On June 15, 2022 Aqemia, the next-gen pharmatech company leveraging artificial intelligence and quantum physics reported that it has entered a new research collaboration with Sanofi (Press release, Aqemia, JUN 15, 2022, View Source [SID1234616012]).

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This new agreement is a follow-up to a Research Collaboration initiated at the end 2020 by Sanofi to bring the unique technologies of Aqemia to the design and discovery of novel molecules in several projects in oncology, a priority therapeutic area for Sanofi.

This initial collaboration resulted in promising molecules for an oncology program, for which Sanofi and Aqemia decided to pursue joint efforts.

Aqemia will take responsibility for the AI-based design of optimized molecules that fulfill several small molecule design goals among which potency and selectivity in a priority project in oncology. Unlike most AI-based technologies that need experimental data to train their algorithms prior to starting the design, Aqemia will tackle the drug discovery project by generating its own data with quantum and statistical physics-based calculations.

This collaboration includes an undisclosed upfront payment from Sanofi.

Maximilien Levesque, CEO and co-founder of Aqemia, commented, "We are really proud of the results obtained in the first Sanofi-Aqemia oncology collaboration and are very excited to continue working together to accelerate important projects in oncology." He added, "This follow-up of our first collaboration project with Sanofi, a global leader in the Pharmaceutical industry, demonstrates our ability to quickly generate novel potent and selective compounds for a given target, and we can’t wait to scale it up to dozens of drug discovery projects."

"We are also extremely excited by the promising results obtained by Aqemia using their proprietary and disruptive technology to design potent inhibitors on given targets. We are eager to prolong our collaboration to speed up our candidate finding process for the sake of patients suffering from cancer," said Laurent Schio, head of Integrated Drug Discovery of Sanofi France,

On June 15, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported inter- and intra-reader reproducibility results from its Phase 3 SPOTLIGHT trial of 18F-rhPSMA-7.3 in recurrent prostate cancer (Press release, Blue Earth Diagnostics, JUN 15, 2022, View Source [SID1234616011]). Results for the inter-reader agreement showed that agreement was high across all readers. The inter-reader agreement for 18F-rhPSMA-7.3 PET/CT was more than 75% overall and greatest for the pelvic lymph node region, with more than 87% concordance. Intra-reader agreement was more than 85% overall. 18F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The results were reported in an oral presentation at the 2022 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.

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"Biochemically recurrent prostate cancer can be locally recurrent disease, metastatic disease, or both. Therefore, optimal assessment of the extent and location of recurrent prostate cancer is critical for clinical decision-making by physicians and patients," said Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Needham, Mass., on behalf of the SPOTLIGHT study group. "Unfortunately, recurrence of prostate cancer is common. Conventional imaging, such as CT and bone scintigraphy, is often negative particularly when PSA is still low, so the demonstrated performance of PSMA-PET imaging fits an important unmet need. But no matter how good the radiotracer or scanner, reliable and consistent interpretation of PET imaging is foundational and has the potential to substantially impact patient care. These findings from the SPOTLIGHT study showed high inter-reader and intra-reader agreement for interpretation of 18F-rhPSMA-7.3 PET/CT scans in the setting of biochemical recurrence. Such high reproducibility, particularly for extra-prostatic regions, is clinically valuable, due to the potential of these findings to influence patient management."

"We are pleased to present these reader interpretation results from the Phase 3 SPOTLIGHT trial at SNMMI’s 2022 Annual Meeting, as they will be a critical element of a New Drug Application with the U.S. Food and Drug Administration (FDA) for 18F-rhPSMA-7.3 PET imaging," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. "In designing the image interpretation training to be used for the 18F-rhPSMA-7.3 Phase 3 program, we drew upon Blue Earth Diagnostics’ expertise and experience in designing PET image interpretation programs and training for commercialized Axumin (fluciclovine F 18). We selected 18F as the isotope of choice for PET imaging with rhPSMA in consideration of its spatial resolution and resulting high quality of PET images, and its physical half-life which greatly facilitates ease of large-scale manufacturing and distribution for broad-based patient access. 18F-rhPSMA-7.3 represents a new class of high affinity PSMA-targeted PET radiopharmaceuticals. Early studies of 18F‐rhPSMA‐7.3 showed a binding affinity for PSMA, together with biodistribution data suggesting the potential for low bladder activity."

