< PreviousM&A ROUND-UP 10 Pharma Business International (RSV), strengthening AstraZeneca’s Vaccines & Immune Therapies late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX- A12. Sanofi - Inhibrx Sanofi kicked off 2024 with the announcement that it had entered into a definitive agreement to acquire Inhibrx in a $2.2bn deal, following the spin-off of non-INBRX-101 assets into New Inhibrx. INBRX-101 is a human recombinant protein that holds the promise of allowing Alpha-1 Antitrypsin Deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent dosing. AATD is an inherited rare disease characterized by low levels of AAT protein, predominantly affecting the lung with progressive deterioration of the tissue. INBRX-101 may help to reduce inflammation and prevent further deterioration of lung function in affected individuals. INBRX-101 has completed a Phase 1 trial, demonstrating positive results in terms of safety and pharmacokinetics, and is currently enrolling a Phase 2 clinical trial to further evaluate the potential of INBRX-101 as a treatment for AATD. Houman Ashrafian, head of Research and Development, Sanofi, said: “The addition of INBRX-101 as a high potential asset to our rare disease portfolio reinforces our strategy to commit to differentiated and potential best-in-class products. With our expertise in rare diseases and growing presence in immune-mediated respiratory conditions, INBRX-101 will complement our approach to deploy R&D efforts in key areas of focus and address the needs of the underserved AATD patients and communities.” Johnson & Johnson - Ambrx Meanwhile, Johnson & Johnson has revealed plans to acquire Ambrx Biopharma, a clinical-stage biopharmaceutical company with a proprietary synthetic biology technology platform to design and develop next- generation antibody drug conjugates (ADCs), for approximately $2bn. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety of its candidate therapeutics in multiple cancer indications, including ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma. Yusri Elsayed, M.D., M.H.Sc., Ph.D., global therapeutic area head, Oncology, Johnson & Johnson Innovative Medicine, said: “Ambrx’s ADC technology offers unique advantages in the conjugation of stable antibodies and cytotoxic linker payloads, which results in engineered ADCs that effectively kill cancer cells and limit toxicities. The results seen to date with ARX517 in mCRPC are promising and represent a potential first- and best- in-class targeted therapy for the treatment of this aggressive disease. In addition, Ambrx’s pipeline and ADC platform present exciting future opportunities to deliver enhanced, precision biologics as we look to transform the treatment of cancer and improve patients’ lives.” GSK - Aiolos Bio Moreover, GSK has entered into an agreement to acquire Aiolos Bio, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for $1.4bn. The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the Pharma Business International 11 M&A ROUND-UP treatment of adult patients with asthma, with potential for additional indications like chronic rhinosinusitis with nasal polyps. Tony Wood, chief scientific officer, GSK, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.” AbbVie - Cerevel Therapeutics Finally, AbbVie has announced a definitive agreement to acquire Cerevel Therapeutics and its neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease (PD), and mood disorders. The $8.7bn deal complements AbbVie’s neuroscience portfolio, adding a range of potentially best-in-class assets that may transform standards of care across psychiatric and neurological disorders. “Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade,” said Richard A. Gonzalez, chairman and Chief Executive Officer, AbbVie. “AbbVie will leverage its deep commercial capabilities, international infrastructure, and regulatory and clinical expertise to deliver substantial shareholder value with multibillion-dollar sales potential across Cerevel’s portfolio of assets.” These represent just a handful of deals revealed since our last issue, with further acquisitions from the likes of giants such as MSD, Novartis, Roche, and more, with M&A in the pharma industry picking up pace. © stock.adobe.com/AtlasLABORATORIES 12 Pharma Business International www.pbiforum.net Labs are changing with the times, and not only because of the lingering memory of COVID-19. Employee shortages and recruitment problems are forcing labs to reassess how they keep their talent, and artificial intelligence may soon become a gamechanger. P harmaceutical laboratories play a critical role in the development of life-saving drugs and medical advancements. In recent years, the pharmaceutical industry has witnessed a shift towards a safety-centric culture, recognizing the importance of prioritizing the well-being of laboratory personnel. Companies now understand that investing in comprehensive health and safety protocols not only protects their employees but also leads to increased productivity and reduced financial liabilities, and with recruitment remaining a major issue for many labs, it’s important to retain current staff. For many, this means increased investment in PPE but also stricter adherence to Good Laboratory 14 ÁPharma Business International 13 www.pbiforum.net LABORATORIESLABORATORIES 14 Pharma Business International www.pbiforum.net Practice routines, with an emphasis on employee wellbeing, safety and happiness. On the surface much of this may seem like natural progression from the COVID- 19 pandemic and worldwide fears of future pandemics, but the lockdown only exacerbated a problem that was already felt in the industry – that of a dwindling supply of new pharma talent compared to the increasing rise in demand from an ever-evolving industry. Lab recruitment has gotten so bad in fact that some larger brands have said it’s easier to buy out existing companies not for their IP or drugs, but so that they can scrap all of those and just have a lab staffed with employees. This is, of course, a risk all of its own because the high