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Cell and Gene Therapy

Merck and Orna Therapeutics Collaborate to Advance Orna’s Next Generation of RNA Technology

Merck and Orna Therapeutics | August 17, 2022 | Read time : 02:00 min

Merck and Orna
Merck known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology.

Under the terms of the agreement, Merck will make an upfront payment to Orna of $150 million, which will be expensed by Merck in the third quarter of 2022 and included in non-GAAP results. In addition, Orna will be eligible to receive up to $3.5 billion in development, regulatory, and sales milestones associated with the progress of the multiple vaccine and therapeutic programs, as well as royalties on any approved products derived from the collaboration. Orna will retain rights to its oRNA-LNP technology platform and will continue to advance other wholly owned programs in areas such as oncology and genetic disease. Merck will also invest $100 million of equity in Orna’s recently completed Series B financing round.

Orna’s proprietary oRNA technology creates circular RNAs from linear RNAs by self-circularization. oRNA molecules have been shown to have greater stability in vivo than linear mRNA and have the potential to produce larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules are more compactly packaged into custom lipid nanoparticles  which Orna has engineered to target key tissues in the body. Preclinical data, including presentations at the 2022 American Society of Gene & Cell Therapy  Annual Meeting, have demonstrated the potential of oRNA expression and delivery as an approach for further development in multiple areas, including vaccines and oncology therapeutics.

“This broad strategic collaboration brings together Merck’s significant expertise in nucleic acid biology, clinical development, and manufacturing with Orna’s compelling circular RNA technology to explore the opportunity to develop a new generation of potential vaccines and therapeutics. We look forward to working with the talented scientific and technical teams at Orna."

Fiona Marshall, senior vice president and head of discovery, preclinical and translational medicine at Merck Research Laboratories

“We are thrilled to collaborate with Merck, a company committed to breakthrough science, which has recognized the potential our platform can bring to patients. Our oRNA technology plus novel delivery solutions are designed to unlock the full potential of RNA in therapeutics and vaccines,” said Tom Barnes, Chief Executive Officer of Orna. “The combined expertise of Orna and Merck aims to accelerate the development of RNA therapeutics for patients in need of better treatment options.”

About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. 

About Orna Therapeutics
Orna Therapeutics was founded on groundbreaking research by Alex Wesselhoeft, Ph.D., and Daniel G. Anderson, Ph.D. from MIT and built by MPM Capital and BioImpact Capital, an investment management affiliate of MPM. Orna’s proprietary circular RNA (oRNA) is engineered as linear RNA that self-circularizes. By taking a line and turning it into a circle, oRNA exhibits numerous advantages over traditional linear mRNA therapies such as simplified production, increased protein expression, and a superior immunogenicity profile. With proprietary lipid nanoparticles including those from Orna’s joint venture with ReNAgade Therapeutics, an RNA delivery company, our technologies expand the possibilities of what RNA therapeutics can achieve.

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Exacta Bioscience and Ginkgo Bioworks Announce Partnership to Optimize Exacta's Crop Protection Product

prnewswire | September 01, 2023

Exacta Bioscience, a biotech company that harnesses the power of nature and its microorganisms for crop protection, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that Exacta is leveraging Ginkgo's end-to-end agricultural R&D services to run a fermentation optimization and scale-up program to enhance one of its crop protection products, FitoRoot®, paving the way for large-scale commercialization. FitoRoot, a biostimulant product composed of three Bacillus strains, is designed to help crops better absorb water, nutrients and strengthen their defenses against abiotic stress. This can lead to overall better crop health, improved yield and increased resistance to stress conditions such as drought or extreme temperatures. Through this partnership, Exacta will use Ginkgo's fermentation and formulation optimization services to reduce the cost of goods to make its FitoRoot technology more competitive. Accordingly, FitoRoot is currently marketed in Chile and is expected to expand to other Latin American markets, with a planned launch in 2023 by Adama Chile, who is driving biological adoption in the region. Adama Ltd is one of the world's leading crop protection companies. "We chose Ginkgo because their deep expertise in agricultural product development and optimization positions us to make one of our key crop protection products, FitoRoot, more accessible," said José Bustos, CEO at Exacta Bioscience. "We're proud of the progress Exacta has made, and this partnership marks a vital step toward accelerating our efforts to assure the quality and availability of one of our products and creating a stable and safer ecosystem." "Exacta Bioscience's emphasis on microbial solutions in crop health brings more sustainable and differentiated solutions to farmers throughout the Americas," said Magalie Guilhabert, Head of Ag Biologicals, Ginkgo Bioworks. "Together, we can continue to push the boundaries of agricultural innovation through biotechnological solutions that promote a more sustainable future for our food systems." Ginkgo's end-to-end agricultural services can help R&D teams develop more effective biological products across a variety of applications. Find out more. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats. About Exacta Bioscience Exacta Bioscience is a pioneering biotech company that uses microorganisms to create innovative bioproducts for agriculture. Their nature-inspired solutions support a future without chemical pesticides and antibiotics. With extensive knowledge of microorganisms and their effects on crops and soil, Exacta tackles modern farming challenges. Their expertise is in formulating microorganism mixtures, providing a wide range of bioproducts, specifically for crop protection. They are dedicated to delivering effective, stable, and safe crop protection and soil-enhancing products. They invite everyone to join in advancing sustainable practices for a healthier future.

