Pharmaceutical Technology Editors

Shanghai Fosun Pharmaceutical (Fosun Pharma), a China-based healthcare group, and Insilico Medicine, a US-based artificial intelligence (AI)-driven drug discovery and development company, announced on Jan. 11, 2022 that they have entered into a collaboration agreement to advance the discovery and development of drugs targeting a number of different targets globally using AI technology.

The partnership includes an AI-driven drug discovery R&D collaboration on four biological targets as well as the co-development of Insilico’s glutaminyl-peptide cyclotransferase-like (QPCTL) program. Under the agreement, Insilico will receive a total upfront payment of $13 million for the four R&D collaboration projects and the co-development of the QPCTL program. Insilico will also receive potential milestone-based payments and share commercialization profits from the QPCTL program. Fosun Pharma will also make an equity investment in Insilico.

Through the collaboration, Insilico will combine its end-to-end AI-driven drug discovery platforms with Fosun Pharma’s clinical development and commercial expertise. Their goal is to discover and develop a portfolio of novel therapeutics. According to the agreement, Insilico will take responsibility for delivering a preclinical candidate for the QPCTL program and advancing it to the investigational new drug (IND) stage (via its R&D team). After that, Fosun Pharma will conduct human clinical studies and co-develop the candidate globally. Fosun Pharma’s R&D team will also nominate four therapeutic targets to be assessed by Insilico’s AI platform and R&D team in parallel programs.

In addition, as part of the collaboration, Fosun Pharma will gain access to Insilico’s PandaOmics and Chemistry42 platforms to advance its own internal AI-powered discovery and development efforts.

“We are pleased to enter into strategic collaboration with Insilico. Fosun Pharma is committed to promoting innovative R&D and is oriented towards fulfilling unmet clinical needs and improving products’ accessibility. We look forward to working with Insilico to leverage the technological and clinical development strengths of both companies, jointly improving the efficiency of innovative drug R&D and benefiting more patients worldwide," said Yifang Wu, chairman and CEO of Fosun Pharma, in a company press release.

“In partnering with Fosun Pharma, a leading pharmaceutical company, we begin a new era of AI-powered end-to-end drug discovery and development as human-machine collaboration becoming the new normal in precision drug discovery and development. We previously demonstrated that AI can be used to discover novel targets and generate novel molecules that can be tested in humans in record time. Now, we are partnering with one of the leading scientific teams in the pharmaceutical industry to take this technology to the next level for the benefit of patients worldwide,” said Alex Zhavoronkov, founder and CEO of Insilico Medicine, in the press release.

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Fosun Pharma and Insilico Medicine will collaborate on AI-driven drug discovery and development of product candidates targeting multiple disease targets.

Fosun Pharma and Insilico Medicine Partner on Drug Discovery and Development Using Artificial Intelligence

According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the 

Amgen announced on Jan. 9, 2022, that the European Commission (EC) granted conditional marketing authorization for the company’s first-in-class KRASG12C inhibitor, LUMYKRAS (sotorasib), for the treatment of advanced non-small cell lung cancer (NSCLC) with 

 G12C mutation in patients that have progressed after one prior line of systemic therapy. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) 

recommended conditional authorization in November 2021

According to an Amgen press release, the conditional authorization was based on results from a Phase II CodeBreaK 100 clinical trial in NSCLC. “LUMYKRAS 960 mg, administered orally once-daily, demonstrated an objective response rate of 37.1% (95% CI: 28.6-46.2) and a median duration of response (DoR) of 11.1 months. The most common adverse reactions were diarrhea (34%), nausea (25%), and fatigue (21%). The most common severe (grade ≥ 3) adverse reactions were increased alanine aminotransferase level (ALT; 5%), increased aspartate aminotransferase (AST; 4%), and diarrhea (4%),” Amgen stated in the press release.

"The approval of LUMYKRAS, the first and only targeted therapy for 

 G12C-mutated NSCLC with proven efficacy, has the potential to transform treatment outcomes for people in the European Union living with this notoriously difficult-to-treat cancer," said David M. Reese, executive vice president of Research and Development at Amgen, in the press release. "Amgen's landmark scientific discovery allowed investigators to advance the first KRASG12C inhibitor into the clinic, and we look forward to bringing this critical innovation to more patients across the globe."

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on Dec. 22, 2021, that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd), to treat adults with multiple myeloma, when an autologous stem cell transplant (ASCT) is suitable. Eligible patients in England and Wales will be able to access DVTd through the National Health Service (NHS).

According to a press release, NICE’s recommendation was based on “data from the Phase [III] CASSIOPEIA study (Part 1) with a median follow-up of 18.8 months which compared DVTd to standard of care (bortezomib, thalidomide and dexamethasone [VTd] alone) as induction and consolidation therapy in newly diagnosed multiple myeloma patients eligible for ASCT.”

“Multiple myeloma is a relapsing and remitting cancer, and while existing therapies can control it, these patients are in need of effective and well-tolerated treatment options that are given as early as possible in the treatment pathway to elicit a deep response and improve outcomes,” said Karthik Ramasamy, consultant haematologist at Oxford University Hospitals NHS Foundation Trust and lead clinician for Myeloma for the Thames Valley Cancer Network, in the press release. “A front-line treatment option such as daratumumab in combination with VTd will give clinicians an effective regimen to produce deeper and longer remissions for newly diagnosed myeloma patients compared to VTd alone.”

“We are delighted that people with multiple myeloma in England and Wales will now be able to access DVTd on the NHS,” said Amanda Cunnington, director of Health Economics, Market Access, Reimbursement and Health Affairs, Janssen-Cilag Limited, in the release. “[This] decision means access will now be equal across the UK and we’re proud to have worked collaboratively with stakeholders to achieve this outcome. Importantly, our work in multiple myeloma doesn’t stop here, and we remain committed to furthering advances in science and evolving innovation in blood cancers.”

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

NICE Recommends Darzalex in Combination with Velcade to Treat Multiple Myeloma

Bristol Myers Squibb announced on Jan. 10, 2022 that it has entered into a research collaboration and license agreement with Century Therapeutics, a US-based biotechnology company, to develop and commercialize up to four induced pluripotent stem cell (iPSC)-derived, engineered natural killer cell (iNK) and/or T cell (iT) programs for hematologic malignancies and solid tumors.

The first two programs include one in acute myeloid leukemia (AML) and another in multiple myeloma. These programs could incorporate either the iNK or a gamma delta iT platform. Under the agreement, Bristol Myers Squibb has the option to add two additional programs, which can be nominated depending on certain conditions being met in the agreement.

Also under the agreement, Century will be responsible for development candidate discovery and preclinical development activities. Afterwards, Bristol Myers Squibb will be responsible for clinical development and commercialization activities subject to Century’s co-promotion rights on certain programs. Century will receive a $100 million upfront payment, and Bristol Myers Squibb will make a $50 million equity investment in Century’s common stock at $23.14 per share. Furthermore, Century will receive reimbursement of certain preclinical development costs for development candidates licensed by Bristol Myers Squibb. Century is also eligible for additional payments for future program initiations and development, regulatory, and commercial milestone payments totaling more than $3 billion across the four potential programs.

In addition, Century will also receive tiered royalties as a percentage of global net sales in the high-single to low-double digits. It may also elect to co-promote the AML program and one of the additional programs in the United States for no exercise fee. This latter would also trigger enhanced US royalties.

As part of this transaction with Bristol Myers Squibb, Century has amended its agreements with FUJIFILM Cellular Dynamics for Japanese development and commercialization rights for the products in these development programs.

“We are pleased to partner with Bristol Myers Squibb, a global leader in oncology and hematology, to further expand our pipeline of iPSC-derived cell therapy products for challenging hematological and solid tumor malignancies,” said Lalo Flores, CEO, Century Therapeutics, in a company press release. “Bristol Myers Squibb is an ideal partner for us because they bring extensive clinical development and scientific expertise in cell therapy that will increase the probability of technical success of these programs. Additionally, this collaboration will enable deployment of our next-generation iPSC platform to develop products targeting malignancies that are difficult for biotech companies to tackle on their own.”

“The collaboration with Century Therapeutics is an important part of our investment strategy in next-generation cell therapies for hematologic and solid tumors,” said Rupert Vessey, executive vice-president and president, Research & Early Development, Bristol Myers Squibb, in the press release. “Century’s iPSC-based gamma delta T and NK cell platforms show promise and are complementary to Bristol Myers Squibb’s existing cell therapy technologies. We look forward to exploring the full potential of the iPSC approach to develop potentially best-in-class allogeneic cell therapies to help patients with hematologic and solid tumor malignancies.”

The collaboration between Bristol Myers Squibb and Century Therapeutics will combine Century’s iPSC-derived allogeneic cell therapy platform with Bristol Myers Squibb’s expertise in cell therapy and oncology drug development.

Bristol Myers Squibb and Century Therapeutics to Collaborate on Developing iPSC-derived Allogeneic Cell Therapies

Fujifilm Diosynth Biotechnologies is expanding its BioProcess Innovation Center in Research Triangle Park (RTP), N.C., the company announced in a Jan. 5, 2022 press release.

The project, which will feature an additional 89,000 ft

 of laboratory space equipped with state-of-the-art analytical instrumentation, high throughput bioprocessing equipment, and automation technologies, is expected to double the company’s capacity to support process characterization programs and complements the enhanced capabilities at its UK facility. This expansion will also allow Fujifilm Diosynth Biotechnologies to further support its partners in guiding clinical process development that can create more robust commercial processes. 

The expanded space is expected to be operational by mid-2024, which is also when approximately 145 new jobs are anticipated to open up, many of those positions being for researchers and scientists.

“ … We are delighted to be adding this additional capacity to support our growing pipeline of customers,” notes Christine Vannais, chief operating officer, Fujifilm Diosynth Biotechnologies, RTP, North Carolina, in a company press release. “The cutting-edge laboratory equipment and automation tools, combined with the deep technical expertise of our scientific community, will allow us to better serve our partners to rapidly generate and assess data to understand complex molecules, along with the processes used in their manufacture.”

Fujifilm Diosynth Biotechnologies' 89,000 square-foot expansion of its BioProcess Innovation Center in Research Triangle Park, N.C., will double its capacity to support process characterization.

Fujifilm Grows Lab Space at North Carolina Facility

Bio-Rad Laboratories, a life science research company, now offers their Bio-Plex Pro Human SARS-CoV Variant Neutralizing Antibody Assays, which the company launched in December 2021. Designed for research use only, these assays are designed to allow scientists to measure neutralizing antibodies against both wild-type and significant variants of the SARS-CoV-2 virus.

According to a Dec. 20, 2021 press release, the product is a ready-to-use 96-well kit containing premixed magnetic capture beads, a detection converting enzyme (ACE)-2 receptor, a standard and positive control, and buffers that measure levels of neutralizing antibodies and percentage inhibition of the ACE-2 receptor binding the viral antigens coupled on the beads.

“As variants of interest and concern become the predominant forms of SARS-CoV-2 infecting populations, it’s critical to understand whether the antibodies, elicited by a prior COVID-19 infection or vaccination, are still able to neutralize the circulating virus variants,” said Candice Cox, Bio-Rad immunoassays marketing manager, Life Science Group, in the press release. “We are pleased to be able to add these neutralizing antibody assays to our offering of existing Bio-Plex Pro IgA, IgG, and IgM 4-plex serology kits for COVID-19 related research in vaccine development and post-market surveillance studies.”

It will be offered in an 11-plex complete all-in-one kit format that consists of wild-type receptor-binding domain (RBD) and S1 and 9 variant antigens, customizable singleplex assays, and 2-plex Delta variant coupled beads. Additionally, a custom Assay Developer Kit to create assays for any new SARS-CoV-2 variant—such as Omicron—is included.

Bio-Rad’s new assays are designed to measure neutralizing antibodies against wild-type and significant variants of COVID-19.