A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects

This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.

Start Date23 Sep 2020

Sponsor / Collaborator

CSL Behring LLC

NCT03375606

/ TerminatedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous CSL730 in Healthy Caucasian and Japanese Subjects

To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects

Start Date10 Jan 2018

Sponsor / Collaborator

CSL Behring LLC

100 Clinical Results associated with M-230

100 Translational Medicine associated with M-230

100 Patents (Medical) associated with M-230

Literatures (Medical) associated with M-230

01 Mar 1976·BiochimieQ3 · BIOLOGY

Purification and properties of two initiation factors from Bacillus stearothermophilus

Q3 · BIOLOGY

Article

Author: Monique Graffe ; Marianne Grunberg-Manago ; Alan C. Kay

Two initiation factors have been isolated from the thermophilic bacterium, Bacillus stearothermophilus, and purified to near homogeneity. The two factors possess physical characteristics and activities associated with the E. coli initiation factors IF-2 and IF-3, and are interchangeable with these factors. The two systems present, however, several differences : S-IF-2 is significantly more heat stable than E. coli IF-2, loosing less than 50 per cent of its activity after 20 minutes at 70degreesC. S-IF-2 alone is unable to promote initiation complex formation on B. stearothermophilus or E. coli ribosomes, and S-IF-3 is absolutely necessary for initiation of complex formation on B. stearothermophilus ribosomes. No factor corresponding to IF-1 has been found. S-IF-3 appears to be able to replace at least partially IF-1, since S-IF-3 and E. coli IF-2 are sufficient to promote maximum fMet-tRNA binding to E. coli ribosomes, while E. coli IF-3 and IF-2 also require IF-1. The differences between the two systems are perhaps required because of the elevated temperature at which B. stearothermophilus normally grows.

News (Medical) associated with M-230

28 Feb 2017

·www.biospace.com

Momenta to Become Neighbors With Biogen, Ironwood in Kendall Square Next Year

February 28, 2017 By Alex Keown , BioSpace.com Breaking News Staff CAMBRIDGE, Mass. – Momenta Pharmaceuticals , a company developing M923, a biosimilar to AbbVie ’s Humira, is expanding, taking on an additional 80,000 square feet of space in Kendall Square. The company expects to take on the new space on Jan. 1, 2018. According to a filing with the U.S. Securities and Exchange Commission , Momenta indicated it was taking on an additional 80,000 square feet of laboratory and office space on Binney Street. The extra Binney Street space provides Momenta with a total of 263,500 square feet of laboratory and office space in Cambridge. The bulk of Momenta’s space is on Bent Street. The company maintains 105,000 square feet of office and lab space there, according to the filing. The new space on Binney Street puts Momenta in close proximity with other Kendall Square stalwarts including Ironwood Pharmaceuticals , Ra Pharmaceuticals , Ariad Pharmaceuticals and Biogen . The expansion follows close behind a setback for its Copaxone generic the company is developing with Sandoz . On Feb. 17, Momenta’s contract manufacturing partner Pfizer received a warning letter from the U.S. Food and Drug Administration regarding issues with one of its facilities. The Pfizer facility is a key part of the supply chain for Momenta’s Glatopa products. Momenta’s 40mg dosage of Glatopa is currently under review by the FDA. An approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility, Momenta said. As a result, the company does not expect an approval by the FDA during the first quarter of 2017. A 20mg dosage of Glatopa, a generic for Teva Pharmaceuticals ’ Copaxone for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz, has already been approved for marketing. In January, Momenta forged a deal with Australia-based CSL Limited to develop and market Fc multimer proteins, including Momenta’s M230. M230 is a selective immunomodulator of Fc receptors, and is projected to start in the clinic this year, BioSpace previously reported. In September 2016, Momenta regained the global development and commercialization rights to M923 after Shire terminated the collaboration agreement. The agreement was initially struck in 2011 between Momenta and Baxalta , which Shire acquired. Under the agreement between the companies, Shire will be obligated to fund the M923 project until the window for termination has been met. In November, Momenta announced M923 met its endpoints in a Phase III trial. M923 is being developed to treat severe chronic plaque psoriasis. M923 is not the only biosimilar Momenta is developing. Last year the company struck a co-development deal with Mylan to initiate a Phase I trial to study M834 , a biosimilar to Orencia, a rheumatoid arthritis drug developed by Bristol-Myers Squibb . In 2015, worldwide sales of ORENCIA totaled $1.9 billion. Data from the Phase I trial is expected to read out later in 2017. Momenta closed out 2016 with $353.2 million in the bank. That does not include a $51.2 million payment from Shire in January 2017 and the $50 million upfront payment from CSL that the company expects to receive in the first quarter of 2017. Shares of Momenta are down 2 percent this morning, trading at $15.58.

