On October 13, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has fully accrued the initial planned number of participants in Cohort C (third-line or greater) of its Phase 2 trial studying a combination immunotherapy (Nant Cancer Vaccine) in advanced metastatic pancreatic cancer (Press release, ImmunityBio, OCT 13, 2021, View Source [SID1234591162]). The majority of participants in the study to date remain on therapy and 90% (43/48) of the evaluable patients have exceeded the approximately two-month historical survival rate. Of the 48 evaluable patients, 23 (48%) had extremely advanced disease upon enrollment (i.e. had progressed after three to six prior lines of therapy) and, of these patients, 20 out of 23 (87%) have exceeded historical survival rates. On the strength of this early data and significant unmet medical need, the company has submitted an amendment to increase enrollment in Cohort C.

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"Patients with advanced metastatic pancreatic cancer who have failed all standards of care have very grave prognoses with few treatment options. This study was to explore if the Nant Cancer Vaccine could address this unmet need," said Patrick Soon-Shiong, M.D., Founder and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. "It is gratifying to note that patients in this study, who had progressed after up to six lines of prior therapy, have exceeded historical survival rates despite having very advanced pancreatic cancer upon enrollment."

QUILT 88 is an open-label study to evaluate the safety and efficacy of the Nant Cancer Vaccine, comprising ImmunityBio’s IL-15 receptor agonist Anktiva (N-803), its off-the-shelf targeted natural killer cells (PD-L1 t-haNK), and aldoxorubicin, an albumin-modulated agent, plus low-dose chemotherapy. This combination therapeutic vaccine will be randomized against standard-of-care high-dose chemotherapy for first- and second-line treatment; the third-line cohort, with a target of 50 patients, is a single arm with the primary endpoint of overall survival.

Pancreatic cancer is the fourth leading cause of cancer-related death in the United States and has one of the highest mortality rates of all major cancers, taking nearly 50,000 lives in the U.S. every year. Surgery and subsequent adjuvant chemotherapy are the preferred treatment options for pancreatic cancer today and the five-year survival rate for late-stage cases is just 3%. For the majority of patients who present with more advanced disease, treatment typically consists of chemotherapy alone or supportive care for metastatic patients, and chemotherapy with or without radiation for those with locally advanced disease.

"Achieving robust enrollment in this patient group and early promising efficacy evidence are important milestones in ImmunityBio’s effort to develop this therapeutic with the potential to improve survival rates and provide a replacement for toxic chemotherapy," continued Soon-Shiong. "As the historical survival rate for third- to sixth-line pancreatic cancer patients is approximately two months, we are encouraged by this early data and have decided to open this cohort to more patients with advanced metastatic disease who have no further treatment options."

QUILT-88 Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohorts A, B, and C, respectively, with Cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of Cohorts A and B is progression-free survival (PFS) per RECIST V1.1, and the objective of Cohort C is overall survival (OS). Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which serves patients in the tri-state area (Iowa, Nebraska and South Dakota).

On October 13, 2021 Prescient Therapeutics (ASX: PTX) reported that it has revealed new data that demonstrates the capability of its OmniCAR cell therapy technology in killing multiple cancer cells (Press release, Prescient Therapeutics, OCT 13, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-unveils-new-data-validating-cancer-cell-therapy-technology [SID1234591148]).

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The company is presenting this pre-clinical data this week at a cell therapy conference in California, US known as the ‘Cell and Gene Meeting on the Mesa’.

In its conference presentation, Prescient said OmniCAR’s key attributes include a dose response relationship that exhibits tumour killing activity and high potency, a demonstrated re-arming of OmniCAR-T cells, and sequential arming to re-direct OmniCAR-T cells from one cancer antigen to another.

This most recent work was conducted in collaboration with the Peter MacCallum Cancer Centre in Melbourne, Victoria and Prescient director of scientific affairs Dr Rebecca Lim said data continues to be "extremely positive".

