On June 25, 2021 Prescient Therapeutics (PTX) reported that it has slipped on the ASX despite some key developments for its CAR-T cancer therapy programs (Press release, Prescient Therapeutics, JUN 25, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-manufactures-new-range-of-binders-for-car-t-cancer-therapy [SID1234584323]).

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The oncology company said today it has manufactured and delivered "crucial components" of its OmniCAR platform for its in-house programs of the next generation of CAR-T therapies.

Specifically, Prescient has developed and manufactured a range of binders against several cancer cells, including CLL-1 and CD33, each expressed in types of leukemia cells; Her2, a gene that can play a role in the development of breast cancer; and EGFRviii, which is associated with brain tumours.

Prescient has incorporated SpyTag and SpyCatcher molecular binding system, which it is licenced to use from Oxford University, into each of the binders.

This next phase of CAR-T programs is focussed on making the therapy safer and broadening its application, particularly into solid tumours.

"Demonstrating that novel components can be manufactured is a crucial milestone in the development of an innovative next-generation CAR platform like OmniCAR," Prescient CEO and Managing Director Steven Yatomi-Clarke said.

"Successfully producing binders for CLL-1; CD33; Her2 and EGFRviii will enable our research team to produce CAR-T cells for our three in-house programs."

Prescient is taking on the CAR-T research program in partnership with the Peter MacCallum Cancer Centre in Melbourne.

What does it all mean?
Essentially, Prescient’s CAR-T programs, based on the OmniCAR platform, are designed to be the next step in the world of cell therapy for cancer treatment.

Cell therapy works by modifying a cancer patient’s own cells to recognise and then kill cancer cells that would normally be hidden from the immune system. This type of treatment has been groundbreaking for certain types of cancers around the world.

However, an issue with cell therapy is that it can typically only direct cells to target and kill a single cancer antigen — meaning if the cancer mutates or expresses different types of antigens, cell therapy becomes less effective.

The OmniCAR platform is designed to mitigate this issue by administering cancer-killing CAR-T cells and "binders" to a patient separately.

The CAR-T cells, when administered, are inactive in the immune system until "armed" with a binder.

The cancer-killing agent has no effect on the body until a specific binder is administered — say, a CLL-1, CD33, Her2, or EGFRviii binder, as announced by PTX today. The binder then directs the CAR-T cells to target a specific cancer antigen.

With this method, cell therapy treatments can attack several types of cancers by simply switching out the arming binder.

As Prescient puts it, the CAR-T cell activity is now "controllable" and its target can be switched at will.

Despite the update on its CAR-T treatment development, shares in PTX slipped over 11 per cent in early action today.

The company has since recovered some of the lost ground, with shares down 4.44 per cent and trading at 22 cents each at 10:59 am AEST.

On June 25, 2021 Alvotech Holdings SA reported that it has entered into an amendment and restatement agreement with bondholders of its $300m covertible bond issued on December 14, 2018 (Press release, Alvotech, JUN 25, 2021, View Source [SID1234584373]). Bondholders have exercised their conversion rights on approximately one quarter of the value of the bond, converting $106m of principal and accrued interest into equity at an exercise price that gives the company a pre-money valuation of $2.7bn.

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The company and bondholders also agreed to improve terms on the remaining bond and extend its maturity to 2025, thereby decreasing the company’s cost of capital and freeing resources to apply to the execution of its business strategy. Further terms were amended to add additional capital to the company.

Robert Wessman, Chairman of Alvotech commented: "With this transaction our stakeholders have reiterated their longstanding confidence in and commitment to our mission: to increase access to the highest quality biologics medicines for patients around the world."

In November of 2020, the U.S. Food and Drug Administration and European Medicines Agency accepted Alvotech’s regulatory submissions for AVT02, a candidate interchangeable biosimilar to AbbVie’s Humira. A decision from the FDA regarding the company’s Biologics License Application (BLA) for AVT02 is expected in September of 2021 and an EMA decision for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVie’s key patents. The lawsuit also argues that AbbVie’s patent strategy, which has been under recent Congressional scrutiny, renders its Humira patents unenforceable. Further, the lawsuit points out that AbbVie has failed to sue Alvotech’s US affiliate (the actual BLA applicant) at all. At stake are billions of dollars of cost to the US healthcare system, negatively impacting consumers and taxpayers.

In June of 2021, Alvotech’s switching study for AVT02 reached primary completion. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product. Top-line results from the switching study are expected later this year.

On June 25, 2021 Prescient Therapeutics reported that it will now proceed to its next phase of research at the world-leading Peter Mac cancer research centre (Press release, Prescient Therapeutics, JUN 25, 2021, View Source;utm_medium=rss&utm_campaign=prescient-equips-car-t-cells-with-cancer-fighting-binders-in-manufacturing-milestone [SID1234584324]).

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Clinical stage oncology company Prescient Therapeutics (ASX:PTX) has announced another crucial step forward in the development of its CAR-T cancer treatment solutions.

The company confirmed that manufacturing is complete for a range of binders which target multiple cancers.

The work was carried out by a leading US manufacturer, and their construction successfully incorporated SpyTag – a central requirement for covalent binding to immune cells as part of Prescient’s proprietary OmniCAR system.

Concurrently, Prescient has also taken delivery of lentiviral vectors that will be used to produce CAR-T cells expressing SpyCatcher.

"Together, the SpyTagged binders and CAR-T cells expressing SpyCatcher form the basis for the unique, modular OmniCAR platform," Prescient said.

Next-gen OmniCAR solution
Prescient’s OmniCAR platform is being developed as a market-leading solution in the field of CAR-T (Chimeric antigen receptor T-cells) – the engineering of the immune system’s T-cells to target specific proteins.

