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Gilead has acquired MiroBio for $405 million.

Vicebio has emerged from stealth raising $18 million. Eleven Therapeutic has raised $22 million seed funding.

Aug 5, 2022

Gilead has acquired MiroBio for $405 million.

AUG 5, 2022 | 020

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Summary

Back from a quick summer break with all my holiday essentials: loads of cycling, great food and a sunburn. Worry not, today’s edition of Cambridge Biocapital is covering for last week too, so get your Italian mocca sorted. MiroBio was established in 2019 and has just been acquired by Gilead. It is quite busy at Sosei Heptares headquarters, and no less busy at Vertex Therapeutics. F2G lead candidate is now backed by Sofinnova in what may constitute, if approved, the first new class of anti-fungal with a novel, differentiated mechanism of action in more than 20 years. And then there were none! Three vaccines executives from GSK, including former Head of Vaccines R&D Dr Emmanuel Hanon, have left the big pharma company to launch Vicebio, a new biotech venture now backed by medicxi. Not great as Vicebio’s lead candidate is a direct competitor to GSK’s phase 3 respiratory syncytial virus vaccine. Blimey! NASDAQ-listed British companies are obliged to offer pre-emption rights if they are incorporated in England or Wales (as if they were listed in UK markets), which puts these biotechs in massive disadvantage over their peers. The British BioIndustry Associationis doing great in trying to enable change regarding pre-emption rights. This week: Blur. Let’s dive in!

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Startup Funding News

University of Oxford-spinout MiroBio has been acquired by Gilead Sciences(NASDAQ: GILD) for $405 million. The acquisition provides Gilead with MiroBio’s proprietary discovery platform and pipeline of immune inhibitory receptor agonists., including a PD-1 agonist (MB151) and its lead candidate (MB272), an antibody that acts as agonist of the immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA), currently in Phase 1. Their proprietary platform I-ReSToRE (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to discover and develop agonist antibodies against immune receptors. Overall, the acquisition strengthens Gilead’s portfolio of checkpoint agonist antibodies for patients with autoimmune disease. The transaction is still subject to expiration or termination of the waiting period under the Antitrust Improvements Act and other customary conditions. MiroBio was founded in 2019 based on over 15 years of research from the laboratories of Professor Simon Davis and Professor Richard Cornall. Recently the company closed a $97 million Series B and it is backed by Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.

Cambridge and Tel Aviv-based Eleven Therapeutics has raised $22 million in seed round in equity and grant funding. The round has been participated by the Gates Foundation, Kindred Capital, NFX Bio (former TechBio), Harel Technology Investments and Entrée Capital plus an Innovate UK Smart Grant. The proceedings of the round will be used to advance the company’s proprietary AI-enabled drug discovery platform capable of designing siRNAs with improved half life. In addition, the platform will be scaled up to to explore the structure-activity relationship of siRNAs leveraging combinatorial chemistry and molecular dynamics. The platform is target-agnostic but currently focuses on respiratory diseases. The startup’s flagship invention is the small-combinatorial, small interfering RNA (SCSI-RNA), a fully programable molecule designed for an improved delivery, durability, and efficacy. Eleven Therapeutics was co-founded in 2020 by Yaniv Erlich (CEO) and Dr Greg Hannon (CSO), currently Director of the Cancer Research UK Cambridge Institute at the University of Cambridge, and pioneer en the field of RNAi.

London-based Vicebio has emerged from stealth and has raised $18 million seed funding from medicxi. The startup was founded in 2019 to tackle life-threatening respiratory viral infections using their proprietary technology Molecular Clamp. The technology was developed at the University of Queensland (UQ) and licensed to Vicebio by UniQuest, UQ’s commercialisation company. Dr Emmanuel Hanon (ex-Head of Vaccines R&D at GSK) has been appointed as Chief Executive Officer. Molecular Clamp technology can stabilise viral glycoproteins in its pre-fusion conformation to deliver protective and ready-to-use fully liquid vaccines. Stabilisation is done by adding a tag that stabilises a wide range of complex viral proteins and clinical proof of concept (PoC) has already been achieved for SARS-CoV-2. Stabilisation allows these viral proteins to achieve the optimal conformation for high immunogenicity, stability, and manufacturing productivity. Vicebio is progressing its lead candidate VXB-211, a respiratory syncytial virus vaccine, through preclinical studies to reach Phase 1 PoC clinical study during the second half of 2023. Two former GSK Vaccines Executives have also joined Vicebio, Dr Giovanni Della Cioppaas Chief Medical Officer and Dr Jean Smal as Chief Technology Officer.

