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MacroGenics Announces Date of First Quarter 2020 Financial Results Conference Call

On April 28, 2020 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the first quarter 2020 after the market closes on Tuesday, May 5, 2020 (Press release, MacroGenics, APR 28, 2020, View Source [SID1234556696]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, May 5, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 2993147.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

Court Issues Favorable Patent Litigation Decision for Eagle Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. for
BENDEKA (bendamustine hydrochloride injection)

On April 28, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") and Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) ("Teva") reported that on April 27, 2020, the U.S. District Court for the District of Delaware (the "Court") has issued a patent decision in favor of Eagle and Teva for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCl), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride (Press release, Eagle Pharmaceuticals, APR 28, 2020, View Source [SID1234556695]).

The Court upheld the asserted patent claims as valid and found that the defendants’ proposed ANDA products would infringe those claims. Under this decision, the patent defendants – Slayback Pharma LLC, Apotex Inc. and Apotex Corp., Fresenius Kabi USA, LLC, and Mylan Laboratories Limited – will not be able to launch their ANDA products before 2031.

"We are delighted with the Court’s decision upholding our patents for BENDEKA, and further protecting the longevity of this important product," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals. "With this decision, BENDEKA’s value is likely to be intact for many years, thus ensuring our continued ability to invest in our growing research program and product pipeline," concluded Tariff.

Ultragenyx Announces Upcoming Data Presentations at American Society of Gene & Cell Therapy 2020 Virtual Annual Meeting

On April 28, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, reported that clinical, preclinical and manufacturing data from its investigational gene therapy programs will be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 23RD Annual Meeting, which will be held virtually May 12-15, 2020 (Press release, Ultragenyx Pharmaceutical, APR 28, 2020, View Source [SID1234556694]). Information will be available at www.asgct.org.

Nine Ultragenyx abstracts have been accepted for virtual presentation, including:

An oral presentation of available data from the confirmatory cohort of the Phase 1/2 study of DTX401, an AAV-based gene therapy for the treatment of glycogen storage disease Type Ia (GSDIa) (Abstract #1306)
An oral presentation of new data from the first three cohorts of the Phase 1/2 study of DTX301, an investigational adeno-associated virus (AAV) gene therapy for the treatment of ornithine transcarbamylase (OTC) deficiency (Abstract #505)
Multiple presentations, including two orals, highlighting the HeLa producer cell line platform and improvements in the HEK293 triple transfection system (Abstracts #539 and #543)
"We have made meaningful progress across all of our gene therapy programs, including continued improvements to both the HeLa PCL and HEK293 transient transfection manufacturing technology platforms which we believe will enable highly reproducible, more consistent and scalable gene therapy manufacturing," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "In addition to the presentations that support our gene therapy manufacturing approach, we look forward to sharing first-time results from the confirmatory cohort of our GSDIa study and updated clinical data from the OTC study."

Details of the nine presentations are as follows:

Tuesday, May 12
Oral Presentation
Abstract #98: AAV9/hCDKL5 delivery to cerebrospinal fluid of juvenile CDKL5-deficient mice improves learning and memory and motor function in adult mice

Time: 5:15-5:30 PM ET
Poster Presentation
Abstract #172: Characterization and correction of an in vitro model of Wilson Disease by recombinant adeno-associated virus (rAAV) delivered ATP7B transgene

Time: 5:30-6:30 PM ET
Poster Presentation
Abstract #451: Rapid CMC development and pre-commercial considerations for rAAV gene therapy products for rare diseases

Time: 5:30-6:30 PM ET
Wednesday, May 13
Oral Presentation
Abstract #539: HeLa 3.0: CRISPR knockout of genes modulating titer in established rAAV-producing cell lines

Time: 4:00-4:15 PM ET
Oral Presentation
Abstract #505: AAV8 gene therapy as a potential treatment in adults with late-onset OTC deficiency: results from a Phase 1/2 clinical trial

Time: 4:15-4:30 PM ET
Oral Presentation
Abstract #543: Characterization of phenotypic and genotypic stability of rAAV producing HeLa cell lines

Time: 4:45-5:00 PM ET
Poster Presentation
Abstract #586: Gene therapy for Wilson Disease using rAAV to restore ATP7B gene function

Time: 5:30-6:30 PM ET
Thursday, May 14
Poster Presentation
Abstract #1008: Elongation of the Rep-Cap cassette with a cellular intron reduces reverse-packaged Rep-Cap trans plasmid sequences and increases therapeutic vector genome packaging in a HEK293 triple transfection rAAV vector production system

Time: 5:30-6:30 PM ET
Friday, May 15
Oral Presentation
Abstract #1306: AAV8-mediated liver-directed gene therapy as a potential therapeutic option in adults with glycogen storage disease type Ia (GSDIa): results from a Phase 1/2 clinical trial

Time: 10:30-10:45 AM ET

Denovo Biopharma To Acquire Tocagen’s Entire Replicating Gene Therapy Platform and Related Assets

On April 28, 2020 Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, reported it is acquiring Tocagen’s retroviral replicating vector platform (RRV) in its entirety, including its investigational gene therapy and drug regimen for oncology: Toca 511 and Toca FC (now known as DB107), and several early-stage development programs, including programs targeting PD-L1 and other immunooncology targets (Press release, Denovo Biopharma, APR 28, 2020, View Source [SID1234556693]). This acquisition is pending the close of Tocagen’s anticipated merger with Forte Biosciences. These programs greatly expand Denovo’s product portfolio into gene therapy and immunooncology, yet remain consistent with Denovo’s precision medicine approach.

The lead acquired asset, DB107, is an innovative approach utilizing a proprietary gene therapy platform, RRV, combined with a prodrug, to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high grade glioma and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. Although the Phase 3 trial results were negative overall, there were subsets of patients who showed signs of beneficial activity of DB107. After the acquisition, Denovo will use its unique biomarker platform to search for pharmacogenomic predictor for DB107 efficacy.

"With this strategic acquisition, Denovo gains a pioneering gene therapy platform with unlimited potential. Together with Denovo’s world leading precision medicine capabilities, the RRV platform along with lead product candidate DB107 presents us with an unprecedented opportunity to effectively target a wide range of oncology indications," said Wen Luo, Ph.D., Denovo’s Chief Executive Officer. "DB107’s Phase 3 trial aimed to treat recurrent high grade glioma, which primarily consists of glioblastoma (GBM). This asset, together with our DB102 asset to be tested in the front-line treatment of GBM, positions Denovo as a leader in the field of neuro-oncology that continues to have a high unmet need."

"We are pleased to have a company with the capabilities of Denovo Biopharma acquiring our gene therapy platform technology to build upon the work that was done by our employees and investigators, as well as the patients in our clinical trials," said Marty J. Duvall, Tocagen’s Chief Executive Officer.

ORIC Pharmaceuticals Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On April 28, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the closing of its initial public offering of 8,625,000 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase 1,125,000 additional shares of its common stock, at a price to the public of $16.00 per share (Press release, ORIC Pharmaceuticals, APR 28, 2020, View Source [SID1234556692]). The gross proceeds from the offering were $138.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the shares were offered by ORIC. The shares began trading on The Nasdaq Global Select Market on April 24, 2020, under the symbol "ORIC."

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on April 23, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at (800) 831-9146; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected].

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