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Nasdaq: IMMX Profile

OUR NEW PROFILE IS:   (NASDAQ: IMMX)

Novel Tissue-Specific Therapeutics Targeting Oncology & Immuno-Dysregulated Diseases

Nexcella is a one time treatment compared the current drug on the market that is a weekly injection

Nexcella, an Immix Biopharma Subsidiary, Announces New Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in AL Amyloidosis Patients + Additional Positive Multiple Myeloma Safety Data Demonstrating NXC-201 Outpatient CAR-T Treatment Potential

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,
We have another exciting profile for you to research for Thursday.
This is another Biopharma that closed up 12% on very minimal interest.  It was up even higher in the after market.
You are going to want to research this one Immediately.
Pull up IMMX right away.

Immix Biopharma, Inc. (ImmixBio™) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases. Our proprietary SMARxT Tissue-Specific™ Platform produces drug candidates that circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all 3 components of the tumor micro-environment (TME). We believe ImmixBio’s TME Normalization™ technology severs the lifelines between the tumor and its metabolic and structural support.Amyloidosis Market Size – 6B by 2025.

Nexcella, Inc., a 98%-owned subsidiary IMMX (as of January 2023), is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. To learn more about Nexcella, Inc. visit us at www.nexcella.com.

Myeloma Market Potential Size – 28.7B by 2027

Multiple myeloma (“MM”) is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 34,470 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor.

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory multiple myeloma, all of which as of October 23, 2022 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody).
The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates according to International Myeloma Working Group (IMWG) Uniform Response Criteria.

In Amyloidosis treatment sector there have been some noteworthy events recently.  Caelum Biosciences was acquired for $500Mill by AstraZeneca.

The company is already treating patients – 58 across the company, in Amyloidosis the company is still seeing a 100% complete response. This means drug working for everyone and in and in treating Multiple Myeloma they’re seeing a 90% overall response.

Let’s compare this with some of the billion dollar players in the sector:

Arcellx (ACLX) – 1.5B Market Cap –

ACLX at IPO (Jan 2023, raised $124 million)

CART-ddBCMA 

 Nexcella

CAR-T

NXC-201 
Drug BCMA-targeted autologous CAR-T Therapy BCMA-targeted autologous CAR-T Therapy
Market Cap $1.5bn  [ ]
# of Patients treated at high dose 19  29 
Overall Response Rate 100%  90%
Complete Response Rate 71%  59%
Outpatient Potential No Yes 
Neurotoxicity? Yes No 

Prothena (PRTA) – 2.5B Market Cap

Prothena

 

Birtamimab 

 Nexcella

CAR-T

NXC-201 
Drug Antibody BCMA-targeted autologous CAR-T Therapy
Market Cap $2.5bn  [ ]
Treatment Birtamimab + cytoxan + bortezomib + decadron NXC-201 only
Treatment Frequency Weekly One-time
Organ Response (liver) – 100% 
Organ Response (cardiac) 57% 100% 
Organ Response (renal) 60% 100% 
Overall Hematologic (Blood) Response Rate 89% 100% 
Complete Hematologic (Blood) Response Rate 52% 100% 

PIPELINE

Their pipeline includes Tissue-Specific Therapeutics and Tissue-Specific Biologics for soft tissue sarcoma, colorectal cancer, and inflammatory bowel disease. We believe our oncology drug candidates will replace first-line therapies across a multitude of cancer indications. Next planned clinical trial is a Phase 2a proof-of-concept first-line-therapy study of IMX-110 as a monotherapy in soft tissue sarcoma.

Their pipeline is clinically impactful, with lead candidate BCMA-targeted CAR-T NXC-201 in Phase 1b/2a relapsed/refractory multiple myeloma NEXTIVATE-1 – NCT04720313 and AL Amyloidosis

Nexcella Announces 50 Patients Already Treated with CAR-T NXC-201; Estimates 100-Patient Total Enrollment for U.S. Food and Drug Administration Approval BLA Submission

  • Robust enrollment of up to 5 patients per month continues in ongoing Phase 1b/2a next-generation CAR-T NXC-201 clinical trial in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis
  • Nexcella on track to present 50-patient cohort multiple myeloma data later this year at a premier scientific forum

Los Angeles, Feb. 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), today announced 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. Nexcella anticipates 100-patient open-label total enrollment to seek U.S. FDA BLA approval.

