On September 18, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that abstracts from its LOXO-292 and larotrectinib programs have been accepted for oral presentations at the 88th Annual Meeting of the American Thyroid Association to be held October 3-7, 2018, in Washington, DC (Press release, Loxo Oncology, SEP 18, 2018, View Source [SID1234529642]).

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The LOXO-292 oral presentation will provide an updated analysis of patients with RET mutant medullary thyroid cancer and RET fusion thyroid cancers enrolled in the dose escalation cohorts of the ongoing LIBRETTO-001 Phase 1/2 clinical trial. The larotrectinib oral presentation will provide an analysis of patients with TRK fusion thyroid cancer enrolled to the larotrectinib clinical program.

The schedule for the presentations is as follows:

LOXO-292 Oral Presentation Session Date & Time: October 6, 2018, 9:05 a.m.-9:20 a.m. ET
Title: Clinical Activity of LOXO-292, a Highly Selective RET Inhibitor, in Patients with RET-Altered Thyroid Cancers
Session Title: Clinical Short Call Oral
Presenter: Lori J. Wirth, M.D.

Larotrectinib Oral Presentation Session Date & Time: October 4, 2018, 1:50 p.m.-2:05 p.m. ET
Title: Activity of Larotrectinib in Patients with Advanced TRK Fusion Thyroid Cancer
Session Title: Thursday Clinical Oral Abstracts
Presenter: Marcia S. Brose, M.D., Ph.D.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in the RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

About Larotrectinib
Larotrectinib is an oral and selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, using a July 17, 2017 data cutoff, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority (93 percent) of all adverse events were grade 1 or 2.

Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology are jointly developing the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com/trk-trials.

About TRK Fusion Cancer
TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, is constantly active, triggering a permanent signal cascade. These proteins become the primary driver of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of cells or tissues and can occur in any part of the body. NTRK gene fusions occur in various adult and pediatric solid tumors with varying prevalence, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. Only sensitive and specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide a comprehensive view of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer, and immunohistochemistry (IHC) can be used to detect the presence of TRK protein.

On September 18, 2018 Rapamycin Holdings, Inc. (RHI), a privately-held drug development company based in San Antonio, Texas, reported that it has treated its first human patient with the company’s pharmaceutical formulation of its eRapaTM compound (Press release, Rapamycin Holdings, SEP 18, 2018, View Source [SID1234529479]). This first in human Phase 1b clinical trial of eRapa focuses on men with early stage prostate cancer.

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The trial will dose an expected twelve to 24 qualified patients to establish safety and explore the optimal biologic dose of eRapa. The trial is led by Michael Liss, M.D., a urologic oncologist at UT Health San Antonio MD Anderson Cancer Center, where the Phase 1b study is being conducted.

"This trial holds tremendous promise, not only for early stage prostate cancer patients but for many people with age-related diseases," commented RHI President and CEO, Dan Hargrove. "In addition to evaluating the safety and optimal dose of eRapa to potentially prevent the progression of prostate cancer, this trial will explore the ways in which eRapa can rejuvenate the body’s immune system, which is one of the strongest weapons against cancer. The final results will help signal our next clinical trials, as well as identify the various opportunities to explore to move eRapa toward becoming a platform therapy to alleviate a number of age-related diseases."

Dr. Liss, the principal investigator of the trial, said, "Early stage prostate cancer is a good target for eRapa because past research has shown that the compound has inhibited the growth of certain types of cancer cells. In this trial, men will be given eRapa in different doses to find the level that provides the biggest benefit with minimal side effects. The therapy has the potential to change how we manage men with early prostate cancer."

Dr. Ruben Mesa, director of UT Health San Antonio MD Anderson added, "This is a great example of the innovative clinical trials that are taking place here. Our cancer center has a long history of testing cancer breakthrough therapies in our world-renowned, early-phase cancer treatment program, the Institute for Drug Development. I am particularly excited about the potential of this new therapy to make an impact on early stage prostate cancer and possibly decrease the chance of recurrence."

RHI anticipates that the trial will conclude in mid 2019, leading the company closer to collaboration with the US FDA toward the expedited 505(b)(2) regulatory pathway. The company is also looking ahead to future clinical trials in potential indications that may expedite marketing authorization and commercialization of eRapa.

For information about participating in the study, please contact Allison Sherrill at (210) 567-1172.

About eRapaTM

Researchers at UT Health San Antonio discovered that an improved formulation of the well-known drug, Rapamycin, extended life span and health span in rodents by mitigating the effects of age-related diseases. Rapamycin Holdings, as the exclusive licensee of this technology, is capitalizing on this discovery by developing a novel proprietary and patented formulation for the treatment of serious unmet medical needs.

On September 18, 2018 BioClin Therapeutics, Inc., a privately-held clinical stage drug development company, reported the appointment of Scott Myers as Chief Executive Officer, and Julie Eastland as Chief Financial Officer and Chief Business Officer (Press release, BioClin Therapeutics, SEP 18, 2018, View Source [SID1234529480]). Mr. Myers will also continue in his role as company Chairman.

