Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us", "IMMX") (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune disease, reported that the 1st patient has been dosed at MSKCC in its U.S. NEXICART-2 trial with NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy (Press release, Immix Biopharma, JUL 8, 2024, View Source [SID1234644712]).

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The NEXICART-2 study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study builds on positive data from the initial ex-U.S. study, NEXICART-1, presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024) which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients (12/13). The best responder experienced a 28.0 month duration of response (as reported May 10, 2024, with ongoing follow-up).

"I am excited to initiate the only CAR-T clinical trial currently recruiting for AL Amyloidosis patients that have progressed on front-line daratumumab (DARZALEX)-combination therapy," said Heather Landau, MD, Memorial Sloan Kettering Cancer Center Amyloidosis Program Director and NEXICART-2 principal study investigator. "A one-time therapy such as NXC-201 would provide an attractive option for AL Amyloidosis patients and clinicians. There are no approved drugs for relapsed/refractory AL Amyloidosis today."

"We believe initiation of the U.S. NEXICART-2 study is an important advancement in AL Amyloidosis. NXC-201 has the potential to become a first-in-class safe and durably-effective therapy for patients with relapsed/refractory AL Amyloidosis. We are humbled by the enthusiasm across the U.S. AL Amyloidosis community and look forward to robust enrollment for NEXICART-2," said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "Dosing of the first patient in line with our mid-2024 guidance is a testament to the stellar execution of our extraordinary team and partners."

NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled "Systemic Light Chain Amyloidosis" published in June, 2024 New England Journal of Medicine.

About NEXICART-2
NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety-run in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells), with the potential for further escalation to 800 million CAR+T cells (all 3 dose levels were evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients). The study aims to evaluate the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012).

About NEXICART-1
NEXICART-1 (NCT04720313) is an open-label, ex-U.S. Phase 1b/2a clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis (including AL Amyloidosis patients with impaired cardiac function and including AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and efficacy, as well as confirm the recommended Phase 2 dose (RP2D) of NXC-201 (which has already been confirmed). NEXICART-1 clinical results, most recently from ASGCT (Free ASGCT Whitepaper) 2024, are available at View Source

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2a ex-U.S. study NEXICART-1 has demonstrated short duration of cytokine release syndrome (CRS) and no grade 3 or delayed neurotoxicity in high-volume disease, as well as short duration CRS and no neurotoxicity of any kind in AL Amyloidosis.

NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into autoimmune indications. The NXC-201 NEXICART-2 U.S. clinical trial builds on a robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in the US by the FDA and in the EU by the EMA in AL Amyloidosis.

About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure, and leads to high mortality rates.

The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

On July 7, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class therapies for hematological malignancies, reported that its novel BCR-ABL1 tyrosine kinase inhibitor (TKI), olverembatinib, has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of the People’s Republic of China for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs (Press release, Ascentage Pharma, JUL 7, 2024, View Source [SID1234644697]). This approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications.

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Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program, is the first third-generation BCR-ABL1 inhibitor approved by China’s National Medical Products Administration (NMPA). As a potential global best-in-class drug that can effectively target BCR-ABL1 and a spectrum of BCR-ABL1 mutants, including the T315I mutation, clinical trial results of olverembatinib have already been included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of CML.[1] Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. All lead drug candidates are being studied as they are an investigational drug and not approved in the US.

"Olverembatinib has the potential to be a global best-in-class drug. We are glad that the drug is set to benefit patients with CML in Macau, China, with the approval marking another major milestone in the clinical development of olverembatinib," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. "Since its inception, Ascentage Pharma has steadfastly committed to its mission of addressing unmet clinical needs in China and around the world. We are confident that over time, olverembatinib and our other investigational drugs will bring greater benefits to more patients globally."

On July 5, 2024 Zhiyi Biotech, a clinical-stage biotech leading in discovery and development of LBPs (live biotherapeutic products), reported positive results from a Phase 1 clinical trial in U.S. of SK10 (Press release, Guangzhou Zhiyi Biotech, JUL 5, 2024, View Source [SID1234644693]). SK10 is an innovative heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhea (CID).

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This was a randomized, double-blind, placebo-controlled, sequential dose-escalation clinical study to evaluate the safety and tolerability of SK10 in healthy adult subjects. A total of 24 healthy subjects were enrolled in the study. All dose groups of SK10 were generally safe and well tolerated. All the TEAEs (treatment-emergent adverse event) were mild in severity without dose-dependent increase.

This promising result lays the foundation for SK10 as a potential novel drug for CID patients.

About SK10:

SK10, the first Bacteroides fragilis-based LBP obtained FDA IND approval, is also the first LBP of Next-generation probiotics developed by Chinese biotech company that approved for clinical trials by FDA. Studies have shown that SK10 can ameliorate 5-FU induced injury via mitochondrial apoptotic BCL2/BAX pathway, reduce inflammatory cytokines, and enhance mucosal barrier function, thereby effectively inhibiting the inflammatory response of intestinal epithelial cells induced by chemotherapy and the associated diarrhea symptoms.

Meanwhile, heat-killed Bacteroides fragilis has better safety in cancer patients and better commercialization performance.

About CID:

Cytotoxic drugs or targeted therapy can cause drug-associated diarrhea. However, available drugs for CID are limited. For example, loperamide, as a short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection, serious adverse effects have been reported for both drugs. Hence the need for effective drugs is urgent.

On July 5, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases, reported that on July 2, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 25 new employees in restricted stock units for an aggregate of 123,070 shares of the Company’s common stock (Press release, BridgeBio, JUL 5, 2024, View Source [SID1234644684]). One-fourth of the shares underlying each employee’s restricted stock units will vest on August 16, 2025, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019, and amended and restated on February 10, 2023 and on December 13, 2023.

On July 5, 2024 Kura Oncology, Inc. (the "Company") (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that on July 1, 2024, the Compensation Committee of the Company’s Board of Directors (the "Compensation Committee") granted inducement awards consisting of nonstatutory stock options to purchase 128,700 shares of common stock to eight (8) new employees under the Company’s 2023 Inducement Option Plan (Press release, Kura Oncology, JUL 5, 2024, View Source [SID1234644685]). The Compensation Committee approved the stock options as an inducement material to such employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each stock option has an exercise price per share equal to $21.20 per share, the Company’s closing sales price on July 1, 2024, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with the Company through the applicable vesting dates. The stock options are subject to the terms and conditions of the Company’s 2023 Inducement Option Plan and the terms and conditions of an applicable stock option agreement covering the grant.