ImmixBio Announces FDA Orphan Drug Designation for IMX-110 for the Treatment of Soft Tissue Sarcoma

On September 30, 2021 Immix Biopharma, Inc. ("ImmixBio"), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma (Press release, Immix Biopharma, SEP 30, 2021, View Source [SID1234590560]).

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The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.

"We are pleased to receive FDA’s orphan drug designation in soft tissue sarcoma for IMX-110, the first clinical-stage product of our SMARxT Tissue-Specific Platform," said Ilya Rachman MD PhD, ImmixBio Founder & CEO. "We are thrilled to potentially contribute to expanding therapeutic options for oncology patients, beginning with soft tissue sarcoma."

Gabriel Morris, ImmixBio Chief Financial Officer, added: "Orphan drug designation for IMX-110 represents a substantial value creating step along our path of building a strong, independent biopharmaceutical organization."

About IMX-110

IMX-110 is a Tissue-Specific TherapeuticTM built on ImmixBio’s TME NormalizationTM Technology encapsulating a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumor blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumor-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumor and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumor apoptosis, a non-inflammatory tumor-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumor progression).

IMX-110 is currently being evaluated in a phase 1b/2a open-label, dose-escalation/dose-expansion safety, tolerability and pharmacokinetic study in patients with advanced solid tumors in the United States and Australia.

CBMG Holdings Completes $120 Million in Series A Funding, Accelerating Development of CAR-T Therapy Pipelines and R&D for Innovative Solid Tumor Therapies

On September 30, 2021 CBMG Holdings (or the "Company"), a Cayman Island biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer and degenerative diseases, reported the closing of a $120 million Series A investment, led by AstraZeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital (Press release, Cellular Biomedicine Group, SEP 30, 2021, View Source [SID1234590559]). Both new and certain existing investors, including GIC and TF Capital, subscribed to the Series A financing.

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This round of financing will largely be used to accelerate the clinical development of the Company’s immune-oncology platform. Specifically, C-CAR039, an anti-CD19/CD20 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL) and C-CAR088, a B cell maturation antigen (BCMA) therapy for patients with late-stage relapsed/refractory (r/r) multiple myeloma (MM), as well as armored CAR-T therapies and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. In addition, the capital injection will support the continuing development of the Company’s stem cell platform, including the study of acute respiratory distress syndrome (ARDS) using allogeneic human adipose mesenchymal stem cell exosomes (haMSC-Exos) and extracellular vesicle, and the data compilation from its off-the-shelf product AlloJoin applying adipose-derived stem cells in the treatment of Phase II knee osteoarthritis (KOA) clinical trial in China.

This round of financing will be used to accelerate the clinical development of the Company’s immune-oncology platform.

One of the earliest pure-play biotechnology companies from China to be approved for listing on the NASDAQ Market, Cellular Biomedicine Group successfully completed its privatization in February 2021.

As a result of its strong research and development and cell and gene therapy manufacturing know-how, Cellular Biomedicine Group was invited to present two abstracts at the esteemed American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Among them, C-CAR039 for r/r NHL displayed a very encouraging safety and efficacy profile, with the potential to be a Best-in-Class drug. The U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted CBMG an Orphan Drug Designation (ODD) to C-CAR039, for the treatment of Follicular Lymphoma, an indolent form of non-Hodgkin Lymphoma.

"We are pleased to complete this Series A funding shortly after our successful privatization", commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings. "We are blessed to have our long-term investors continue to support us before, during, and after, privatization. Thank you, Novartis, Sailing Capital, and other long-term investors for believing in us. Accolades from shareholders has helped continue to attract new strategic investors. I am grateful to Yunfeng Capital, GIC and TF Capital for continuing to increase their investment after the initial privatization investment. We are honored that AstraZeneca-CICC Fund, Sequoia Capital China and other high-quality, valuable new partners have joined the shareholder base. With the support of these long-term and new, marquee investors, we affirm our mission of ‘Saving Lives and Revitalizing Lives’ and bringing to market innovative therapies to address significant unmet medical needs."

Cannabics Announces New Corporate Logo, New Website and New Company Presentation

On September 30, 2021 A global leader in the development of cancer related cannabinoid-based medicine and a pioneer in the development of psychedelic inspired medicine, reported that it has updated its corporate image with a new logo and a new website (Press release, Cannabics Pharmaceuticals, SEP 30, 2021, View Source [SID1234590557]). In addition, the company announced that a new corporate presentation is now available on its new website.

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These updates more fully reflect the company’s strategic shift from a pre-clinical stage company towards now becoming a clinical stage development corporation focused primarily on FDA regulatory compliance.

The updated site, www.cannabics.com, provides current details on each of the company’s drug candidates and their corresponding clinical path. As always, the site offers current news and investor information, including press releases, SEC filings and the newly updated company presentation featuring the latest on Cannabics development.

ArcticZymes attending 6th Bioproduction Congress in Lyon France

On September 30, 2021 ArcticZymes Technologies reported that it is attending the 6th Bioproduction Congress in Lyon, France from 30th September through October 1st (Press release, Biotec Pharmacon, SEP 30, 2021, View Source [SID1234590551]).

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VECT-HORUS will attend to BioJapan Digital Conference

On September 30, 2021 Elodie DORMES, Business Development Manager, reported that it will attend to the BioJapan Digital Conference, starting the 12th of October 2021 and ending the 15th of October (Press release, Vect-Horus, SEP 30, 2021, View Source [SID1234590549]). 4 days dedicated to digital networking and interaction with Biotech and Pharmaceutical companies needing to enhance the delivery of Key candidate compounds to the brain or other organs and tumours.

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