Feliza Mirasol is the science editor for 

Feliza Mirasol

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on July 21, 2023 that they have received a positive opinion for two novel bispecific antibodies from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP has recommended conditional marketing authorization for TALVEY (talquetamab) and has recommended the approval of a Type II variation for teclistamab (marketed under the brand name TECVAYLI).

Janssen is seeking approval of talquetamab as a monotherapy to treat adult patients with relapsed and refractory multiple myeloma (RRMM). The indication is for RRMM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, but who have still demonstrated disease progression on the last therapy. Talquetamab, a subcutaneous bispecific antibody, binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells, according to a company press release.

The CHMP’s recommendation for the Type II variation for teclistamab means that, if approved, then the dosing schedule for the therapy can be reduced to a biweekly dosing schedule in patients who have achieved a complete response or better for six months or longer. Teclistamab is a bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells. According to the company press release, it is the first bispecific antibody with this mechanism of action to be licensed in Europe for treating adult RRMM patients who have had at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who have demonstrated disease progression on the last therapy.

“With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to … bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis,” said Edmond Chan, senior director EMEA Therapeutic Area Lead Hematology, Janssen-Cilag, in the press release. “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”

“Pending approval, this variation for teclistamab will be an important step forward for this first BCMA bispecific therapy, offering flexible, less frequent dosing depending on a patient’s response,” said Sen Zhuang, vice president, Clinical Research and Development, Janssen Research & Development, in the release.

Articles

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies

MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt Germany, has invested $25 million to expand its cell culture media production facility in Lenexa, Kan. With the investment, the company intends to add 98,000 ft2 of lab space and cell culture media production capability, the company announced in a July 12, 2023 press release.

Counting its Lenexa site, the company has a total of three centers of excellence for dry powder cell culture media manufacturing. The other two centers are in Nantong, China, serving the Asia Pacific region, and Irvine, Scotland, serving Europe, the Middle East, and Africa region.

“This expansion makes Lenexa the company’s largest dry powder cell culture media facility and [c]enter of [e]xcellence in North America,” said Darren Verlenden, head of Process Solutions, Life Science, MilliporeSigma, in the press release. “Investing in the region reflects our strategy to expand and diversify our supply chain to ensure we meet current and future demand for cell culture media.”

“The new production line represents the company’s vision for our Lenexa site, as it was initially constructed for three manufacturing lines for dry powder cell culture media,” Verlenden said in the release. “The new production line is the culmination of multiple years of planning, and now we are able to offer greater flexibility and faster cell culture media manufacturing for our customers.”

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

MilliporeSigma Expands Production Facility for Cell Culture Media

US-based biotechnology company Crossbow Therapeutics announced an $80 million Series A funding round that was led by investment company MPM BioImpact and Pfizer Ventures. The funding will allow Crossbow to advance the development of novel antibody therapies that target peptide-loaded major histocompatibility complexes on cancer cells. The antibodies are T-cell receptor (TCR)-mimetics, according to a July 11, 2023 company press release.

The company uses its proprietary technology to develop TCR-mimetic antibodies with both high affinity and specificity for cancer cells. These TCR-mimetics are incorporated into off-the-shelf, easy-to-assemble T-cell engagers and other immunotherapies. The resulting products are known as tumor-bolts (T-Bolt) molecules, which can be adapted to address a broad range of cancers. The company can thus leverage these molecules to target the vast landscape of cancer proteins, according to the press release.

“We aim to cure cancer,” said Briggs Morrison, CEO, Crossbow Therapeutics, in the release. “ … [O]ur revolutionary T-Bolt products strike cancer cells like a crossbow shoots bolts at its target. The influx of additional capital enables us to scale our efforts to build an arsenal of TCR-mimetic-based immunotherapies designed to overcome the limitations of current treatments.”

“Our continued investment in Crossbow Therapeutics reflects our confidence in the team’s differentiated approach to vastly expand the range of targets for immunotherapies,” said Todd Foley, managing director of MPM BioImpact and co-founder and chair of the Crossbow board of directors, in the release.

The Series A funding was also supported by Polaris Partners, BVF Partners, Eli Lilly and Company, Mirae Asset Venture Investment, and Mirae Asset Capital.

Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.

Crossbow Therapeutics Debuts with $80 Million in Series A Financing to Advance Antibody Therapeutics

Bristol Myers Squibb has exercised its option to enter into an exclusive global license agreement with Germany-based Evotec, a drug discovery company, for selected late-stage discovery programs that were developed and progressed from a collaboration between the companies.

According to a July 11, 2023 press release, the companies originally formed a neurodegeneration partnership in 2016, which proved to be highly productive. Under the collaboration, Evotec and Bristol Myers Squibb generated a pipeline of discovery-to-clinical-stage programs. The current licensing agreement expands on that original collaboration, extending the partnership to another eight years.

