Daria G. Husni

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On Oct. 5, 2023, Wheeler Bio, a contract development and manufacturing organization (CDMO) for next-gen protein therapeutics, announced the grand opening of their new drug substance current good manufacturing practices (CGMP) facility. The facility is located inside the Ziggurat building in the heart of Oklahoma City, Oklahoma. Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.

Two single-use drug substance lines (50L and 500L scale HyPerforma DynaDrive)

A RightSourceSM quality control testing lab (Charles River Labs)

Document control, utilities, and office space.

The 35,000-square-foot space was designed and built by Wheeler Bio, CRB, and Lingo Constructions Service in collaboration with their automation and validation partners, Lucid and CAI. Two commissioned runs were completed recently using Wheeler’s Portable CMC antibody process platform, and the first orders for CGMP drug substance batches have already been delivered to the client.

Founded by Dr. Jesse McCool, Christian Kanady of Echo, and Errik Anderson of Alloy Therapeutics and 82VS in 2021, Wheeler Bio partners with venture capital to aid with the process from discovery to clinic for those in biologics innovation. As a CDMO service provider, Wheeler aims to be more accessible, affordable, and agile than larger competitors through use of its hub-and-spoke operational model and Portable CMC platform.

“We are leveraging the cost advantages and the trained biomanufacturing workforce in Oklahoma City to create a highly differentiated CDMO,” stated Jesse McCool, co-founder and CEO at Wheeler, in a Wheeler press release “With our accessible, modular approach to CMC development, extensive technology stack, and pools-based workflow parallelization, Wheeler is raising the bar for early-clinical-phase biologics services.”

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Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price. 

Wheeler Bio Announces Opening of Biomanufacturing Facility in Oklahoma City

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On Oct 12, 2023, Pfizer announced that FDA approved BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) to treat adults with metastatic non-small lung cancer (NSCLC) with a BRAF V600E mutation. BRAF V600E mutations can be found using plasma or tumor tissue with the FoundationOne Liquid CDx or the FoundationOne CDx FDA-approved companion diagnostic tests. BRAFTOVI + MEKTOVI combination therapy was previously approved by FDA in 2018 for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

This approval is predicated on data from the ongoing Phase II PHAROS clinical trial, which is an open-label, multicenter, single-arm study assessing the BRAFTOVI + MEKTOVI combination therapy in both new and previously treated patients with BRAF V600E-mutant metastatic NSCLC. NSCLC comprises 80–85% of all lung cancer, which is the second most common type of cancer and the leading cause of cancer-related deaths worldwide. Some lung cancers are linked to acquired genetic abnormalities, such as the BRAF V600E mutation, which occurs in around 2% of NSCLC cases. It aids tumor cell growth and spread by changing the MAP kinase signaling pathway. Precise targeting of this pathway’s components can potentially aid in inhibiting the tumor growth and spread caused by BRAF mutations.

“Today’s approval builds on our long-standing commitment to deliver innovative, personalized medicines to patients with lung cancer. By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumor biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, Chief Oncology Research and Development Officer and Executive Vice President at Pfizer in a Pfizer press release. “Since its initial FDA approval in 2018, BRAFTOVI + MEKTOVI combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma. We look forward to helping even more patients with our BRAFTOVI + MEKTOVI targeted combination therapy.”

This approval builds on a previous approval of the combination therapy for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.


FDA Approves Pfizer’s Treatment for BRAF V600E-Mutant Non-Small Cell Lung Cancer

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On Oct 8, 2023, Bristol Myers Squibb and Mirati Therapeutics announced that Bristol Myers Squibb has acquired Mirati for a total equity value of $4.8 billion. Mirati stockholders will receive one non-tradable Contingent Value Right for each Mirati share held, possibly representing another $1 billion. Both boards unanimously agreed on the merger.

Mirati is a commercial-stage targeted oncology company designed to create breakthrough therapies for cancer patients, making it a good fit with Bristol Myers Squibb’s oncology portfolio. One of Mirati’s most attractive assets, KRAZATI (adagrasib),is a lung cancer medicine that Bristol Myers Squibb will now add to its commercial portfolio. Adagrasib was given accelerated approval by FDA for the treatment of KRAS-mutated Non-Small Lung Cancer (NSCLC) in patients who have gone through one prior systemic therapy.

Other assets include MRTX1719, and a leading KRAS and KRAS enabling program. MRTX1719 is “a potential first-in-class MTA-cooperative PRMT5 inhibitor” currently in phase one development. It targets MTAP-deleted tumors, which make up around 10% of all cancers. The second phase of development is planned to start in the first half of 2024. The KRAS and KRAS enabling program include MRTX1133 and MRTX0902. MRTX113 targets the KRAS mutation, which contributes to key tumor types, and is implicated in over 30% of pancreatic cancer patients. MRTX0902 is a phase one SOS1 inhibitor that may have use in combination with other agents targeting the MAPK/RAS pathway, including Adagrasib.

“Mirati strengthens and complements our current portfolio by adding assets focused on intrinsic tumor targets in the MTAP and MAPK pathways,” said Samit Hirawat, M.D., Bristol Myers Squibb’s chief medical officer and head of Global Drug Development, in a press release. “We believe Mirati’s assets have the potential to change the standard of care in multiple cancers, both as standalone therapies and in combination with Bristol Myers Squibb’s existing pipeline. We are excited about the significant potential that this transaction creates to transform patients’ lives through science around the world.”

