Pharmaceutical Technology Editors

Ymmunobio AG, a biotech company specializing in the development of CEACAM antibodies as anti-cancer treatments, announced on April 7, 2022 that it has signed a purchase agreement with LeukoCom GmbH. The agreement will grant Ymmunobio AG ownership of the patents and intellectual property to several CEACAM antibodies.

Ymmunobio AG will have the rights to all future CEACAM-related patents developed or secured by LeukoCom GmbH. The company also has the rights to CEACAM1 antibodies YB-200, YB-300, YB-400, and one additional antibody targeting CEACAM8.

The company is focused on employing the immune system in the development of cancer therapies by developing a proprietary class of CEACAM antibodies to increase the efficiency of the immune system to fight cancer.

"We are excited to obtain the patent rights to the new immune-agonistic CEACAM antibodies,” said Dr. Katrin Rupalla, CEO of Ymmunobio AG, in a press release. “There are potential significant advantages for the treatment of solid tumors in leveraging both the physiological and pathophysiological roles of CEACAMs. This broader mechanism is a benefit as compared to other CEACAM antibodies and novel checkpoint inhibitors currently in development.”

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Ymmunobio AG has signed a patent purchase agreement with LeukoCom GmbH to expand its development of cancer therapies.

Ymmunobio AG Signs Patent Purchase Agreement with LeukoCom GmbH

Pfizer announced on April 7, 2022 that it will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on developing novel antiviral therapeutics that target respiratory syncytial virus (RSV). Pfizer’s acquisition on ReViral would strengthen its capabilities in infectious disease research and development by utilizing ReViral’s R&D, manufacturing, and commercialization expertise.

The acquisition will also advance the company’s goal to address the significant unmet need for RSV treatments worldwide. RSV is a respiratory pathogen that can lead to severe and life-threatening lower respiratory tract infections (LRTIs) in high-risk populations, including young infants, immunocompromised individuals, and older adults. According to the press release, the virus is estimated to cause infections in approximately 64 million people, resulting in about 160,000 deaths each year worldwide.

“Currently, treatment options for RSV are extremely limited and focus primarily on supportive care,” said Annaliesa Anderson, PhD, senior vice president and chief scientific officer, Bacterial Vaccines and Hospital, at Pfizer. “The proposed acquisition of ReViral’s pipeline of therapeutic candidates is complementary to our efforts to advance the first vaccine candidate to help protect against this harmful disease. Combining the capabilities and expertise of our organizations will enable us to further the clinical development of a potential therapy for those with RSV disease.”

“At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, chairman and CEO of Pfizer, in the press release. “We’re continuing to grow our pipeline—through our own research-and-development efforts, such as our investigational RSV vaccine programs, as well as strategic investments in companies like ReViral—with a focus on end-to-end capabilities to help protect patients from severe illness, hospitalization, and death.”

Pfizer plans to acquire ReViral and its respiratory syncytial virus therapeutic candidates to strengthen Pfizer’s capabilities in infectious disease research.

Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates

Lonza and Asher Biotherapeutics announced on April 7, 2022 that they have entered into a manufacturing agreement for a cis-targeted IL-2 immunotherapy, AB359. While conventional immunotherapies act on multiple cell types, cis-targeted immunotherapies selectively activate only the immune cell types that drive the desired therapeutic response. This results in reduced side effects and optimized activity through a new level of selectivity.

The manufacturing agreement outlines that Lonza will provide drug substance manufacturing for AB359 for preclinical and clinical testing, which will take place at Lonza’s Slough, UK site. AB359 is intended to broaden Asher Biotherapeutics’ application of cis-targeted immunotherapies for infectious diseases. The project will also reflect Lonza’s growing focus on biospecific antibodies and emerging biotechs.

“I’m looking forward to collaborating with Lonza on this program,” said Julie Trulson, head of CMC of Asher Bio, in a press release. “Lonza’s determination in implementing steady improvements, and offering its customers a more integrated experience, will be essential as we advance our cis-targeted immunotherapies closer to patients.”

“This collaboration marks our commitment and flexibility in tailoring our offering to the specific needs of emerging biotechs,” added Jeetendra Vaghjiani, executive director of clinical development and strategic marketing of Lonza. “Our teams have built the capabilities and experience, including more complex protein formats, to help take Asher Bio’s AB359 from development into the clinic.”

Lonza and Asher Biotherapeutics have entered a manufacturing agreement for a cis-targeted IL-2 fusion protein, AB359.

