Tragedy struck the CAR-T space this month with a US company halting a trial of its lead therapy after the deaths of two patients, a sobering reminder of the dangers involved in cell therapy. Image: Getty Safety in mind as Prescient Therapeutics develops next-generation CAR-T platform

On June 28, 2021 Prescient Therapeutics (ASX:PTX) reported that it is developing a next-generation CAR-T platform called OmniCAR, based on technology licensed from the University of Pennsylvania, a pioneer in the space, as well as Oxford University (Press release, Prescient Therapeutics, JUN 28, 2021, View Source;utm_medium=rss&utm_campaign=tragedy-struck-the-car-t-space-this-month-with-a-us-company-halting-a-trial-of-its-lead-therapy-after-the-deaths-of-two-patients-a-sobering-reminder-of-the-dangers-involved-in-cell-therapy-image-ge [SID1234584529]).

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Chief executive Steven Yatomi-Clarke acknowledges that some industry observers had assumed that safety was no longer a serious issue for CAR-T, but this latest tragedy puts safety back into sharp focus. Prescient’s OmniCAR platform seeks to make CAR-T therapy safer by enabling clinicians to control its activity even once infused into a patients

Right now, CAR-T involves injecting living cells into a patient’s body – their own genetically modified blood.

"Once these current generation CAR-T cells are infused, they propagate of their own accord, and you’ve got no way of controlling it," Yatomi-Clarke says.

"If a doctor gives you any other medication, if you have a bad reaction, what do they tell you to do? To stop taking it, reduce the dose, or maybe change medications. But when the medicine is a living cell you can’t yet do that."

‘Druggable and controllable’
But OmniCAR is different from current generation CAR-Ts. It is designed to be controlled even after it is infused into the patients. The key to this is the modular nature of the platform, which separates the CAR-T cell and the part that binds to the cancer cells. The therapy is viable but inactive until the two components come together and bind the cancer cells.

"We’re making CAR-T cells druggable and controllable," Yatomi-Clarke says. "Basically we are combing all of the good things about a T-cell – it can kill a cancer cell like nothing else – but giving it the control and flexibility that a doctor typically expects from a traditional medicine."

Yatomi-Clarke says traditional CAR-T therapies are like sending soldiers into battle with a single weapon, a single map, and no communication and control in the field.

"Whereas what we’ve got is a soldier, because of this modularity, we can arm it with any weapon, send it anywhere, direct it against any target, and have full communication and control."

The activity of the OmniCAR cells can be increased or decreased to achieve safe and efficacious levels. And even if the patient has a deleterious effect, a physician could simply stop administering the binder, and the engineered white blood cells would switch off.

"Because you can control it, it’s not a runaway train," Yatomi-Clarke says.

The doctor could later try the therapy again at a lower dose, without the need to manufacture and administer new CAR-T cells, he said.

This plug-and-play approach is also useful if the cancer mutates, which is a problem facing current generation CAR-T. Currently in that case the patient would be left with "all of the bad side effects of CAR-T, and zero benefits, Yatomi-Clarke says. But with OmniCAR the physician could simply switch out the binder, and the T-cells would be redirected to the new target.

As Stockhead reported on Thursday, Prescient confirmed that manufacturing is complete for a range of binders that target multiple cancers.

The eventual goal is to have off-the-shelf cell therapies, so doctors don’t have to spend 22 days harvesting and manufacturing a patient’s cells so they can be infused into their body, Yatomi-Clarke says.

Novo Nordisk A/S – Share repurchase programme

On June 28, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUN 28, 2021, View Source [SID1234584464]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 21 June 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 14,707,509 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 25 June 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 15,869,011 B shares at an average share price of DKK 461.50 per B share equal to a transaction value of DKK 7,323,503,112.

BioVaxys Announces Non-Brokered Private Placement

On June 28, 2021 BioVaxys Technology Corp. (CSE: BIOV, FRA:5LB, OTCQB:BVAXF) ("BioVaxys" or the "Company") reported a non-brokered private placement (the "Private Placement") consisting of up to 9,090,909 units ("Units") at a price of $0.22 per Unit for total gross proceeds of up to approximately $2,000,000 (Press release, BioVaxys Technology, JUN 28, 2021, View Source [SID1234584456]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant"). Each Warrant is exercisable for one additional Common Share at an exercise price of $0.50 for a period of 30 months.

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All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company may pay cash finder’s fees on all or a portion of the Private Placement.

The Company intends to use the net proceeds of the Private Placement to advance its research and development programs and for working capital. Closing of the Private Placement is subject customary conditions of closing, including the approval of the Canadian Securities Exchange, and is expected to complete within the next week.

Innovent Announces License Agreement with Synaffix in an ADC Technology Deal

On June 28, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the signing of a non-exclusive, target-specific license agreement with Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index (Press release, Innovent Biologics, JUN 28, 2021, View Source [SID1234584432]).

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Under the terms of the agreement, Synaffix will provide all the necessary proprietary ADC technologies including GlycoConnect , HydraSpace and one of its toxSYN linker-payloads, to enable Innovent to rapidly progress one of its antibodies as a best-in-class ADC candidate. The deal is the culmination of a successful initial proof-of-concept research period between the companies.

Upon signature, Innovent is granted the rights to deploy the above ADC technologies for one therapeutic molecule. Innovent will be responsible for the research, development, manufacturing and commercialization of the ADC product. Synaffix will closely support Innovent’s research activities and will be responsible for the manufacturing of components that are specifically related to its proprietary technologies.

Under the terms of the agreement, Synaffix is eligible to receive upfront payment, potential milestone payments related to certain development and sales performance achievements as well as royalties based on potential future commercial sales of the ADC product.

Dr. Yongjun Liu, President of Innovent said, "We are excited to collaborate with Synaffix as Innovent is expanding its pipeline into the ADC space. Our collaboration with Synaffix adds a promising new ADC candidate to our preclinical pipeline through leveraging Synaffix’s validated, differentiated and innovative ADC technology platform and Innovent’s strong antibody capabilities. Based on Synaffix’s seamless partnering model, we could rapidly combine Synaffix’s ADC technologies with Innovent’s antibody, generate compelling research data and keep moving the project ahead swiftly."

Peter van de Sande, CEO of Synaffix said, "This collaboration is yet another example that illustrates the potential of the Synaffix platform to increase the competitive position of our partners within the ADC space. Innovent is an ideal partner for Synaffix due to its strategic focus on innovative medicines and strong R&D capability for high quality biologic drugs. We look forward to working closely together on this exciting development program."

InnoCare Announces Breakthrough Therapy Designation of Orelabrutinib by US FDA for Treatment of R/R MCL

On June 28, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL) (Press release, InnoCare Pharma, JUN 28, 2021, View Source [SID1234584431]).

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Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell malignancy and autoimmune diseases. On Dec. 25, 2020, orelabrutinib was approved by the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) /small lymphocytic lymphoma (R/R SLL), and the treatment of patients with R/R MCL.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare said, "We are very proud that orelabrutinib was granted BTD after obtaining Orphan Drug Designation. We will continue to uphold the concept of ‘Science drives innovation for the benefit of patients’ and accelerate clinical trials for multiple indications of orelabrutinib in China and the rest of the world to benefit patients worldwide."

Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and have demonstrated preliminary clinical evidence of substantial improvement over existing therapies.