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 https://doi.org/10.3324/haematol.2022.281628, 5th European CAR-T cell meeting https://www.nexcella.com/publications/) 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 https://doi.org/10.1158/1078-0432.CCR-22-0637, 5th European CAR-T cell meeting https://www.nexcella.com/publications/)
  • 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.

Immix Biopharma Subsidiary Nexcella, Inc. Presents 42-Patient Interim Data, with 90% Overall Response Rate in Relapsed or Refractory Multiple Myeloma at NXC-201 Therapeutic Dose from its Phase 1 Expansion Trial at the 5th European CAR T-cell Meeting

  • The poster presents data for 42 patients with relapsed or refractory multiple myeloma who were treated with NXC-201 (formerly HBI0101), of which 29 received the therapeutic dose of 800 million CAR+T cells as of the data cutoff of October 23, 2022
  • 90% overall response rate (ORR) was observed in 29 multiple myeloma patients receiving the therapeutic dose of NXC-201
  • 17 of 29 (59%) of patients receiving the therapeutic dose reached complete response (CR) or stringent complete response (sCR)
  • Cytokine release syndrome (CRS) was manageable and no neurotoxicity was observed
  • The therapeutic dose of NXC-201 (800 million CAR+T cells) has been established as the recommended Phase 2 dose (RP2D)
  • Data supports investigating NXC-201 as the first potential outpatient CAR-T cell therapy

LOS ANGELES, Feb. 09, 2023 — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), 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), today announced updated clinical data from its ongoing Phase 1 NEXICART-1 (NCT04720313) study of its 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). The dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma and one new evaluable patient in AL (previous clinical data published in Haematologica 2022 and Clinical Cancer Research 2022). The new data are being presented during a poster presentation at the European Society for Blood and Marrow Transplantation and European Hematology Association 5th European CAR T-cell Meeting to be held in Rotterdam, Netherlands February 9-11, 2023.

“I am pleased to present promising NXC-201 efficacy data from our interim Phase 1 dataset, which brings us one step closer to meeting an urgent need for greater access to CAR-T therapies that can considerably shorten treatment waiting time for patients with relapsed or refractory multiple myeloma,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children and study investigator. “Also encouraging is that we have not yet reached median progression free survival or overall survival, which means that not only could we improve patient outcomes with efficacy, but we may be able to extend lives as well. I look forward to continuing to enroll patients in our ongoing NXC-201 clinical trial.”

As of the data cutoff of October 23, 2022, 42 multiple myeloma patients were evaluable for efficacy and safety. These patients comprised the dose escalation cohorts for the first dose level (150 million CAR+ T cells, n=6), the second dose level (450 million CAR+T cells, n=7), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells (n=29). This dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma at the NXC-201 RP2D.

The interim NXC-201 data demonstrate potentially meaningful efficacy and durable responses in relapsed or refractory patients who have a poor prognosis.

  • Of the 42 evaluable patients across all dose levels with median follow-up of 146 days (range, 18-314):
    • 35 of 42 (83%) overall response rate (ORR) was achieved per International Myeloma Working Group criteria
    • 21 of 42 (50%) patients achieved complete response (CR) or a stringent complete response (sCR)
    • 34 of 42 (81%) patients achieved > very good partial response (VGPR)
    • 1 of 42 (2%) patients achieved a partial response (PR)
  • Improved outcomes were observed in the 29 relapsed or refractory multiple myeloma patients receiving the therapeutic dose of NXC-201 (800 million CAR+T cells):
    • 90% ORR was achieved per International Myeloma Working Group criteria
    • 17 of 29 (59%) patients achieved CR or sCR
    • 25 of 29 (86%) patients achieved > VGPR
    • 1 of 29 (4%) patients achieved a PR
  • NXC-201 continues to be well-tolerated. Of the 42 evaluable patients:
    • No cases of immune effector cell-associated neurotoxicity syndrome (ICANs)
    • Low-grade CRS duration of median 2 days (range, 1-7 days) was observed, with the vast majority of CRS events starting on the day of infusion

“We are excited to present 42 patients of NXC-201 clinical trial data in Rotterdam. As of the data cutoff, 29 patients have been treated at our identified recommended phase 2 dose. We plan to continue to enroll additional NXC-201 patients at RP2D in Israel and expand to United States clinical trial sites,” said Gabriel Morris, President of Nexcella.