F2G has raised $70 million financing to advance the development and commercialization of a novel antifungal agent. The financing was co-led by new investors Forbion and Sofinnova Partners and participated by existing investors (Novo Holdings, Morningside Ventures, Cowen Healthcare Investments and Advent Life Sciences). The proceedings of the financing will enable F2G to advance late-stage development and commercialisation of Olorofilm, a novel oral antifungal therapy indicated for invasive aspergillosis (IA) and other rare mold infections. Olorofilm inhibits the de novo pyrimidine synthesis pathway, a novel and unique mechanism of action. F2G is a biotech with operations in the UK, US and Austria. The company has developed a pipeline of new antifungal agents called orotomides. If Olorofim is approved, it would constitute the first new class of anti-fungal with a novel, differentiated mechanism of action in more than 20 years.

Oxford-based iLof has raised $4.1 million seed funding. The round was led by FabCapital and participated by the Microsoft’s venture fund M12, Quiet Capital, Lunar Ventures, Alter Venture Partners, re.Mind Capital, Fluxunitand Charlie Songhurst. iLof (Intelligent Lab on a Fibre) was founded by Mehak Mumtaz (COO) and Luis Valente (CEO) and has secured $8 million in funding to date. The company is developing a photonics and AI- powered platform to accelerate personalised drug discovery and development. The company analyses blood samples from patients using optical lasers which excite relevant targets in the samples. Then, their proprietary AI platform reads through the optical signal and creates a molecular profile, a set of biomarker and biological profiles, which can be then leveraged to improve patient screening, diagnostics, monitoring and, eventually, personalised treatment. The pipeline is target agnostic, requires less than 10 seconds after sample extraction and requires no consumables. The proceedings of the round will be used to speed up partnerships in pharma and biotech and expand their platform.

Nottingham’s School of Chemistry spinout Alevin Therapeutics has raised £1 million pre-seed funding. The round has been co-invested by o2h Ventures and the University of Nottingham’s Innovation Fund. Alevin Therapeutics was founded in March 2022 by Thomas McInally (ex-AstraZeneca, Fisons) and Prof Chris Moody (ex-Roche, former Sir Jesse Boot Chair of Chemistry) experts in the field of RGD integrins and it is working to develop a small molecule RGD integrin inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF), kidney disease and related cancer. The proceedings of the round will be used to advance in the discovery phase and de-risk pipeline assets. The company has two preclinical candidates, a αvβ6 integrin inhibitor delivered as inhaled drug for IFP, and a pan-integrin inhibitor delivered as oral drug for liver and kidney fibrosis.

BIOS Health has secured $1.4 million grant funding from MEDTEQ+, the pan-Canadian Consortium for Industrial Research and Innovation in Medical Technology, the Ministry of Economy and Innovation of Quebec, Mitacs Accelerate and the Healthy Brains, Healthy Lives program at McGill University. The proceedings of the funding will be used to develop an AI-controlled closed-loop neuromodulation system for chronic cardiac conditions in collaboration with the University of Montreal, McGill University and Mila Research. BIOS is leveraging machine learning to link cardiac activity to neural data and identify the neural biomarkers of cardiac activity.

The British Heart Foundation has granted £30 million to CureHeart, a project led by the University of Oxford and Harvard Medical School. CureHealth research focuses on designing and delivering gene therapy for inherited heart muscle diseases that can silence or correct mutated genes and aims to bring base and prime editing to heart diseases for the first time. Every week in UK, 12 people under 35 lose their lives due to sudden cardiac arrest. CureHeart is led byProf Hugh Watkins. This funding constitutes one of the largest non-commercial grants ever given in the UK and a once in a generation opportunity many families.

