10-Q – Quarterly report [Sections 13 or 15(d)]

Exelixis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Prescient Therapeutics in a sweet spot with significant progress in multiple cancer programs

On August 5, 2021 Prescient Therapeutics Limited (ASX:PTX) reported that it is engaged in developing a robust drug pipeline comprising CAR-T and targeted therapies (PTX-100 & PTX-200) for various challenging cancers with unmet medical needs (Press release, Prescient Therapeutics, AUG 5, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-in-a-sweet-spot-with-significant-progress-in-multiple-cancer-programs [SID1234586072]). The personalised medicine approaches of the Company seek to improve patient outcomes in combating cancer.

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Furthermore, Prescient is working to rapidly expand the application of universal CAR-T therapies capable of addressing difficult-to-treat cancers.

On 4 August 2021, the Company announced its participation in Reach Markets’ ‘The Insider: Meet the CEO’ session, where PTX gave a presentation highlighting key developments in multiple cancer programs.

Prescient’s innovative pipeline in personalised medicine, Source: PTX Investor Presentation, 4 August 2021

ALSO READ: Prescient ends June quarter with notable progress in cancer programs and a healthy financial position

PTX-100 showed an excellent safety profile and exhibited encouraging activity in Phase 1b trial
In the Phase 1b basket trial, PTX-100 demonstrated an impressive safety profile and was well tolerated at the highest dose of 2,000mg/m2. In addition, no serious adverse events (SAEs) related to PTX-100 were observed during the study. Notably, the drug also exhibited clinical benefit in two T cell lymphoma (TCL) patients with aggressive disease that had not responded to 3-5 prior therapies.

The Company is now planning to conduct an expansion cohort study of PTX-100 concentrating on the treatment of TCL with a possibility of subsequent registration study. Currently, the Company anticipates enrolling up to 12 patients with T cell lymphoma (mainly Peripheral T-Cell Lymphoma or PTCL), which represents an area of considerable unmet need.

RELATED ARTICLE: Prescient takes its PTX-100 trial to next level after Phase 1b success

PTX-200 Phase 1b trial underway: Acute myeloid leukemia (AML)
The PTX-200 AML study is spearheaded by world-renowned leukemia specialist Professor Jeffrey Lancet at Moffitt Cancer Center and Dr Tara Lin at the University of Kansas Medical Center (KUMC).

Initially, PTX-200 was tested for 25 mg/m2. Having proved its safety, the AML study was advanced to a higher dose of to 35 mg/m2. The Company highlighted that the three patients treated with the 35 mg/m2 dose had achieved complete responses in the study so far. Currently, PTX is screening the second cohort at 45 mg/m2.

Moreover, PTX-200 has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration.

RELATED ARTICLE: Prescient Therapeutics’ (ASX:PTX) AML trial progresses to next dosing level

OmniCAR- A universal next-generation CAR-T
Prescient is developing next-generation products in-house. In January 2021, the oncology player disclosed its three OmniCAR programs-

In June, the Company completed another CAR-T milestone with the completion of manufacturing and delivery of crucial components of the OmniCAR platform. In addition, PTX highlighted that the binders against various cancer targets, including CLL-1, CD33, Her2, and EGFRviii, were produced by a US-based leading antibody manufacturer.

Additionally, in-silico evaluation confirmed the non-immunogenic profile of these crucial components. The results demonstrated that OmniCAR’s binding system components – SpyTag and SpyCatcher – have very low immunogenicity, lower than a panel of humanised therapeutic antibodies already approved for human use.

OnmiCAR also offers collaboration and licensing opportunities for third parties via partnerships based on targets, specific constructs as well as cell types.

Source: PTX Investor Presentation, 4 August 2021

RELATED ARTICLES:

Prescient Therapeutics reaches a major CAR-T manufacturing milestone
Positive results from immunogenicity testing send Prescient’s shares higher
Cell Therapy Enhancements (CTE) programs

Prescient has several other initiatives in progress to develop new cell therapy programs. The new programs overcome the efficiency challenges confronted by other CAR-T therapies.

CTE programs are now being undertaken at Peter MacCallum Cancer Centre, another sign of the fast-developing relationship between the two organisations. Notably, Prescient would have 100% ownership of intellectual property (IP) generated from the ongoing research on cell therapy enhancement programs.

On 4 August 2021, PTX shares closed at AU$0.185, up by 5.714%.

Icon Group First in World to Adopt New Multi-Disciplinary Oncology Information System from Varian

On August 5, 2021 Varian, a Siemens Healthineers company, reported that cancer patients in Australia will be the first in the world to benefit from streamlined, coordinated cancer care facilitated by an upcoming release of the ARIA oncology information system (OIS) with new multi-disciplinary functionality (Press release, Varian Medical Systems, AUG 5, 2021, View Source [SID1234586060]). Australia’s Icon Group will become the first in the world to deploy this new system, which is scheduled for release in Australia and other global sites in early 2022.

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Icon plans to go live with its first location in 2022. After a successful deployment, the new ARIA system will serve as Icon’s next-generation platform for enhancing clinical operations, and further deployments at other Icon sites will commence. The longer-term plan is to install this integrated solution across Icon’s global footprint of 44 locations over several years.

Icon will also be the first in the Australian and Asia/Pacific regions to deploy Varian’s Noona electronic patient-reported outcomes (ePRO) solution, a digital application that enables real-time patient engagement and seamlessly integrates with the new ARIA release.

Mark Middleton, CEO, Icon Group, said, "Icon is delighted to once again be at the forefront of technology evolution alongside Varian. As a global provider of comprehensive cancer care, having systems that address the breadth of our operations is vital to seamless patient care. Varian’s new solution will ensure we continue to advance clinical efficiency, quality assurance, and information security, and it will enhance our team’s ability to focus on the most important part of their day – their patients."

Icon, a long-time and experienced user of ARIA for the management of radiation oncology, is expanding its use of the software to also manage medical oncology. By adding the Noona ePRO application, Icon will be able to integrate patient-reported outcomes data into its patient care practices.

"Icon has chosen a combination of integrated tools that will provide its clinical teams with multiple benefits, including efficient and standardized clinical workflows, a cloud-based software-as-a-service operations model, and the ability to use real-time symptom information to manage the patient’s cancer treatment journey more proactively," said Kenneth Tan, president, Asia Pacific and Japan, Varian. "We are proud to be working with Icon Group, a dedicated group of professionals who are committed to bringing the latest innovations to their patients."

ARIA is Varian’s comprehensive oncology information system for managing clinical, administrative, and financial processes in comprehensive cancer treatment environments. It interconnects clinical functions and provides clinical staff members with up-to-the-minute information for making important clinical decisions quickly at every point in a patient’s course of treatment.

Berry Oncology Completes $99 Million Funding for Genomic Testing

On August 5, 2021 Berry Oncology Corporation reported that it completed a $99 million Series B round to support its portfolio of genomic testing products and services for oncology (Press release, Berry Oncology, AUG 5, 2021, View Source [SID1234586058]). In 2017, Berry Oncology was spun out from Berry Genomics, an early cancer screening firm. Its offerings include cancer genetic susceptibility analysis, early screening, plus companion diagnostics, response monitoring and prognosis predictions of targeted and immune therapies. With the new funding, the company has raised $309 million it total, the highest in its industry.

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Knight to Present at the Canaccord Genuity 41st Annual Growth Conference

On August 5, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Operating Officer, is scheduled to present at Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11, 2021 at 3:00 pm ET, that will be held virtually (Press release, Knight Therapeutics, AUG 5, 2021, View Source [SID1234586050]). A copy of the investor presentation will be available at www.gud-knight.com.

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