Pieris-Genentech deal; Xilio inks deal with Merck; BMS taps Xencor’s tech; GenSight’s gene therapy reports partial recovery

Posted on May 27, 2021 by Delveinsight

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Pieris Pharmaceuticals declares Respiratory and Ophthalmology deal with Genentech

Pieris, a clinical-stage biotechnology company, declared that it has entered into a multi-program research collaboration and license collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialise locally delivered respiratory and ophthalmology therapies, which leverage Pieris’ proprietary Anticalin® technology.

The research deal will let Pieris to combine its robust discovery engine with Genentech’s targets, and its preclinical and clinical development expertise, to develop novel therapies for the treatment of respiratory and ophthalmological diseases. These two main areas of the deal are uniquely suited to the advantages proffered by the tiny size of Anticalin proteins when delivered locally.

Under the collaboration terms, Pieris will receive USD 20 million as an upfront payment. They may be eligible to secure more than USD 1.4 billion in additional milestone payments across various programs, as well as tiered royalties for commercialised programs. Pieris will be responsible for discovery research and early preclinical development of the programs, and Genentech will be accountable for IND-enabling activities, clinical development, and commercialisation of those programs. Genentech will also have the option to choose additional targets in return for an option exercise fee. 

Xilio and Merck collaborate on Anti-CTLA-4 Antibody/Keytruda combo in solid tumors

Xilio Therapeutics has signed a deal with Merck to assess its anti-CTLA-4 monoclonal antibody XTX101 in combination with Keytruda. The deal sets Xilio up to show whether it can merge the checkpoint inhibitors without causing the toxicities associated with other cocktails that aim CTLA-4 and PD-1. 

Bristol Myers Squibb has achieved approvals in seven indications for its combination of CTLA-4 drug Yervoy and PD-1 inhibitor Opdivo on the strength of evidence the cocktail works better than either molecule alone in some indications. However, Big Pharma has also linked the combination to a higher rate of specific grade 3 and 4 adverse events, including liver enzymes. 

Xilio is trying to develop a safer CTLA-4 inhibitor by linking the active molecule to a peptide. By pairing the antibody to the peptide, Xilio is zeroing in on it to keep it masked until it reaches the tumour. The presence of proteases should cleave the link and hence limit systemic exposure.

The Merck agreement offers Xilio a chance to evaluate whether its approach results in safer combination therapy. Xilio intends to run a trial that will test XTX101 as a monotherapy and in combination with Merck’s Keytruda in solid tumour patients. The biotech plans to file an IND in the second quarter and commence the study promptly once it gets the green light from the FDA.

Bristol Myers permits Xencor’s technology platform to prolong the half-life of COVID-19 antibodies

Xencor, Inc. declared that it has entered into a technology license deal with Bristol-Myers Squibb Company under which the latter will have non-exclusive access to Xencor’s Xtend™ Fc technology to prolong the half-life of a novel antibody combination therapy, which is planned to neutralise the SARS-CoV-2 virus (SARS-CoV-2 mAb Duo) for treatment or prevention of COVID-19. SARS-CoV-2 mAb Duo was found by researchers at The Rockefeller University and was subsequently authorised by Bristol Myers Squibb. Investigators are conducting phase 1 clinical evaluation to test the dosing and safety of the antibody combination at the Rockefeller University Hospital. In contrast, the initial Phase 2 and 3 studies are being scheduled as part of the NIH ACTIV-2 trial examining the treatment of infected outpatients.

Bassil Dahiyat, PhD, president and chief executive officer at Xencor, said that Xencor’s Xtend Fc domains had been incorporated into more than a dozen clinical-stage programs or commercialised medicines, comprising two programs under study for the treatment of COVID-19 and five for other infectious diseases. This reflects the potential of Xencor’s XmAb® protein engineering platforms to improve the therapeutic performance of novel antibody candidates. By extending half-life, they improve upon a candidate’s product profile and potentially reduce costs, both of which are essential features, particularly for an anti-viral therapy intended for pandemic use. 

Under the terms of the deal, Bristol Myers Squibb will have single responsibility for supporting and progressing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to secure royalties from net sales of products, including these antibodies.

GenSight’s mutation-agnostic gene therapy prompts partial vision recovery

GenSight Biologics has reported the partial recovery of the vision of a retinitis pigmentosa patient treated with its mutation-independent approach to the restoration of visual function.

Spark Therapeutics, now part of Roche, won FDA approval for its retinitis pigmentosa gene therapy Luxturna in 2017. However, the approval only included the use of Luxturna in patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. As changes cause retinitis pigmentosa to more than 70 genes, it is questionable whether mutation-specific approaches can cover all patients. 

Identifying that, GenSight is developing GS030, an optogenetic therapy. The drug component of the intervention comprises a viral vector designed to cause the expression of the light-sensitive opsin ChrimsonR in retinal ganglion cells.

In a phase 1/2 clinical trial, physicians administered the gene therapy via a single intravitreal injection to the worse-seeing eye of a 58-year-old man diagnosed with retinitis pigmentosa 40 years ago and could not detect objects visually. The patient was still unable to see objects visually after the injection.

However, the patient could perceive, locate, count and touch different objects using his treated eye while wearing a pair of goggles. The goggles identify changes in light intensity and send pulses of light to the retina in real-time, effectively increasing the signal sent to the ChrimsonR-expressing cells.

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