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Monopteros Therapeutics Initiates Clinical Trial to Reprogram Regulatory T Cells in Solid Tumors

On April 22, 2021 Monopteros Therapeutics Inc. ("Monopteros"), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, reported that it has dosed the first patient in its Phase 1/1b dose escalation and cohort expansion clinical trial (Press release, Monopteros Therapeutics, APR 22, 2021, View Source [SID1234578347]). The trial aims to evaluate the safety, efficacy, and pharmacology of MPT-0118 and to demonstrate the reprogramming of regulatory T cells.

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Monopteros’ clinical program is based on research by Thorsten Mempel, MD, of Massachusetts General Hospital and Harvard Medical School and published in Nature in 2019.1 He discovered that regulatory T cells ("Tregs") located in the tumor microenvironment have an increased dependence on the MALT1 enzyme. Inhibition of MALT1 results in the selective reprogramming of the tumor-associated Tregs, characterized by the loss of their immunosuppressive function and pro-inflammatory interferon-gamma production. The resulting tumor inflammation is recognized as essential for the success of checkpoint inhibitor therapy. Treg reprogramming through MPT-0118 therefore has the potential to enable a powerful anti-tumor immune attack in cancer patients that are otherwise not responsive to checkpoint inhibitor therapy.2,3

"Immunosuppressive regulatory T cells are preventing many patients with solid tumors from realizing the durable benefit from cancer immunotherapy currently achieved by a minority of patients," commented Keith Flaherty, MD, director of developmental therapeutics at the Massachusetts General Hospital Cancer Center and chairman of the Monopteros clinical advisory board. "MPT-0118 demonstrates the potential to reprogram Tregs, which can be an essential mechanism for increasing the response rates of checkpoint inhibitors for patients with these common cancer types."

Monopteros started its operations in the first quarter of 2019 following a $20 Million Series-A commitment by Medicxi and recruited a team of experienced drug developers and advisors to advance MPT-0118 to the clinic.

"We have achieved our goal of expeditiously bringing Dr. Mempel’s breakthrough research to the clinic while both confirming and expanding on his results," said Peter Keller, CEO. "We now shift our focus to the clinical development of MPT-0118 and to bringing the benefits of immunotherapy to more patients with solid tumors."

In the Phase 1/1b clinical trial, MPT-0118 is provided to patients as a tablet formulation for oral dosing.

ImmunityBio Announces 100th Patient Dosed with Proprietary Natural Killer Cells; NK Trials Cover Multiple Indications

On April 22, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has administered its proprietary Natural Killer cells to more than 100 patients (Press release, NantKwest, APR 22, 2021, View Source [SID1234578346]). The cells were administered as part of combination therapies in trials across multiple indications, including pancreatic, triple-negative breast, and Merkel Cell Carcinoma cancers. The 100th patient to receive ImmunityBio’s NK cells is participating in the company’s QUILT 88 trial for pancreatic cancer (NCT04390399).

To support that scale of testing, the company has manufactured more than 5 trillion clinical-grade, off-the-shelf NK cells (haNK, PD-L1.t-haNK) since 2017 and has more than 2.7 trillion cryopreserved cells in storage, representing a pipeline of 1,400 doses for our clinical trials. Over the last six months, ImmunityBio has invested in substantial upgrades to its cell therapy production equipment, as well as in process improvements, resulting in a 400% increase in process performance.

"We believe ImmunityBio is the first natural killer cell therapy-based company to accomplish manufacturing, storage and administration of cryopreserved NK cells at this scale," said ImmunityBio CEO Richard Adcock. "As a result of developing increased efficiencies and driving best manufacturing practices, we will be able to accelerate the development of our cell therapy platforms and immunotherapies to deliver better outcomes for patients in their fight against cancer and infectious diseases."

ImmunityBio’s off-the-shelf Natural Killer cell platform is comprised of several allogeneic NK therapies derived from the company’s proprietary, universal NK-92 cell line, a fast growing, stable NK cell line that is uniquely amenable to complex genetic enhancements and large-scale production. The NK platform has demonstrated the ability to induce cell death in cancers and virally infected cells through a variety of concurrent mechanisms including innate killing, antibody-mediated killing, CAR-directed killing and a combination of both antibody-mediated and CAR-directed killing.

The platform is designed to be manufactured as an "off-the-shelf" therapy that can be molecularly engineered in a variety of ways to boost its killing capabilities against cancers and virally infected cells. Unlike normal natural killer cells, NK-92 cells lack inhibitors that are often exploited by diseased cells to ward off an NK cell attack. They also are designed to deliver a more lethal blow to their target with a larger payload of lytic enzymes and cytokines. ImmunityBio has extensive cell therapy and adenovirus vector manufacturing expertise, with a combined footprint of more than 400,000 square feet of manufacturing facilities in Los Angeles, San Diego, and Louisville, Colorado, with capacity to expand as demand warrants.

