Boxing Day! If you need a break from trying to get hold of all the bits of wrapping paper, Cambridge Biocapital is here to bring you the last round of news of the year in the UK biotech ecosystem. Santa knows how to please a girl and I have got cycling kit. Some other companies have also got great news. Adaptimmune has announced Biologics License Application for its TCR T-cell therapy in what can potentially become the first approved engineered TCR T-cell therapy for a solid tumour;  RQ Biotechnology has entered the clinic, and F2G has achieved FDA Filing Acceptance of New Drug Application. If you are having a think over the holiday period about job prospects, know that Martlet Capital is hiring and so is the Cambridge Department of Biochemistry. Now, Britain consumes more than 95 million cups of coffee per day (and allegedly 5% of these cups are directly linked to me). Glasgow-based Revive Eco has raised investment to extract natural valuable chemicals from coffee grounds to create a palm oil alternative. More on mining, Carlyle Group is struggling to raise the $22 billion fund by March 2023, more to follow. The single largest public grant for cellular agriculture in the world has just been awarded… in Finland! Also, a statue of Henrietta Lacks is going to replace the Confederate General Robert E Lee’s one. It was about (damn) time. Jointly developed by Sanofi and GSK, the first and only protein-based variant COVID-19 booster vaccine in Great Britain and the European Union has just been approved. More good news for patients,  AstraZeneca’s has been approved in the European Union as 1st-line treatment for patients of metastatic castration-resistant prostate cancer. The UK’s Competition and Markets Authorityis not happy about Cochlear planned acquisition of Oticon Medical and is raising anti-competition concerns. Former Senior Vice President of Neurosciences at GSK and former Vice President of Neurosciences at Pfizer Dr Atul Pande has joined Pangea Botanica’s Board of Directors and SV Health-backed Mestag Therapeutics has appointed Prof Ton Logtenberg as Chair of the Board. This week, music by The Cardigans and arts by Chris Killip. Let’s dive in!

A housekeeping note: if news bloom over the New Year, the newsletter will be here on January, 2. Alternatively, it will be on the 9th. At some point in April, we will be celebrating the first anniversary of Cambridge Biocapital and I am already working on ways to keep it growing. If you have suggestions, please do reach out, (good) coffee is on me. Last, due to email clients (Outlook, Gmail, etc.) being particular about newsletters, they may be sending your friendly Biocapital to the Spam or Promotions folder. If you are not receiving the newsletter regularly, worth checking there. Also, it makes a huge difference to me personally and to the project if you save this email address as a known one. Thank you for reading after so many weeks and, friends, happy new year to you all.

Glasgow-based Revive Eco has raised a £375,000 round. The investment was led by Gabriel Investment Syndicate and participated by Scottish Enterprise and the University of Strathclyde. The proceedings of the round will be used to grow the engineering team and expand production from the lab to industrial scale. Revive Eco has developed a patent-pending process to extract high-value natural chemicals from coffee grounds to create a palm oil alternative for the pharmaceutical, food, cosmetics and chemistry industry. Fergus Moore and Scott Kennedy launched Revive Eco in 2019 and received £235,000 of funding from Zero Waste Scotland, the Stirling-based non-government organisation. In addition, John Waddell, former CEO of Archangels, has been appointed as Chair.

Merck and Cancer Research UK-spinout iOnctura has raised €17.5 funding from the European Investment Council’s (EIC) Accelerator Program to develop IOA-289 for pancreatic cancer. IOA-289 is a a first-in-class autotaxin inhibitor originally designed and synthesises in Cancer Research Horizons’s Therapeutic Innovations Labs. IOA-289 was licensed to iOnctura in 2019. The proceedings of the funding will be used to support iOnctura’s clinical program for IOA-289. Early December, the company announced the first patient was dosed in a Phase Ib clinical trial of IOA-289 in metastatic pancreatic cancer. The Phase Ib AION-02 study (NCT05586516) is a dose-escalation study of IOA-289 in combination with standard-of-care gemcitabine/nab-paclitaxel chemotherapy in first-line metastatic pancreatic cancer.