Ilya Rachman, M.D., Executive Chairman of Nexcella added: “These data continue to highlight meaningful, durable responses with a favorable tolerability profile. We believe NXC-201 could be the world’s first out-patient CAR-T. These results reinforce our plan to advance NXC-201 to BLA submission in 1H 2025.”

The poster can be accessed on the Nexcella corporate website at this link: https://www.nexcella.com/publications/

NEWS

Immix Biopharma Confirms No Exposure to Silicon Valley Bank or Silvergate Bank

LOS ANGELES, March 10, 2023 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, today confirms that neither ImmixBio, nor any of its subsidiaries, have any exposure to Silicon Valley Bank (“SVB”) […]
on Mar 11
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ImmixBio to Discuss Recent Positive NXC-201 Clinical Data in AL Amyloidosis and Multiple Myeloma at the 35th Annual Roth Conference on March 14

LOS ANGELES, March 06, 2023 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases, and its subsidiary Nexcella, Inc. (“Nexcella”), a biopharmaceutical company engaged in the discovery and development of novel cell […]
on Mar 6
Read more

Nexcella Announces 50 Patients Already Treated with CAR-T NXC-201; Estimates 100-Patient Total Enrollment for U.S. Food and Drug Administration Approval BLA Submission

Robust enrollment of up to 5 patients per month continues in ongoing Phase 1b/2a next-generation CAR-T NXC-201 clinical trial in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis Nexcella on track to present 50-patient cohort multiple myeloma data later this year at a premier scientific forum Los […]
on Feb 27
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Immix Biopharma Subsidiary Nexcella Enters into U.S. GMP Manufacturing Agreement to Expand Ongoing NXC-201 Phase 1b/2 Clinical Trial to the U.S.

Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that will supply Phase 1b/2 NXC-201 clinical trial materialNXC-201 is in development for the treatment of patients with relapsed or refractory multiple myeloma […]
on Feb 15
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Immix Biopharma Subsidiary Nexcella, Inc. Presents 42-Patient Interim Data, with 90% Overall Response Rate in Relapsed or Refractory Multiple Myeloma at NXC-201 Therapeutic Dose from its Phase 1 Expansion Trial at the 5th European CAR T-cell Meeting

The poster presents data for 42 patients with relapsed or refractory multiple myeloma who were treated with NXC-201 (formerly HBI0101), of which 29 received the therapeutic dose of 800 million CAR+T cells as of the data cutoff of October 23, 202290% overall response rate (ORR) was […]
on Feb 9
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Immix Biopharma Announces Dosing of First 2 Patients in its IMX-110 + BeiGene/Novartis anti-PD-1 Tislelizumab Phase 1b/2a Combination Clinical Trial in Patients with Advanced Cancer

IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab combination designed to enhance response to solid tumors by turning immunologically “cold” tumors “hot”Initial data anticipated in 1H 2023 LOS ANGELES, Feb. 07, 2023 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics […]
on Feb 7
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Immix Biopharma Doses Additional Patients in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial

In January 2023, the 17th new patient was dosed with IMX-110 to datePositive safety data enabled continued dosing of previously enrolled patients Patients undergo CT scans every 8 weeks after dosing to assess tumor response to IMX-110; clinical data expected to be released on a rolling […]
on Jan 13
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Immix Biopharma Subsidiary Nexcella, Inc. Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached

NXC-201 treatment continues to demonstrate 100% complete response rate in 6 relapsed/refractory AL amyloidosis patients to-dateClinical data published December 2022 in Clinical Cancer Research demonstrated 100% complete response rate; 100% organ response rate; Duration of Response Not Yet Reached at a median follow-up of 5.2 months, […]
on Jan 6
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Nexcella, Inc., a subsidiary of Immix Biopharma, announces poster presentation at the European Society for Blood and Marrow Transplantation and European Hematology Association 5th Annual European CAR T-cell Meeting

Updated clinical data for NXC-201, a next-generation CAR-T for multiple myeloma and AL amyloidosis, will be presented in Rotterdam, Netherlands February 9-11, 2023LOS ANGELES, CA, Dec. 28, 2022 — Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced […]
on Dec 28
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Immix Biopharma Announces 16th Patient Dosing in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial

16th patient dosed with IMX-110 to dateThis is the second patient dosed with IMX-110 in December 2022Patients undergo CT scans every 8 weeks after dosing to assess tumor response to IMX-110; clinical data expected to be released on a rolling basis beginning in Q1 2023 LOS […]
on Dec 20
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ImmixBio Ships Tislelizumab for Patient Dosing in its Combination Clinical Trial with IMX-110 in Advanced Solid Tumors

