On December 11, 2018 Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that its global Phase 1b clinical trial of Oraxol (oral paclitaxel plus HM30181A) plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies has completed the study of the second cohort of patients (Press release, Athenex, DEC 11, 2018, View Source;p=RssLanding&cat=news&id=2380209 [SID1234532013]). The results indicated strong positive signals of efficacy and the treatment was well tolerated.

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In the first cohort of six patients treated with a 200 mg/kg dose of Oraxol, partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). There was one severe adverse event (SAE) of grade-4 neutropenia in one patient who had complete recovery from this event.

Athenex now reports that for the second cohort of six patients on an escalated Oraxol dose of 250 mg/kg, partial response, according to RECIST criteria, occurred in 3 patients (50%). There was one SAE of grade-3 vomiting in one patient, who elected to withdraw from the study and subsequently had complete recovery. The Oraxol dose is currently being further escalated to 300 mg/kg in the third cohort of patients and the study is ongoing.

"We are pleased by the strong positive signals of efficacy together with a good safety profile in this Phase 1b clinical trial of Oraxol plus ramucirumab in the second-line treatment of gastric cancer patients so far and look forward to further results from the continuation of this study. The results also echoed the strong positive signal that we have observed in other clinical studies of Oraxol as monotherapy for the treatment of metastatic breast cancer," stated Dr. Rudolf Kwan, Athenex’s Chief Medical Officer.

Oraxol is a novel oral formulation of paclitaxel currently in Phase 3 clinical trial in metastatic breast cancer.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company under the name CYRAMZA.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oraxol from Athenex and is a partner in the development of Oraxol in the territory

On December 11, 2018 Abbott (NYSE: ABT) reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 8, 2019. Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 11 a.m. Central time (Press release, Abbott, DEC 11, 2018, View Source [SID1234532014]).

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A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

On December 11, 2018 INmune Bio, Inc., an immunotherapy company developing treatments to reprogram the innate immune system, reported that its lead drug candidate for treatment-resistant cancers, INB03, successfully inhibited the proliferation of tumor growth in pre-clinical models of trastuzumab treatment-resistant breast cancer (Press release, INmune Bio, DEC 11, 2018, View Source [SID1234531998]). The study was conducted by Roxana Schillaci, PhD., Researcher at the Institute of Biology and Experimental Medicine (IBYME-CONICET). Dr. Schillaci presented the data during a poster presentation at the San Antonio Breast Cancer Symposium in San Antonio, Texas, on December 8th.

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In the United States, one out of eight women will develop invasive ductal carcinoma (IDC) breast cancer in their lifetime. Two of those eight will have human epidermal growth factor receptor 2 (HER2) positive breast cancer that is treated with trastuzumab, an immunotherapy targeting HER2. Primary or secondary treatment resistance is a significant clinical problem that occurs in up to half of patients receiving trastuzumab for treatment of their HER2 positive breast cancer.

"Today, the definition of trastuzumab resistant breast cancer is the progression of breast cancer while the patient is on trastuzumab therapy," said Dr. Schillaci. "Our work shows that mucin 4 (MUC4) proteins, that block trastuzumab from binding with HER2 receptors, can be used as a biomarker to predict treatment-resistance. Additionally, the data shows that trastuzumab resistance can be reversed by eliminating soluble tumor necrosis factor (sTNF) in the tumor microenvironment".

Dr. Schillaci’s work showed that expression of MUC4 protein on cancer cells predicts trastuzumab resistance. The expression of MUC4 is caused by sTNF. Dr. Schillaci used INB03 to inhibit sTNF in mice to decrease MUC4 expression and reverse trastuzumab resistance. In further work, Dr. Schillaci’s team demonstrated that women resistant to trastuzumab express MUC4 on tumor while patients sensitive to trastuzumab do not.

"The results of this study suggest a possible solution for an ongoing problem in the treatment of women with HER2 positive breast cancer – predicting and treating trastuzumab resistance", said RJ Tesi, M.D., CEO and Co-Founder of INmune Bio. "If this work is confirmed in the clinic, the addition of therapy targeting sTNF, such as INB03, may improve the treatment options for a group of women previously unable to benefit from immunotherapy with trastuzumab."

