On September 24, 2018 Foundation Medicine, Inc. reported that FoundationOneLiquid, its next-generation liquid biopsy test for solid tumors, is commercially available in the United States (Press release, Foundation Medicine, SEP 24, 2018, View Source [SID1234530052]). Using a blood sample, FoundationOne Liquid analyzes 70 genes known to drive cancer growth, including homologous recombination deficiency (HRD) genes, and reports the genomic biomarker for microsatellite instability (MSI),1 to help inform the use of checkpoint inhibitor immunotherapies and multiple targeted therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors, as well as clinical trials for patients with advanced cancer.

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"With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that has the potential to match more patients to targeted therapies," said Tom Civik, Chief Commercial Officer at Foundation Medicine. "For many cancer patients, traditional tissue testing is not feasible, and there is a pressing need for minimally invasive solutions to help inform personalized treatment decisions. FoundationOne Liquid meets our highest standards for sensitivity and analytical validation and offers providers additional insights to help guide treatment options, including immunotherapies and PARP inhibitors. In addition to the clinical advancements this test provides, it will also help our biopharma partners improve trial design and accelerate drug development."

FoundationOne Liquid is a hybrid capture-based, next-generation sequencing in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels), copy number alterations (CNAs) and select gene rearrangements using circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood. The FoundationOne Liquid test expands upon the previous version of the Company’s liquid biopsy test, FoundationACT, which has been analytically validated across the four main classes of genomic alterations. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity2 and positive predictive value3, even at the low allele frequencies often observed in clinical samples.4

"This is an important new option for metastatic cancer patients with insufficient tumor tissue specimens or for those at risk for invasive biopsy," said Tianhong (Tina) Li, MD, PhD, University of California Davis Comprehensive Cancer Center. "FoundationOne Liquid expands the ability of clinicians to select the most appropriate cancer therapy based on individual patients’ molecular and immune biomarker profile at initial diagnosis and as the disease progresses."

FoundationOne Liquid represents the latest advance in Foundation Medicine’s long-standing commitment to develop innovative liquid biopsy technologies. In April 2018, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Device designation for the Company’s liquid biopsy assay currently in development that includes the genomic biomarker blood tumor mutational burden (bTMB). If approved, this forthcoming test could be the first FDA-approved liquid biopsy test to incorporate multiple companion diagnostics (CDx) and multiple biomarkers to inform the use of targeted oncology therapies, including immunotherapies.

FoundationOne Liquid can also be used to complement prior tissue-based testing methods, providing results with longitudinal comparisons to previous Foundation Medicine test results. Foundation Medicine offers an option to automatically reflex to FoundationOne Liquid if tissue is insufficient for tissue-based testing. Healthcare providers can order a FoundationOne Liquid kit online at www.foundationmedicine.com/genomic-testing/foundation-one-liquid/order-kit, or visit www.foundationmedicine.com/genomic-testing/foundation-one-liquid to learn more.

On September 24, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into purchase agreements with several institutional investors for the purchase in a registered direct offering of 286,633 shares of its common stock at a public offering price of $17.02 per share, for expected gross proceeds of approximately $4.9 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, SEP 24, 2018, View Source [SID1234529902]). The offering is expected to close on or about September 26, 2018, subject to customary closing conditions.

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Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our clinical-stage product pipeline, general corporate purposes, and strategic growth opportunities.

Roth Capital Partners acted as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 24, 2018 Tiziana Life Sciences plc ("Tiziana", AIM: TILS), the research and clinical stage biotechnology company focussing on proprietary drug candidates to treat cancer and autoimmune diseases, reported its interim results for the six months ended 30 June 2018 (Press release, Tiziana Life Sciences, SEP 24, 2018, View Source [SID1234529857]).

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Highlights during the period:

LEADERSHIP

The Company significantly enhanced its commercial and strategic development strength with the addition of a highly experienced executive to its Board of Directors:

Leopoldo Zambeletti joined as a non-executive director of the Company.

RESEARCH & DEVELOPMENT

CLINICAL PROGRAMMES

Foralumab

TZLS-401

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in contrast to the previous non-human or humanized anti-CD3 mABs. Recent data from studies conducted in the laboratories of Prof. Howard Weiner (Harvard University)[1] and Prof. Kevan Herold (Yale University) suggest that oral administration of formalumab has the potential to improve efficacy while minimizing toxicity in the treatment of inflammatory diseases such as NASH (nonalcoholic steatohepatitis), PBS (primary biliary cholangitis) and other autoimmune and inflammatory diseases.

Results from a previous Phase 1 evaluation of foralumab administered via intravenous injection in patients with Crohn’s disease demonstrated foralumab’s immunomodulatory activity in humans. Recent clinical studies conducted by Prof. Yaron Ilan with oral administration of anti-CD3 (OKT3; murine mAb) in hepatitis C virus infected patients and in NASH patients suggested that the treatment was well-tolerated and produced immunologic effects consistent with potential clinical benefits.

Our strategy is to build on these exciting findings to develop foralumab for treatment of NASH, PBC and other liver diseases. Foralumab may also be combined with TZLS-501, a fully human anti-IL-6R mAB, for treatment of rheumatoid arthritis and other diseases.

Milciclib

TZLS-201

The Company’s lead compound, acquired from Nerviano Medical Sciences, is an orally bioavailable, small molecule pan-inhibitor of cyclin-dependent kinases (CDK: 1, 2, 4, 5, and 7) as well as Src family kinases.

The compound was well tolerated by patients with thymoma in Phase I and Phase 2 clinical trials. Interim data analysis from the Phase 2 trial indicated that the treatment was well-tolerated and it produced encouraging clinical responses. In another study, milciclib in combination with gemcitabine was found to be well tolerated, and the treatment improved clinical outcomes in patients with refractory solid tumors.

