs, including two Phase 3 trials
  • Flexible, commercial scale manufacturing facility
  • Significant financial resources resulting from IMVAMUNE supply contracts and government-funded R&D programs

Through a long-standing collaboration with the U.S. Government, Bavarian Nordic has developed a portfolio of biological countermeasures, including the non-replicating smallpox vaccine, IMVAMUNE, which is stockpiled for emergency use by the U.S. and other governments. The vaccine is approved in the EU (under the trade name IMVANEX) and in Canada. Bavarian Nordic and its partner Janssen are pioneering the development of an Ebola vaccine, which has been fast-tracked by authorities in response to the current situation in West Africa. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies based on its versatile pox-virus based technologies, including PROSTVAC, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC.

Bavarian Nordic is a biotech company headquartered in Denmark, Germany and USA. Bavarian Nordic’s shares are listed on Nasdaq Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.

More about Bavarian Nordic : www.bavarian-nordic.com

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE