On April 22, 2019 Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, reported that two year clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting being held April 28-May 2, 2019, in Vancouver, British Columbia (Press release, Aura Biosciences, APR 22, 2019, View Source [SID1234535318]).

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Poster presentation details are as follows:

Title: Two Year Results of a Phase 1/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma
Poster Number: B0197
Poster Presenter: Tara McCannel, M.D., Ph.D, Director of the Ophthalmic Oncology Center, Jules Stein Eye Institute, UCLA School of Medicine
Session: Clinical Melanoma – Therapy and Complications
Date and time: Sunday, April 28, 2019; 1:00-2:45pm PT
Location: Vancouver Convention Centre, Western Exhibition Hall

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

On April 22, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that the first patient has been dosed in a Phase 2a triple negative breast cancer (TNBC) clinical trial with AVID100, a novel, tumor-specific anti-epidermal growth factor receptor (EGFR) antibody-drug conjugate (ADC) (Press release, Forbius, APR 22, 2019, View Source [SID1234535319]).

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Approximately 20% of patients with TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for EGFR-overexpressing TNBC.

The multicenter, dose-expansion, Phase 2a trial (AVID100-01; NCT03094169) will evaluate the efficacy, safety, and tolerability of AVID100 in patients with advanced, EGFR-overexpressing, TNBC (IHC 2+/3+). This is the third cohort launched and follows the previously announced cohorts evaluating AVID100 in patients with advanced squamous non-small cell lung cancer (sqNSCLC) and squamous cell carcinoma of the head and neck (SCCHN). In total, approximately 100 patients will be evaluated across three EGFR-overexpressing tumor types: sqNSCLC, SCCHN, and TNBC.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

A recommended Phase 2 dose (RP2D) of 220 mg/m2 (~6mg/kg) was established for AVID100 in a completed Phase 1 study. This RP2D is expected to be in the therapeutically active range based on preclinical efficacy studies. The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.

AVID100-01 (NCT03094169) is an open label, multicenter, dose-expansion study to evaluate the efficacy, safety, and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+), and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).

On April 22, 2019 Turning Point Therapeutics, Inc. (Nasdaq:TPTX), a clinical-stage precision oncology company designing and developing novel drugs to address treatment resistance, reported the closing of its initial public offering of 10,637,500 shares of its common stock, which includes 1,387,500 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $18.00 per share (Press release, Turning Point Therapeutics, APR 22, 2019, View Source [SID1234535339]). The gross proceeds to Turning Point Therapeutics from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $191.5 million.

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Goldman Sachs & Co. LLC and SVB Leerink acted as joint book-running managers for the offering. Wells Fargo Securities also served as a joint book-running manager. Canaccord Genuity acted as lead manager.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: 1-866-471-2526 or via email: [email protected];
SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132 or by email at [email protected]; or
Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, or by telephone at 1-800-326-5897, or by email at [email protected].
Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on April 16, 2019. 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 April 22, 2019 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq:EGRX) reported that the Centers for Medicare & Medicaid Services (CMS) has established a unique, product-specific billing code, or J-code (J9036), for BELRAPZO (bendamustine 500mL hydrochloride injection) (Press release, Eagle Pharmaceuticals, APR 22, 2019, View Source [SID1234535325]). The J-code will become effective on July 1, 2019. Eagle’s bendamustine 500mL hydrochloride injectable will be sold as BELRAPZO beginning June 3, 2019.

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"We launched our 500mL bendamustine hydrochloride injection, to address the need in the market for our unique formulation at a lower price point. The new J-code provides reimbursement coding clarity to outpatient facilities and physicians that will administer BELRAPZO, facilitating access for patients, and Medicare, Medicaid and commercial insurance reimbursement," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

About BELRAPZO

Indications

BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL). Efficacy relative to first-line therapies other than chlorambucil has not been established.

BELRAPZO is indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Important Safety Information

Contraindication: BELRAPZO is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions.

Myelosuppression: Delay or reduce dose. Restart treatment based on ANC and platelet count recovery. Complications of myelosuppression may lead to death.

Infections: Monitor for fever and other signs of infection or reactivation of infections and treat promptly.

Anaphylaxis and Infusion Reactions: Severe anaphylactic reactions have occurred. Monitor clinically and discontinue bendamustine hydrochloride. Pre-medicate in subsequent cycles for milder reactions.

Tumor Lysis Syndrome: Acute renal failure and death; anticipate and use supportive measures.

Skin Reactions: Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported.

Hepatotoxicity: Monitor liver chemistry tests prior to and during treatment.

Other Malignancies: Pre-malignant and malignant diseases have been reported.

Extravasation Injury: Assure good venous access and monitor infusion site during and after administration.

Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving bendamustine hydrochloride.