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Medical, Industry Outlook

NANOBIOTIX Announces License Agreement for Worldwide Co-development and Commercialization of Potential First-In-Class Radioenhancer NBTXR3

Globenewswire | July 13, 2023

NANOBIOTIX a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3. NBTXR3 is currently being evaluated in several studies across solid tumor indications including NANORAY-312, a global Phase 3 pivotal study evaluating NBTXR3 for the treatment of patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for patients with metastatic cancers. Under the terms of the license agreement, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio. Dial-in information for a conference call Nanobiotix will host to discuss the agreement can be found below. “As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization capabilities,” said Laurent Levy, Nanobiotix chairman of the executive board. “We are delighted to collaborate with Janssen as we aim to improve the lives of patients with cancer around the world.” Nanobiotix will receive near term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million that Janssen may provide at its sole discretion. Nanobiotix will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix. Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion; and of up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen. Following commercialization, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3. “We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realization of its promise for patients in need,” said Bart van Rhijn, Nanobiotix chief financial officer. “We look forward to maximizing the value of NBTXR3 for our global stakeholders.” Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) including, as part of capital increases without preferential subscription rights: (1) an initial tranche equal to the lower of 5% of the Company and $5 million; and (2) a second tranche of $25 million subject to certain maximum ownership caps in connection with a future financing. The price of the initial tranche will be equal to $5.21 per American Depositary Share (“ADS”) if that price (1) is approved by Nanobiotix shareholders or (2) exceeds 85% of the volume-weighted average price (“VWAP”) of Nanobiotix ordinary shares on Euronext: Paris for three consecutive trading days, starting with the fourth trading day after the date of agreement, in each case if occurring within the ninety trading days following the date f the agreement. Also, JJDC may elect any time during that ninety-trading day period to instead consummate the initial tranche at a price per ADS equal to 85% of the VWAP of Nanobiotix ordinary shares on Euronext for three consecutive trading days starting with the fourth trading day after the date of the agreement. The second, $25 million tranche is conditioned upon, and at the same price as, a concurrent Nanobiotix financing with gross proceeds of at least $25 million (excluding the potential investment by JJDC) occurring prior to certain long-term development milestones or December 31, 2027, at the latest. For illustrative purposes only1, in the event that the initial tranche is implemented at $5.21 per ADS, the dilutive impact for shareholders resulting from this capital increase would be 0.97% and JJDC group would own 2.65% of the Company’s share capital. The transaction is subject to customary closing conditions and regulatory clearances including clearance by US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as these conditions have been met. As of the date the license agreement becomes effective, prior to utilizing the second tranche of equity investment outlined above and excluding near term development milestones, Nanobiotix expects to extend its cash runway into the first quarter of 2024. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The Company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

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Medical

Melinta Therapeutics Partners with BARDA to Advance Two FDA-Approved Antibiotics for Use in Pediatric Patients

Businesswire | July 11, 2023

Melinta Therapeutics, LLC a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications. BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA® and VABOMERE® to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population. "I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.” BAXDELA® (delafloxacin) is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA® pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years. In addition, Melinta aims to advance BAXDELA® as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA® can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity. VABOMERE® is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US. The CDC (Centers for Disease Control) classifies CRE as an “urgent” threat because there are few alternative antibiotics to treat CRE-infections. The VABOMERE® pediatric development plan will support the filing of sNDAs to extend the adult cUTI indication to children aged 3 months to less than 18 years and target the indication of late onset neonatal sepsis in children aged less than 90 days. “The ability to partner with BARDA on these important programs is exactly the type of work that brought me to Melinta and what excites me about the work we do,” said Douglas Girgenti, MD, VP, Head of Development and Clinical Operations, Melinta. “Pediatric clinical development of BAXDELA® and VABOMERE® will help inform drug safety and tolerability as well as determine optimal antibiotic dosing, with the ultimate goal of enabling use in pediatric cases and expanding the arsenal of healthcare providers in their fight to save lives. The potential addition of BAXDELA® to the biodefense armamentarium will likewise provide a much-needed option for public health emergencies in both children and adults.” This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022. About Melinta Therapeutics Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). About BAXDELA® (delafloxacin) BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