The findings presented at SNMMI discussed inter- and intra-reader agreement for the interpretation of 18F-rhPSMA-7.3 scans. Overall agreement between all three blinded readers who received identical training was assessed and repeated for the regions of the prostate/prostate bed, pelvic lymph nodes, and other (extra-pelvic) sites (lymph nodes outside pelvis, soft tissue/parenchyma, and bones). Results showed that agreement was high across all readers. The inter-reader agreement for 18F-rhPSMA-7.3 PET/CT was more than 75% overall and greatest for the pelvic lymph node region, with more than 87% concordance. Intra-reader agreement was more than 85% overall. Reproducibility was lower for the prostate/prostate bed than other regions; however, the high reproducibility for extra-prostatic regions is clinically valuable due to the potential of these findings to influence patient management.

The SPOTLIGHT trial (NCT04186845) is a Phase 3, multi-center, single-arm imaging study conducted in the United States and Europe to evaluate the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. Key results for 18F-rhPSMA-7.3 PET were previously presented at ASCO (Free ASCO Whitepaper) GU in February 2022,1 with additional results announced at AUA in April 20222.

The findings were discussed in an oral presentation at SNMMI 2022 on June 14, 2022, "Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET image interpretation in patients with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study (SPOTLIGHT)," by Phillip Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, Ariz. and Invicro, Boston, Mass., on behalf of the SPOTLIGHT study group. Full session details and the abstract are available in the SNMMI online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

On June 15, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, and Metagenomi, Inc., a genetic medicines company with a versatile portfolio of next-generation, wholly-owned gene editing tools, reported a partnership to enable Affini-T’s next generation ex vivo T cell receptor (TCR) cell therapies for solid tumor patients using Metagenomi’s novel proprietary gene editing systems (Press release, Affini-T Therapeutics, JUN 15, 2022, View Source [SID1234616010]).

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"We are delighted to announce our partnership with Metagenomi and to apply their next-generation gene editing systems to our cell therapies targeting oncogenic and viral driver genes, including KRAS and p53, to provide the greatest impact for patients across a variety of hard-to-treat solid tumor types," said Jak Knowles, M.D., Co-founder, President and Chief Executive Officer, Affini-T Therapeutics. "By working with Metagenomi, we will gain access to powerful, novel gene editing tools to make precise and multiplex edits to immune cells, thereby optimizing the effector function of our cell-based therapeutics."

"With this collaboration, Metagenomi is executing on its ex vivo therapeutics partnering strategy in the immuno-oncology space. We are especially excited to partner with the outstanding team at Affini-T and its scientific founder Dr. Phil Greenberg, who has fundamentally advanced this field. We believe that cell therapy, combined with our powerful gene editing tools, is the future of immuno-oncology, treating patients with the highest unmet medical need," said Brian C. Thomas, Ph.D., Founder and Chief Executive Officer of Metagenomi. "Our strategy in cell therapy strives to create a broad pipeline of licensed, partnered and in-house development programs with leading scientific teams."

The partnership will leverage Metagenomi’s proprietary gene editing systems to complement Affini-T’s state-of-the-art TCR discovery and synthetic biology platforms to generate groundbreaking cell therapy products. Affini-T will have the option to exclusively license Metagenomi’s technology to make gene edits in autologous TCR T cell therapies for specific tumor targets, with the option to expand non-exclusively to editing certain allogeneic approaches. In the future the parties will discuss further targets for co-development and co-commercialization.

