Artios collaborates with Novartis; Scholar Rock eyes Phase III trial; Novavax starts crossover arms in Covid-19 trials; Volastra nabs $44M

Posted on Apr 8, 2021 by Delveinsight

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Artios Pharma announces collaboration with Novartis to tap next-generation DDR cancer therapies

Artios Pharma Limited, a leading DNA Damage Response (DDR) company exploiting synthetic lethality to create a broad pipeline of precision medicines for cancer treatment, announced a global research collaboration with Novartis to discover and validate next-generation DDR targets to improve Novartis’ Radioligand Therapies (RLT).

Artios and Novartis will execute target discovery and confirmation under the three-year deal, and Novartis will choose three exclusive DDR targets and receive global rights on these targets to be utilised with its RLT’s.

Under the terms of the contract, Novartis will make an up-front payment of USD 20 million and provide near term research funding to bolster the agreement. Artios will be eligible to obtain discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of products commercialised by Novartis. The collaboration does not comprise Artios’ lead programs, ART0380, which is now in clinical development, or ART4215, a first-in-class Pol Theta inhibitor.

Novartis’ RLT conveys targeted radiation to a particular subset of cancer cells, with minimal effect on surrounding healthy cells. RLT has been shown to enhance overall survival and quality of life, particularly in the setting of cancers with bone metastases

Scholar Rock eyes Phase III trial for SMA Drug

Scholar Rock has announced 12-month data on spinal muscular atrophy (SMA) candidate apitegromab. SMA has quickly gone from a completely unmet need to a disease served by various products. However, there are still opportunities for treatments that can improve current products, either as single agents or combination therapies. Scholar Rock displayed its selective inhibitor of the activation of latent myostatin, a mechanism of action distinct from existing treatments, which could improve existing options last year.

The 12-month update broadly confirms the encouraging previous findings. Explanation of the results is again complicated by the open-label study design, but most effects observed at six months have shown to be durable.

In some cases, the efficacy outcomes enhanced between the six and 12-month readouts. A cohort of kids with type 2 SMA aged two years and older who started treatment with Biogen and Ionis’ Spinraza before turning five years old experienced a mean enhancement of 5.6 points on a motor scale after getting 20-mg/kg infusions of apitegromab on top of their current therapy for six months. At 12 months, the improvement was 7.1 points. Scholar Rock observed a similar trend in the lower dose arm.

Around one-third of the low and high-dose arm participants experienced at least a 10-point improvement on the motor function scale at 12 months. Roughly 60% of patients had a five-point growth.

Scholar Rock is now preparing to put apitegromab through a phase 3 study designed to validate the signs of efficacy seen in phase 2. The trial is slated to initiate by the end of the year. Scholar Rock is also working on expanding the use of apitegromab. A proof-of-concept study in Becker muscular dystrophy is scheduled for next year.

Novavax initiates crossover arms in Covid-19 vaccine trials 

Novavax has announced the beginning of crossover arms in the current phase IIb South African trial and pivotal phase III UK trial of its Covid-19 vaccine candidate NVX-CoV2373.

A protein-based vaccine candidate, NVX-CoV2373, is engineered from the genetic sequence of SARS-CoV-2. It can be stored and remains stable at 2°C to 8°C, conferring currently available vaccine supply chain channels for distribution.

The company observed crossover guarantees that all subjects in the trials are inoculated with the active vaccine. As per Novavax’s updated trial protocols, all subjects in phase III UK and US trials will have an opportunity to get a further round of vaccine doses.

Subjects in all three trials will be blinded to their treatment courses to preserve the ability to assess efficacy in each trial. They will also be pursued for two years to evaluate vaccine-provided protection’s safety and durability.

So far, half of the subjects were administered the active vaccine in the South African trials and the UK, while two-thirds of subjects in the PREVENT-19 trial conducted in the US and Mexico received the active vaccine.

Novavax hopes to conduct a crossover in the PREVENT-19 study, with initial clinical data readout anticipated during the second quarter. 

Furthermore, the company schedules to extend the trial for paediatric and adolescent arms in the second quarter of this year.

In February, Novavax announced that several regulatory authorities commenced the rolling review process for the authorisation of NVX-CoV2373.

Volastra nabs USD 44 Million to advance metastasis-targeted drug discovery

Volastra Therapeutics has raised USD 44 million to further its technology platform, which exploits insights into chromosomal instability to recognize and validate novel drug targets to stop cancer metastasis.

The company is developing proprietary computational and experimental approaches to comprehend chromosomal instability biology and drive drug discovery. The company’s tools are a proprietary technology suite to bulk-measure and exploit vulnerabilities in chromosomally unstable cancer cells. Volastra is zeroed in on developing novel compounds to hinder metastasis with this technology.

This announcement followed the company’s partnership with Dewpoint Therapeutics to discover novel molecules capable of blocking immuno-suppressive signalling in chromosomal instability (CIN)-high tumors. Volastra is also partnering with Microsoft to develop artificial intelligence algorithms to detect and predict metastatic potential in human tissue samples. New investors Vida Ventures and Catalio Capital Management joined the seed financing extension.

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