Applications for the Francis Crick Institute and **Bioindustry Association’**s PULSE Programme are now open. PULSE is a free three-day leadership and entrepreneurship training programme for aspiring entrepreneurs and first-time CEOs looking for practical advice, support and feedback from established leaders in life sciences. Applications for the 2023 cohort will close Sunday 22nd January 2023.

Ian Walmsley, Imperial College Provost and Chair and co-founder of ORCA Computing, has written a piece on how to tackle the universities’ innovation dilemma. The Russell Group, an alliance of 24 leading UK universities has set out a proposal for a deep-tech seed fund, backed by a one-off investment from government.

The Financial Times reports U.S. buyout group Carlyle Group is struggling to raise the $22 billion fund by March 2023. Carlyle has asked its investors for an extension until the end of August, 2023 and would have raised $17 billion for the fund so far.

Cambridge-based Martlet Capital is hiring an Investment Manager in Deep Tech. Martlet is a pre-seed and seed-stage investor and has invested in more than 65 companies so far, including Porotech, AI VIVO, Qkine, and Kalium Health. Deadline: February 3, 2023.

London-based RQ Biotechnology has entered the clinic with AZD3152, the first of its discovered monoclonal antibodies to prevent COVID-19 in vulnerable patients. AstraZeneca licensed AZD3152 from RQ Bio in May 2022 and the trial will commence with the with the start of AZ’s SUPERNOVA Phase I/III trial of AZD5156 (a combination of AZD3152 and cilgavimab) in pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents 12 years of age or older with conditions that cause immune impairment. The launching has triggered a $5 million milestone payment to RQ Biotechnology. AZD3152 was isolated from vaccinated volunters after they had an Omicron-BA.1 infection and has neutralising activity across all known SARS‑CoV-2 variants.

Manchester-headquartered F2G has announced FDA Filling Acceptance of New Drug Application for Olorofilm. The company has requested approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited and defined population with invasive fungal infections and limited or no treatment options. These include aspergilllosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis. Submission is based on positive data from ongoing Phase 2b open-label study of oral Olorofim in 100 patients. Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA and works leveraging fungal cell death inhibiting the dihydroorotate dehydrogenase (DHODH), an enzyme in the pyrimidine synthesis pathway.

Jason Chin’s lab at the MRC-LMB has published pivotal research on cell based synthesis of non-natural peptide and depsipeptides (peptides with one or more ester bonds) macrocycles. The team has achieved cellular, ribosomal synthesis of a wide range of macrocycles, an under-explored class of peptides with important therapeutic potential. Constructive.bio, a techbio startup that span out of Chin’s lab, will leverage these findings to discover sustainably sourced bio-polymers for various applications.

University of Birmingham’s researchers Prof Dr Julie Rayes and Dr Martina Colicchia (Birmingham Platelet Group) have identified a novel mechanism for platelet activation in pathogenic blood clotting. It comprises the platelet receptor glycoprotein I alpha (GPIbα), and an anti-microbial protein S100A8/A9, which is released from activated immune cells. The mechanism is not blocked by classical anti-platelet drugs currently used to treat arterial thrombosis and is distinct from the well-described ‘clotting cascade’. The University of Birmingham Enterprise has filed a patent application covering the targeting of the S100A8/A9-GPIbα axis in the treatment and prevention of thrombosis in chronic inflammatory and thrombotic diseases and is now seeking partners for commercial development or licensing.

The Antibody Alliance Laboratory is a collaboration between Cancer Research Horizons and AstraZeneca. This article explores how the partnership has benefited Richard Gilbertson’s long term mission to improve the lives of childhood brain cancer patients.

The UK’s Competition and Markets Authority has raised concerns on Cochlear’s plan to acquire Oticon Medical, a Demant subsidiary. A press release indicated “90-100% share of the bone conduction solutions market in the U.K.”. An in-depth inquiry is ongoing.