International research commercialisation collaboration TenU has secured £4 million, including a £2.5 million grant from Research England, endorsed by the Department for Business, Energy and Industrial Strategy. TenU members are the research commercialisation offices of 10 top universities: Cambridge (UK), Columbia (USA), Edinburgh (UK), Imperial College London (UK), Leuven (Belgium), Manchester (UK), MIT (USA), Oxford (UK), Stanford (USA) and University College London (UK). The funding will be used to support growth of university spinouts and set up various training programs and advocate work over the next five years.

Digital health startup Cera Care has raised $320 million in equity and debt. The round has been participated by Schroders Capital, Jane Street Capital, KairosHQ, and Vanderbilt University. The proceedings of the round will be used to increase the platform outreach from 15,000 to 100,000 patients. Cera hopes to reduce NHS burden, freeing beds, and care capacity, by predicting patient health deterioration before it occurs. Currently, Cera provides services such as prescriptions deliveries and at-home nursing care.

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Investment Funds & Accelerators

Carlyle Group (NASDAQ: CG) has completed acquisition of Abingworth and has announced leadership team. Together, Carlyle and Abingworth will operate across the full risk-return spectrum of life sciences and healthcare investing. Kurt von Emster has been appointed as Managing Partner and Head of Abingworth Life Sciences; Bali Muralidhar has become Managing Partner and Chief Investment Officer, Tim Haines continues as Managing Partner, and Genghis Lloyd-Harris and Natalie Mount have become a Venture Partner. Carlyle and Abingworth have set up Launch Therapeutics, an operating company that partners with biotechs and pharma at late-stage development of clinical assets. Launch Therapeutics is led by Anshul Thakral, Carlyle Operating Executive, Abingworth Venture Partner, and former Chief Commercial Officer of PPD.

Cancer Research Horizons has expanded the alliance with Deep Science Ventures to double down on cutting-edge ventures across oncology. It builds on the success from Enedra Therapeutics, Stratosvir and Neobe Therapeutics. In addition, Children’s Tumor Foundation is joining the alliance, hoping to create more opportunities in neurofibromatosis and deep re-profiling of the immune system within new specific immunotherapy-resistant contexts. Each venture launched will be led by a Deep Science Ventures founding analyst and overseen by a joint steering committee.

Illumina Ventures is expanding operations in Europe. Illumina Ventures is is an independently managed venture firm in strategic partnership with Illumina. The firm has appointed Arnaud Autret, PhD, MSc as Principal and Head of European Operations (ex-Investment Director at M Ventures, the Merck KGaA venture capital arm; ex-Seventure Partners, ex-KPMG), William Byrne, PhD as Associate, and Ronan Byrne and Ivan Coulter, PhD, BSc, as Venture Advisors. Illumina Ventures will double down in European early-stage startups, mainly focusing on clinical diagnostics and life science research tools, as well as therapeutic platforms, digital health initiatives and genomic applications.

Flashpoint Venture Capital has closed an oversubscribed $100 million fund for its VC III Fund. Investment has come from a series of institutional and private investors, including Hungarian fund manager Széchenyi Funds, which has contributed to the fund with $20 million. The Fund will deploy capital between $1 and $4 million, and up to $15 million per startup, in late-seed and Series A startups across UK, Europe and Israel. Fellow London venture capital firm Concept Ventures targets British pre-seed startups with its £50m fund. Flashpoint was founded by Michael Szalontay (General Partner) and currently has $450 million assets under management.