Lonza and Asher Biotherapeutics to Collaborate on Manufacturing AB359

Moderna announced on April 7, 2022 that it is entering a new collaboration with IAVI, a nonprofit scientific research organization, to employ the use of messenger RNA (mRNA) technology to meet the challenge of a range of global health threats. The target diseases include HIV, COVID-19, tuberculosis (TB), and antimicrobial-resistant pathogens.

These diseases are estimated to have caused at least 95 million new infections and more than 4 million deaths in 2020 alone, according to the press release. The collaboration will aim to tackle these global health issues by combining Moderna’s mRNA platform and IAVI’s expertise in discovery and product development to advance vaccines and antibodies to be globally accessible, especially in low-income countries where the targeted diseases have higher prevalence.

mRNA technology enables more rapid productions of material for clinical testing. The companies aim to harness the speedier production to accelerate research and development, resulting for faster manufacturing as a larger scale.

"We are excited to partner with IAVI to leverage the power of mRNA and extend our commitment to global health across multiple diseases. Moderna's mRNA platform, with its speed, scale, and flexibility, is uniquely suited to tackle current and emerging pathogens," said Stéphane Bancel, CEO of Moderna, in the press release. "With our mRNA technology and IAVI's discovery and development expertise, together we have an opportunity to address persistent global health threats."

"Since our founding 25 years ago, we at IAVI have been focused on translating scientific discovery into broadly accessible solutions for global health problems,” said Mark Feinberg, MD, PhD, president and CEO of IAVI, in the release. “Moderna's proven, innovative platform has the potential to be a key that unlocks rapid production of vaccine and antibody candidates that could significantly accelerate our ability to solve the most difficult public health problems. IAVI's partnership with Moderna is a unique example of two organizations with complementary expertise and shared goals combining the best of our science to address urgent global public health needs.”

IAVI and Moderna have announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health issues.

IAVI and Moderna Partner to Tackle Global Health Priorities Using mRNA for Vaccines and Antibodies

Evonetix, a synthetic biology company, announced that it had been granted patent EP3551331B1 in Europe for its proprietary thermal control technology for DNA synthesis as well as the design and manufacture of its silicon chips. The new approach uses thermal control with semiconductor-based arrays, which are designed to offer greater accuracy and selectivity in both sequence deprotection and mismatching sequence removal.

In contrast to conventional methods that use acid deprotection to control the synthesis cycle, Evonetix intends to exert control through precise, independent control of temperature at thousands of individual synthesis sites across the surface of a silicon chip. According to an April 4, 2022 press release, this thermal control of DNA synthesis enables highly parallel synthesis and the ability to work through sequences that are hard to synthesize through methods such as acid deprotection.

“There is currently an unmet need in the synthetic biology industry for long, accurate, DNA sequences, and the ability to remove errors during assembly allows researchers to achieve longer strands of DNA and run applications such as gene synthesis, [clustered regularly interspaced short palindromic repeats], screening, and protein engineering,” said Matthew Hayes, chief technology officer, Evonetix, in the press release. “Securing this patent to cover our core technology adds further strength to our [intellectual property] portfolio and underlines Evonetix’s position as leaders in our field. Our technology will give researchers the capabilities of service centers in their own lab, accelerating the advancement of synthetic biology and opening new possibilities in this exciting market.”

Evonetix’s thermally controlled DNA synthesis technology is designed to enable highly parallel DNA synthesis in a benchtop platform.

Evonetix Receives Patent for Thermally-Controlled DNA Synthesis Technology

Roche announced on April 4, 2022 that FDA has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra/RoActemra intravenous for the treatment of COVID-19 in hospitalized adults. The treatment is for patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Actemra/RoActemra is currently approved for the treatment of COVID-19 in 16 countries, including the European Union. According to Roche, more than one million hospitalized patients with COVID-19 have been treated with Actemra/RoActemra worldwide. The treatment received Emergency Use Authorization from FDA in June 2021 and prequalification by the World Health Organization (WHO) for patients with severe or critical COVID-19 in February 2022. A decision on FDA approval is expected in the second half of 2022.

Roche is also aiming to establish a comprehensive access approach to improving the availability of its COVID-19 medicines around the world. The company is specifically focusing on providing Actemra/RoActemra via WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative to low and middle-income countries, as well as implementing an international differentiated pricing strategy designed to improve accessibility and affordability worldwide.

“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, in a press release. “More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.