INmune Bio initiated a Phase I clinical trial of INB03 on May 23. The company’s other drug candidate, INKmune, will enter clinical trials in early 2019.

On December 10, 2018 Immix Biopharma, Inc reported positive interim results from its ongoing phase 1b/2a study testing IMX-110 in advanced solid tumors (Press release, Immix Biopharma, DEC 10, 2018, View Source [SID1234531999]). Immix observed Stable Disease at cohort (dose-level) 2 in a middle-aged male with stage IV colorectal cancer that was refractory to radiation therapy, chemotherapy and immunotherapy. The team observed no adverse events at this dose level.

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The study is a multiple-ascending dose, Phase 1b clinical trial of IMX-110 to evaluate the compound’s safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in patients with advanced solid tumors and is led by Principal Investigator Prof. Paul de Souza of Western Sydney University, Sydney. Currently, the team is awaiting additional preliminary efficacy readouts from patients in cohorts (dose-levels) 3 and 4, with cohort 5 enrollees set to be recruited imminently. For information about participating in this study, please visit clinicaltrials.gov: View Source

The company is also announcing its plans to investigate IMX-109, a nanoformulation of curcumin, in neurodegenerative and age-related diseases, with preliminary human data scheduled to be shared publicly in early 2019.

About IMX-110
IMX-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability while inducing apoptosis. IMX-110 contains NF-kB/Stat3/pan-tyrosine kinase inhibitor curcumin combined with a small amount of doxorubicin encased in a nano-sized delivery system for optimal tumor penetration. The nanoparticle is tunable in that it can be bound to various targeting moieties, allowing it to deliver even more payload to tumors or other cell populations of interest, if needed. IMX-110 showed preclinical efficacy in glioblastoma, multiple myeloma, triple-negative breast, colorectal, ovarian, and pancreatic tumor models — with the mechanism of action being a 5x increase in cancer cell apoptosis compared to doxorubicin or curcumin alone, and a wholesale shift in the tumor-immune system microenvironment post administration.

About IMX-109
IMX-109 is a nanoformulation of curcumin, a substance with significant preclinical evidence of activity in inflammation-driven and age-related diseases, whose clinical use to-date has been hampered by the poor bioavailability of natural curcumin.

On December 10, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported it will present data on its investigational anti-PD-1 antibody tislelizumab at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress, being held December 13-16 in Geneva, Switzerland (Press release, BeiGene, DEC 10, 2018, View Source;p=RssLanding&cat=news&id=2380046 [SID1234531983]).

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Mini Oral Presentation:

Title: A Phase 1A/1B trial of Tislelizumab, an Anti-PD-1 Antibody (Ab), in Patients (Pts) With Advanced Solid Tumors
Presentation #: 70O
Session: Mini Oral Session (ID37)
Location: Room A, Geneva Palexpo
Date: Saturday, December 15
Time: 08:30 CET
Presenter: Chia-Chi Lin, M.D., Ph.D., National Taiwan University Hospital
Poster Presentation:

Title: Tislelizumab, an Anti-PD-1 Antibody, in Patients With Urothelial Carcinoma (UC): Results From an Ongoing Phase 1/2 Study
Presentation #: 76P
Session: Poster display session (ID 9)
Location: Foyer, Geneva Palexpo
Date: Friday, December 14
Time: 12:30 CET
Lead Author: Shahneen Sandhu, M.D., Peter MacCallum Cancer Centre-East Melbourne, East Melbourne, Victoria, Australia
About Tislelizumab

Tislelizumab (BGB-A317) is an investigational 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.

Discovered by BeiGene scientists, tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. The new drug application (NDA) for tislelizumab in China for patients with R/R cHL has been accepted by the China National Medical Products Administration (NMPA, formerly known as CFDA) and granted priority review status. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumors in the United States, Europe, Japan and the rest of world outside Asia