The UK Innovation and Science Seed Fund (UKI2S) has raised £37 million backed by UK Research and Innovation(UKRI), Biotechnology and Biological Sciences Research Council (BBSRC), Natural Environment Research Council, Defence Science and Technology, UK Atomic Energy Authority, BEIS, UK Health Security Agency, Animal and Plant Health Agency, National Physical Laboratory and the James Hutton Institute. UKI2S is managed by Midven Ltd which is part of Future Planet Capital Group (FPCG). FPCG manages $400M for institutional investors and has backed +180 companies across the globe. The funding will be used to invest on early-stage firms from within UK innovating on synthetic biology, knowledge assets, fusion energy, defence and security, publicly funded research centres.

The P4 Precision Medicine Accelerator has released the successfully selected startups to take part in the program. These are: Cansor (prostate cancer screening), Dr Julian Medical Group (digital mental health), Elixir AI (remote paediatric diagnosis), Holly Health (digital tool for targeting health behavioural changes), Inovia Bio (AI-SaaS to accelerate drug development), Migration Biotehrapeutics (new class of precision therapies for oncology and regenerative medicine), Neucruit (data-driven clinical recruitment tool), StoreGene (library of report templates for whole genome data), Third Eye Intelligence (data collection in ICUs to predict organ failure), and Turing Biosystems (hybrid AI platform for optimised clinical trial design). The P4 Precision Medicine Accelerator was launched by Prof Phil Beales, Professor of Molecular Genetics at UCL, and the non-profit Capital Enterprise. The program is funded by Lambeth Council’s Economic Resilience Fund and delivered in partnership with MedCity.

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Public Policy & Regulation

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Startup & Science News

Cambridge-based Neophore has entered a collaboration with the Memorial Sloan Kettering Cancer Center (MSK). The aim is to determine the potential of Noephore’s proprietary technology in enhancing tumour immunogenicity and ability to induce tumour immunity. Neophore’s first-in-class DNA mismatch repair inhibitors (MMRi) are compounds targeting components of the DNA mismatch repair pathway (MMR). These MMR modulators increase the tumour mutational burden in cancer cells. This, in combination to high neoantigen presentation can potentially reawaken the anti-tumour immune response and leverage sensitivity to immune checkpoint blockade.

Edinburgh-based RoslinCT and Lykan Bioscience have entered into a business combination agreement to form a global cell and gene therapy Contract Development and Manufacturing Organisation (CDMO). The group will offer development expertise and cGMP manufacturing for a range of autologous and allogeneic cell therapies, as well as gene editing and induced Pluripotent Stem Cell (iPSC) capabilities. Global Healthcare Opportunities (GHO), a European specialist investor in global healthcare, announced earierl in 2022 an investment in RoslinCT. As part of the merge, GHO has become the majority shareholder in Lykan and is backing the funding of the combined entity. Former majority investors in Lykan, WindRose Health Investors, have reinvested in the new combined group along with Lykan Management.

Owkin has partnered with the Francis Crick Institute and the Royal Marsden NHS Foundation Trust to develop artificial intelligence-enable tools to investigate how renal cell carcinoma (RCC) evolution links to differences in histological characteristics. RCC is the most common kidney cancer and rates are increasing due to ageing population, increasing obesity and smoking. Artificial intelligence will be used to analyse over 1000 tissue samples from 100 different tumours. The project aims to improve the interpretation of routine kidney cancer biopsies and help the transition to precision medicine. Owkin was co-founded in 2016 by Thomas Clozel MD (former Assistant Prof in clinical onco-haematology) and Gilles Wainrib (expert in the field of machine learning in biology). The company has raised over $300 million and in November 2021 raised $180 million investment from Sanofi.

The NHS-Galleri trial carried out by GRAIL and the NHS England has completed enrolment of 140,000 participants, the largest study of multi-cancer early detection trial. The NHS-Galleri is a prospective, blinded, randomised controlled trial where participants will provide a blood sample during three annual visits to a mobile health clinic—at baseline, year 1 and year 2. Participants in the intervention arm will have their blood tested by GRAIL’s Galleri test, a multi-cancer early detection test could detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. If a cancer signal is detected, the Galleri test could predicts the cancer signal origin and location and help guide the next steps to diagnosis. Galleri is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. The study is sponsored by GRAIL and is being run by The Cancer Research UK and King’s College London Cancer Prevention Trials Unit (UK), in collaboration with eight cancer alliances in England.