Mirati’s focus on breakthrough cancer treatments will bolster Bristol Myers Squibb’s oncology portfolio.

Bristol Myers Squibb Acquires Mirati Therapeutics for up to $5.8 Billion

On Oct 4, 2023, Novartis announced it has completed its plan to spin-off Sandoz, its generics and biosimilars business, into an independent company. The spin-off took place through a dividend-in-kind distribution to holders of Novartis shares and American Depositary Receipts (ADR), which was held at the close of business on Oct 3, 2023. Holders received one Sandoz share for every five Novartis shares, or one Sandoz ADR for every five Novartis ADRs. Novartis stated that this spin-off will allow it to finish its journey to becoming a leading, focused medicines company.

Novartis is now focused on four core therapeutic areas: cardiovascular, immunology, renal and metabolic, and oncology. The company plans to tackle high disease burden, as well as the possibility of major growth, in prioritized areas of the United States, China, Germany, and Japan. Novartis wrote that several major in-market and pipeline assets in those therapeutic areas will enable it to follow through on its plans.

While Novartis has two established technology platforms, chemistry and biotherapeutics, it plans to prioritize three next-generation platforms: cell and gene therapy, radioligand therapy, and xRNA. These prioritizations reflect its ongoing investment into novel R&D capabilities and manufacturing scale, shown in Novartis’ pipeline of 150 projects in clinical development.

“This is a truly historic moment for Novartis and Sandoz, as we begin new chapters as independent companies (. . .), and I am confident [Sandoz] are poised to deepen their impact on patients and society,” said Vas Narasimhan, M.D., CEO of Novartis, in a Novartis press release. “We are entering this new era with strong financial performance and R&D momentum, and I’m more confident than ever in our ability to reimagine medicine for and with patients around the globe.”

Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology.

Novartis Completes Sandoz Spin-off

On Oct 3, 2023, Sanofi announced an agreement with Janssen Pharmaceuticals to develop and commercialize Janssen’s Phase III vaccine candidate for extraintestinal pathogenic 

 (9-valent). Both companies will co-fund current and future research and development costs, and there will be a profit-share agreement in the United States, the European Union, and the United Kingdom. Janssen will receive tiered royalties and sales milestones in the rest of the world. Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones. The Phase III trial, called 

, is intended to assess the efficacy 9-valent extraintestinal pathogenic 

 vaccine (ExPEC9V0), as compared to placebo, in the prevention of invasive 

 (ExPEC) is a main bacterial cause of sepsis, a chronic and life-threatening bloodstream infection, especially in older adults. Major risk factors for ExPEC include age (especially older than 60) and chronic illnesses, such as diabetes, kidney disease, or cancer. It causes around 10 million cases of invasive ExPEC disease annually worldwide and is a large force behind the global Antimicrobial Resistance crisis. Antimicrobial resistant 

 strains are an ongoing concern in the global healthcare community.

In a Sanofi press release, Thomas Triomphe, executive vice president, Vaccines, Sanofi, said, “

 is a significant cause of sepsis, mortality, and antimicrobial resistance in older adults, and the number of cases is rising as the population ages. In line with our commitment to design and deliver first- or best-in-class medicines and vaccines, this agreement

aims to positively impact public health by reducing hospitalization costs and the burden on health systems associated with ExPEC

help older adults around the world to live longer, healthier lives

Sanofi is set to pay $175 million upfront to Janssen, followed by development and commercial milestones.


Sanofi and Janssen Sign Agreement for Phase III Extraintestinal Pathogenic E. coli Vaccine Candidate

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On Oct 4, 2023, the BioIndustry Association (BIA) released a new report detailing how the United Kingdom is positioned to become a global leader in messenger RNA (mRNA) medicine. To see the importance of mRNA technology, one only has to look to the recent Nobel Prize in Physiology or Medicine jointly awarded to Dr. Karikó and Dr. Weissman. The award was given for their nucleoside base modification discoveries that paved the way for modern mRNA development, including the development of the COVID-19 vaccines.

mRNA Revolution: A New Generation of Medicine

, the BIA report highlights the UK’s strong foundation in research and development of mRNA, as well as several UK-based companies that are developing mRNA products. These companies include SiSaf, AstraZeneca, and GlaxoSmithKline, as well as international companies such as Moderna and CPI. While Moderna and CPI are not based in the UK, they both have large UK facilities, at which they have conducted important mRNA studies.

Key organizations in the UK mRNA market include organizations providing research funding, such as The Wellcome Trust, The Medical Research Council, and Innovate UK, as well as organizations with strong research bases, such as The University of Oxford and Imperial College London. In 2020, the UK government allotted £200 million of funding for mRNA research and development, which is being used by a range of projects. Development of new mRNA vaccines, mRNA-based cancer treatments, and new delivery methods for mRNA make up some of the development projects that are being bolstered by this funding.

The article’s release falls close to the first RNA Vaccines and Therapeutics Conference held at the Royal Academy of Engineering on October 4–5, 2023. The conference, sponsored by CPI and Imperial College London, focused on the evolving science of encoding RNA medicines, and the entire pharmaceutical cycle of next-generation RNA vaccines and therapies.

The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.