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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

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.

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.

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.

Merus Announces Financial Results for the Second Quarter and Provides Business Update

On August 5, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the second quarter that ended June 30, 2021 and provided a business update (Press release, Merus, AUG 5, 2021, View Source [SID1234586049]).

"We are encouraged by the interim results on Zeno in patients with NRG1 fusion cancers that we reported in the second quarter and remain focused on successful execution of our Zeno program and our other clinical trials," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We are planning to provide a clinical update on MCLA-145 and MCLA-158 later this year."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics)

Phase 2 part of the phase 1/2 trial continues: update planned by the first half of 2022

We shared interim clinical data of our zenocutuzumab (Zeno) program in patients with NRG1 fusion (NRG1+) cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The highlights from the presentation included:

As of the April 13, 2021, efficacy data cutoff, 61 patients with NRG1+ cancer were enrolled, including 45 patients evaluable for response.
Encouraging early clinical activity was observed, with confirmed partial responses by investigator review (RECIST v1.1) in 42% (5 of 12) patients with pancreatic cancer and in 29% (13 of 45) patients across all NRG1+ tumor types treated.
One additional partial response was confirmed after the data cutoff date, which if included in the interim efficacy analysis, would increase the percentage of confirmed partial responses across all NRG1+ tumor types treated to 31% (14 of 45 patients).
More than three quarters (34 of 45) of evaluable patients showed tumor reduction. In addition, 40% (19 of 47) of all patients remained on therapy as of the data cutoff date.
Zeno continues to be well tolerated with a favorable safety profile.
As of June 4, 2021, more than 70 patients had been treated in the eNRGy trial and Early Access Program (EAP). We continue to be encouraged by the ongoing trial, rate of enrollment, observed clinical activity and safety profile, and plan to provide a clinical and regulatory program update by the first half of 2022.

In the second quarter of 2021, we entered into collaborations with several companies and medical organizations in Israel, Italy and Spain with the goal of raising awareness of the eNRGy trial and providing access to molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions. Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions, to raise awareness of and support enrollment into the eNRGy trial.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors

Phase 1 trial continues with dose expansion cohorts: update planned for Q4’21

The phase 1, open-label, multicenter clinical trial of MCLA-158 is ongoing in the dose expansion phase. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues, and preliminary evidence of antitumor activity has been observed. We plan to provide an update at a medical conference in the fourth quarter of 2021.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors

Phase 1 trial continues: update planned for Q4’21

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of a dose escalation phase, to be followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation ("Incyte"), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States. We plan to provide an update at a medical conference in the fourth quarter of 2021.

We published a report in Nature Communications in July titled "A human CD137×PD-L1 bispecific antibody promotes anti-tumor immunity via context dependent T cell costimulation and checkpoint blockade" demonstrating in preclinical models that MCLA-145 potently activates T cells, even in the presence of suppressive conditions, as well as enhances T cell priming and promotes long-term T cell immunity. In addition, the antitumor activity of MCLA-145 in in vivo models was superior to those of the current standard immune checkpoint inhibitor comparators and associated with recruitment and intratumoral expansion of CD8+ T cells.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

The phase 1/2, open-label, single-agent clinical trial of MCLA-129 is ongoing and consists of a dose escalation phase, to be followed by planned expansion cohorts evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

Second Quarter 2021 Financial Results

We ended the second quarter with cash, cash equivalents and marketable securities of $352.8 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Eli Lilly and Company ("Lilly"), net of cash used in operations and other items. Based on the Company’s current operating plan, we expect that our existing cash and cash equivalents and marketable securities of $352.8 million as of June 30, 2021, will fund the Company’s operations into the second half of 2024.

Collaboration revenue for the three months ended June 30, 2021 increased by $6.3 million as compared to the three months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $4.6 million that commenced in the first quarter of 2021, and a $1.4 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended June 30, 2021 increased by $10.9 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended June 30, 2021 increased by $2.6 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs.

Collaboration revenue for the six months ended June 30, 2021 increased by $8.4 million as compared to the six months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $6.0 million that commenced in the first quarter of 2021, and a $2.2 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the six months ended June 30, 2021 increased by $14.7 million as compared to the six months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the six months ended June 30, 2021 increased by $3.0 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs and travel expenses.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.