demand for lab staff means employees have a lot of options when it comes to choosing who to work from, and situations like this will often lead to companies poaching from one another where possible. Headhunting has traditionally been for managers, directors and CEOs but may soon be a commonplace feature for even the lowest lab position. With all that in mind, companies are finding it increasingly important to keep staff motivated and happy. It used to be that a good pay packet was all that was required for that, but people are nowadays wanting a life less tied to a company slaving away for money, so emphasis is being put instead on more intangible benefits such as company vision, the working experience, and commitments to social, economic and environmental concerns. Tech companies are leading the way when it comes to the employee experience, creating huge Pharma Business International 15 www.pbiforum.net LABORATORIES © stock.adobe.com/Songkhla Studio breakrooms and filling them with gadgets, toys, and odd-looking furniture. They’ve been mocked by many old- fashioned businesses for such means and methods, but they’ve remained powerful and attracted the best talent, with many tech graduates fighting to work for those companies. The pharma sector as a whole could stand to learn some lessons from them. Laboratory work especially can be highly stressful and demanding in terms of focus and precision, so taking more care to provide employees with ample time to rest and reset themselves can be valuable. Artificial Intelligence is a factor that many are looking to incorporate to take some of the work off employees, though not necessarily to replace them entirely. Leaving aside the ethical dilemma, there’s the far more human problem of convincing patients that it would be safe to consume medicine designed by an AI. One only has to look at the reaction in the western world to the COVID vaccine to imagine the conspiracy theories that would crop up if the human element was removed from drug production entirely. Whether or not the results were benign, society simply isn’t ready to accept such things as of yet. However, by using AI to take less necessary work off staff, employees can be allowed to focus their energies on more crucial matters. AI should be seen as a tool to improve employee performance, not one to replace them. With the stringent requirements and nature of a testing laboratory, it may just be the perfect sector to see widespread AI investment in. MICROBIOLOGY AND R&D 16 Pharma Business International www.pbiforum.net © stock.adobe.com/sinhyuPharma Business International 17 www.pbiforum.net MICROBIOLOGY AND R&D Artificial intelligence. Latest gimmick or the future of microbiology? I t goes without saying that many sectors in numerous industries are looking at the best ways to introduce AI into their business. The microbiological sector is no different, but it is much riskier than other business models. With conspiracy theorists running rampant, care has to be taken with how AI is used lest the reputation of a product be forever tainted by those who believe AI may have gotten it wrong or somehow “fudged” the results. However, while the world may not be ready for full AI usage in medicine, that’s not to say it can’t be used in other ways. Microbiology labs are currently testing AI with its potential for image analysis – specifically in use with image-taking microscopes. These, if implemented correctly, could help speed up the work of human lab technicians by allowing AI to accurately identify and label the results of microscope inspection, up to and including identifying any pathogens, enzymes and other microbes. Image analysis can be very time consuming for Artificial microbiology 18 Á Artificial microbiology MICROBIOLOGY AND R&D 18 Pharma Business International www.pbiforum.net © stock.adobe.com/peshkovaPharma Business International 19 www.pbiforum.net MICROBIOLOGY AND R&D humans because there’s a lot to go over and every little bit has to be analysed. While it’s certainly necessary work, the sheer number of images that may have to be considered along with double-checking can cut into the hours. While AI image analysis may still be at a stage where its work needs to be checked over, it’s much easier to look at its identifications and grade whether they are right or wrong than it is to start from scratch. With learning algorithms and neurological networks, the AI can also grow to learn from its mistakes and reduce the frequency with which it makes them. Microbiologists are also investigating how useful AI can be in genome sequencing analysis, however, and are looking into how accurate it can be at identifying the order of nucleotides in a DNA module. With enough data to work from, and some run-time, an AI can not only identify the order but automate tasks such as assembly of gene data and, in theory, even be used to model genome data to discover novel genes, pathways and DNA behaviours. So far, AI is being best used for analysis of data rather than innovation, and while there certainly are studies into AI’s ability to design and even research pharma material on its own, the concerns from a marketing perspective (in terms of how much the public would trust AI’s results to take a product) are holding the technology back to data analysis and ordering. Even in that limited spectrum, however, the potential uses for AI to free up time for microbiologists to focus on testing and research are quickly being recognised across the industry. Attitudes are expected to change in the future with regards to AI, especially once people get used to the technology, so it behoves the industry to get ahead of the curve and start working in advance. As AI becomes more mainstream, recruiting talent to help maintain and look after it will become an almost impossible challenge. In the same way that IT professionals are already in high demand, one can only imagine the demand that will come with those capable of working with AI. It may be best to get ahead of the curve before the demand really kicks in. Next >