Decipher Test Clinically Validated as a Predictor of Overall Survival in Men with Prostate Cancer

On February 11, 2021 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, with a focus in urologic oncology specific to prostate and bladder cancers, reported publication of the results, in JAMA Oncology, from an analysis of the NRG Oncology Phase 3 randomized controlled trial RTOG 96-01 (Press release, Decipher Biosciences, FEB 11, 2021, View Source [SID1234574961]). In this study, the Decipher Prostate RP, a radical prostatectomy post-surgery test, was clinically validated to predict overall survival and is believed to be the first known genomic test in localized prostate cancer to accomplish this milestone. The study, which followed patients for a median of 12 years, validated the Decipher RP test as an independent predictor of distant metastases, prostate cancer-specific mortality, and overall survival.

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"This is very exciting, as the study validates Decipher Prostate as the first independent predictor of overall survival and shows how predicting metastatic risk with the Decipher test can be utilized to better guide treatment decisions in men with a prostate specific antigen (PSA) recurrence," said Tina S. Nova, PhD, president and chief executive officer of Decipher Biosciences. "We consider this a significant milestone in the development of evidence for Decipher Prostate."

Additionally, this study demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men having received greater absolute benefit from hormone therapy than Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality, and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

"Identifying which patients with recurrent disease are most likely to benefit from hormonal therapy will improve our ability to extend patient survival, while minimizing unnecessary toxicity for a large group of men with prostate cancer," said Felix Feng, MD, vice chair of radiation oncology at University of California, San Francisco. "Decipher Prostate RP improves upon clinical and pathological risk stratification methods and informs the use of hormonal therapy, making it a reasonable and recommended component of the prostate cancer standard of care."

About Decipher Prostate
Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Protalix BioTherapeutics Announces Pricing of its Upsized Public Offering of Common Stock

On February 11, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX, TASE: PLX) (the "Company"), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell–based protein expression system, reported the pricing of its previously announced underwritten public offering of 7,608,695 shares of its common stock at a public offering price of $4.60 per share (Press release, Protalix, FEB 11, 2021, View Source [SID1234574960]). The Company granted the underwriters in the offering a 30-day option to purchase up to an additional 1,141,304 shares of its common stock. The offering is subject to customary closing conditions and is expected to close on February 17, 2021.

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The Company estimates that the net proceeds from the offering, after deducting the underwriting discount but not other estimated offering expenses payable by the Company, will be approximately $32.9 million.

BofA Securities is acting as the book-running manager and Oppenheimer & Co. is acting as the co-manager for the offering. The Company expects to use the net proceeds from the offering to fund clinical trials for its product candidates, to fund its research and development activities and for working capital and general corporate purposes.

The offering is being made pursuant to an effective shelf registration statement. Before you invest, you should read the base prospectus in such shelf registration statement, the preliminary prospectus supplement and other documents the Company has filed with the U.S. Securities and Exchange Commission (the "SEC") for more information about the Company and the offering. The offering may be made only by means of a prospectus supplement and an accompanying prospectus, copies of which may be obtained by visiting EDGAR on the SEC’s website at View Source or by sending a request to the offices of BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte NC 28255-0001, Attention: Prospectus Department, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the 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.

Starpharma signs DEP® ADC Research Agreement with MSD

On February 11, 2021 Starpharma (ASX: SPL,OTCQX: SPHRY) reported that is has signed a Research Agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth NJ USA (Press release, Starpharma, FEB 11, 2021, View Source [SID1234574959]). Under the agreement, MSD will conduct a preclinical research evaluation of dendrimer based Antibody Drug Conjugates (ADCs) utilising Starpharma’s proprietary DEP technology .

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Dr Jackie Fairley, CEO of Starpharma commented: "MSD is a recognised leader in oncology, and we are delighted to have signed this new Research Agreement in such an innovative and valuable area."

DEP ADCs exploit the unique potential of Starpharma’s DEP technology to provide enhanced characteristics to ADCs including greater homogeneity, site specific attachment, and higher drug antibody ratio (DAR), than conventional ADC approaches. DEP ADCs are the subject of internal and partnered programs.

Starpharma has previously demonstrated the significant advantages conveyed by DEP ADCs in multiple preclinical studies, including its DEP HER-2 ADC, which showed significant tumour regression and 100% survival, outperforming Herceptin & Kadcyla in a human ovarian cancer model. Starpharma’s DEP technology has already yielded four clinical stage oncology products, including one under development by AstraZeneca.

ImmunoGen Announces Webcast of Presentation at Upcoming SVB Leerink 10th Annual Global Healthcare Conference

On February 11, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming SVB Leerink 10th Annual Global Healthcare Conference (Press release, ImmunoGen, FEB 11, 2021, View Source [SID1234574958]). The presentation is scheduled for February 25, 2021 at 3:40pm ET.

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A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year 2020 Financial Results

On February 11, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 25, 2021, following release of its fourth quarter and full year 2020 financial results (Press release, Puma Biotechnology, FEB 11, 2021, View Source [SID1234574957]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.