Los Angeles-based Calibre Scientific has acquired Stansted, UK-based Agar Scientific, a 50-year old global manufacturer and distributor of microscopy consumables and equipment. Calibre enhances its overal product offering in the structural biology space and, together with the Molecular Dimensions business unit, in particular, expands operations in the growing fields of electron microscopy and cryogenic electron microscopy. The financial terms of the acquisition have not been disclosed.

Monument Therapeutics have presented positive preclinical data for their lead candidate (MT1988) indicated for cognitive impairment associated with schizophrenia. These data represent proof of mechanism for the company’s biomarker and drug combination, indicating positive pro-cognitive effects prior to reaching the clinic. Monument Therapeutics is leveraging their proprietary non-invasive biomarkers to reduce patients heterogeneity and identify those with homogenous underlying neurobiology, which are then matched with appropriately targeted compounds.

EptivA Therapeutics has become a clinical stage company upon partnering with To Better Days (TBD). EptivA has signed a licensing agreement with TBD for worldwide exclusive rights to develop and commercialise their proprietary cholecalciferol patch unique dosage form, which produces an improved half-life profile. EptivA was founded in 2020 by Mark Field (ex-Senior Vice President for Pain R&D at Grünenthal) and Harald F. Stock (ex-CEO of Grünenthal, biotech co-founder and board member

iLoF has been awarded the LifeArc Advise & Connect Innovation Award, becoming its first ever awardee. The funding will enable iLof to leverage their technology for COVID-19 evolution forecasting to help screen and stratify patients for targeted treatment and monitoring.

The Wellcome Sanger Institute has launched the Genomic Surveillance Unit (GSU), a global hub for genomic surveillance to help tackling infectious diseases. GSU will accelerate the generation of genomic data on a large scale and initially will focus on bringing forward the Institute’s MalariaGEN and the COVID-19 surveillance projects and implementing scientific pipelines with new partners.

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Talent & Operations

Cambridge-based Closed Loop Medicine has appointed David Van Sickle, PhD as Non-Executive Director and Simon Ramsden CA, as Chief Financial Officer. Dr Van Sickle was co-founder and CEO of Propeller Health (integrated software/device for respiratory disease management, acquired by Resmed in 2018) and was founding board member of the Digital Therapeutics (DTx). Ramsden joins from EUSA Pharma where he was Vice-President Head of Global Finance. Prior to this, he spent a decade at GSK, recently as Finance Director of Consumer Health R&D. Closed Loop Medicine is a precision medicine company developing personalised dose optimisation using their proprietary technology platform, currently focusing on insomnia and hypertension. The company has raised over £22 million to date and is backed by Ananda Impact Ventures, BGF, LifeArc, LongWall, Meltwind, IQ Capital, Downing Ventures, and Cambridge Angels.

Oxford-based Grey Wolf Therapeutics has appointed Brett Carter as Non-Executive Director. Mr Carter will be part of the Board of Grey Wolf’s wholly owned Australian subsidiary. Mr Carter joins from Australia’s Cancer Therapeutics Cooperative Research Centre (now Canthera Discovery) where he was Chief Executive Officer and led licensing two oncology programs to Pfizer ($670 million deal in total). Prior to Canthera Discovery, he held several roles at GSK for over 11 years and recently was Director at the Global Corporate Transactions division. Grey Wolf Therapeutics is a drug discovery and development company spearheading a first-in-class immuno-oncology approach inhibiting the aminopeptidases (ERAP1/2) located at the endoplasmic reticulum. ERAP1/2 play a key role in the antigen presentation pathway. By inhibiting these, novel neoantigens are generated thus mobilising an entirely novel T cell response against the tumour and bypassing the challenge of T cell exhaustion. Their lead candidate, an ERAP1 inhibitor, is expected to enter the clinic in Q4 2022/Q1 2023.

