On January 7, 2020 Sirnaomics Inc. ("Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics against cancer and fibrotic diseases, and Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, jointly reported that the two companies have entered a strategic collaboration to conduct clinical studies, using Sirnaomics’ RNAi drug candidate STP705 (cotsiranib) and Innovent’s antibody drug Tyvyt (sintilimab injection), for combination treatment in advanced cancers, such as Hepatocellular Carcinomas (HCC) and Cholangiocarcinoma (CCA), with high unmet need in the US (Press release, Sirnaomics, JAN 7, 2020, View Source [SID1234552814]).

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Patrick Lu, PhD, President and Chief Executive Officer of Sirnaomics, stated, "This collaborative effort between Sirnaomics and Innovent will be the first example of a combination strategy using an RNAi drug candidate together with an approved immune checkpoint antibody drug for the treatment of liver cancers. This represents an important clinical approach for combating these deadly diseases where the silencing of gene targets that reduce T-cell access and activity may augment the activity of checkpoint inhibitors in liver cancer."

Michael Molyneaux, MD, Chief Medical Officer of Sirnaomics, stated, "Sirnaomics is very excited to enter into this collaboration agreement with Innovent to potentially bring lifesaving therapies to patients with Hepatocellular Cancers. It is well known that, despite recent advances in cancer therapies, HCC is still a deadly form of liver cancer with high unmet need. Our pre-clinical Proof of Concept oncology data has consistently demonstrated single agent efficacy with STP705 in HCC and our most recent work on mechanism of action strongly suggest that the use of our lead asset (STP705) in combination with antibody therapies could greatly benefit patients with HCC. Innovent has a very strong track record for innovation and execution in the clinical space and a shared vision of bringing lifesaving therapies to their patients. We believe that combining Sirnaomics novel siRNA technology with Innovent’s cutting edge antibody therapies has the potential to significantly improve the current treatment landscape for patients with Hepatocellular Cancer."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated, "Sintilimab has been granted marketing approval by the NMPA and is the only PD-1 inhibitor included in the NRDL. Sintilimab has gained broad recognition by the market, due to its profiles in safety and efficacy. Through partnership with other companies, we are exploring more sintilimab-based combination therapies and have seen some promising results. Developing a combination therapy, comprised of an antibody drug and a RNAi drug, may provide more comprehensive and effective treatments for patients. The potential clinical value of the combination therapy of sintilimab and cotsiranib will be evaluated and we hope more patients will benefit from this potential therapy globally."

About STP705 (Cotsiranib)
Sirnaomics’ leading product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma and Primary Sclerosing Cholangitis. STP705 has demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis.

About Tyvyt (Sintilimab Injection)
Tyvyt (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, was granted marketing approval by the NMPA for r/r cHL in 2018, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology ("CSCO") for Lymphoid Malignancies. Tyvyt (sintilimab injection) has been the only anti-PD-1 monoclonal antibody included in the NRDL since 2019.

Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials. Innovent is also conducting clinical studies of sintilimab injection in the United States.

On January 7, 2020 Hummingbird Bioscience, an innovative biotherapeutics company pioneering the discovery and development of new breakthrough precision antibody therapeutics for difficult-to-treat conditions, reported the publication of preclinical data for its lead candidate, HMBD-001, an anti-HER3 antibody, in Molecular Cancer Therapeutics, a high-impact peer-reviewed American Association of Cancer Research journal (Press release, Hummingbird Bioscience, JAN 7, 2020, View Source [SID1234552813]).

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HMBD-001 is a unique anti-HER3 antibody with a novel mechanism of action and favorable safety profile. HER3 is a member of the EGFR tyrosine kinase receptor family, which is responsible for driving cancer cell division and growth, and is expressed in over half of colorectal and gastric cancers, at least a third of breast cancers, as well as significant sub-populations of many other indications.[1] HER3 activation is implicated in cancer progression as well as in acquired resistance to drugs against other tyrosine kinase receptor family members such as EGFR (e.g. cetuximab or Erbitux) and HER2 (e.g. trastuzumab or Herceptin). HMBD-001 was developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery Platform to specifically bind to and inhibit a difficult-to-access region of the HER3 protein that is essential for activation.

The published findings show that HMBD-001 (also known as 10D1F) is superior at tumor growth inhibition, regardless of how HER3 is activated, compared to previous anti-HER3 drugs with different binding sites and mechanisms of action. HMBD-001 demonstrated potent efficacy in a broad panel of in vitro and in vivo tumor models that had high HER3 activity and oncogenic downstream signaling.

"Previous attempts to target HER3 with other drugs failed as they could not inhibit activation of HER3 effectively. The highly specific binding of HMBD-001 to a difficult-to-target region on HER3 allows us to completely shut off activation of this important cancer-associated protein," said Dr Jerome Boyd-Kirkup, Chief Scientific Officer and co-founder, Hummingbird Bioscience. "This preclinical data provides proof-of-concept and represents exciting therapeutic opportunities for us as we look to develop HMBD-001 in hard-to-treat conditions such as gastric, colorectal, lung and pancreatic cancers."

