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.

On June 24, 2021 Monte Rosa Therapeutics reported that it is capping off a fundraising spree with a $222.3 million IPO to get two of its "molecular glue" treatments into the clinic and advance its other discovery-stage programs (Press release, Monte Rosa Therapeutics, JUN 24, 2021, View Source [SID1234584378]).

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The company raised $96 million in September 2020 to develop its drug discovery platform and expand its pipeline into diseases beyond cancer. It followed up with another $95 million six months later, ending the first quarter of 2021 with $168.4 million, according to a securities filing. Of course, drug development is an expensive business, and Monte Rosa filed in early June to raise up to $100 million in its IPO.

Despite being a preclinical biotech with much to prove, it bumped that IPO goal up to $213 million earlier this week, eventually collecting $222.3 million by offering 20% more shares than originally planned. But seeing a biotech go public without any human data isn’t unusual these days; even before the COVID-19 pandemic spurred interest and investment in the sector, companies had been hitting Wall Street at increasingly earlier stages of development.

RELATED: Monte Rosa snags $95M to speed lead ‘molecular glue’ treatment into the clinic

Molecular glues are small molecules designed to treat disease by commandeering the body’s own protein degrading process. As their name suggests, they work by sticking proteins to each other.

Monte Rosa earmarked about $47 million to $57 million for a cancer treatment that targets GSPT1, which plays a role in cancers driven by the Myc family of transcription factors. The cash should get it through a phase 1/2 study.

Beyond GSPT1, Monte Rosa will use between $120 million and $130 million to get a second program into phase 1, a third program to an IND filing and a fourth to IND-enabling studies, according to the filing. Another $65 million to $75 million will bankroll the development of its drug discovery platform.

"[Molecular glues] work by allosterically changing the receptor surface of E3 ligases to attract a protein target," said Monte Rosa CEO Markus Warmuth, M.D., referring to enzymes that tag proteins with ubiquitin for degradation by a protein complex called a proteasome, in a previous interview. "We have a singular focus on finding these molecules that reshape the surface of an E3 ligase and thereby attract otherwise undruggable targets."

RELATED: Sana snags $587.5M IPO to catapult cell therapies into the clinic

The best-known molecular glue medicines are thalidomide and its successor molecule lenalidomide—aka Bristol Myers Squibb’s blood cancer drug Revlimid—which both reshape an E3 ligase receptor called cereblon. However, this class of drugs hasn’t been hunted in a systematic way in the past, which is exactly what Monte Rosa’s technology allows it to do.

Monte Rosa isn’t alone in the protein degradation field, but it believes molecular glues can go where other approaches cannot. Other players are working on the hypothesis that eliminating disease driving proteins is a better approach than inhibiting them. They’re "redrugging the druggable," Warmuth said, developing degraders for targets that can be inhibited by traditional drugs.

Arvinas, for example, is developing drugs called proteolysis targeting chimeras, or PROTACs, to degrade the androgen and estrogen receptors, which are major drivers of prostate cancer and breast cancer, respectively. And Kymera Therapeutics is working on degraders of scaffolding kinase IRAK4 and transcription factor STAT3, both of which play a role in cancer.

Monte Rosa wants to go after targets like GSPT1 that haven’t been accessible because drug developers didn’t have the technology to handle them.