Under the license agreement, Bristol Myers Squibb has selected a number of programs (not disclosed) that were developed and progressed in a short time frame using Evotec’s precision medicine platforms. Based on this achievement, Evotec get a $40 million payment and is eligible to earn performance-based milestone payments. The company is also eligible to receive tiered royalties up to low double-digit percentages based on product sales, according to the press release.

“This license agreement will further bolster our joint pipeline of programs targeting several neurodegenerative conditions. We are confident that the strong collaboration of the experienced teams at Evotec and Bristol Myers Squibb will make novel innovative treatment options available to patients living with a broad range of neurodegenerative conditions,” said Cord Dohrmann, chief scientific officer, Evotec, in the release.

Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.

Bristol Myers Squibb and Evotec Extend Neuroscience Pact

On Jul 18, 2023, Novartis announced in its 2023 second quarter (Q2) earnings that its board of directors has unanimously endorsed the 100% spin-off of Sandoz, the company’s generics and biosimilars division, into a standalone, publicly traded entity. Novartis had previously announced its intent to separate the Sandoz business in August 2022 (1). The proposed spin-off is expected to happen early in the 2023 fourth quarter.

According to a company press release, the next step involves Novartis shareholders voting on the proposed spin-off and a related reduction of the share capital of Novartis AG at a general meeting planned on Sept. 15, 2023. The plan is for Sandoz to be listed on the SIX Swiss Exchange, with an American Depositary Receipt program in the United States.

Novartis reported in its Q2 earnings that Sandoz sales grew 8% for the quarter, with net sales of $2.4 billion. Growth was primarily driven by Europe, which totaled $1.3 billion. Global sales of biosimilars grew 13% to $531 million for the quarter.

According to Novartis’ Q2 earnings release, the spin-off of Sandoz is part of the company’s new strategy to transform itself into a “pure-play” innovative medicines business. It will now focus on five core therapeutic areas: cardiovascular, immunology, neuroscience, solid tumors, and hematology. The company also intends to prioritize three emerging technology platforms for cell and gene therapy, radioligand therapy, and xRNA (i.e., ribonucleosides). The company plans to prioritize continued investment into R&D capabilities and manufacturing scale for these three platforms.

1. Novartis, Novartis Announces Intention to Separate Sandoz Business to Create a Standalone Company by Way of a 100% Spin-Off. Press Release, Aug. 25, 2022.

The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.

Sandoz Spin-off Gets Green Light from Novartis Board

Novartis has acquired DTx Pharma, a US-based, preclinical-stage biotechnology company, for an upfront payment of $500 million plus additional payments of up to $500 million, dependent on the completion of pre-specified milestones, the companies announced in their respective July 17, 2023 press releases.

DTx Pharma focuses on RNA-based therapeutics with its proprietary Fatty Acid Ligand Conjugated OligoNucleotide (FALCON) technology platform, which conjugates small interfering RNAs (siRNAs) to naturally occurring fatty acids to enhance biodistribution and cellular uptake throughout the body. Under the acquisition, Novartis will gain access to the FALCON platform as well as DTx Pharma’s lead program, DTx-1252, a product candidate that targets the root cause of a subtype of Charcot-Marie Tooth disease (CMT)—CMT1A.

CMT1A is the overexpression of peripheral myelin protein 22 (PMP22), a protein that causes the myelin sheath insulating the nerves in the peripheral nervous system to function abnormally. DTx-1252 has been shown to decrease the expression of PMP22 in Schwann cells (target cell type), allowing for the development, maintenance, and function of peripheral nerves, according to DTx Pharma’s company press release.

Also under the acquisition, Novartis will gain two additional preclinical programs for other neuroscience indications. Together with DTx-1252 and the FALCON platform, these assets will expand Novartis’ siRNA toolkit and allow the company to build on its xRNA (i.e., ribonucleosides) capabilities, according to Novartis’ press release.

“I am thrilled that Novartis will be moving forward with our CMT1A therapeutic program and the FALCON platform. With its resources and capabilities in neuromuscular diseases, Novartis is well positioned to accelerate the development of DTx-1252 and provide hope to patients, who are desperately in need of therapy,” said Artie Suckow, co-founder and CEO of DTx Pharma, in that company’s press release.

“We look forward to continuing the development of DTx’s therapeutic programs and bringing new hope to patients with neuromuscular and other neurological disorders for which there have historically been few treatment options,” said Fiona Marshall, president of the Novartis Institutes for BioMedical Research, in the Novartis press release. “We are also excited to bring DTx’s FALCON technology to Novartis and explore its potential to deliver drugs to extrahepatic tissues.”

Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.