Cambridge-based Stroma Bioscience has appointed Dr John Beadle as Executive Chairman. Dr Beadle was former founding CEO at PsiOxus Therapeutics, a clinical-stage cancer gene therapy company) and was co-founder, Board Director, and Chief Medical Officer at Powermed (Acquired by Pfizer in 2006). He was Vice President of Global Medical Operations at GSK and Vaccines Site Head at Pfizer. Stroma is currently backed by Start Codon.

AviadoBio has appointed Dr David Cooper as Chief Medical Officer. Dr Cooper joins from uniQure (VP Clinical Development). Previously he was at Novo Nordisk where he contributed to the strategic clinical development. AviadoBio is a pre-clinical stage company developing gene therapies for neurodegenerative disorders, focusing on frontotemporal dementia and lateral sclerosis.

Purespring Therapeutics has appointed Dr Pille Harrison as Vice President of Clinical Development, Dr Aoife Watersas Medical Director, Nick Cetateanu as Head of Operations and Andreea Luras as Programme Manager. Dr Harrison (ex-Galapagos, Argenx) joins from being Vice President of Clinical Development at Alpine Immune Sciences. Dr Waters is a specialist in children’s kidney disease with 20-year experience in paediatric centres in UK, Ireland, and Canada. Nick Cetateanu has held a variety of senior roles across cell and gene therapy and joins from being senior director at Orchard Therapeutics. Andreea Luras (ex-Autolus, GSK, AstraZeneca) joins too from Orchard Therapeutics.

Achilles Therapeutics has appointed James Taylor as Chief Business Officer (CBO) and Prof Cassian Yee, MD to the Scientific Advisory Board. Taylor joins from Sosei Heptares where he was CBO and bring over 25 years of experience building global platforms and asset deals in pharma and biotech. Dr Yee is Professor of melanoma medical oncology at the University of Texas MD Anderson Cancer Center, and Director of their Solid Tumour Cell Therapy (STCT) program.

Domainex has appointed Dr Eddy Litter as Executive Chairman. Dr Litter was the company’s CEO from 2008 to 2016 and Non-Executive Chairman since 2020. He led ReViral series B fundraise in 2018 ($55 million) and played a key role in ReViral acquisition by Pfizer earlier this year. Domainex is an integrated medicines research service partner and provides customized biology and chemistry services to advance the disease research, from target expression to pre-clinical development candidate nomination. Recently, Domainex has opened a new additional facility at the Unity Campus (Sawston, Cambridgeshire).

Nuclera has unveiled their new Cambridge global headquarters in partnership with Lateral, a UK-based real estate investment firm. The new location will combine the three existing Nuclera facilities into a single 30,000 sq ft unit at the One Vision Park. The new headquarters, due to open in late 2022, will allow expanding operations and accelerate the development of Nuclera’s eProtein desktop bioprinter, for which the company recently raised $58 million Series B. JLL and SMB advised Lateral, and Taylor Wessing acted for Nuclera.

Five Alarm Bio has appointedDr Janette Thomas as Chief Executive Officer. Dr Thomas has held senior and leadership roles at Atlantic Healthcare PLC and Horizon Discovery PLC. Five Alarm Bio is developing small molecule candidates in the age-related diseases field by targeting “the chemical damage associated with age” (sic).

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Pharma Affairs

Cancer Research UK and Sosei Heptares have entered a Clinical Trial and Licence Agreement (CTLA) to advance cancer immunotherapy candidate into a first-in-human clinical trials. Under the CTLA, Cancer Research UK’s Centre for Drug Development will sponsor, design, and execute a Phase 1/2a clinical trial of HTL0039732, whereas Sosei Heptares will be responsible for CTA enabling activities, including GLP toxicology, IMP manufacture and other necessary pre-clinical studies. HTL0039732 will be tested as both a combination therapy and a monotherapy in the context of a range of cancers including microsatellite stable colorectal, gastroesophageal, head and neck and castrate resistant prostate cancer. To date, the Cancer Research UK Centre for Drug Development has taking over 140 potential new anti-cancer agents into clinical trials in patients. HTL0039732 is an EP4 antagonist binding and blocking a specific type of prostaglandin receptor called EP4. Prostaglandin E2 (PGE2) mediated signalling through EP4 can trigger cancer cells to evade the immune system and influence tumour cell growth. Blocking EP4 could potentially improve patient survival, especially if used in combination with another immunotherapy.