Hummingbird Bioscience, in partnership with Cancer Research UK, will be advancing HMBD-001 into clinical trials for the treatment of HER3 driven cancers. Manufacturing of the material for the Phase 1 clinical trial of HMBD-001 is underway and is expected to be completed in the second half of 2020.

The paper titled 10D1F, An Anti-HER3 Antibody that Uniquely Blocks the Receptor Dimerization Interface, Potently Inhibits Tumor Growth Across a Broad Panel of Tumor Models can also be accessed online at View Source

About HMBD-001

HMBD-001 represents a unique, highly-specific, anti-HER3 neutralizing antibody with a novel mechanism of action that offers significant potential for broad clinical benefit. Previous attempts to block the HER3 receptor, a key player in the signaling pathway that promotes cell division and tumor growth in cancer, have not proven to be efficacious. HER3 is activated by the binding of neuregulin (NRG1), which stabilizes a transient open conformation to allow it to form heterodimers with HER2/EGFR. In the presence of abundant HER2/EGFR, heterodimers can form without NRG1.

Preclinical models have shown that HMBD-001 is able to effectively and uniquely bind to a
difficult-to-target region on HER3, blocking the heterodimerization of HER3 with HER2/EGFR independent of NRG1 binding. This potently inhibits the activation of the signaling pathway – and consequently, stops tumor growth.

Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3 driven cancers. The clinical trial of this investigational candidate is expected to commence following the completion of manufacturing and the subsequent submission of regulatory approval.

On January 7, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of the NeXT Dx Test to help oncologists identify potential therapies and clinical trial options for cancer patients (Press release, Personalis, JAN 7, 2020, View Source [SID1234552810]). The Personalis NeXT Dx Test is one of the first cancer diagnostic platforms to profile approximately 20,000 genes in both the tumor exome and transcriptome, providing a comprehensive genomic testing solution that goes beyond many existing cancer diagnostic panels that focus on a few hundred genes. The Personalis NeXT Dx Test includes advanced analytics to provide a diagnostic report on genetic alterations in medically-important cancer genes, as well as emerging immunotherapy composite biomarkers of medical importance. Additionally, immunotherapy-related biomarkers such as microsatellite instability (MSI) status and tumor mutational burden (TMB) are included in the clinical report.

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"With new cancer immunotherapy and combination therapies, there is an increasing need for the development of more advanced composite biomarkers that can model the complex biology driving the response and resistance to cancer therapy. Our NeXT Dx Test provides oncologists with clinical reports on key diagnostic markers driving therapies today as well as provides information that can support the identification of new, advanced biomarkers. With the NeXT Dx Test, we look forward to expanding engagements with both leading clinical cancer centers as well as biopharmaceutical companies looking to push forward cutting-edge precision medicine in cancer," said Dr. Richard Chen, MD, Chief Scientific Officer at Personalis.

About NeXT Dx Test

The NeXT Dx Test, optimized for formalin-fixed, paraffin-embedded tumor samples, is a laboratory-developed test performed at Personalis’ CAP-accredited and CLIA’88-certified laboratory. The test utilizes ImmunoID NeXT, a high-accuracy, clinical-grade, next-generation sequencing and analysis platform, to report base substitutions, insertions/deletions, gene fusions, and copy number alterations in cancer driver genes of clinical significance. Additionally, MSI status is reported based on five canonical loci (BAT25, BAT26, NR-21, NR-24, and NR-27), and TMB status is reported by leveraging the exome-wide analysis of non-synonymous somatic mutations. Based on the tumor’s molecular profile, the report delivers relevant therapy recommendations and appropriate clinical trial matches. Each case is reviewed by a team of board-certified molecular geneticists and genetic counselors. Test results are electronically delivered to the ordering clinician.

About ImmunoID NeXT Platform

ImmunoID NeXT is a universal cancer immunogenomics platform that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its tumor microenvironment from a single sample. The platform represents an end-to-end solution for immuno-oncology and supports precision oncology biomarker discovery applications. It combines the pioneering NeXT assay (whole exome and transcriptome sequencing), sophisticated analytics engines, and quality support to provide researchers with comprehensive immunogenomic data to drive their drug development programs.

On January 7, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 12:00 p.m. PST on Wednesday, January 15, at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Puma Biotechnology, JAN 7, 2020, View Source [SID1234552809]). The conference will be held at the Westin St. Francis Hotel in San Francisco.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

On January 7, 2020 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference being held next week in San Francisco (Press release, Exelixis, JAN 7, 2020, View Source [SID1234552808]). Exelixis’ presentation has been scheduled for Tuesday, January 14, 2020 at 7:30 PM EST / 4:30 PM PST.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.