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Medical

Exacta Bioscience and Ginkgo Bioworks Announce Partnership to Optimize Exacta's Crop Protection Product

prnewswire | September 01, 2023

Exacta Bioscience, a biotech company that harnesses the power of nature and its microorganisms for crop protection, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that Exacta is leveraging Ginkgo's end-to-end agricultural R&D services to run a fermentation optimization and scale-up program to enhance one of its crop protection products, FitoRoot®, paving the way for large-scale commercialization. FitoRoot, a biostimulant product composed of three Bacillus strains, is designed to help crops better absorb water, nutrients and strengthen their defenses against abiotic stress. This can lead to overall better crop health, improved yield and increased resistance to stress conditions such as drought or extreme temperatures. Through this partnership, Exacta will use Ginkgo's fermentation and formulation optimization services to reduce the cost of goods to make its FitoRoot technology more competitive. Accordingly, FitoRoot is currently marketed in Chile and is expected to expand to other Latin American markets, with a planned launch in 2023 by Adama Chile, who is driving biological adoption in the region. Adama Ltd is one of the world's leading crop protection companies. "We chose Ginkgo because their deep expertise in agricultural product development and optimization positions us to make one of our key crop protection products, FitoRoot, more accessible," said José Bustos, CEO at Exacta Bioscience. "We're proud of the progress Exacta has made, and this partnership marks a vital step toward accelerating our efforts to assure the quality and availability of one of our products and creating a stable and safer ecosystem." "Exacta Bioscience's emphasis on microbial solutions in crop health brings more sustainable and differentiated solutions to farmers throughout the Americas," said Magalie Guilhabert, Head of Ag Biologicals, Ginkgo Bioworks. "Together, we can continue to push the boundaries of agricultural innovation through biotechnological solutions that promote a more sustainable future for our food systems." Ginkgo's end-to-end agricultural services can help R&D teams develop more effective biological products across a variety of applications. Find out more. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats. About Exacta Bioscience Exacta Bioscience is a pioneering biotech company that uses microorganisms to create innovative bioproducts for agriculture. Their nature-inspired solutions support a future without chemical pesticides and antibiotics. With extensive knowledge of microorganisms and their effects on crops and soil, Exacta tackles modern farming challenges. Their expertise is in formulating microorganism mixtures, providing a wide range of bioproducts, specifically for crop protection. They are dedicated to delivering effective, stable, and safe crop protection and soil-enhancing products. They invite everyone to join in advancing sustainable practices for a healthier future.

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Medical, Industry Outlook

NANOBIOTIX Announces License Agreement for Worldwide Co-development and Commercialization of Potential First-In-Class Radioenhancer NBTXR3