"By improving our proprietary manufacturing and distribution processes now, we are in a strong position to meet future commercial demand in the challenging field of cellular therapeutics," Adcock said.

Mission Therapeutics to Participate in Upcoming SVB Leerink Biopharma Private Company Connect Event

On April 22, 2021 Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), reported that members of its management will be attending the upcoming SVB Leerink Biopharma Private Company Connect Event (Press release, Mission Therapeutics, APR 22, 2021, View Source [SID1234578340]).

The event, which will take place virtually on 6-7 May 2021, is intended to bring together private companies with institutional investors and to facilitate discussions on the trends and opportunities shaping the future of healthcare.

For individuals interested in attending the conference, please contact SVB Leerink for more information.

Chimeric achieves milestone on Phase I cell therapy for glioblastoma cancer

On April 22, 2021 Chimeric (ASX:CHM) reported that has just confirmed that all patients dosed in its Phase I of its CLTX CAR T cell clinical trial have now advanced beyond the 28-day follow-up period, without experiencing dose-limiting toxicities (Press release, Chimeric Therapeutics, APR 22, 2021, View Source [SID1234578339]).

This development has achieved the targeted safety milestone, and will enable the trial to go ahead to the second dosing level.

The second dosing will administer CAR T cells at a total dose of 88 x 106 CAR T cells. Thi will be done via two routes – intratumoral (ICT ) and intracranial intraventricular (ICV).

The clinical study is taking place at the City of Hope, a world-renowned cancer research and treatment centre near Los Angeles.

Cell therapy for glioblastoma patients
The objective of the study is to evaluate the safety and maximum tolerated dose of Chimeric’s Chlorotoxin CAR T cell therapy in patients with recurrent or progressive glioblastoma (GBM).

GBM is an aggressive cancer that occurs in the brain or spinal cord. The cancer is formed around the nerve cells, and often causes headache, nausea, and blurred vision.

The CAR T cell therapy is essentially a new form of immunotherapy that uses specially altered T-cells (an important component of the immune system) to directly and precisely target cancer cells.

The therapy utilises chlorotoxin (CLTX), derived from scorpion toxin, which has demonstrated potent anti-tumour activity against glioblastoma in pre-clinical models.

In March, the company announced that it was conducting a Phase 1 study that aims to enrol 18-36 patients with recurrent or progressive GBM, across four dose levels.

The goal was to evaluate the safety and efficacy of CAR T cells, and to establish recommended dosing for a phase 2 trial.

The success of the first dosing today means that the study will now continue to the second dosing level, without the need for staggered doses as was done in the first one.

Market opportunity
Chimeric says that more than 300,000 patients globally are diagnosed each year with brain and nervous system cancer, and GBM is the most common and most lethal of these cancers. Only around 38% of patients with GBM survive more than one year.

In 2020, Chimeric licensed the exclusive global rights to the CLTX CAR T cell therapy.

The company is yet to make any revenue, and the latest half shows a $3.6 million loss.

Chimeric floated its shares on the ASX at an IPO price of 20 cents a share in January, and is now trading at 30 cents.

Bristol Myers Squibb Invests in Europe with New Cell Therapy Manufacturing Site Planned in the Netherlands

On April 22, 2021 Bristol Myers Squibb reported the company has selected Leiden, Netherlands to house a new cell therapy manufacturing site in Europe, leveraging the growing life sciences region near Amsterdam and convenient access to transportation for shipping patient cells (Press release, Bristol-Myers Squibb, APR 22, 2021, View Source [SID1234578338]).

As part of Bristol Myers Squibb’s continuing commitment to patients with aggressive hematological cancers and its growing cell therapy franchise, the company is making this significant new investment to expand global manufacturing capacity and bring treatments to patients faster. Leiden will be the company’s fifth state-of-the-art cell therapy manufacturing facility and first in Europe, in addition to major contract manufacturing partnerships globally.

"A key element of BMS’ commitment to cell therapy is our continuous investment in advanced manufacturing capabilities, from the expansion of our global network and capacity to treat patients to reduced turn around time and optimized costs," said Ann Lee, Ph.D., Senior Vice President, Cell Therapy Development & Operations, Bristol Myers Squibb. "We continue to grow our presence in Europe and the Netherlands, which offers an innovative life sciences hub and world class industry talent, and we look forward to hiring several hundred talented people over the coming years to join our global team and participate in our cell therapy journey."

The European facility will be commercially focused with capabilities for multi-product cell therapy manufacturing and the ability to scale up capacity. It will leverage innovative technologies,the latest manufacturing equipment and advanced digital systems to deliver these critical cell therapies to patients.

Planning for site design and development is underway, with construction slated to begin later this year.