Phase 1Drug ApprovalPhase 3Clinical ResultLicense out/in

06 Jan 2017

·www.biospace.com

Cambridge’s Momenta Jumps on $600 Million R&D Pact With This Global Biotech

January 6, 2017 By Mark Terry , BioSpace.com Breaking News Staff Cambridge, Mass.-based Momenta Pharmaceuticals and Australia-based CSL Limited announced yesterday they had signed a research collaboration and global licensing deal. The two companies plan to collaborate on developing and commercializing Fc multimer proteins, including Momenta’s M230. M230 is a selective immunomodulator of Fc receptors, and is projected to start in the clinic this year. Momenta is granting CSL an exclusive, worldwide license to its intellectual property relating to M230. CSL is paying $50 million upfront. Momenta will also be eligible for up to $550 million in various clinical, regulatory and commercial milestone payments. In addition, there is a cost and profit sharing component to the deal. Moment will fund a percentage of global development and commercialization expenses in return for a share of U.S. profits, as well as milestones and royalties outside the U.S. Momenta also has an option to co-promote M230 and other collaboration products in the U.S. “This collaboration and license agreement with CSL validates our belief that M230 is an exciting recombinant product candidate for potential use in autoimmune indications,” said Craig Wheeler , Momenta Pharmaceuticals’ president and chief executive officer, in a statement. “It was developed using our proprietary Fc biology platform and understanding of how intravenous immunoglobulin (IVIg) works in autoimmune diseases. As the global leader in immunoglobulin (Ig) therapy, CSL is the ideal development and commercialization partner for us in the area of Fc biology given their expertise in developing plasma-derived medicines and focus on creating disruptive recombination products in the autoimmune space.” On November 29, 2016, Momenta announced that its biosimilar to Humira (adalimumab), M923, which it developed in collaboration with Baxalta , now part of Shire , met its primary endpoint in a Phase III trial in severe chronic plaque psoriasis. In addition, all its secondary efficacy endpoints were achieved. Momenta is currently trading for $16.72. Shares rose significantly after the company’s corporate update, as well as the CSL collaboration deal. Over the last three months, company shares have risen 36 percent compared with a 5.0 percent increase in the S&P 500 SPX. “We are delighted to announce this collaboration with Momenta, who are leaders in the Fc biology space,” said Paul Perreault , chief executive officer and managing director of CSL, in a statement. “M230 is a very exciting prospect and offers CSL the potential to further grow and expand our long-term global leadership in helping those patients with autoimmune diseases that are treated with immunoglobulins.” CSL is a global specialty biotherapeutics company. It has facilities in Australia, Germany, Switzerland, the U.K. and the U.S. It employs over 16,000 people in more than 30 countries. On December 1, 2016, CSL announced it had moved three programs into Phase I clinical trials. All three are monoclonal antibodies. CSL324 is an anti-GCSFR monoclonal antibody being studied in inflammatory diseases. CSL312 is an anti-factor XIIa monoclonal antibody being studied for multiple indications, including Hereditary Angioedema (HAE). CSL346 is an anti-VEGF-B monoclonal antibody being studied in Type 2 diabetes. CSL is currently trading for $102.33 (AUS).

Phase 1License out/inPhase 3Clinical ResultImmunotherapy

100 Deals associated with M-230

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Immune Complex Diseases	Phase 1	United Kingdom	CSL Behring LLC	23 Sep 2020
Autoimmune Diseases	Phase 1	United Kingdom	CSL Behring AB	23 Sep 2020

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