On August 27, 2021 Immix Biopharma, Inc. ("ImmixBio") reported a clinical trial and supply agreement with BeiGene, Ltd. to evaluate the safety, tolerability and efficacy of combining IMX-110, a Tissue Specific Therapeutic with TME Normalization Technology, with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumors, in the U.S. and internationally (Press release, Immix Biopharma, AUG 27, 2021, View Source [SID1234586965]).

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Under the terms of the agreement, ImmixBio will evaluate the combination of IMX-110 with tislelizumab in a Phase 1/2a trial in patients with advanced solid tumors.

"ImmixBio is proud to showcase our Tissue Specific Therapeutics (TSTx) platform to the world. Promising data from our ongoing IMX-110 clinical trial, from pre-clinical studies in a genetic mouse model of pancreatic cancer showing IMX-110 turning "cold" tumors "hot," and IMX-110 in combination with murine anti-PD-1 demonstrating extended survival in a genetic mouse model of pancreatic cancer versus multi-drug combinations in the literature, have demonstrated substantial rationale to combine IMX-110 and tislelizumab," said Ilya Rachman, MD, PhD – ImmixBio CEO. "We have high hopes that IMX-110 in combination with tislelizumab could expand the population of cancer patients experiencing extended remissions."

About IMX-110

IMX-110 is a Tissue-Specific Therapeutic built on ImmixBio’s TME Normalization 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.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab market authorization in four indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab is not approved for use outside of China.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On August 27, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that management will present a company overview at the following conferences (Press release, PTC Therapeutics, AUG 27, 2021, View Source [SID1234586962]):

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Morgan Stanley Virtual 19th Annual Global Healthcare Conference
Friday, September 10th at 11:00 a.m. ET

2021 Cantor Virtual Global Healthcare Conference
Monday, September 27th at 3:30 p.m. ET

The presentation will be webcast live on the Events and Presentations page under the investor relations section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentation. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On August 27, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported the grant of patent no. ZL201580013695.X entitled "Antibody molecules to LAG-3 and uses thereof" by the Chinese Patent Office (Press release, Immutep, AUG 27, 2021, View Source [SID1234586961]).

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This new Chinese patent follows the grant of the corresponding Australian, United States, European, and Japanese patents announced in 2018 through 2020.

In particular, the claims of the patent are directed to LAG525, pharmaceutical compositions comprising LAG525, nucleic acid molecules that code for the LAG525 antibody, an expression vector or host cell that comprises the nucleic acid molecules, and to the use of LAG525 in the manufacture of a preparation for the treatment of cancer or infectious disease.

LAG525 (INN: leramilimab) is a humanised form of Immutep’s IMP701 antibody which is out-licensed to Novartis AG.

The patent is co-owned by Novartis AG and Immutep S.A.S. and will expire on 13 March 2035.

About IMP701 and LAG525

IMP701 is a therapeutic antagonist antibody originally developed by Immutep S.A. (now Immutep S.A.S.) to target LAG-3. This antibody plays a role in controlling the signalling pathways in both effector T cells and regulatory T cells (Treg). The antibody works by activating effector T cells by blocking inhibitory signals that would otherwise switch them off, and also by inhibiting Treg function that normally prevents T cells from responding to antigen stimulation. The antibody therefore removes two brakes that prevent the immune system from responding to and killing cancer cells. In contrast, some other antagonist LAG-3 antibodies in development target only the effector T cell pathway and don’t address the Treg pathway.

LAG525, a humanised form of IMP701, is being evaluated in several Phase I and/or Phase II clinical trials in combination with Novartis’ PD1 inhibitor spartalizumab for the treatment of various cancers. Novartis has full responsibility for the continued development of the antibody program and Immutep is eligible to receive development-based milestone payments and royalties on sales following commercialisation of the antibody.

On August 27, 2021 Carina Biotech reported that has entered a collaboration agreement with Melbourne biotech AdAlta to develop precision engineered, i-body enabled CAR-T therapies that provide new hope for patients with cancer (Press release, Carina Biotech, AUG 27, 2021, View Source [SID1234586959]).

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This is a collaboration at the cutting-edge of cancer medicine, bringing together Carina’s world-leading proprietary CAR-T technologies with AdAdlta’s unique i-body platform. The agreement will develop i-body enabled CAR-T cancer immunotherapies against up to five solid tumour antigen targets.

The small size and unique targeting of i-bodies provides for greater flexibility and design options for CAR-T cells, which are ideally suited for the production of bi-specific CAR-T cells.

Bi-specific CAR-T cells have the potential to deliver precisions to difficult-to-target cancers – by targeting two antigens on cancer cells, reducing the opportunity for tumour cells to be missed, and reducing the chances of damaging healthy tissue.

Carina’s CEO, Dr Deborah Rathjen, commented: "This collaboration with AdAlta gives us the capability to generate bi-specific CAR molecules and then next-generation CAR-T cell products with enhanced cancer targeting and efficacy – something we are very excited about. The collaboration is off to a great start with Carina already having successfully inserted an AdAlta i-body into a CAR-T cell with functional cancer killing capability."

Carina and AdAlta will jointly fund pre-clinical proof-of-concept studies in mouse tumour models and will jointly own products emerging from the collaboration.

On August 27, 2021 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported a poster presentation showcasing initial findings from its ongoing study of ALRN-6924 in healthy volunteers at the International Society for Experimental Hematology (ISEH) 50th Annual Scientific Meeting, which is currently underway (Press release, Aileron Therapeutics, AUG 27, 2021, View Source [SID1234586958]). The initial findings demonstrated that a 0.3 mg/kg dose of ALRN-6924 has been very well tolerated and resulted in p53-mediated induction of the cell cycle inhibitor p21 in healthy, normal bone marrow cells without concurrent induction of apoptosis. The poster can be viewed on Aileron’s website here.

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"We’re pleased to present our first human data demonstrating ALRN-6924’s mechanism of action, namely, p53-mediated induction of p21 in healthy, normal cells without concurrently inducing apoptosis," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "We believe these data validate our previously presented preclinical mechanism of action results for ALRN-6924 and also support the robust chemoprotective effect ALRN-6924 demonstrated against multiple chemotherapy-induced bone marrow toxicities in our Phase 1b trial in patients with p53-mutated small-cell lung cancer (SCLC). We look forward to presenting additional data from the ongoing healthy volunteer study in the future and evaluating clinical translation of these findings in our ongoing randomized, double-blind, placebo-controlled trial of ALRN-6924 in patients with p53-mutated NSCLC."

The healthy volunteer study is designed to characterize the time to onset, magnitude and duration of p21-induced cell cycle arrest in human bone marrow relative to ALRN-6924 administration. The ultimate aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a selective chemoprotective agent across a range of chemotherapies and p53-mutant tumor indications.

Aileron is currently evaluating ALRN-6924 in a Phase 1b randomized, double-blind, placebo-controlled trial of ALRN-6924 in patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors.

In October 2020, Aileron presented data from its now completed Phase 1b clinical trial of ALRN-6924 in SCLC, demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against neutropenia, thrombocytopenia and anemia in patients with p53-mutated SCLC treated with topotecan. Aileron will present final data from the Phase 1b SCLC trial and additional data from the healthy volunteer study at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held September 16-21, 2021.