"Our most recent work… showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed.

"The team also showed that OmniCAR-T cells could be re-armed and continue to kill tumour cells without loss of cytotoxicity," she added.

Dr Lim described the early wins as "extremely encouraging".

"Excitingly, we saw for the first time the real-time ‘switchability’ of the OmniCAR system where the tumour killing ability of the OmniCAR-T cells could be redirected towards a different antigen through the addition of a different binder."

"We look forward to the next phase of pre-clinical testing where the OmniCAR technology will be put through its paces using gold standard cancer models."

Cells able to be redirected to different antigen target
Prescient is developing OmniCAR programs for next-generation CAR-T therapies for acute myeloid leukemia (AML), Her2-plus solid tumours including breast, ovarian and gastric cancers, and the brain cancer known as glioblastoma multiforme (GBM).

In particular, GBM is characterised by antigen heterogeneity and rapid mutations that drive rapid progression of the cancer. These characteristic make CAR-T and other therapies challenging as they rely on single antigen targeting.

Prescient is seeking to overcome these limitations with the development of OmniCAR to enable mutli-antigen targeting.

In a novel experiment, OmniCAR was tested sequentially against a co-culture of GBM cells expressing antigens, Her2 or EGFRviii. OmniCAR-T cells pre-armed with EGFRviii binders demonstrated rapid cytotoxicity against those GBM cells expressing EGFRviii.

Meanwhile, subsequent administration of Her2 binders demonstrated rapid switching of OmniCAR-T cells arming with Her2, and corresponding rapid cytotoxicity against Her2-plus GBM cells.

According to Prescient this shows that OmniCAR cells can be redirected to a different antigen target upon administration of a different SpyTagged binder without needing new cells. In each case, OmniCAR exhibited highly targeted tumour killing.

Prescient believes this highly novel feature will also be important in developing OmniCAR for AML, which is another cancer characterised by high antigen heterogeneity, rapid mutations and rapid disease progression.

Yet to discover true limits of OmniCAR technology
Prescient managing director and chief executive officer Steven Yatomi-Clarke said the large body of work accomplished so quickly and successfully is a credit to the team and its collaborators at Peter MacCallum Cancer Centre.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology," he said.

"OmniCAR is proving to be a predictable and powerful system to work with. We look forward to sharing updates as our programs progress."

On October 13, 2021 Prescient reported it’s OmniCAR platform could overcome the limitations of CAR-T treatments for cancer and it’s attracting the attention of leading global therapy decision makers (Press release, Prescient Therapeutics, OCT 13, 2021, View Source;utm_medium=rss&utm_campaign=prescient-has-some-very-positive-findings-to-share-about-its-omnicar-platforms-tumour-killing-abilities [SID1234591147]).

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Clinical stage oncology company Prescient Therapeutics (ASX:PTX) will present pre-clinical data on its OmniCAR platform at a key international cell and gene conference.

OmniCAR was developed to overcome challenges and limitations of CAR-T treatments – a new type of intervention used in immunotherapy and cancer treatment.

Prescient Director of Scientific Affairs Dr Rebecca Lim said the latest results demonstrate important capabilities of OmniCAR to deliver next generation cell therapies that are controllable and able to target multiple cancer antigens.

These are key milestones for Prescient’s in-house OmniCAR programs as well as in the development of the overall platform and for potential partners and collaborators.

It is these crucial milestones which will be presented at the Cell & Gene Meeting on the Mesa in Carlsbad, California in the coming days. The conference brings together international senior executives and decision makers on therapies, including cell therapy.

The company’s most recent work, conducted in collaboration with the Peter MacCallum Cancer Centre in Melbourne, showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed.

"The team also showed that OmniCAR-T cells could be re-armed and continue to kill tumour cells without loss of cytotoxicity," Lim said.