The Government has identified five key industries to target for growth (digital technologies, green industries, life sciences, advance manufacturing and creative industries) and has appointed industry leaders to lead the Chancellor plan. The project is led by the government’s chief scientific adviser Sir Patrick Vallance. On the tech/bio appointments, Matt Clifford (Chair of the Advanced Research and Invention Agency) and Priya Lakhani OBE (AI Council member) will oversee the artificial intelligence sector; Sir John Bell (member of the board of directors at Genomics England) and Camilla Fleetcroft (Eclevar UK) will lead the life science division; and Jane Toogood (CEO of catalysts technologies at Johnson Matthey) will manage green industries.

Cambridge-based Mestag Therapeutics has appointed Prof. Ton Logtenberg as Chair of the Board of Directors. Prof. Logtenberg is founder and former President and CEO of Merus (NASDAQ:MRUS), founder and ex-CEO of U-BiSys, which merged with Introgene to become Crucell and then was acquired by Johnson and Johnson in 2011 for $2.4 billion. In addition, Prof. Houman Ashrafian, Managing Partner at SV Health Investors, is stepping down as founding Chairman and will remain part of the Board. Mestag is developing antibody-based immunotherapies harnessing new insights into fibroblast-immune interactions. The company is backed by SV Health, Johnson and Johnson Innovations, Forbion, GV (formerly Google Ventures) and Northpond Ventures.

Cambridge Enterprise has appointed Caroline Hyde, FRSA as Head of Ecosystem Initiatives and Partnership. Formerly, Hyde was Head of International Relations and Outreach at Cambridge Enterprise and Chief Executive Officer of the Allia Future Business Centres.

University of Dundee spinout Tay Therapeutics (formerly In4Derm Ltd) has appointed Dr Andrew Woodland as Chief Executive Officer. Dr Woodland has been promoted from being Chief Scientific Officer as Tim Sparey is stepping down as part-time CEO and will become Executive Chair. Mark Bell (co-founder of Tay) has been promoted to Chief Technology Officer. The company is developing topical and oral therapies for inflammatory conditions, such as eczema or rheumatoid arthritis. Its pan-Bromo- and Extra Terminal (BET) domain inhibitor ‘soft drug’ (now known as VYNE201) was out-licensed to VYNE Therapeutics in 2021 and progressed into a Phase 1b clinical trial for vitiligo in November 2022. Tay Therapeutics has secured £6.5 million in revenue and investment so far and is backed by o2h Ventures, University of Dundee, Scottish Enterprise, Wren Capital and Meltwind.

Cambridge-based CN Bio has appointed Dr Paul Brooks as Chief Executive Officer. Dr Brooks joined the company in May 2022 as Chief Business Officer and has led the expansion of CN Bio’s PhysioMimix Organ-on-a-chip range of ingle-and multi-organ microphysiological systems, consumables, kits and services. Prior to that, he was Head of Business Operations & Managing Director for PerkinElmer’s Horizon Discovery, and Chief Commercial Officer, Executive Director and Board member at Oxford Genetics. In addition, Dr David Hughes (former Chief Executive Officer) has been appointed to the company’s Scientific Advisory Board.

The United Kingdom Science Park Association has appointed three new Board Directors: Grant Bourhill, Chief Executive Officer at Surrey Research Park, Prashant Shah, co-Chief Executive Officer and co-founder of o2h Group, and Philip Macdonald, Managing Partner at Oberlanders Architects. In addition, Rhian Hayward MBE (Chief Executive Officer at AberInnovation) has been appointed Vice-Chair and Ian McFadzen (Chief Executive Officer at Plymouth Science Park) has been appointed as the new Company Secretary and Honorary Treasurer.

Cambridge-Xampla and Gousto have been awarded the SEAL Business Sustainability Award ‘Sustainable Innovation Award’ for their edible stock cube wrapper made from pea protein. Other winners of the SEAL Business Sustainability Awards range from global brands such as Disneyland or General Electric, as well as tech startups. Xampla’s pea protein panacking will be part of new product launches in 2023 as part of the company’s growth strategy.

Pangea Botanica has appointed Dr Atul Pande to its Board of Directors. Dr Pande is currently a Board member at Immunovant, Sio Gene Therapies, Perception Neurosciences, Karuna, and Autifony. Formerly, he was Chief Medical Officer at PureTech Health, Senior Vice President of Neurosciences at GSK, and Vice President of Neurosciences at Pfizer.

