On October 30, 2019 Invivoscribe, Inc. reported that the European Commission (EC) has proceeded to authorize the drug Astellas XOSPATA (gilteritinib) as monotherapy for the treatment of adults affected by leukemia Recurrent or refractory acute myeloid (AML) presenting FLT3 mutations ( FLT3 mut +) detected with the LeukoStrat CDx FLT3 mutation analysis (Press release, Invivoscribe Technologies, OCT 30, 2019, View Source [SID1234550067]).

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The LeukoStrat test is presented as a service that comprises a range of determinations and is marketed through several subsidiaries of Invivoscribe: LabPMM LLC, of San Diego ( California , USA); LabPMM GmbH, of Martinsried (Germany), and LabPMM GK, of Kawasaki (Japan). Currently, lots of CDx FLT3 mutation analysis are also distributed in Europe, Japan, Switzerland and Australia and it is planned to do so, in the future, in the United States and China .

Invivoscribe developed the LeukoStrat CDx FLT3 , in collaboration with Astellas, as an accompanying diagnostic test that allows predicting the patient’s response to the drug XOSPATA (Gilteritinib fumarate), from Astellas, for AML. The authorization that has just been granted is based on the results of the ADMIRAL phase III trial, in which gilteritinib was studied in comparison to rescue chemotherapy in patients with relapsing or refractory FLT3 AML . Thus, patients treated with gilteritinib had a markedly greater overall survival (OS) than those who received rescue chemotherapy: the median of OS was, in the case of the first, 9.3 months, compared with 5.6 of the patients who were only given chemotherapy.

Such a milestone consolidates the position of the LeukoStrat CDx FLT3 mutation analysis as a reference method of general evaluation of the FLT3 gene in critically ill patients of AML, since this accompanying diagnostic test allows FLT3 mutations in the tyrosine kinase domain (DTC) to be identified. and that show internal tandem duplication (DIT). LeukoStrat is marketed internationally.

This authorization is complementary to the others that have already been granted by the health authorities to the analysis of the LeukoStrat CDx FLT3 mutation as an accompanying diagnostic method of XOSPATA (Gilteritinib fumarate) from Astellas; RYDAPT (midostaurin) from Novartis, and quizartinib hydrochloride from Daiichi Sankyo.

"The authorization of the European Commission constitutes a notable advance for patients with recurrent or refractory acute myeloid leukemia with a FLT3 mutation . In Invivoscribe we welcome the introduction of more therapeutic options that allow the patient to be extended and we would be delighted to partner with pharmaceutical laboratories interested in taking advantage of our Streamlined CDx program with a view to speeding up obtaining authorization for their drugs in different parts of the world, regardless of whether the treatments in question are aimed at hemopathies or solid tumors, "said Jeffrey Miller , director of Strategy and CEO of Invivoscribe.

About the LeukoStrat CDx FLT3 mutation analysis of Invivoscribe
The LeukoStrat CDx
FLT3 mutation analysis is an in vitro diagnostic test for PCR designed to detect mutations in D835 and I836 with internal tandem duplication (DIT) and in the tyrosine kinase domain (DTC) ) of the FLT3 gene , a detection that is performed on genomic DNA extracted from mononuclear cells taken from peripheral blood or bone marrow aspirates from patients who have been diagnosed with acute myelogenous leukemia.

The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with midostaurin (in the United States, Europe, Switzerland and Australia ),

The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with gilteritinib fumarate (in the United States, Europe and Japan).

The LeukoStrat CDx FLT3 mutation analysis is used as an auxiliary system for the evaluation of patients with AML for those considering the possibility of starting treatment with quizartinib hydrochloride (in Japan).

The international standardized test includes software that interprets the data and generates signal ratios of mutant and natural alleles corresponding to mutations with DIT and in the DTC. This widely validated analysis makes it possible to standardize the detection of genetic mutations in the FLT3 gene , which are among the most important oncogenic initiators of acute myeloid leukemia (AML).

On October 30, 2019 Amgen (NASDAQ: AMGN) reported a publication in Nature unveiling the discovery of AMG 510, a small molecule inhibitor of KRASG12C being investigated as a treatment for a variety of solid tumors with KRAS G12C mutation (Press release, Amgen, OCT 30, 2019, View Source [SID1234550066]). AMG 510 is the first investigational KRASG12C inhibitor to advance to the clinic and is currently enrolling in a potentially registrational Phase 2 study.

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Titled "The Clinical KRASG12C Inhibitor AMG 510 Drives Anti-Tumor Immunity," the paper highlights novel structural insights that led to the discovery of AMG 510, the preclinical evidence of AMG 510 activity, its potential ability to induce tumor-cell killing as both a monotherapy and in combination with other therapies, and its impact on the immune system that may render tumor cells particularly sensitive to immunotherapy. Early evidence of clinical activity of AMG 510 is also presented in the paper.

"We are pleased to share how our team of scientists at Amgen were the first to exploit the previously hidden groove on the protein surface to finally identify a potential drug against this important oncogenic protein," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These scientific insights, coupled with superb molecular engineering, paved the way for AMG 510 to be first to clinic, where it has demonstrated early evidence of clinical activity."

KRAS, identified over 30 years ago as a proto-oncogene, is one of the most frequently mutated oncogenes in human cancer.1,2 Amgen researchers first identified the novel histidine 95 (H95) groove located on an inactive KRASG12C protein. Through extensive compound screening and structure-based design, AMG 510 emerged as the top investigational candidate from the optimization of a series of H95 groove-binding molecules. It is designed to irreversibly bind to KRASG12C protein and permanently lock it in an inactive state, leading to inhibition of tumor cell growth in KRASG12C driven tumors. In preclinical experiments, AMG 510 demonstrated favorable potency and selectivity, and induced regression in mice bearing KRASG12C mutated tumors.