"Excitingly, we saw for the first time the real-time ‘switchability’ of the OmniCAR system where the tumour killing ability of the OmniCAR-T cells could be redirected towards a different antigen through the addition of a different binder.

"These early wins are extremely encouraging, and we look forward to the next phase of pre-clinical testing where the OmniCAR technology will be put through its paces using gold standard cancer models."

OmniCAR aims to overcome major CAR-T therapy obstacle
A dose response relationship is the correlation between the amount of drug given and magnitude of response. In conventional pharmacology, dose responses are typically straightforward to establish, with typically higher doses leading to greater effects.

However, in cell therapies such as CAR-T therapy, where living cells that continue to grow and divide are administered to patients, effects are considerably less predictable and controllable.

OmniCAR aims to overcome this challenge by combining the potent cytotoxicity of cell therapy with the control and predictability of a conventional drug.

Prescient conducted treatment of glioblastoma multiforme (GBM) cells with OmniCAR-T cells armed with varying amounts of SpyTagged EGFRviii and Her2 binders to test whether different doses of binders resulted in commensurate levels of CAR-T activity.

In both cases, OmniCAR showed dose-dependent tumour killing activity, with the ability to control OmniCAR-T cell activity proportional with the amount of binder administered.

Furthermore, this version of OmniCAR, employing version 3 of the SpyTag/SpyCatcher (ST/SC) system, demonstrated especially high potency, with 60-fold less binder, which has implications for further improving patient safety and lowering cost of goods.

Re-arming capability of OmniCAR a game-changer in CAR-T cell treatment
Single infusions of CAR-T cells may be insufficient to drive meaningful patient outcomes in many cancers, especially solid tumours. Whilst some CAR-T studies have demonstrated clinical efficacy in stubborn cancers with up to seven separate infusions of CAR-T cells, the time, cost, logistics and patient requirements of this approach is prohibitive.

In contrast, achieving ongoing control of T cell activity through complete control of binder administration is viable, logistically undemanding, and inexpensive. Moreover, this method is identical to infusions of biological therapeutics used routinely in clinical practice today.

Prescient has demonstrated the re-arming capability of OmniCAR. OmniCAR-T cells pre-armed with Her2 binders demonstrated potent ability to kill cancer cells expressing Her2.

The cells were then washed and rested for seven days, resulting in unarmed OmniCAR cells. These same OmniCAR-T cells were then capable of being re-armed with Her2 binders, and once again demonstrated targeted killing.

Furthermore, the re-armed cells exhibited the same levels and kinetics of cytotoxicity of pre-armed OmniCAR-T cells, demonstrating that OmniCAR cells can be unarmed, re-armed and still kill.

Treatment hope for GBM brain cancer
Glioblastoma (GBM) is a fast-growing and aggressive brain tumor, characterised by antigen heterogeneity and rapid mutations that drive rapid progression of disease.

These characteristics present significant challenges for therapies, including CAR-T therapies, that rely on single antigen targeting. However, Prescient is seeking to overcome these limitations and provide more effective treatment with the development of OmniCAR to enable multi-antigen targeting.

Prescient has now demonstrated a unique feature of OmniCAR to redirect a single cell product from one cancer antigen to another in GBM cells.

In a novel experiment, OmniCAR was tested sequentially against a co-culture of GBM cells expressing antigens Her2 or EGFRviii. OmniCAR-T cells pre-armed with EGFRviii binders demonstrated rapid cytotoxicity against those GBM cells expressing EGFRviii.

Prescient still to discover true powers of OmniCAR
Prescient Managing Director and CEO Steven Yatomi-Clarke the company looks forward to presenting their data at Cell & Gene Meeting to prominent companies in the field.

"It is very pleasing to see a large body of work accomplished successfully so quickly and is a credit to the Prescient team and the incredible collaborators at Peter MacCallum Cancer Centre," he said.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology.

"OmniCAR is proving to be a predictable and powerful system to work with and we look forward to sharing updates as our programs progress."

