On May 22, 2023 Breakpoint reported that its Managing Director Daniel Speidel will present a company overview at BIO International Convention in Boston on June 7, 2023 (Press release, Breakpoint Therapeutics, MAY 22, 2023, View Source [SID1234631909]).

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12:15pm, Session Room 104A.

On May 22, 2023 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that, in conjunction with its partner Moffitt Cancer Center, it has commenced treatment of the second patient in the ongoing clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, MAY 22, 2023, View Source [SID1234631907]).

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This study (NCT05316129) is a dose-escalation Phase 1 trial to evaluate safety and to determine the maximum tolerated dose of follicle stimulating hormone receptor T-cells and to preliminarily assess clinical activity. The study is being conducted at Moffitt Cancer Center. All patients being enrolled in the trial have disease that is progressing and have failed at least two, but often more, therapeutic interventions. This patient received the same dose of engineered T-cells as the first patient in the trial, and the next (third) patient is expected to also receive the same dose. The successive three-patient cohort is expected to receive a higher dose of cells.

The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The cell therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females.

"We are optimistic about the potential of this therapy to impact ovarian cancer patients who are out of all other options. Our goal is to increase enrollment at a responsible rate that enables us to understand the impact that our therapy is exhibiting," stated Dr. Robert Wenham, the principal investigator of this trial at Moffitt Cancer Center.

"We are pleased to have treated the second patient in our ovarian cancer CAR-T clinical study," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We anticipate an increase in the rate of patient recruitment, and expect the third and potentially last patient of the current dose cohort to be treated soon. Since this is the early stage of patient enrollment, we are announcing publicly the treatment of the second patient, but it is not our intent to announce enrollment of each subsequent patient. We will make periodic announcements when warranted."

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On May 21, 2023 Laekna, a clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of LAE102 antibody to initiate clinical development (Press release, Laekna Therapeutics, MAY 21, 2023, View Source [SID1234631890]). This is Laekna’s first internally-discovered drug candidate to obtain IND clearance, reflecting the company’s strength in internal discovery.

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LAE102 is a potent and selective monoclonal antibody against a novel target that has regulatory effects on tumor growth, immune activation, muscle regeneration, and hematopoietic development. The drug candidate is now cleared for a phase I/II study targeting solid tumors, with the indication of Non-Small Cell Lung Cancer (NSCLC).

Dr. Justin Gu, Chief Scientific Officer of Laekna, said, "We are very proud that one of our internally discovered drug candidates has been cleared for clinical trials in the U.S. LAE102 represents a journey from ‘zero to one’ and a potential first-in-class innovative drug. Laekna’s internal discovery focuses on identifying innovative biological therapies and small molecule drugs for patients with cancer or liver diseases, and we are advancing ten programs at various pre-clinical stages."

Dr. Chris Lu, Chief Executive Officer of Laekna, said, "Leveraging our know-how and R&D approach, Laekna has implemented a ‘Tri-Pillar’ product development model at the beginning of our establishment: internal discovery, translational research, and business development. The IND clearance of LAE102 marks a key milestone for Laekna’s internal discovery efforts. This is also the first time that Laekna completed FDA filing independently, demonstrating the close collaboration and robust execution of our teams in China and the U.S."

On May 21, 2023 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us"), reported updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a 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 (AL) amyloidosis (Press release, Immix Biopharma, MAY 21, 2023, View Source [SID1234631889]). Additional NXC-201 clinical data was presented on eight DARZALEX (daratumumab) relapsed or refractory AL amyloidosis patients. The new data are being presented during a late-breaking oral presentation at the 26th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Los Angeles on May 19, 2023.

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"We continue to be very encouraged by NXC-201," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. "In AL amyloidosis, these data are compelling as recent trials demonstrate an overall response rate of 55% for DARZALEX-relapsed or refractory AL amyloidosis patients receiving investigator’s choice. Importantly, NXC-201 may offer a valuable option for the increasing number of AL amyloidosis patients who have progressed on DARZALEX-based standards of care."

Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT (Free ASGCT Whitepaper): 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Immix Biopharma, Inc. (Nasdaq:IMMX)

The presentation can be accessed on the Nexcella corporate website at this link: View Source

Oral Presentation:

Title: "BCMA-Targeted CART (HBI0101), a Safe and Efficacious Novel Modality of Treatment for Light Chain Amyloidosis Patients"
Oral Presentation Date/Time: Friday May 19, 2023, 9:15am – 9:30am
Session Title: Late-Breaking Abstracts 1
Session Date/Time: Friday May 19, 2023, 8:00am – 9:45am

Data were presented from eight patients in the ongoing Phase 1b/2a NEXICART-1 study of NXC-201 (formerly HBI0101), a novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy for the treatment of relapsed/refractory multiple myeloma and DARZALEX relapsed/refractory light chain (AL) amyloidosis patients. AL amyloidosis patients were infused with CAR+T cells at doses ranging from 150×106 to 800×106. This is the largest cohort of AL amyloidosis patients treated with a BCMA CAR-T therapy to-date. Of the patients treated, 62% (5/8) had NYHA classification III or IV heart failure prior to treatment. The highlights of the data presented include the following:

Overall response rate of 100% (8/8)
Complete response rate of 63% (5/8) (MRD 10-5)
Organ response rate of 75% (6/8)
Zero grade 4 cytokine release syndrome (CRS) events were reported
The best responder had a duration of response of 16.5 months as of the data cutoff of May 11, 2023, with response ongoing
Rapid organ response is believed to be related to fast reduction of free light chain toxicity
Data demonstrates that BCMA CAR-T therapy is well tolerated and potentially efficacious for the treatment of advanced, relapsed/refractory AL amyloidosis

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory multiple myeloma and AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) 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.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Over the coming months, Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. Nexcella plans to submit data to the FDA in multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. Nexcella plans to submit data to the FDA in AL amyloidosis once 30-40 patients are treated with NXC-201.