Under the terms of the agreement, Metagenomi will be entitled to receive tiered payments for each optioned cancer target plus additional milestone and royalty payments.

On June 15, 2022 Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), reported that Shionogi B.V. had signed an agreement with NHS England to begin an innovative subscription payment model reimbursement of Cefiderocol in England (Press release, Shionogi, JUN 15, 2022, View Source [SID1234616009]). In this model, companies are paid a fixed sum for antimicrobials based on a health technology assessment of their value to the NHS, rather than the volumes used.1 Shionogi welcomes the introduction of pull incentives to help bring urgently needed new antibiotics to market.

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The deal follows draft guidance from NICE issued in April, which recommended Cefiderocol within its marketing authorisation as an option to treat severe multidrug resistant aerobic Gram-negative bacterial infections. It also states that the drug should be reserved for difficult to treat resistant infections, where there are few alternative options, and can only be used either in the microbiology-directed (‘confirmed’) treatment setting, or as risk-based empiric treatment.5 NICE’s evaluation of Cefiderocol considered long-term population benefits, including the ‘insurance/diversity’ value of having additional antimicrobial treatment options available for the future, and the ‘enablement’ value associated with the continued ability to provide other healthcare (such as chemotherapy and surgical procedures), that might otherwise be jeopardised by increasing antimicrobial resistance.5

Cefiderocol is one of two antimicrobial products selected and made available as part of the scheme by NICE and NHS England6 because they address key disease areas of unmet need in the UK and internationally, treating serious infections including blood stream infection (BSI), sepsis and hospital or ventilator acquired pneumonia (HAP & VAP). Shionogi has entered into an initial three-year contract, with the option to extend, by agreement, for up to another seven years, receiving an annual, value-based payment.5

"We are delighted that NICE and NHS England have recognised the important role of Cefiderocol as an option to treat some of the most serious multidrug-resistant infections and its value to healthcare systems and society," said Mark Hill, SVP, Global Head of Market Access, Shionogi. "Antimicrobial resistance is becoming a significant global threat and subscription-style schemes like this help to ensure that antibiotics are used to benefit patients who need them and according to effective stewardship principles to limit the potential development of resistance."

While developing antibiotics is a long, costly and uncertain process, commercialisation can also be challenging. Once launched, there is often a low frequency of use driven by the need for stewardship to prevent resistance development. Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialisation of antibiotics, and several smaller biotech companies have filed for bankruptcy.2

"The introduction of this first of its kind pilot subscription reimbursement model reinforces the UK’s leadership position in creating a more predictable and sustainable market for new antibiotics," commented Takuko Sawada, Executive Vice President, Shionogi. "We hope that other countries will follow suit and introduce pull incentives to help address the challenges faced in bringing novel antibiotics to market."

Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. There are 700,000 deaths globally3, ~25,000 deaths per year in the EU7 and 5,000 deaths in England4 from infections with multidrug-resistant bacteria. Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.8 If no action is taken, antibiotic resistance is predicted to result in 10 million deaths every year globally by 2050, at a cumulative cost to global economic output of 100 trillion USD.3

Resistant Gram-negative infections

The increasing resistance of many infections caused by Gram-negative bacteria to existing therapies, including carbapenem-resistant Enterobacterales and non-fermenting species such as P. aeruginosa, A. baumannii, and S. maltophilia, makes them difficult to treat and results in high mortality rates.9,10 The World Health Organization have identified carbapenem-resistant strains of Enterobacterales, P. aeruginosa and A. baumannii as the top priority in the research and development of new antibiotics.11 Cefiderocol is the first antibiotic to address all three major mechanisms of carbapenem-resistance and is an important treatment option to address this urgent unmet need.12