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"We are excited to announce the appointment of Scott Myers as Chief Executive Officer," said David Kabakoff, Ph.D., Director of BioClin Therapeutics and Executive Partner at Sofinnova Ventures. "Scott’s track record of leadership and shareholder value creation are an excellent fit for our company."

"We are also pleased to announce the appointment of Julie Eastland as our Chief Financial Officer and Chief Business Officer. Scott and Julie previously partnered to successfully transform Cascadian Therapeutics, leading to its acquisition by Seattle Genetics for $614M earlier this year."

"On behalf of the entire board, I would like to thank our founding CEO Stephen Lau, who is stepping down, for his exceptional contribution to the company from inception to its current Phase 2 clinical stage. We are grateful that he will continue to serve as an advisor to the company."

"I have been privileged to lead BioClin over the past 6 years and to have advanced the development of B-701, which is a potential best-in-class therapy for metastatic bladder cancer. I look forward to supporting Scott and team during the transition," said Stephen Lau, founder of BioClin Therapeutics.

"I’m delighted to welcome Julie Eastland to our management team as our Chief Financial Officer and Chief Business Officer," said Scott Myers. "Julie has a strong background in finance, business strategy and licensing, having previously worked at a number of publicly traded and private biotechnology companies. Her fundraising and business development experience will prove invaluable as we execute on our clinical development plans and enter the next phase of growth. Julie, I and the entire management team are focused on advancing vofatamab (B-701) into registration trials, keeping BioClin well-funded, and strengthening the company’s market profile."

Scott Myers was appointed Chairman of BioClin in June 2018. Mr. Myers most recently served as CEO, President and Director of Seattle based, Cascadian Therapeutics (NASDAQ: CASC), an oncology company that was acquired by Seattle Genetics (NASDAQ: SGEN) in March 2018. Prior to Cascadian, Mr. Myers was CEO of Aerocrine AB, a publicly-traded medical device company based in Stockholm, Sweden and Morrisville, NC, that was acquired by Circassia, PLC in 2015. Prior to Aerocrine, Mr. Myers held senior commercial operations, business development, general management and information management positions for UCB SA, a Belgium based biopharmaceutical company, and Johnson & Johnson.

Julie Eastland most recently served as Chief Financial Officer and Chief Business Officer of Cascadian Therapeutics, from September 2010 to May 2018, through the sale and transition of the company to Seattle Genetics. From 2006 to 2010, Ms. Eastland was the Chief Financial Officer and Vice President of Finance and Operations of VLST Corporation, a privately-held biotechnology company. Prior to VLST, Ms. Eastland held various financial and strategic management positions at publicly-traded biotechnology companies including Dendreon and Amgen.

On September 18, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $60.00 per share, for total gross proceeds of $180,000,000 (Press release, G1 Therapeutics, SEP 18, 2018, View Source [SID1234529789]). All of the shares in the offering will be sold by G1 Therapeutics. In addition, G1 Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock at the public offering price, less the underwriting discount. The offering is expected to close on September 21, 2018, subject to customary closing conditions.

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J.P. Morgan Securities LLC and Cowen and Company, LLC are serving as joint book-running managers for the offering. Needham & Company, LLC and Wedbush Securities Inc. are acting as lead managers for the offering. BTIG, LLC and H.C. Wainwright & Co., LLC are acting as co-managers for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 592-5973.

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 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 18, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy (Press release, Johnson & Johnson, SEP 18, 2018, View Source [SID1234529481]). Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.

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"Erdafitinib has demonstrated promising results in the treatment of metastatic urothelial cancer, a disease where patients unfortunately have limited treatment options today," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We look forward to working with the FDA in the agency’s review of the application as we believe erdafitinib will provide patients with an important therapeutic option."

The NDA submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations. The primary endpoint of this study was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1* criteria. The study results were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago (Abstract #4503) and were recognized as a "Best of ASCO (Free ASCO Whitepaper)" selection.

"The erdafitinib FDA submission is an important milestone as we work to bring a new treatment option to patients diagnosed with metastatic urothelial cancer," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. "Our organizational focus on areas of high unmet medical need underscores our commitment to advancing transformational science and developing solutions that may prolong and improve patient lives."

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well a cancer patient responds to treatment and is based on whether tumors shrink, stay the same, or get bigger.1

For information about Janssen’s pre-approval access program, visit View Source

About Urothelial Cancer

Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the U.S.2 In 2018, an estimated 81,190 new cases of bladder cancer will be diagnosed in the U.S. and an estimated 17,240 bladder cancer deaths will occur.2 The relative five-year survival rate for patients with Stage IV metastatic bladder cancer is currently five percent.3 Patients with metastatic urothelial cancer, who have FGFR genetic alterations, have poor prognoses and a high unmet need based on low response rates and may be resistant to treatment with immune-checkpoint inhibitors.4

About Erdafitinib

Erdafitinib is an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) inhibitor being studied in Phase 2 and Phase 3 clinical trials for the treatment of patients with locally advanced or metastatic urothelial cancer.5 FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.6 A companion diagnostic to identify patients with FGFR alterations is an integral part of the development program for erdafitinib. In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.