Globenewswire | July 13, 2023

NANOBIOTIX a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced a global licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the investigational, potential first-in-class radioenhancer NBTXR3. NBTXR3 is currently being evaluated in several studies across solid tumor indications including NANORAY-312, a global Phase 3 pivotal study evaluating NBTXR3 for the treatment of patients with locally advanced head and neck cancer. NBTXR3 is also being evaluated for its potential as a systemic agent in combination with anti-PD-1 immune checkpoint inhibitors for patients with metastatic cancers. Under the terms of the license agreement, in collaboration with the Interventional Oncology R&D Unit at Johnson & Johnson, Nanobiotix will grant Janssen a worldwide license for the development and commercialization of NBTXR3. The license is exclusive, excepting territories previously licensed to Nanobiotix partner LianBio. Dial-in information for a conference call Nanobiotix will host to discuss the agreement can be found below. “As pioneers in the field of nanotherapeutics for the past 20 years, we knew that the true impact of our innovation in oncology would be in its potential to reach millions of patients around the world. For that, we needed to find the right partner, at the right time, with proven global development and commercialization capabilities,” said Laurent Levy, Nanobiotix chairman of the executive board. “We are delighted to collaborate with Janssen as we aim to improve the lives of patients with cancer around the world.” Nanobiotix will receive near term cash and operational support valued up to $60 million. This includes an upfront cash licensing fee of $30 million, and in-kind regulatory and development support for study NANORAY-312 valued at up to $30 million that Janssen may provide at its sole discretion. Nanobiotix will maintain operational control of NANORAY-312 and all other currently ongoing studies, along with NBTXR3 manufacture, clinical supply, and initial commercial supply. Janssen will be fully responsible for an initial Phase 2 study evaluating NBTXR3 for patients with stage three lung cancer and will have the right to assume control of studies currently led by Nanobiotix. Nanobiotix is eligible for success-based payments of up to $1.8 billion, in the aggregate, relating to potential development, regulatory, and sales milestones. Moreover, the agreement includes a framework for additional success-based potential development and regulatory milestone payments of up to $650 million, in the aggregate, for five new indications that may be developed by Janssen at its sole discretion; and of up to $220 million, in the aggregate, per indication that may be developed by Nanobiotix in alignment with Janssen. Following commercialization, Nanobiotix will also receive tiered double-digit royalties on net sales of NBTXR3. “We expect this agreement, and the collaboration it enables, to further drive the expansion of NBTXR3 development and accelerate the realization of its promise for patients in need,” said Bart van Rhijn, Nanobiotix chief financial officer. “We look forward to maximizing the value of NBTXR3 for our global stakeholders.” Separately, Nanobiotix is eligible to receive up to $30 million in equity investments from Johnson & Johnson Innovation – JJDC, Inc. (“JJDC”) including, as part of capital increases without preferential subscription rights: (1) an initial tranche equal to the lower of 5% of the Company and $5 million; and (2) a second tranche of $25 million subject to certain maximum ownership caps in connection with a future financing. The price of the initial tranche will be equal to $5.21 per American Depositary Share (“ADS”) if that price (1) is approved by Nanobiotix shareholders or (2) exceeds 85% of the volume-weighted average price (“VWAP”) of Nanobiotix ordinary shares on Euronext: Paris for three consecutive trading days, starting with the fourth trading day after the date of agreement, in each case if occurring within the ninety trading days following the date f the agreement. Also, JJDC may elect any time during that ninety-trading day period to instead consummate the initial tranche at a price per ADS equal to 85% of the VWAP of Nanobiotix ordinary shares on Euronext for three consecutive trading days starting with the fourth trading day after the date of the agreement. The second, $25 million tranche is conditioned upon, and at the same price as, a concurrent Nanobiotix financing with gross proceeds of at least $25 million (excluding the potential investment by JJDC) occurring prior to certain long-term development milestones or December 31, 2027, at the latest. For illustrative purposes only1, in the event that the initial tranche is implemented at $5.21 per ADS, the dilutive impact for shareholders resulting from this capital increase would be 0.97% and JJDC group would own 2.65% of the Company’s share capital. The transaction is subject to customary closing conditions and regulatory clearances including clearance by US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as these conditions have been met. As of the date the license agreement becomes effective, prior to utilizing the second tranche of equity investment outlined above and excluding near term development milestones, Nanobiotix expects to extend its cash runway into the first quarter of 2024. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The Company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. Nanobiotix has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020.

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Melinta Therapeutics Partners with BARDA to Advance Two FDA-Approved Antibiotics for Use in Pediatric Patients

Businesswire | July 11, 2023

Melinta Therapeutics, LLC a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications. BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA® and VABOMERE® to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population. "I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.” BAXDELA® (delafloxacin) is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA® pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years. In addition, Melinta aims to advance BAXDELA® as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA® can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity. VABOMERE® is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US. The CDC (Centers for Disease Control) classifies CRE as an “urgent” threat because there are few alternative antibiotics to treat CRE-infections. The VABOMERE® pediatric development plan will support the filing of sNDAs to extend the adult cUTI indication to children aged 3 months to less than 18 years and target the indication of late onset neonatal sepsis in children aged less than 90 days. “The ability to partner with BARDA on these important programs is exactly the type of work that brought me to Melinta and what excites me about the work we do,” said Douglas Girgenti, MD, VP, Head of Development and Clinical Operations, Melinta. “Pediatric clinical development of BAXDELA® and VABOMERE® will help inform drug safety and tolerability as well as determine optimal antibiotic dosing, with the ultimate goal of enabling use in pediatric cases and expanding the arsenal of healthcare providers in their fight to save lives. The potential addition of BAXDELA® to the biodefense armamentarium will likewise provide a much-needed option for public health emergencies in both children and adults.” This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00022. About Melinta Therapeutics Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). About BAXDELA® (delafloxacin) BAXDELA® is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

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