Cefiderocol

Cefiderocol is the world’s first siderophore cephalosporin antibiotic with a novel mechanism of entry through the outer membrane of Gram-negative pathogens by using the bacteria’s own iron uptake system to gain cell entry, acting like a Trojan horse.13 In addition to entering cells by passive diffusion through porin channels14, Cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria.15 These mechanisms allow Cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.13

Carbapenem resistance (CR) in Gram-negative bacteria is due to three main mechanisms:16

Beta-lactamases which cause enzymatic breakdown of beta-lactams
Changes in porin channels (through mutations and decrease in number) through which beta-lactams and other antibiotics diffuse into cells,
Overexpression of efflux pumps which occurs post-exposure and pumps antibiotics out of cells17
As a result of its novel structure and mechanism of cell uptake,18 Cefiderocol can overcome these three major mechanisms of CR.

Shionogi’s commitment to fighting antimicrobial resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. (The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies19).

On June 15, 2022 Orion Corporation ("Orion") reported that it has entered into an agreement with Belgian private company Inovet BV ("Inovet") to acquire its wholly owned subsidiary V.M.D. NV and all companies belonging to V.M.D. NV’s group of companies (V.M.D. NV and its subsidiary companies collectively, "VMD") (Press release, Orion , JUN 15, 2022, View Source [SID1234616008]). VMD is a veterinary pharmaceuticals company specialised in medicines and health products for livestock. It also has a product portfolio for companion animals and minor species. VMD is headquartered in Arendonk, Belgium. VMD has production sites in Arques, France (manufacturing) and in Arendonk (packaging) as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD’s revenues in 2021 were EUR 61 million, and the group was profitable. Following this acquisition, the 181 employees of VMD will join the Orion Group.

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Through this acquisition, Orion’s Animal Health unit will expand its product portfolio and get a foothold in the livestock market, expand its own geographical presence to Western Europe and expand export markets, and gain a production unit that is specialised in manufacturing of veterinary medicines. The acquisition also supports Orion Group’s growth strategy.

The transaction price is approximately EUR 130 million debt free. The transaction will be funded from Orion’s cash reserves. The immediate cash flow impact of the transaction is approximately EUR 90 million. The transaction will have a positive impact on Orion Animal Health unit’s net sales and EBITDA starting from 2022. The impact on Orion Group’s net sales and operating profit is not material and the transaction does not impact Orion’s outlook for 2022, given on 10 February 2022. Orion will report VMD’s net sales as part of Orion Animal Health’s net sales as of June 2022.

The agreement was signed and the transaction was completed simultaneously today on 15 June 2022.

"We are pleased to welcome our new colleagues to the Orion team. With this acquisition, Orion Animal Health becomes a comprehensive animal health company with wider geographical presence and broad product portfolio covering both companion animals and livestock. In addition, we are strengthening our manufacturing capabilities," said Timo Lappalainen, CEO of Orion Corporation.

"I believe that becoming part of the Orion family ensures the further growth of our business. I have a very good feeling about the new collaboration with the Orion Animal Health unit – mindsets and spirits are very similar to ours. We are looking forward to joining forces and strengthening our presence in the consolidating animal health industry," said Jan Moons, CEO of Inovet.

V.M.D. NV, established in 1973, is a veterinary pharmaceuticals company headquartered in Arendonk, Belgium. Until the transaction it was a wholly owned subsidiary of the Belgian family-owned private holding company Inovet BV. VMD’s product portfolio consists of over 200 generic products which are sold in more than 120 countries. VMD has a production site in Arques, France, logistics and packaging operations in Arendonk as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD is currently expanding its manufacturing capacity at the Arques site. The companies Biové Laboratoires SAS, Biard SAS, V.M.D. Állatgyógyászati Kft and Inovet Indochine Co., Ltd. are part of VMD.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held today on Wednesday, 15 June 2022 at 11.00 EEST. Please register and join the live webcast at View Source

Questions can be asked through the webcast chat function. A recording of the webcast and the presentation material will be available on Orion’s website View Source later today.