Tislelizumab supplied by BeiGene as part of ImmixBio’s Clinical Trial and Supply Agreement with BeiGene to Evaluate Combination of IMX-110 and Tislelizumab in Solid TumorsIMX-110 + Tislelizumab clinical trial data expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients […]
on Dec 19
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Immix Biopharma in-licenses NXC-201, BCMA-targeted Next-Generation CAR-T Therapy Demonstrating High Complete Response Rate in Heavily Pre-Treated Multiple Myeloma (71% Complete Responses) and AL Amyloidosis (100% Complete Responses)

Multiple Myeloma – 85% overall response rate (71% CR/sCR) for NXC-201 at therapeutic dose in an ongoing Phase 1b study in 20 relapsed/refractory patients as of June 27, 2022 data cutoff (Haematologica https://doi.org/10.3324/haematol.2022.281628)AL Amyloidosis – 100% complete responses, 100% organ response rate for NXC-201 in 4 […]
on Dec 14
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Immix Biopharma Announces Patient Dosing in Ongoing Phase 1b/2a IMX-110 Monotherapy Clinical Trial

In December 2022, the 15th patient was dosed with IMX-110IMX-110 clinical trial data expected to be released on a rolling basis beginning in Q1 2023; once dosing begins, patients undergo CT scans every 8 weeks to assess tumor response to IMX-110IMX-110 monotherapy and IMX-110 combination clinical […]
on Dec 13
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ImmixBio Releases and Ships Scaled-Up GMP Batches of IMX-110 for Clinical Trial Patient Dosing

LOS ANGELES, CA, Dec. 12, 2022 — Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, today announced that it has completed release testing and shipped Good Manufacturing Practice (“GMP”) process manufactured batches […]
on Dec 12
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Immix Biopharma Receives Institutional Review Board Approval to Enroll Pediatric Patients in Upcoming IMX-110 Clinical Trial, Key Requirement for U.S. Food and Drug Administration Approval of Rare Pediatric Disease Priority Review Voucher

Enrolling pediatric patients in a clinical trial is a key requirement for FDA approval of a Priority Review Voucher (“PRV”)While their future value is uncertain, PRVs are transferable to other companies and have historically sold for $67 to $350 million according to a January 2020 report […]
on Nov 11
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MANAGEMENT

ILYA RACHMAN, MD PHD

Chief Executive Officer, Director

Dr. Rachman is a physician/scientist and former community clinical faculty at UCLA. He received both his MD and PhD from the University of Illinois, and his MBA from UCLA Anderson. Ilya founded a Clinical Research organization that conducted clinical trials of pharmaceutical drugs, and is also currently the CEO of Immix Biopharma, Inc. He has completed several clinical trials as a Principal Investigator and developed strong relationships in the clinical research industry.

GABRIEL MORRIS, BA

Chief Financial Officer, Director

Gabriel Morris is the Chief Financial Officer of Immix Biopharma, Inc. Mr. Morris has been managing partner of Alwaysraise LLC, a life sciences advisory and investment firm based in San Francisco, since founding. Prior, Mr. Morris was the interim Chief Financial Officer of Zap Surgical Systems, a brain radiosurgery company, where he completed a growth equity financing round. Prior, Mr. Morris led cross-border mergers & acquisitions transactions at Goldman Sachs and other global investment banks for more than a decade, where he participated in greater than $50 billion in completed transactions. Mr. Morris received his B.A. from the Columbia University in the City of New York.

GRAHAM ROSS, FFPM

Chief Medical Officer & Head of Clinical Development

Dr. Ross is an experienced pharmaceutical physician executive with a successful track record of development and post-marketing activities of a number of cancer therapeutics (including topoisomerase inhibitors and therapeutic antibodies, such as immune checkpoint inhibitors and next generation immunotherapeutics). Prior, Dr. Ross was Senior Medical Science Director, AstraZeneca and Global Clinical Leader at Roche Pharmaceuticals, where he was responsible for the clinical development and registration of pertuzumab in breast cancer indications (marketed as PERJETA® by Roche). Prior to Roche, Dr. Ross was Director of Clinical Development at GlaxoSmithKline for a decade. Dr. Ross trained in oncology in Durban, South Africa and specialized a second time as a pharmaceutical physician in the UK.

Sincerely,

MICROCAPDAILY

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