NanoMosaic Partners with BrickBio to Increase its Neurology Content with Novel Tau (Phospho-Thr217) Antibody

On June 3, 2022 NanoMosaic, the pioneer and leader of nanoneedle technology (MosaicNeedle) for proteomics and multi-omics, is increasing its capabilities in neurology companion diagnostics (CDx) and future diagnostic tests, by offering a novel, reported that highly sensitive site-specific conjugated antibody against phosphorylated Tau (Phospho-Thr217) (Press release, BrickBio, JUN 3, 2022, View Source [SID1234615554]). The novel antibody has been designed to have higher affinities and enhanced performance on NanoMosaic’s Tessie platform.

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The demand from pharmaceutical partners for a highly sensitive, wide dynamic range, proteomics platform in neurology, utilizing a fully automated sample preparation solution on a standard liquid handler, initiated the collaboration between NanoMosaic and BrickBio, the leader in unnatural amino acid (UAA) incorporation and site-specific conjugation. BrickBio has designed a novel Phospho-Thr217 antibody, and using its Site-Select Panel will rapidly procure variants of the antibody conjugated with proprietary NanoMosaic moieties at optimal performance enhancing sites. The final sites chosen will significantly emphasize key properties of the antibody’s performance, while working in conjunction with the surface chemistry dynamics on the NanoChip, that will result in a sensitive, label-free, robust proteomic neurology solution with digital quantitation.

"NanoMosaic’s unique approach to high-sensitivity detection is significantly enhanced by expanding our conjugation strategies," said Josh Ritchey, VP of Product Development at NanoMosaic. "Utilizing proprietary moieties to enable these unique binding modes truly places NanoMosaic at the forefront of proteomic assay performance," Ritchey concluded.

"The site-specific introduction of stable conjugation handles across the entire antibody scaffold, powered by BrickBio’s Site-Select Panel, continues to expand the repertoire of previously inaccessible applications," said James Italia, VP of Commercial Development at BrickBio. "No other technology enables the breadth of conjugation site flexibility necessary to drive spatially oriented surface functionalization with unprecedented control," Italia concluded.

"The collaboration between BrickBio and NanoMosaic to develop a novel Phospho-Thr217 antibody, for pharmaceutical partners developing CDx assays and future IVD, in vitro diagnostic, applications will enable unprecedented, fully automated workflow advantages that provide precise digital measurements at the highest throughput with the widest dynamic range, in comparison to any current commercial proteomics system," stated John Boyce, Co-Founder of Tiger Gene. "These development and measurement advantages may translate to a significant increase in efficacious treatments for patients," Boyce concluded.

Gracell Biotechnologies Schedules Clinical Update Call After EHA2022

On June 3, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the Company plans to hold a clinical update call on June 13 after the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA 2022) as the data is subject to meeting’s embargo policy until June 12 (Press release, Gracell Biotechnologies, JUN 3, 2022, View Source [SID1234615552]).

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The management team intends to highlight clinical data from three investigator-initiated trials (IIT) for its BCMA/CD19 dual-targeting FasTCAR-T candidate GC012F and allogeneic TruUCAR-T candidate GC502 that will be presented at 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022) Annual Meeting and EHA (Free EHA Whitepaper) 2022 as follows:

Updated clinical data from a multicenter IIT evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in oral abstract presentations on June 5 at ASCO (Free ASCO Whitepaper) 2022 and on June 12 at EHA (Free EHA Whitepaper) 2022
Initial clinical data from an ongoing IIT evaluating GC012F for the treatment of relapsed/refractory B-NHL in a poster presentation on June 10 at EHA (Free EHA Whitepaper) 2022
Updated data with longer follow-up of GC502 in relapsed/refractory B-ALL in a poster presentation on June 10 at EHA (Free EHA Whitepaper) 2022

Benefit of Adding Ibrutinib to Bendamustine/Rituximab as Frontline Treatment for Mantle Cell Lymphoma: First Phase III Trial Changing the Paradigm for the Care of Elderly Patients

On June 3, 2022 Hackensack Meridian John Theurer Cancer Center investigators participated in the large phase III multicenter SHINE study, which reported that using the drug ibrutinib (Imbruvica) in combination with standard bendamustine and rituximab (BR) therapy as initial treatment for mantle cell lymphoma (MCL) slowed disease growth by 52% in older people newly diagnosed with the disease (Press release, Hackensack Meridian Health, JUN 3, 2022, View Source [SID1234615551]). The treatment could become the new standard of care for older people with MCL, who may not be able to tolerate more intensive treatment regimens. The study was published in the New England Journal of Medicine on June 3, 2022.

