IMX-110 + anti-PD-1 Combination Produced Extended Median Survival in Genetic Pancreatic Cancer Mouse Model, Bolstering Planned 2022 IMX-110 Combination Clinical Trial Rationale

Rhea-AI Summary

Immix Biopharma, Inc. (Nasdaq: IMMX) reports promising data on IMX-110 in combination with anti-PD-1, achieving a 63-day median survival in a KPC pancreatic cancer mouse model, compared to the historical median of 42 days from a standard 4-drug regimen. This significant result underlines the potential of IMX-110, which is set to enter a Phase 1b/2a clinical trial with BeiGene's tislelizumab in advanced solid tumors in 2022. The FDA has granted orphan drug and rare pediatric disease designations for IMX-110, positioning it well for future clinical advancements.

Positive

• IMX-110 + anti-PD-1 resulted in a median survival of 63 days, outperforming the historical 42 days.
• The upcoming Phase 1b/2a trial with BeiGene positions the company for expanded oncology applications.
• IMX-110 holds orphan drug designation for soft tissue sarcoma, enhancing its market potential.
• The FDA has also granted rare pediatric disease designation for rhabdomyosarcoma, allowing for a priority review voucher.

Negative

• None.

• IMX-110 + anti-PD-1 produced 63-day median survival in a genetic (KPC) pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system
• Historically, 42-days is the median survival produced by a 4-drug combination of 2 chemotherapies and 2 immunotherapies in the same genetic pancreatic cancer mouse model according to Winograd et al., 2015
• 2022 - plan to commence combination IMX-110 + BeiGene anti-PD-1 tislelizumab Phase 1b/2a clinical trial in advanced solid tumors

A chart accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d970eaab-d8f9-43e3-b8d9-91a952d18b58

LOS ANGELES, Jan. 25, 2022 (GLOBE NEWSWIRE) -- 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 announced data showing that IMX-110 + anti-PD-1 produced 63-day median survival in a genetic pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system. Historically, according to Winograd et al., 2015, 42-days is the median survival produced by a 4-drug combination: 2 chemotherapies (gemcitabine, nab-paclitaxel) and 2 immunotherapies (anti-PD-1, anti-CD40) in the same genetic pancreatic cancer mouse model.

“This data highlights why we are excited to collaborate with BeiGene on our planned 2022 Phase 1b/2a combination clinical trial of IMX-110 + BeiGene anti-PD-1 tislelizumab in advanced solid tumors,” said Ilya Rachman, MD PhD, CEO of ImmixBio. “We believe this upcoming combination clinical trial will allow us to rapidly expand into multiple oncology indications.”

The U.S. Food and Drug Administration (“FDA”) has approved orphan drug designation (“ODD”) for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease (“RPD”) designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize anti-PD-1 tislelizumab in North America, Europe, and Japan in exchange for an upfront payment by Novartis of US$650 million plus royalties and milestone payments.

As of January 2022, anti-PD-1 tisleizumab has been approved or granted conditional approval in 6 cancer indications in China, including non-squamous non-small cell lung cancer (“NSCLC”), squamous NSCLC, classical Hodgkin’s lymphoma, Hepatocellular Carcinoma, and urothelial carcinoma.

About Immix Biopharma, Inc.

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 lead asset IMX-110, currently in Phase 1b/2a clinical trials, holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) for the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPPD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. 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. Learn more at www.immixbio.com.

Forward Looking Statements

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Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

Contacts
Immix Biopharma, Inc.
Gabriel Morris
Chief Financial Officer
ir@immixbio.com
+1 (888) 958-1084 

FAQ

What is the purpose of IMX-110 in the recent study?

IMX-110 is being studied as a treatment for pancreatic cancer, showing improved survival rates in a mouse model.

When is the IMX-110 + anti-PD-1 clinical trial scheduled to start?

The Phase 1b/2a clinical trial is planned to commence in 2022.

What survival advantage does IMX-110 provide over historical treatments?

IMX-110 combined with anti-PD-1 achieved a median survival of 63 days, significantly better than the 42-day median from traditional 4-drug therapies.

What designations has IMX-110 received from the FDA?

IMX-110 has received orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma.