On February 27, 2023 Nexcella, Inc. ("Nexcella", "Company"), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), reported 50 relapsed/refractory multiple myeloma patients have already been dosed with next-generation CAR-T NXC-201 in its ongoing Phase 1b/2a clinical trial (Press release, Immix Biopharma, FEB 27, 2023, View Source [SID1234627729]). Nexcella anticipates 100-patient open-label total enrollment to seek U.S. FDA BLA approval.

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Robust enrollment of up to 5 patients per month continues in the NXC-201 ongoing Phase 1b/2a clinical trial. Nexcella is on track to present this 50-patient cohort multiple myeloma data later this year at a premier scientific forum.

"Few companies are as far advanced with the quantity and quality of patient data that we have at Nexcella in multiple myeloma and AL amyloidosis," said Gabriel Morris, President of Nexcella. "50-patient data represents significant progress on our path to BLA submission to seek FDA approval of NXC-201."

Ilya Rachman, M.D., Executive Chairman of Nexcella added, "There are waiting lists with thousands of patients across America who are currently unable to receive these life-saving multiple myeloma CAR-T therapies like NXC-201. Our team is working tirelessly to bring this groundbreaking treatment to patients in the U.S. and worldwide."

About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:

Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica View Source, 5th European CAR-T cell meeting View Source) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody)
AL Amyloidosis – 100% organ response rate, 100% complete responses (MRD negativity 10-5), published for NXC-201 in 5 relapsed/refractory patients (Clinical Cancer Research View Source, 5th European CAR-T cell meeting View Source)
The therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D)
Additional information on NXC-201 clinical data as of October 23, 2022 is available here.

On February 27, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM, HKEX:​13) reported that it has completed patient enrollment of Phase II registration trial of amdizalisib in patients with relapsed or refractory follicular lymphoma ("FL"), a subtype of non-Hodgkin’s lymphoma ("NHL") (Press release, Hutchison China MediTech, FEB 27, 2023, View Source [SID1234627728]). The last patient was enrolled on February 24, 2023.

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The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of amdizalisib once a day oral monotherapy in patients with relapsed/refractory FL or marginal zone lymphoma ("MZL"). The primary endpoint is objective response rate ("ORR"), with secondary endpoints including complete response rate (CRR), progression-free survival (PFS), time to response (TTR) and duration of response (DoR). A total of 108 relapsed/refractory FL patients were enrolled. The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.

Topline results on the FL patients in this trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical conference. If positive, HUTCHMED would initiate plans to apply for marketing authorization of amdizalisib for relapsed/refractory FL from the China National Medical Products Administration (NMPA).

About PI3Kδ and NHL

PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is a target for drugs that aim to prevent or treat hematologic cancer.

FL accounts for approximately 17% of NHL and MZL accounts for approximately 8% of NHL. In the U.S., there were estimated 13,000 and 6,000 new cases of FL and MZL in 2020, respectively. In China, there were estimated 16,000 and 7,000 new cases of FL and MZL in 2020, respectively.1,2,3

About Amdizalisib

Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetic ("PK") properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

In addition to the current Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in combination with tazemetostat (a methyl­trans­ferase inhibitor of EZH2) in patients with relapsed or refractory lymphoma in a Phase II study in China.

HUTCHMED currently retains all rights to amdizalisib worldwide.

On February 27, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that company management will participate in a fireside chat on Tuesday, March 7, 2023 at 2:10 PM ET at the 43rd Annual Cowen Healthcare Conference, being held March 6-8th, 2023 in Boston, MA (Press release, Heron Therapeutics, FEB 27, 2023, View Source [SID1234627727]).

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A live webcast of the fireside chat will be available on the Company’s website at www.herontx.com in the Investor Resources section.

On February 27, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that Andrew Allen, M.D., Ph.D., Gritstone’s Co-founder, President and Chief Executive Officer will participate in the "Novel Immuno-Oncology" panel at the Cowen 43rd Annual Healthcare Conference on March 6, 2023 (Press release, Gritstone Bio, FEB 27, 2023, View Source [SID1234627726]).

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Panel Details
Title: Novel I-O Corporate Panel
Date and Time: Monday, March 6, 2023 from 9:10 to 10:10am ET
Location: Boston Marriott Copley Place, 110 Huntington Ave, Boston, MA 02116

A live webcast of the panel will be available at View Source An archived replay will be accessible for 30 days following the event.

On February 27, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted three employees nonqualified stock options to purchase an aggregate of 33,000 shares of its common stock with an exercise price of $2.71, which is equal to the closing price of Gritstone’s common stock on February 17, 2023, the date of the grant (Press release, Gritstone Bio, FEB 27, 2023, View Source [SID1234627725]). These stock options are part of an inducement material to each of the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.