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.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage, and high mortality rates.

AL amyloidosis affects roughly 30,000 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.

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

On May 20, 2023 Huihe Biotechnology (CytoCares) reported the completion of nearly 100 million yuan in Series A+ financing, which was funded by Jingxu Venture Capital, Shenzhen Venture Capital, Tailong Investment, Jinyu Bogor, Biosage, etc. Institutional co-investment (Press release, CytoCares, MAY 20, 2023, View Source [SID1234635272]). The funds raised this time will be used for clinical research of the company’s First in Class (FIC) pipeline, promotion of new pipeline research and development, and team building .

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Huihe Biotech has been focusing on the development of new innovative macromolecule drugs for tumor immunotherapy. At present, the company has a first-class immune cell engager drug development platform, and has established multiple innovative drug pipelines for immunotherapy of hematological tumors and solid tumors, focusing on creating antibody drug versions of cell therapy products. Among them, the IND application for CC312 (targeting CD19/CD3/CD28), the first research pipeline of the T cell TriTE platform, has been approved by the FDA and NMPA, and a clinical phase I study has been carried out. CC312 is the world’s first "dual signal activation" T cell engager (tertiary antibody) targeting CD19. Currently, Sanofi and Regeneron’s drugs based on this mechanism are also in phase I clinical research.

The TriTE platform is a new T cell engager multi-antibody drug platform independently developed by Huihe Biotech and based on CD3/CD28 dual signal T cell activation. It has independent intellectual property rights. After years of technology accumulation, the company has carefully optimized each motif sequence and structure of Engager, and has demonstrated better efficacy and similar safety in vivo and in vitro than products of the same category on the market. The pharmacological mechanism of the TriTE platform is similar to the second generation of CAR-T drugs, and new drugs on this platform are expected to have unique advantages in terms of drug accessibility and patient compliance. In a preclinical head-to-head comparison, Huihe Biotech’s research team found that compared with equal doses of CD3/CD19 bispecific antibodies, CC312, the platform’s first pipeline, has a stronger ability to induce T cell activation and cell proliferation. The proportion and number of activated T cell subpopulations are larger, and the ability to induce T cell proliferation is stronger; in addition, a large proportion of T cells will differentiate into memory T cells after drug treatment. This type of product can prevent the recurrence of tumors. It has potential clinical value in extending disease progression-free survival.

With its independent research and development projects, Huihe Biotech has received support from major national projects for new drug creation, Shanghai Science and Technology Innovation Action Plan Biomedical Technology Support Special Project, Shandong Province Antibody Drug Innovation and Entrepreneurship Community Major Science and Technology Projects, etc. It has also received support from Shanghai Specialized, Special and New Small and Medium Enterprises, Honorary qualifications such as scientific and technological small and medium-sized enterprises and innovative small and medium-sized enterprises.

The board of directors of Huihe Biotechnology stated that
"We are very grateful to various investment institutions and new shareholders for their high recognition and trust in the company. Huihe Biotech’s current clinical research on CC312 is progressing smoothly, and other pipeline products of the T cell engager platform targeting solid tumors will soon enter the preclinical CMC and pharmacology/toxicology stages. , at the same time, the pipelines of the NK cell platform and macrophage platform are also accelerating, and very meaningful preliminary efficacy verification data have been obtained. With the completion of the new round of financing, Huihe Biotech will continue to uphold the principle of " continuous innovation, "Benefiting the people, working together with one heart, and embracing all rivers", we adhere to our own innovative ideas, develop original drugs with real clinical value in China, and are committed to creating greater clinical value and capital returns for patients and shareholders."

Mr. Qian Tingzhi, managing partner of Jingxu Venture Capital, said "Huihe Biologics has the world’s leading technology platform and experienced team in the field of antibody drug research and development for tumor immunotherapy. Relying on the three independently developed tumor immune cell new drug platforms, combined with clinical and market needs, the biopharmaceutical version of "CAR- "The efficacy and cost advantages are significant, and we continue to be optimistic about the application potential of Huihe Biotech’s team’s technology in the field of tumor treatment."

Shenzhen Venture Capital investment team stated "Tumor immunotherapy is the frontier in the field of biomedicine. Huihe Biotech has excellent technical capabilities and experience in the research and development of multi-specific antibody innovative drugs. Since monoclonal antibodies and dual antibodies have successively set off a wave of research and development in tumor immunotherapy, three Anti-antibodies make the combination of antibodies richer and more diverse, and also provide more space for the development of antibody drugs. We believe that with the efficient R&D platform of dual-signal activated T cells, Huihe Biotech can continue to lead the innovative development and industrial implementation of tumor treatment antibodies , we are very optimistic about the team’s capabilities, and we look forward to accompanying and helping the company become a global leader in innovative antibody research and development."

The person in charge of Tailong Investment said "Huihe Biotech is based on the differentiated perspective of global unmet clinical needs, deeply cultivates original innovation, develops antibody research and development platform technology, and continues to sustain the research and development of new drugs. Tailong Investment has always pursued globally innovative products and an excellent operation team. We Seeing the rise of innovative drugs in China, and continuing to be firmly optimistic about Huihe Biologics, we expect this round of financing to help the company ride the wave and bring more products with real clinical value to benefit patients."