A unique feature of milciclib is its ability to reduce microRNAs miR-221 and miR-222. These microRNAs are consistently upregulated in hepatocellular carcinoma (HCC) patients and might contribute towards resistance to treatment with sorafenib. Thus, we believe milciclib has potential to be developed as a drug candidate for treatment of HCC either as a monotherapy or in combination with sorafenib.

Our strategy is to first initiate clinical studies as a Phase 2a monotherapy with milciclib, which will be followed immediately by a Phase 2b clinical study in combination with sorafenib.

PRE-CLINICAL PROGRAMMES

Anti IL-6R mAb

TZLS-501, formerly NI-1201

Recently acquired anti IL-6R mAb is a fully human monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Anti IL-6R mAb offers a unique mechanism of action in which, it binds to both the membrane-bound and soluble forms of the IL-6R and depletes circulating levels of the IL-6 in the blood. An excessive production of IL-6 is regarded as a key driver of chronic inflammation, associated with autoimmune diseases such as multiple myeloma and rheumatoid arthritis.

StemPrintER

StemPrintER is a multi-gene signature assay intended for use in patients diagnosed with estrogen-receptor positive ER+/HER2 negative breast cancers. This in-vitro prognostic test will be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.

Our diagnostic has a unique biological basis, being based on the detection of cancer stem cell markers, uses a reliable platform (qRT-PCR, FFPE), and has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2400 patients with breast cancer. The development team is preparing for a retrospective validation study using an independent cohort and has discussed submission plans with the FDA.

FINANCIAL

£1.67m raised through issuance of equity.

For the six months to 30 June 2018 the consolidated Group made a loss of £3.94m (six months to 30 June 2017: £3.87m).

The Group ended the period with £0.1m cash as at 30 June 2018 (31 Dec 2017: £0.1m).

The Company continues to carefully manage its working capital position and continues the process,as referred to below, to seek to raise further funds through the issueof ADSs through a United States Offering.

Highlights post period:

In July 2018, the Company announced the filing of a registration statement on Form F-1 with the U.S. Securities Exchange Commission ("SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares"), in the United States (the "Offering").

On August 16, 2018 – the Company announces the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration in collaboration with the Brigham and Women’s Hospital, Harvard Medical School, Boston, MA ("BWH") to Initiate Phase 1 Clinical Trials with Foralumab, to be administered nasally to healthy volunteers, with the objective of demonstrating proof of concept in a potentially revolutionary approach for the treatment of neurodegenerative diseases, such as progressive multiple sclerosis ("MS").

On September 24, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, and Nektar Therapeutics (Nasdaq: NKTR) reported that the companies are expanding their ongoing research collaboration into a new clinical partnership (Press release, BioXcel Therapeutics, SEP 24, 2018, View Source [SID1234529853]). The collaboration will clinically evaluate the novel combination of BTI’s BXCL701, a small molecule immune-modulator, DPP 8/9 and FAP inhibitor; Nektar’s NKTR-214, a CD122-biased agonist; and a checkpoint inhibitor as a potential therapy for pancreatic cancer.

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Under the terms of the expanded collaboration agreement, BTI will be responsible for initiating and managing the clinical program. The primary objectives of the study are to evaluate safety and efficacy of the triplet combination of BXCL701, NKTR-214 and a checkpoint inhibitor for the treatment of patients with unresectable or metastatic pancreatic cancer. Additionally, correlative immune activation markers will also be evaluated in blood and tumor tissue.

"We are excited to expand our collaboration with Nektar to initiate a clinical program for this novel triplet combination regimen," said Vimal Mehta, Chief Executive Officer of BTI. "Mechanistically, we believe the action of BXCL701 on macrophages and neutrophils within the tumor tissue can activate the innate immune system and then in combination with NKTR-214 and an anti-PD1, we can then prime adaptive immune cells in order to trigger T-cell driven anti-cancer activity and the generation of T-cell memory. The exciting preclinical data presented at this year’s ASCO (Free ASCO Whitepaper) Meeting highlighted the complementary mechanisms by which these three agents can synergize to generate durable responses in various animal models."

"We believe it is essential to target multiple dimensions of the immune system in parallel in order to address the multi-faceted etiologies underlying cancer cell growth in difficult-to-treat tumors such as pancreatic cancer," said Jonathan Zalevsky, Senior Vice President, Biology & Preclinical Development of Nektar Therapeutics. "This experimental triplet combination regimen of BXCL701, NKTR-214 and a checkpoint inhibitor is designed to leverage multiple mechanisms of action at once to better fight pancreatic cancer while potentially generating long-term cancer immunity. We’re pleased to be working with BTI on this program."

BTI and Nektar Therapeutics initially announced a preclinical research collaboration in November 2017. This collaboration focused on utilizing the complementary mechanisms of BXCL701 and NKTR-214 to stimulate the body’s own immune system to overcome immunosuppressive mechanisms in the tumor microenvironment.

On September 24, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that the company will participate in two investor conferences in October (Press release, Valeant, SEP 24, 2018, View Source [SID1234529771]).

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Joseph C. Papa, chairman and chief executive officer, and Sam Eldessouky, senior vice president and corporate controller, are scheduled to participate at the Cantor Fitzgerald Global Healthcare Conference in New York on Oct. 1, 2018 at 3:30 p.m. EDT.

Paul S. Herendeen, executive vice president and chief financial officer, William Woodfield, vice president and treasurer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Deutsche Bank 26th Annual Leveraged Finance Conference in Scottsdale, Ariz. on Oct. 2, 2018 at 10:40 a.m. MST (1:40 p.m. EDT).

Live webcasts and audio archives of the events will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source