Prescient’s drug therapy PTX-100 also shows promise
Meanwhile Prescient’s cancer-fighting drug therapy PTX-100 is also showing significant promise for the company, with early stage trials showing benefit to patients with hard to treat cancers.

PTX-100 works by blocking an important protein known as GGT-1 that is involved in cancer-causing pathways in cells.

The drug was well-tolerated, even at the highest dose, with its safety profile meaning it might benefit fragile patients unable to tolerate more toxic therapies, or as a combination agent with other treatments.

Shares in Prescient continue to rise on its promising results, up 11% at the time of writing to 25 cents.

The company will be hosting an ‘OmniCAR Explainer’ session next Tuesday 19th October at 11am (AEDT) where they will discuss the results in more detail. Click here to book in.

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 October 13, 2021 Biotech company Prescient Therapeutics reported that has given investors a glimpse into the progress of its next-generation CAR-T platform, OmniCAR, with data to be presented at leading cell and gene therapy conference Meeting on the Mesa (Press release, Prescient Therapeutics, OCT 13, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-showcases-pre-clinical-success-of-cancer-fighting-treatment [SID1234591146]).

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In an announcement made this morning, the Melbourne-based company revealed its OmniCAR platform continues to demonstrate several key attributes in early studies.

These attributes include the treatment’s high-potency, dose-responsiveness of cancer killing activity, and the ability for clinicians to disarm and re-arm the cells used in treatment without hindering their effectiveness.

These are important milestones in the development of Prescient’s in-house OmniCAR programs, as well as in the development of the overall platform and demonstrating novel features relevant to potential partners and collaborators.

Dr Rebecca Lim, Prescient’s Director of Scientific Affairs, is encouraged by the result, noting:

"Our most recent work conducted in collaboration with the Peter MacCallum Cancer Centre showed that OmniCAR-T cells begin antigen-directed killing of tumour cells in vitro as soon as they are armed," she said.

"The team also showed that OmniCAR-T cells could be rearmed and continue to kill tumour cells without loss of cytotoxicity."

"Excitingly, we saw for the first time the real-time ‘switchability’ of the OmniCAR system where the tumour killing ability of the OmniCAR-T cells could be redirected towards a different antigen through the addition of a different binder."

Dr Lim said the early wins were "extremely encouraging", adding that she is excited for the next round of tests.

The results will be shared in detail with the industry’s most prominent companies at the Cell & Gene Meeting on the Mesa conference, based in Carlsbad, California, US.

Prescient Therapeutics CEO Steven Yatomi-Clarke said he is excited by the opportunity to share the company’s results with the industry’s leading businesses.

"It is very pleasing to see a large body of work accomplished successfully so quickly and is a credit to the Prescient team and the incredible collaborators at Peter MacCallum Cancer Centre," he added.

"Importantly, none of these tests have even been optimised, so we have yet to see the true limits of this technology. OmniCAR is proving to be a predictable and powerful system to work with."

OmniCAR is a next-generation CAR-T platform that aims to overcome challenges that face traditional CAR-T therapies – which use genetically modified cells from a patient’s own immune system to fight cancer.

These challenges include poor dose-responsiveness (leading to unpredictable reactions in patients as the strength of their treatment is increased), an inability to redirect CAR-T cells to attack different tumours, and the need for multiple CAR-T infusions to adequately fight cancer. CEO Steven Yatomi-Clarke and Dr Rebecca Lim will be presenting a session next Tuesday at 11am (AEDT) where they will explain the OmniCAR platform and latest results in more detail. Please click here to register for the session.

Reach Markets have been engaged by PTX to help manage their investor communications.

On October 13, 2021 Roche reported that it will publish its Sales Results for the 3rd Quarter of 2021 prior to the opening of the Swiss Stock Exchange on Wednesday, October 20th, 2021 (Press release, Hoffmann-La Roche, OCT 13, 2021, View Source [SID1234591139]).

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