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 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 24, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that Thierry Guillaudeux, Ph.D., SVP Immuno-oncology at Kineta, participated on multiple panel presentations during the virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," that took place on June 18, 2021 (Press release, Kineta, JUN 24, 2021, View Source;utm_medium=rss&utm_campaign=kinetas-thierry-guillaudeux-participated-on-multiple-panel-presentations-during-virtual-symposium-on-vista-a-new-immunotherapy-approach-to-treating-cancer [SID1234584382]).

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"It was a great pleasure to participate in this symposium focused on VISTA", said Thierry Guillaudeux of Kineta. "The scientific presentations and discussions from the different panelists clearly emphasized how VISTA is a promising new immuno-oncology target for treating patients with advanced tumors. Its unique mechanism of action involving both an innate and adaptive immune response illustrates that antibody therapy targeting VISTA could be an important new path in cancer treatments with this new generation of checkpoint inhibitors."

The scientific symposium focused on the emerging checkpoint inhibitor VISTA, its function, the role it plays in several oncology and current development programs. The event was hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

"Kineta has made tremendous progress developing KVA12.1, our novel anti-VISTA antibody currently in preclinical evaluation", said Thierry Guillaudeux of Kineta. "We nominated KVA12.1 as our lead clinical candidate earlier this year and have initiated IND enabling studies. We expect to initiate Phase 1 safety and tolerability studies in mid-2022".

On June 24, 2021 Takara Bio Inc. reported that it has entered into a License and Supply Agreement with BioNTech Cell & Gene Therapies GmbH ("BioNTech"), a BioNTech SE company (www.BioNTech.de), Germany, under which Takara Bio grants BioNTech a commercial license to use applicable patents relating to RetroNectin (Press release, Lifescience Newswire, JUN 24, 2021, View Source [SID1234584381]). Under this agreement, Takara Bio provides BioNTech with reliable supplies of RetroNectin.

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The patented technologies licensed to BioNTech are based on Takara Bio’s proprietary RetroNectin method, which includes a technology enabling highly efficient gene transduction to cells by retrovirus/lentivirus vector and expansion of T-cells with high efficiency. With such advantages, RetroNectin method is one of the mostly used standard protocols utilized for "Engineered T-cell Therapy", which includes promising TCR and CAR gene therapies recently raising higher expectations.

Under the agreement signed with Takara Bio, BioNTech is allowed to use RetroNectin for production of its cell & gene therapy products, therapies in which a patient’s T cells are genetically engineered to express a CAR for the treatment of multiple solid tumors.

Takara Bio is promoting supply of RetroNectin to clinical development of Engineered T-cell Therapy actively pursued worldwide in recent years, and expects higher sales growth in the future.

On June 24, 2021 Boston Scientific Corporation (NYSE: BSX) reported it exercised its option to acquire the remaining shares of Farapulse, Inc (Press release, Boston Scientific, JUN 24, 2021, View Source,-Inc [SID1234584380]). The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System – a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias .

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"The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. "The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results."

Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27 percent. As a result, the transaction consists of an upfront payment of approximately $295 million for the 73 percent stake not yet owned, up to $92 million upon achievement of certain clinical and regulatory milestones as well as additional revenue-based payments for the next three years.+

"The more than $6 billion electrophysiology market continues to expand, growing double digits year-over-year, and adding this technology to our existing portfolio enables Boston Scientific to be the only company to offer physicians comprehensive therapeutic options they can select based on clinical preference and individualized patient needs," said Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific.

Farapulse became the first company to commercialize a cardiac PFA technology after receiving CE Mark for the FARAPULSE PFA System in Europe in the first quarter of 2021. The company also initiated its pivotal IDE trial in the U.S. – the ADVENT trial – in March 2021. All trial sites have been identified and more than 100 patients have been enrolled to date in the prospective, randomized trial. The study is comparing the FARAPULSE PFA System to standard-of-care ablation in patients with paroxysmal – or intermittent – AF with a primary endpoint of freedom from AF at 12 months after a single ablation procedure.

"We are encouraged by the positive reception to the commercial launch of the FARAPULSE PFA System in Europe, which we believe underscores the demand for a simpler way to treat AF," said Allan Zingeler, president and chief executive officer, Farapulse, Inc. "The strength and breadth of the Boston Scientific team will position this breakthrough technology for success and accelerate progress towards regulatory approval in the U.S."

On an adjusted basis, the transaction is expected to be slightly dilutive to adjusted earnings per share (EPS) in 2021 and 2022, which Boston Scientific expects to offset via internal cost efficiencies and trade-offs. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges, except for a one-time gain to be recognized at closing associated with our previously held equity interest in Farapulse. The transaction is anticipated to close in the third quarter of 2021, subject to customary closing conditions.

*In the U.S., the Farapulse platform is an investigational device and not available for sale.

+Preceding consideration of current equity ownership, debt and other closing adjustments, the transaction price consists of $450 million up front, up to $125 million upon achievement of certain clinical and regulatory milestones as well as additional revenue-based payments through calendar year 2023.