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"The field of mantle cell lymphoma treatment continues to evolve. The standard of care for elderly patients — who account for more than half of all people diagnosed with mantle cell lymphoma and who are not eligible for high-dose therapy upfront — has most frequently been chemoimmunotherapy with bendamustine and rituximab. Over time, however, most patients relapse," explained Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center, who led the center’s participation in the SHINE study. "Ibrutinib was the first inhibitor of the BTK protein approved for MCL, and it has been a game changer for patients with relapsed or persistent disease. Logically, the next step was to bring it to the frontline setting, which was the subject of the SHINE clinical trial."

In this study, previously untreated MCL patients aged 65 and older were randomly assigned to receive six cycles of BR with either ibrutinib (261 patients) or a placebo (262 patients). Patients who responded to treatment received up to 12 additional doses of rituximab as maintenance therapy. Researchers compared progression-free survival (PFS, the time it took for the cancer to continue growing) between the two groups.

Adding ibrutinib to BR dramatically improved the outcome. After a median follow-up of 7 years, PFS was 6.7 years in the BR+ibrutinib arm versus 4.4 years for the BR+placebo group. Concluded Dr. Goy, "This is highly significant and could easily translate into BR+ibrutinib becoming the next standard of care."

AMGEN ANNOUNCES WEBCAST OF 2022 JEFFERIES HEALTHCARE CONFERENCE

On June 3, 2022 Amgen (NASDAQ:AMGN) reported that it will present at the 2022 Jefferies Healthcare Conference at 9:30 a.m. ET on Wednesday, June 8, 2022 (Press release, Amgen, JUN 3, 2022, View Source [SID1234615550]). Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

Arcellx Presents Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at the 2022 ASCO Annual Meeting

On June 3, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with relapsed or refractory multiple myeloma (Press release, Arcellx, JUN 3, 2022, View Source [SID1234615549]). The clinical results are being presented during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Evaluable for efficacy and safety analysis were 31 patients, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 million CAR+ T cells, n=6), the second dose level (300 million CAR+T cells, n=6), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 100 million CAR+T cells (n=19). All patients enrolled in the study have poor prognostic factors with 21 of 31 (68%) patients penta-refractory, 12 of 31 (39%) extramedullary disease (EMD), and all 31 patients having had at least three prior treatments.

The interim CART-ddBCMA clinical results (May 3, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

Of the 31 evaluable patients with median follow-up of 12.1 months
100% overall response rate (ORR) achieved in all patients per International Myeloma Working Group criteria
22 of 31 (71%) evaluable patients achieved complete response (CR) or a stringent complete response (sCR)
29 of 31 (94%) patients achieved > very good partial response (VGPR)
2 of 31 (6%) patients achieved a partial response (PR)
12 of 31 (39%) with extramedullary disease
13 of 16 patients (81%) dosed more than 12 months ago reached CR/sCR; 8 (50%) with EMD; 9 (56%) remain in ongoing response with a median follow up of 17.7 months
Conversions to sCR have occurred as early as 1 month and also at ≥12 months
CART-ddBCMA dosed at RP2D (100 million CAR+T cells) continues to be well-tolerated
Toxicities including CRS and ICANS have been manageable, and all resolved with standard management at both dose levels
No cases of delayed neurotoxicity events or parkinsonian symptoms
No cases of grade 3 (or greater) CRS and only one case (4%) of grade 3 ICANS event with no additional cases from previously reported.
Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "The demand for clinically meaningful and safe CAR-T therapies outweighs what’s currently available to multiple myeloma patients. It is encouraging to see these data continue to demonstrate deep responses and provide a benefit to patients. I look forward to enrolling patients in the Phase 2 pivotal study."

"We’re excited by these long-term results, particularly given the challenging patient demographics, and believe these promising results reflect the potential for our lead program, CART-ddBCMA, to be a best-in-class treatment for patients with multiple myeloma," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "We believe there’s a significant unmet need for cell therapies and we’re committed to providing physicians with a safe and effective treatment option for multiple myeloma patients. We’re honored to have our data presented at ASCO (Free ASCO Whitepaper) by Dr. Frigault and look forward to beginning enrollment in our Phase 2 pivotal study by the end of this year as the next step in the path towards regulatory approval."

The presentation can be accessed on the company’s corporate website here.

Oral Presentation Details:
Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Mass General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003

Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Sunday, June 5, 2022, at 7:00 p.m. CDT. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.