Stevenage Bioscience Catalyst has appointed Oliver King as Development and Leasing Director. Formerly, King was Partner at Colliers and H2SO (Office Leasings and Disposals), among other roles. He will oversee the expansion of the organisation via the development of a brand new 125,000 sq ft building comprising laboratories and offices.

Adaptimmune (NASDAQ: ADAP) has initiated the Biologics License Application (BLA) Submission for Afami-cel. Afami-cel can potentially become the first approved engineered TCR T-cell therapy for a solid tumour. BLA will be presented to the US FDA seeking marketing approval for afami-cel for use as a single-dose regimen for the treatment of advanced synovial sarcoma. The rolling submission is expected for mid-2023 and will then be subjected to priority review under the FDA's regenerative medicine advanced therapy (RMAT) program. Adaptimmune’s proprietary Specific Peptide Enhanced Affinity Receptor (SPEAR) T-cell platform enables the engineering of T-cells to target cancer across multiple solid tumours.

AstraZeneca (LON:AZN) and MSD’s (NYSE:MRK) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union. The approval has been granted following results from the PROpel Phase III trial for the treatment of metastatic castration-resistant prostate cancer in adult men for whom chemotherapy is not clinically indicated. Prostate cancer is the most common cancer in men in Europe, with an estimated 473,000 patients diagnosed and 108,000 deaths in 2020. Following approval, AstraZeneca will receive a regulatory milestone payment of $105 million from MSD.

AstraZeneca (LON:AZN)’s Imfinzi (durvalumab) has been approved in the European Union (EU). The approval has been granted as 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer in combination with chemotherapy. The approval has been granted following results from the TOPAZ-1 Phase III trial. Biliary tract cancer is a group of rare and aggressive cancers that occur in the bile ducts (cholangiocarcinoma) and gallbladder and patients have poor prognosis. Imfinzi plus chemotherapy is [approved](https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-approved-in-us-for-biliary-tract-cancer.html#!) in the US and under review in Japan.

GSK (NYSE:GSK) and Sanofi (EPA:SAN)’s VidPrevtyn Beta COVID-19 booster vaccine has been approved by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The approval is based on results from two separate immunogenicity trials. VidPrevtyn is a monovalent, recombinant-protein vaccine modelled on the Beta variant spike antigen designed by Sanofi, which includes GSK’s pandemic adjuvant. The same recombinant-protein technology is used in Sanofi’s approved seasonal flu vaccines. So far, it is the first and only protein-based variant COVID-19 booster vaccine approved in Great Britain and the European Union.

Business Finland has approved a €34 million grant funding to Solar Foods. The company is developing technology in the intersection of renewable energy and bioprocess engineering. Scientific research programme at VTT Technical Research Centre of Finland and Lappeenranta University of Technology. The team discovered a way to turn emission-free electricity and captured CO2 into edible calories. To date, this is the single largest public grant funding for cellular agriculture in the world.

Interesting piece on what the recession could mean for small biotechs in 2023, featuring Pierre Socha (Partner at Amadeus Capital Partners), Joshua Mandel-Brehm (CEO of CAMP4 Therapeutics), and Joan Koerber-Walker(President and CEO of the Arizona Bioindustry Association), among others.

A statue of Henrietta Lacks is going to replace a monument honouring Confederate General Robert E Lee. Henrietta Lacks was young black mother in Baltimore, Maryland. She began to experience abdominal pain and abnormal bleeding. She was examined by doctors at the Johns Hopkins Hospital and a tumour was discovered. Without asking for permission or even informing her, a sample of the tumour was sent to the lab for research before she was treated. Such cell line could multiply continuously, unlike nearly other cell cultures. The cell line was call HeLa, after her first and last name. Ms Lacks died of cancer at 31 year old. HeLa cells have allowed the invention of the polio vaccine, and pivotal discoveries in the HIV field, cancer and infertility.

Beyond the Biotech Waves podcast has talked to Laksh Aithani, co-founder and CEO of London-based Charm Therapeutics. They discuss the field and his personal trip from co-founding Genei, moving to Exscientia to contribute to the company’s AI platform and taking on entrepreneurship.