Before the T-cells can attack cancerous cells, they need to be matched with a targeting ligand, also known as a binder.

The activated T-cell can then be controlled to target and kill tumours on-demand.

In that context, the successful development of the SpyTag binding mechanism is a "crucial milestone" in Prescient’s OmniCAR treatment pathway, said CEO Steven Yatomi-Clarke.

The binders work against a range of cancer targets, including acute leukemia, breast cancer and glioblastoma multiforme – an aggressive form of cancer that usually begins in the brain.

"Successfully producing binders will enable our research team to produce CAR-T cells for our three in-house programs," Yatomi-Clarke said.

"We are also pleased to have timely delivery of lentiviral vectors, which is rate-limiting in manufacturing CAR-Ts and have proven to be a bottleneck for many developers."

Along with those key manufacturing developments, the company’s research team at the world-renowned Peter MacCallum Cancer Centre in Melbourne has also advanced all the relevant preparatory work for the next phase of OmniCAR development.

"The delivery of the binders and vectors now enables the team to progress the development of our in-house next-generation cell therapies," Yatomi-Clarke said.

The OmniCAR program is being built by Prescient in its capacity as the global licence holder for the technology, which was developed by leading research teams at the University of Pennsylvania and the University of Oxford.

Along with the program itself, to develop improved treatment solutions for different forms of cancer, Prescient is also building an OmniCAR platform that will allow it to license the technology for collaborations and partnerships.

In the wake of its exciting updates on the delivery of binders and lentiviral vectors, Prescient will be holding an online briefing for shareholders at 11am on Thursday, July 1.

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 June 25, 2021 Alliance HealthCare Services, Inc. ("Alliance"), a leading national provider of radiology and oncology solutions to hospitals, health systems and physician groups, reported that it has entered into an agreement to be acquired for $820 million by Akumin Inc. (NASDAQ/TSX: AKU), a premier provider of freestanding outpatient radiology services in the U.S (Press release, Alliance HealthCare Services, JUN 25, 2021, View Source [SID1234584374]). The closing of the transaction is expected in third quarter of 2021, subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

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Upon the closing of the transaction, the combined company will offer the most comprehensive radiology and oncology solutions to patients in the U.S., operating in 46 states, with more than 1,000 hospital and health system customers, 154 independent outpatient radiology centers and 34 radiation therapy centers. The combined company expects to have over 4,000 team members serving more than two million radiology and oncology patient visits annually.

"Bringing together the best of both organizations for the benefit of our patients, partners and customers is truly exciting," said Rhonda Longmore-Grund, President and CEO of Alliance. "Alliance brings an over 30-year history of successful radiology and oncology partnerships with hospitals, health systems and physicians; and Akumin has built and continues to grow its premier outpatient imaging practice. Together we will offer patients and customers profound value unlike any other healthcare solutions company – and we can’t wait to get started."

"We have always said Akumin’s vision is to drive patient-centered innovation, service delivery standardization, and exceptional healthcare value, all in an outpatient care setting," said Riadh Zine, President and CEO of Akumin. "The acquisition of Alliance is transformative in a changing healthcare ecosystem that continues to shift toward outpatient, price-transparent, value-based care. There’s no other organization that has the complement of attributes we will offer together as outpatient healthcare services experts, in particular with Alliance’s longstanding hospital and health system relationships and Akumin’s freestanding operational expertise."

"We thank the Alliance team for five years of partnership, and we look forward to the success we know Akumin and Alliance will achieve as a combined organization," said Qisen Huang, Chairman and Founder of Tahoe Investment Group. Tahoe has been majority owner of Alliance since 2016 and will on closing transition to a minority ownership position in the newly combined, publicly traded entity.

The acquisition has been facilitated for Alliance with the assistance of Citigroup Global Markets, Inc. and SVB Leerink LLC, as financial advisors, and Ropes & Gray LLP and Osler, Hoskin & Harcourt LLP, as legal advisors. Stikeman Elliott LLP and McDermott Will & Emery LLP acted as legal advisors, and PricewaterhouseCoopers LLP as financial advisors, to Akumin.

On June 25, 2021 Alphageneron Pharmaceuticals, Inc. ("Alphageneron" or the "Company"), a privately-held clinical-stage biopharmaceutical company developing autologous and allogeneic Natural Killer (NK) cellular and antibody therapeutics reported that Robert Brooks, JD, founder and Chief Executive Officer of Alphageneron, will participate in the ROTH Healthcare Private Company Forum to be hosted virtually on Monday, June 28, 2021 (Press release, Alphageneron Pharmaceuticals, JUN 25, 2021, View Source [SID1234584647]).

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Alphageneron’s CEO, Robert Brooks will speak on the Cancer Panel 2, entitled "Natural Killer Cell Approaches To Eradicate Tumors," as one of the presenting companies on the panel with "proof of concept" data utilizing NK cells against solid tumors. Mr. Brooks, will discuss a prior completed Phase IIa Clinical Trial with Advanced non-small lung cancer (NSCLC) patients, receiving autologous Hsp70 targeted NK Cell therapy (ENKASTIM), after radio-chemotherapy, in Germany. The Company is planning a Phase IIa Clinical Combination Trial with Advanced NSCLC patients receiving ENKASTIM and PD (L)-1 checkpoint inhibitors, after Standard of Care, in the United States. Alphageneron is also planning a Phase I clinical Combination trial with Metastatic Colorectal cancer with allogeneic donor genetically edited NK cell therapy, (ANKASTIM) in the United States.

Date: Monday January 28, 2021
Time: 12pm-1pm EDT