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CHMP recommends ViiV’s long-acting regimen for HIV

The Committee for Medicinal Products for Human Use (CHMP) has recommended ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets) for the treatment of HIV. If approved, cabotegravir injection used in combination with rilpivirine injection will be the first complete long-acting regimen, dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1 across Europe. This treatment will offer people living with HIV an option with significantly less frequent dosing and comparable efficacy to daily oral regimens. Cabotegravir and rilpivirine injections are administered as two intramuscular (IM) injections in the buttocks during the same visit at a specialist clinic by a healthcare professional. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines. The Marketing Authorisation Application (MAA) for cabotegravir injection and tablets is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. The ATLAS and FLAIR studies included more than 1,100 participants from 16 countries. The studies demonstrated that cabotegravir and rilpivirine when injected intramuscularly in the buttocks, once-monthly, was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period. The long-acting regimen was preferred by approximately 9 out of 10 patients who switched to cabotegravir and rilpivirine long-acting in the ATLAS and FLAIR studies over their previous daily oral therapy. “Today’s positive CHMP opinion marks an important step in providing a new option that changes the treatment experience for people living with HIV across Europe,” said Deborah Waterhouse, CEO of ViiV Healthcare. “Vocabria injection used in combination with Rekambys has the potential to ease the day-to-day burden of HIV by offering significantly less frequent dosing from 365 days with oral regimens to 12 or 6 treatments per year. “Through our innovative R&D, we are now one step closer to offering an HIV medicine in Europe with a novel route of administration and dosing schedule compared to other therapies.”

4D pharma merges with SPAC in $37.6m deal

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4D pharma, the listed Leeds-headquartered pharmaceutical company, has merged with Longevity, a special purpose acquisition company (SPAC), in a deal worth up to $37.6 million. As a result of the merger, 4D pharma plans to launch a new NASDAQ-listed American Depositary Share (ADS) programme and will immediately be admitted to trading on NASDAQ upon completion. 4D pharma will become dual-listed and ordinary shares will continue to be traded on AIM. 4D pharma will benefit from the $14.6 million cash held by Longevity. This extends 4D pharma’s current operational runway into Q3 2021. In addition, 4D pharma may also benefit from the proceeds of warrants to purchase Longevity shares worth up to $23 million. It is currently planned for the merger to be completed and effective in early 2021, and 4D pharma ADSs will begin trading on NASDAQ immediately following completion. This is subject to approval of 4D pharma and Longevity shareholders, and the SEC review process. “A NASDAQ listing allows 4D pharma to capitalise on increased interest from US healthcare investors in recent years, providing access to a much larger pool of specialist capital, and increasing our global profile and exposure. NASDAQ is a very positive environment for growing, innovative biotech companies,” said Duncan Peyton, CEO of 4D pharma. “The merger accelerates and de-risks our entry into the US, while providing immediate access to additional funds to support our pipeline. The increased exposure of a US listing will also support ongoing partnering discussions across our pipeline.”

Cyted acquires Pathognomics Ltd to support expansion of digital pathology and diagnostic reporting services

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Cyted Ltd, a developer and provider of artificial intelligence technology and digital diagnostic infrastructure to enable earlier detection of disease, has acquired Pathognomics Limited, a provider of digital pathology and clinical diagnostic laboratory services. The acquisition of Pathognomics will provide Cyted an accredited laboratory environment and digital pathology technology, enabling the rapid uptake and expansion of the pipeline of novel biomarkers and artificial intelligence (AI) technology at Cyted. Cyted and Pathognomics have already worked together to set up and launch diagnostic services for the earlier detection of oesophageal cancer. Cyted and Pathognomics will now look to scale their combined diagnostic reporting services and infrastructure to further support both existing and future healthcare partners. All Pathognomics employees will now join the Cyted group, taking the Company’s total headcount from 15 to 23. Pathognomics’ Co-Founder and Laboratory Director Christopher Evagora will become Cyted’s Senior Director of Laboratory Operations, and Alec Hirst, Co-Founder and Project Director will become Cyted’s Senior Director of Business Technology. Cyted will remain headquartered in Cambridge whilst laboratory operations will continue in Huntingdon. To accommodate the expanding teams, the Company is increasing its laboratory and office space. Marcel Gehrung, CEO, Cyted, said: “We are delighted to expand our team with the acquisition of Pathognomics. We have seen great synergy in our work and values through our partnership to launch and deliver our integrated diagnostic service. Merging the two companies is the next step in fulfilling our vision at Cyted, to change lives by enabling earlier disease detection and diagnosis.” Christopher Evagora, Senior Director of Laboratory Operations, Cyted, said: “From our first conversations with Cyted, it was clear that the diagnostic technology and infrastructure being developed by the team will bring significant benefit to patient care. Over the past four years, we have established and optimised our workflow here at Pathognomics. I look forward to expanding the scope of our services to the next level with the formal merging of the two companies.” Alec Hirst, Senior Director of Business Technology, Cyted, added: “Since establishing Pathognomics in 2016 we have successfully brought digital tools to the pathology sector. We have developed, adapted, and expanded the technology that underpins our services to deliver their full potential. The ethos behind Cyted and the team’s proven track record resonated with us from day one. This opportunity will bring to the frontline the next generation of digital pathology through the implementation of artificial intelligence and machine learning algorithms in a fully digital laboratory.”