"There is a significant unmet need for tumor-selective therapies that minimize a negative impact on normal cells, and many patients diagnosed with KRAS-mutated solid tumors have typically faced a challenging prognosis with limited targeted treatment options," said David S. Hong, M.D., one of the paper’s authors, AMG 510 clinical study investigator and deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at University of Texas MD Anderson Cancer Center, Houston. "This publication shows investigational AMG 510 has high selectivity in non-clinical experiments, binding only to KRASG12C out of more than 6,000 proteins and likely contributing to the absence of dose-limiting toxicities in the clinical study to date, supporting the potential for an encouraging safety profile."

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to AMG 510 for previously treated metastatic non-small cell lung cancer (NSCLC) and colorectal cancer with KRAS G12C mutation and Fast Track Designation for previously treated metastatic NSCLC with KRAS G12C mutation. Additional data from the ongoing Phase 1 clinical trial evaluating AMG 510 was recently presented at the 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and at the European Society for Medical Oncology 2019 Congress, both of which were held in Barcelona, Spain.

About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.1,2 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.2 A specific mutation known as KRAS G12C accounts for approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.3 Approximately 30,000 patients are diagnosed each year in the United States with KRAS G12C-driven cancers.4 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

On October 30, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported early completion of patient enrollment of its Phase 3 ProVent clinical trial. More than 450 subjects were randomized in the large-scale clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with early-stage prostate cancer on active surveillance (AS) (Press release, Dendreon, OCT 30, 2019, View Source [SID1234550065]).

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"The rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on AS," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "PROVENGE has been proven to extend life in men with mCRPC, and we intend to change the way prostate cancer is treated by showing that immunotherapy can reduce disease progression and the need for aggressive intervention in men with early-stage disease."

Nearly 175,000 men are diagnosed with prostate cancer every year.1 Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS, which includes regular monitoring to assess whether the cancer is progressing, instead of more aggressive treatment options such as surgery or radiation.2,3

"For men with low-risk, localized prostate cancer, the option of AS is regularly recommended; however, variation in PSA monitoring and the anxiety of having a ‘cancer’ diagnosis causes many men to leave surveillance management and undergo interventional treatment," said Neal D. Shore, M.D., FACS, ProVent principal investigator, medical director for the Carolina Urologic Research Center and a practicing urologist at Atlantic Urology Clinics in Myrtle Beach, S.C. "Both patients and physicians have desired a proactive therapy for appropriate AS patients in order to optimize their long-term outcomes. Given the numerous studies describing the effectiveness of sipuleucel-T immunotherapy for advanced prostate cancer, we are optimistic that data from ProVent may lead to the first-ever immunotherapy treatment option for men with early-stage prostate cancer."

About the ProVent Trial
The randomized, multicenter Phase 3 ProVent trial is assessing the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization were eligible to enroll in the study, which is being conducted at approximately 60 sites across the United States. Study participants were randomized 2:1 to receive sipuleucel-T or remain on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher at 33-39 months after randomization. Secondary endpoints include the number of study participants who receive subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate quality of life and the association of immunologic responses with efficacy.

Enrollment in the ProVent study began in late 2018, and topline results are expected in 2023.

For more information, visit www.ProVentStudy.com or clinicaltrials.gov (NCT03686683).

About Active Surveillance (AS)
During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every one to two years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer while retaining the option of definitive therapy. AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)
PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On October 30, 2019 ImmunSYS, Inc., a clinical stage biotechnology company focused on the development of YourVaccx, a new intratumoral immunotherapy system for metastatic castrate resistant prostate cancer and other solid tumor cancers, reported that the company received the top award at the recent BioPitch 2019, a Shark Tank for life science companies that highlighted the 2019 BioFlorida annual conference (Press release, ImmunSYS, OCT 30, 2019, View Source [SID1234550064]).

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The company won $10,000 after besting 15 other seed-stage and early-stage life science firms that also pitched at the Oct. 22 conference in Tampa. More than 20 investor judges worked over the past several months to review a record-breaking number of applications for BioPitch, and they determined the 16 semi-finalists who presented at the conference, said Jane Teague, who organized the pitch competition and is executive director of the Institute for Commercialization of Florida Technology.

In addition to the pitch competition, the conference featured biotech leaders presenting research updates, and panels discussing the state of the industry in Florida.

To learn more about ImmunSYS and BioPitch 2019, you can read the recap here: https://stpetecatalyst.com/meet-the-company-that-won-10000-at-biopitch

On October 30, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported the pricing of its initial public offering of 3,000,000 shares of common stock at a public offering price of $12.00 per share (Press release, RAPT Therapeutics, OCT 30, 2019, View Source [SID1234550062]).

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In addition, the underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of common stock at the initial public offering price, less the underwriting discount. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by RAPT, are expected to be $36.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The shares are expected to begin trading on the Nasdaq Global Market on October 31, 2019, under the ticker symbol "RAPT." The offering is expected to close on November 4, 2019, subject to the satisfaction of customary closing conditions.

BMO Capital Markets, Wells Fargo Securities and UBS Investment Bank are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from: BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected]; Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at [email protected], or by telephone at (800) 326-5897; or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on October 30, 2019. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.