More on Sosei! AbbVie has entered a new multi-target collaboration with Sosei Heptares to discover neurotargets and develop and commercialise novel medicines for neurological diseases. The deal starts with $40 mil­lion up­front and further $40 mil­lion in near-term mile­stones but biobucks shall add up to $1.2 bil­lion. The collaboration is part of a partnership established in June 2020 focused on inflammatory and autoimmune disease areas. The specific targets or diseases have not been disclosed. Sosei will carry out the research and development activities up to IND filling, and AbbVie will move the candidates through clinical trials.

London-headquartered Freeline Therapeutics (NASDAQ:FRLN) has published new data (phase1/2) on long term results of their single shot haemophilia B AAVS3 gene therapy (FLT180a). 9/10 adult patients-maintained factor IX activity at a median follow up of 27.7 months. These positive results might boost their case with FDA, as Freeline prepares for Phase III trial with a larger population in mid-2023. Risk of thrombosis will be evaluated closely as Pfizer voluntarily paused its haemophilia A gene therapy study (2021) after patients experienced abnormal levels of factor VIII. Freeline observed one patient experiencing arteriovenous fistula thrombosis. Currently, patients from haemophilia B need to take weekly injections of factor IX to ensure normal blood clotting in the event of an internal or external cut on their bodies.

Arecor Therapeutics (AIM:AREC) has entered a conditional agreement to acquire Northampton-based Tetris Pharmafor £6 million. Arecor would hand over 651,726 shares worth just over £2 million, £2 millions of Tetris’ liabilities, and £4 million in performance-based deferred payments (revenue and EBITDA performance targets). Tetris Pharma is a commercial-stage pharmaceutical company with operations across UK and UE. Tetris’ lead product, Ogluo, is a pre-filled glucagon 2-step injectable pen for people at severe risk of hypoglycaemia, which would fit into Arecor’s diabetes portfolio.

Now, Vertex Therapeutics! The company (NASDAQ: VRTX) has been granted permission from the FDA to advance its non-opioid pain killer (VX-548) into Phase 3. Compared to placebo (phase 2 data), VX-548 offered rapid relief of pain intensity over 48 hours after bunion-removal or tummy-tuck surgery. VX-548 is a selective Nav1.8 inhibitor which currently has FDA breakthrough tag for patients with moderate to severe pain and permission to progress to phase 2 trial for treating diabetic peripheral neuropathy pain. There is a pressing need for new non-opioid painkillers. SVB Securitiesanalysts have projected VX-548 could reach $510 million in 2030 (estimated risk-adjusted sales). More on Vertex: they have signed an agreement with Verve Therapeutics (NASDAQ: VERV) to develop in vivo gene editing to for a single undisclosed liver disease. Verve will perform the discovery, research and certain preclinical developments, and Vertex will be responsible for development, manufacturing, and commercialisation. Verve will receive $60 upfront payment, including $35 million equity investment. Verve will also be eligible for $66 million in success payments, up to $340 million in development and commercial milestones and tiered royalties on future net sales.

e-therapeutics (AIM: ETX; OTCQX; ETXPF) has filled in eight patent applications in the US related to their proprietary GalNAc-siRNA technology to silence potentially any gene in liver hepatocytes. e-therapeutics is a drug discovery company developing RNAi-based therapeutics currently focusing on liver related diseases.

Roche has announced big changes in leadership: Christoph Franz is stepping down from Chairman of the Board and will be substituted by current CEO, Severin Schwan, after 15 years at the helm of the company. Thomas Schinecker(former Head of Diagnostics Unit) will become the new CEO.

