On July 5, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance and review notification for the Company’s PMA application for its Dovitinib-DRP, the Company’s validated companion diagnostic for the drug dovitinib (Press release, Allarity Therapeutics, JUL 5, 2021, View Source [SID1234584595]). Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical asset.

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On 2 April, 2021, Allarity announced the filing of the PMA application. The FDA’s acceptance of the Company’s PMA application means that the FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Allarity’s PMA application, to gain FDA approval to use the Dovitinib-DRP as a companion diagnostic to select and treat patients likely to respond to dovitinib, supports the Company’s imminent NDA filing for the drug, and is the Company’s first PMA filing for a drug-specific DRP companion diagnostic.

Allarity’s CEO, Steve Carchedi, noted, "The FDA’s acceptance of our PMA filing for the Dovitinib-DRP companion diagnostic is an important milestone for our Company. This marks a turning point for our DRP technology, as it represents the first time in our Company’s history that we have advanced towards regulatory approval for one of our drug-specific DRP companion diagnostics."

Allarity’s unique and clinically validated DRP biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments for individual patients are done based on a biopsy from the patients’ tumor. The Dovitinib-DRP companion diagnostic is intended to be used to identify patients suffering from renal cell carcinoma (RCC) who by the gene expression signature of their tumor are found to have a high likelihood of responding to dovitinib.

Allarity plans to file an NDA with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA, following the agency’s complete review process, provides the anticipated PMA approval of the Dovitinib-DRP as a companion diagnostic for dovitinib, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib in the U.S. to DRP-selected RCC patients as an effective new therapy to treat their disease.

On July 5, 2021 Scandion Oncology A/S ("Scandion Oncology") reported that its President & CEO, Bo Rode Hansen, has bought additional 10,800 shares in Scandion Oncology resulting in a total holding on 35,900 shares in the Company (Press release, Scandion Oncology, JUL 5, 2021, View Source;ceo-has-bought-10-800-shares-in-scandion-oncology,c3380226 [SID1234584594]).

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On July 5, 2021 Prescient Therapeutics reported The results significantly de-risk the project as PTX continues development of its OmniCAR platform (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=prescient-shares-rip-higher-as-immunogenicity-testing-results-for-omnicar-could-not-have-been-better [SID1234584593]).

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As it builds out its OmniCAR cancer treatment platform, clinical stage oncology company Prescient Therapeutics (ASX:PTX) has updated investors with a run of positive news flow in recent weeks.

And that run continued this morning as PTX announced strong results upon completion of its in silico (computer simulated) immunogenicity testing program.

The testing program was carried out on SpyTag and SpyCatcher – Prescient’s two proprietary components that bind cancer-fighting T-cells with a targeting ligand in order to target specific proteins.

Results "could not have been better"
Investors responded to the update, sending shares in PTX more than 13 per cent higher in morning trade to 26c.

"Immunogenicity testing evaluates the body’s immune response against a new therapy, which can adversely affect safety and efficacy", PTX explained.

In that context, the immunogenicity results for SpyTag and SpyCatcher "could not have been better", CEO Steven Yatomi-Clarke said.

The immunogenicity levels were "lower than a panel of humanised therapeutic antibodies already approved for human use", an equivalent to existing antibodies produced naturally by the human body.

"In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself," Yatomi-Clarke said.

That marks a key step forward not only for the development of Prescient’s three in-house OmniCAR programs, but also for potential partners and collaborators that want to licence the OmniCAR platform.

"These results substantially de-risk the entire platform and are important for progressing Prescient’s in-house programs and external collaborations with OmniCAR," Prescient said.

The immunogenicity results follow on from a key manufacturing milestone last month, when Prescient announced production was complete for a range of binders that target multiple cancers.

And today’s update confirms the PTX management team continues to execute on both its in-house CAR-T treatment and the OmniCAR licensing platform.