Most Common Adverse Reactions:

Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

On February 21, 2019 Geneos Therapeutics reported that it has closed its Series A round raising $10.5 Million in financing (Press release, Geneos Therapeutics, FEB 21, 2019, View Source [SID1234535369]). This funding will launch its operations as a standalone entity to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos, created as a spinout of Inovio Pharmaceuticals, Inc. (NASDAQ: INO) will leverage a proven immunotherapy platform ("Geneos Platform") under an exclusive license from Inovio in the field of personalized treatments for cancer. The Series A Financing, which includes a committed initial investment and a milestone driven option, is led by Santé Ventures and joined by Inovio.

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Cancer neoantigens – the mutations and genomic changes that accumulate as tumors develop – have been recognized as important targets in the development of immune mediated treatments for cancer. These are recognized by the immune system as being foreign and generate immune responses directed at the cancer. The Geneos Platform allows the company to develop exquisitely personalized therapies tailored to each patient’s own tumor mutations. The Geneos Platform is poised to deliver the following key advantages: ability to drive potent and broad T cell immune responses, capability to target an unprecedented number of neoantigens in a single formulation, and a rapid manufacturing turnaround time. Geneos, along with its collaborators at The Wistar Institute, recently published preclinical, proof-of-concept animal model data in the prestigious journal, Cancer Immunology Research, demonstrating the advantages of the Geneos Platform.

Dr. Niranjan Y. Sardesai, Chief Operating Officer of Inovio Pharmaceuticals, co-founded Geneos and has served as the company’s Chief Executive Officer. "Geneos holds the potential to become the leader in the development of personalized cancer immunotherapies to provide patients the chance for a cure" said Dr. Sardesai. "My confidence in this start-up, based on industry leading technology, rests on the fact that Geneos can create neoantigen-targeting immunotherapies against any cancer. Our immunotherapies can activate – in vivo – strong T cell responses (both CD4+ and CD8+). In addition, Geneos cancer fighting treatments can be designed in days instead of months or years. This funding will allow us to demonstrate clinical proof-of-concept for treating cancer at an individual patient level. I invite you to learn more about Geneos by visiting www.geneostx.com." Concurrently with the Series A financing, Dr. Sardesai resigned as Inovio COO and will dedicate all his efforts as Geneos’ CEO.

The Series A financing will enable the company to establish its operations and complete IND enabling activities towards the initiation of first-in-human clinical trials. As part of the new financing, Geneos will no longer be a wholly-owned subsidiary of Inovio Pharmaceuticals.

Geneos’ leaders begin operations with a track record of success in building immunotherapy-based companies. Backed by an extensive portfolio of globally issued or filed patents and regulatory experience in Phase I-III clinical development, Geneos takes an exclusive license of Inovio’s DNA-based immunotherapy platform for personalized cancer immunotherapy; while Inovio will continue to develop and commercialize population based (non-personalized) cancer immunotherapies and infectious disease vaccines based on its proprietary SynCon design. To date, the platform technology has demonstrated in multiple clinical trials, animal models, and peer-reviewed publications the ability to elicit a potent and tumor-specific immune response to fight cancer.

Dr. J. Joseph Kim, CEO, Inovio Pharmaceuticals, said, "Establishing Geneos with a patient-specific direction allows Inovio to focus on executing our strategies to develop and commercialize DNA-based vaccines and immunotherapies to attack the major cancer types and challenging infectious diseases affecting global populations. Geneos will build on Inovio’s technology offering patient-specific, tumor-targeted immunotherapies to the world, one patient at a time."

Dr. Sam Broder (former Director of the National Cancer Institute), joins Geneos’ founding Board of Directors alongside Dr. Sardesai, Dr. Kim, Dr. Casey Cunningham (CSO, Santé Ventures) and Dr. James Eadie (Partner, Santé Ventures). Leading the Series A investment, Dr. Eadie said, "We are pleased to be in at the start of Geneos as a standalone company. Neoantigens are increasingly recognized as an important area for therapeutic development and the Geneos platform addresses many of the current limitations to this approach. Niranjan and his team bring a wealth of experience in this area and we look forward to working with them as they build upon Inovio’s great work."

In addition to Dr. Broder, Geneos is advised by a world-leading group of inter-disciplinary experts spanning oncology basic research, clinical development, and commercialization who believe in the potential of the Geneos Platform to impact personalized cancer treatment. Joining the company on its Advisory Board are:

Dr. David B. Weiner, W. W. Smith Endowed Chair in Cancer Research, The Wistar Institute. Dr. Weiner will serve as the Chair of the company’s Advisory Board.
Dr. Chi Van Dang, Scientific Director, Ludwig Institute for Cancer Research and Professor, The Wistar Institute; and
Ms. Shawn Tomasello, former Chief Commercial Officer of Kite Pharmaceuticals and Pharmacyclics; and former President of the Americas, Hematology and Oncology, for Celgene