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Podcasts & Interesting Reads

The British BioIndustry Association (BIA) has secured a change in pre-emption rights to allow better fundraising conditions. For those lucky enough to remain ignorant about pre-emption rights, some context. Pre-emption rights allow for existing shareholders to exert a first refusal. When a company issues new shares, current shareholder holding pre-emption rights are entitled to buy these in proportion to their existing shareholding before such new shares are offered to other investors (Companies Act 2006). This is not that much of an issue (although it could be), when there are 3 shareholders, but it becomes an expensive slow and opportunity consuming process to ask each and every single shareholder of a publicly listed biotech whether they want to exert their pre-emption rights. This issue becomes more obvious due to the lack of pre-emption rules in the US, meaning a) listing and expanding a company in US markets is easier and faster and b) US investors can potentially be put off from investing in UK-listed biotechs. NASDAQ-listed British companies are obliged to offer pre-emption rights if they are incorporated in England or Wales. Currently, companies can ask their shareholders to waive their pre-emption rights up to a threshold, usually 10% although it is not a legal limit. Now, the Government has published an official recommendation to raise such threshold to 75%. Dr Martin Turner (Head of Policy and Public Affairs at BIA) has written a piece on this.

Looking for lab space? Good luck, darling. Life science and tech startups have taken up 76% of the newly available office and laboratory space in Cambridge (192,000 sq ft) during the first half of 2022. According to a report from Savills and another one from Bidwells, there is essentially zero availability of existing fitted lab space until at least 2023/ 2024. Other developments to be completed over 2023 include 3 new laboratory buildings (88,000 sq ft) at the Howard Group’s Unity Campus, a new office area at M&G and Wrenbridge’s Brooklands scheme (67,000 sq ft) and an expansion of the laboratory space (100,000 sq ft) at Cambridge Biomedical Campus. Extra space adjacent to Cambridge North is also set to be available at the end of this year. In 2024, more space is set to be available in Granta Park and Chesterford Research Park (57,000 sq ft laboratory space). More on new life sciences lab space opportunities here. Efforts are (allegedly) being made to level up the country and de-centralise life sciences and tech from the London-Cambridge-Oxford area. Earlier this year the Government scrapped a plan to turn Oxbridge area into a tech rival (sic) to Silicon Valley for not meeting the levelling up policy. Meanwhile, there is no space, neither here nor there.

In 2021, the FDA’s Center for Drug Evaluation and Research approved 50 drugs. This study investigated the proportion of these approvals that can be retrospectively explained based on publicly available human genetic information. It turns out i33 out of the 50 FDA-approved drugs (66%), the genes coding for their primary assigned targets (or for proteins that are known to physically interact with these targets) have been previously associated in some way with the indication for which the drug is approved or a closely related phenotype.

Jason Foster from Ori Spotlight Podcast has talked to Mike Paglia, COO of ElevateBio (former Vice President of CMC Operations at Oncorus and Senior Director of Technical Operations and Head of Cellular Process Development and Manufacturing Operations at bluebird bio). ElevateBio is a centralised R&D and manufacturing company developing innovating in the space of cell and gene therapy.

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Beyond Biotech

This week's song is

Parklife

August is the quintessence of summer. It has something nostalgic and something psychedelic. Just like this week’s song: Parklife, a must from the 90’s.

Featuring

Bikes for Ukrainians

Latest Government Figures show that 735 visas have been issued for Ukrainians in South Cambridgeshire. Bikes for Ukrainians is a free-bike scheme organised by the District Council to help refugees to settle and commute aroudn the region. The Council provides them with details of a free Bikeability cycle training course, which includes a translator. More donations of bicycles are needed, especially ladies cycles. Bicycles, helmets, and bike parts in reasonable conditions can be donated and brought to TAG Bikes at Huntingdon Community Centre, 12a Ambury Road, Huntingdon PE29 1JE.

Talk up the news

If you are a company or startup and want to spread the word about your recent funding round, celebrate your latest scientific achievement, or are seeking investment, do reach out.

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July 22, 2022

Oxford Science Enterprise raises £250 million fund. Catherine Lewis La Torre appointed CEO at British Patient Capital. RxCelerate launches RxNfinity platform.