The company is developing OmniCAR programs for the treatment of myeloid leukemia; Her2+ solid tumours (including breast, ovarian and gastric cancers), and glioblastoma multiforme (the most common form of brain cancer).

Development remains ongoing at the world-leading Peter MacCallum cancer research centre in Melbourne.

This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

On July 5, 2021 Prescient Therapeutics Ltd (ASX: PTX) reported the back of news its cancer treatment drug, OmniCAR, has been substantially de-risked (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=the-prescient-asxptx-share-price-rocketed-10-higher-today-heres-why [SID1234584590]).

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After reaching a multi-year high of 26.5 cents this morning, the Prescient share price has retreated slightly and is currently trading at 25 cents apiece, up 8.7%.

Today, Prescient announced positive results from in silico immunogenicity testing of SpyTag and SpyCatcher, OmniCAR’s key binding components.

Let’s take a look at today’s news from the cancer treatment development company.

Positive immunogenicity results
According to Prescient’s release, the results have de-risked the entire OmniCAR platform.

The in silico tests found SpyTag and SpyCatcher don’t inspire a negative response from human antibodies – meaning, the human body won’t attack the treatment itself.

In silico tests are done on a computer using algorithms. In this case, the tests mimicked the human body’s response to introduced medication.

OmniCAR combines controllable CAR T-cell therapy and multi-antigen targeting. According to Prescient, high levels of immunogenicity – a negative response from antibodies – can negatively impact CAR-T cell expansion and persistence, which can affect the safety and clinical response of the treatment.

OmniCAR is currently being developed to treat acute myeloid leukemia, Her2+ solid tumours (including breast, ovarian and gastric cancers), and the most common form of brain cancer, glioblastoma.

Today’s development follows the successful completion of manufacturing and delivery of critical components of the OmniCAR platform.

Commentary from management
Prescient CEO and managing director Steven Yatomi-Clarke commented on the results, saying:

The immunogenicity results could not have been better. In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself.

This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently.

On July 5, 2021 Prescient Therapeutics (PTX) reported that it recent results from testing show its entire platform has been substantially de-risked (Press release, Prescient Therapeutics, JUL 5, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-returns-successful-immunogenicity-results [SID1234584589]).

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In silico immunogenicity testing of the company’s OmniCAR key binding components, SpyTag and SpyCatcher, evaluated the immune response against a new therapy, affecting safety and efficacy.

OmniCAR is a universal immune receptor platform enabling controllable T-cell activity and multi-antigen targeting with a single cell product. Prescient is developing OmniCAR programs for acute myeloid leukemia, solid tumours like breast, ovarian and gastric cancers, and glioblastoma multiforme, the most common form of brain cancer.

The immunogenicity of SpyTag and SpyCatcher was tested in silico by an independent US research provider to determine if either component has the potential to cause adverse immune responses that could compromise the therapy.

The results demonstrated both SpyTag and SpyCatcher have very low immunogenicity — significantly lower than a panel of humanised therapeutic antibodies already approved for human use.

In the case of CAR-T cell therapies, high levels of immunogenicity can impact CAR-T cell expansion and persistence, which can impact the overall safety and response to the treatment.

The company says the positive results re-risk the entire OmniCAR platform and trigger the next steps for development.

Prescient’s CEO and Managing Director, Steven Yatomi-Clarke, said the immunogenicity results could not have been better.

"In short, it gives us confidence that if these therapies are ultimately delivered to patients, that their immune systems will not impair the therapy itself. This is essential not only for Prescient’s three in-house OmniCAR programs, but also for potential external collaborators, who consider immunogenicity very stringently."

The new development follows Prescient finishing manufacturing and delivering critical components of the OmniCAR platform for several cancer targets and lentiviral vectors used to produce CAR-T cells.

The company says its development plans are on schedule to deliver the next important milestones.

"Together with our talented research team at Peter Mac, we are excited to progress our inhouse next generation cell therapies for cancer patients," said Mr Yatomi-Clarke.