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BerGenBio to present NSCLC and AML clinical data from Phase II development programme with selective AXL inhibitor bemcentinib at ASCO 2019

On April 23, 2019 BerGenBio ASA (OSE: BGBIO) a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that the company and its collaborators will present new interim clinical and biomarker data from its extensive Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) at McCormick Place in Chicago, Illinois (31 May – 4 June 2019) (Press release, BerGenBio, APR 23, 2019, View Source [SID1234535320]).

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Abstract titles have been announced online at View Source and details of the presentations are below.

The posters presented at ASCO (Free ASCO Whitepaper) will be made available on www.bergenbio.com in the Investors / Presentations section at the time of presentation.

Sunday 2 June, 8:00 AM – 11:00 AM Central Daylight Time

A phase II study of bemcentinib (BGB324), a first-in-class highly selective AXL inhibitor, with pembrolizumab in pts with advanced NSCLC: OS for stage I and preliminary stage II efficacy.

Enriqueta Felip et al
Session: Lung Cancer – Non-Small Cell Metastatic
Location: Hall A, poster board #421, abstract 9098
Monday 3 June, 8:00 AM – 11:00 AM Central Daylight Time

First-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC or decitabine exerts anti-leukaemic activity in AML pts unfit for intensive chemotherapy: Phase II open-label study.

Dr Sonja Loges et al
Session: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A, poster board #418, abstract 7043

Elpiscience and Bio-Techne Announce Strategic Collaboration

On April 22, 2019 Elpiscience BioPharma and Bio-Techne Corporation reported that the companies have entered into a strategic collaboration for the development of anti-cancer therapeutics (Press release, Elpiscience, APR 22, 2019, View Source;id=1313 [SID1234536921]). Under the terms of the agreement, Elpiscience will have access to multiple antibodies from Bio-Techne’s antibody library for use in preclinical, clinical and commercial pharmaceutical development.

As a biotech company committed to leading the innovation and development of the next generation of cancer immunotherapy, Elpiscience, in collaboration with Bio-Techne, a global leader in life sciences and molecular diagnostics, will expand mutual capabilities in the field of cancer immunotherapy. This strategic collaboration also aims to accelerate the development of new biologics to address unmet medical needs in Oncology.

Dr. Darren Ji, CEO of Elpiscience, said: "We are very happy to enter into a strategic collaboration with Bio-Techne in therapeutic antibody research and development. This collaboration will leverage the strengths of both companies in the field of anti-cancer therapeutics and speed up the development of new cancer immunotherapies in order to bring more efficient treatment to cancer patients worldwide."

David Eansor, President of Bio-Techne’s Protein Sciences Segment commented "We are extremely excited to partner with Elpiscience in the development of novel cancer immunotherapies. It is our goal to increase our partnerships with therapeutics developers to unleash the potential of our vast library of high-quality antibodies towards the development of next generation immunotherapies."

Poseida Therapeutics Raises $142 Million in Series C Financing

On April 22, 2019 Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, reported closing of a Series C financing round, raising $142 million led by a $75 million equity investment from Novartis Pharma AG, and joined by several new investors including Aisling Capital Management, Pentwater Capital Management, Perceptive Advisors as well as additional undisclosed institutional investors (Press release, Poseida Therapeutics, APR 22, 2019, View Source [SID1234536252]). Current investors Malin Corporation plc., Longitude Capital, Vivo Capital and Boxer Capital, LLC also participated in the financing.

"We welcome the support and investment from Novartis, a leader in the cell and gene therapy field," said Eric Ostertag M.D., Ph.D., chief executive officer of Poseida. "They are joined by an impressive group of new investors whose commitment enables us to accelerate the pursuit of our bold vision to create gene therapy product candidates that could result in single-treatment cures for numerous oncologic indications and orphan genetic diseases, with an initial focus on chimeric antigen receptor T cell (CAR-T) therapies."

The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cell that is self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:

P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.

P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.

P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.

P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.

Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.

Turning Point Therapeutics Announces Closing Of Initial Public Offering And Full Exercise Of Underwriters’ Option To Purchase Additional Shares

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.

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.

CMS Establishes Unique J-Code for BELRAPZO™ (Bendamustine 500mL Hydrochloride Injection)

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.

"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.