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Sprint Bioscience partner Petra Pharma har överlåtit PIP4K2-projektet till nybildade Ravenna Pharmaceuticals

On July 1, 2020 Sprint Bioscience AB (publ) reported that Petra Pharma, in accordance with the opportunities provided by the parties’ licensing agreements, has transferred the licensing agreement and the resulting collaboration project PIP4K2 to the newly formed company Ravenna Pharmaceuticals, Inc (Press release, Sprint Bioscience, JUL 1, 2020, View Source [SID1234561609]). Ravenna Pharmaceuticals thus assumes responsibility for the continued development and financial commitments to Sprint Bioscience. The project aims to develop a new type of drug for leukemia.

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Sprint Bioscience is eligible for up to $ 240 million in interim payments plus royalties on the sale of potential drugs generated within the scope of the project. To date, USD 5 million has been received. A drug candidate has been nominated and the next interim payment occurs when the first patient is dosed in a clinical trial.

"The transfer of the PIP4K2 project to Ravenna Pharmaceuticals does not affect Sprint Bioscience’s rights to future interim and royalty payments, and the newly started company has the same obligations as Petra Pharma to drive the project forward. We look forward to following the continued development of this urgent project, which is based on a whole new approach to the treatment of leukemia, "says Sprint Bioscience CEO Jessica Martinsson.

Ravenna Pharmaceuticals was founded by the same ownership group that was involved in Petra Pharma, including global pharmaceutical companies such as Eli Lilly, AbbVie, Johnson & Johnson and Pfizer.

Merck to Hold Second-Quarter 2020 Sales and Earnings Conference Call on July 31

On July 1, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its second-quarter 2020 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Friday, July 31 (Press release, Merck & Co, JUL 1, 2020, View Source [SID1234561608]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Members of the media are invited to monitor the call by dialing (833) 353-0277 or toll free (469) 886-1947 and using ID code number 2753878. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

ISA Pharmaceuticals receives US Orphan-Drug Designation for ISA101b in HPV16-positive Cervical Cancer

On July 1, 2020 ISA Pharmaceuticals B.V., reported that it received Orphan Drug Designation from the Food and Drug Administration (FDA) in the USA for its lead product ISA101b for treatment of Human Papilloma Virus type 16 (HPV16)-positive cervical cancer (Press release, ISA Pharmaceuticals, JUL 1, 2020, View Source [SID1234561604]).

According to the latest statistics of the Centers for Disease Control and Prevention, HPV causes more than 34,000 cases of cancer in the United States each year. Cervical cancer is the most common HPV-associated cancer in women, with HPV16 being responsible for approximately 50% of cases. HPV16-positive cervical cancer is the number 2 cause of cancer for women in the age 15-44 in the US. At 1% annually, rates of cervical cancer have been dropping only marginally due to prevention through screening and prophylactic vaccination. There is an important medical need for disease modifying therapies to treat women with this terrible disease. For 2020, SEER databases project 13,800 new cases and 4,290 women dying from cervical cancer in the US.

ISA101b is a clinical-stage immunotherapy targeting HPV16-induced diseases such as cervical and oropharyngeal cancer. It induces specific immune responses to the oncogenic E6 and E7 proteins of HPV16 and is based on ISA’s proprietary Synthetic Long Peptide (SLP) technology.

"We are pleased to have Orphan Drug Designation for our ISA101b program targeting HPV16-positive cervical cancers," said Kees Melief, Chief Scientific Officer of ISA Pharmaceuticals. "Our mission is to unleash the power of the patient’s own immune system to eradicate their cancer while maintaining optimal quality of life. We believe the best and most logical way to do this is through the use of SLPs. The metastatic form of cervical cancer has a particularly high unmet medical need with 5 year survival rates not going beyond 17%. The Orphan Drug Designation for ISA101b recognizes the urgent need for more efficacious treatment options for patients suffering from metastatic HPV16-positive cervical cancer."

About Orphan Drug Designation (ODD)

Orphan drugs are intended for the treatment, diagnosis or prevention of serious diseases that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. FDA evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. FDA provides incentives for sponsors to develop products for rare diseases, including development program tax benefits and a waiver of the NDA application user fee, as well as market exclusivity for up to seven years in the US once the product has been approved, provided that the product is first to market.

CRISPR Therapeutics Announces Pricing of Public Offering of Common Shares

On June 30, 2020 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported the pricing of an underwritten public offering of 6,428,572 common shares at a public offering price of $70.00 per share (Press release, CRISPR Therapeutics, JUN 30, 2020, View Source [SID1234561639]). In addition, the underwriters have a 30-day option to purchase up to an additional 964,285 common shares at the public offering price less the underwriting discount. CRISPR Therapeutics anticipates its gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, to be approximately $450.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about July 6, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the offering. Canaccord Genuity, William Blair, SunTrust Robinson Humphrey and Roth Capital Partners are acting as co-managers for the offering.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. 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.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on June 29, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

SBP Receives FDA Fast Track Designation for SBP-101

On June 30, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported receipt of Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead product, SBP-101, being developed for firstline treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) when administered in combination with gemcitabine and nab-paclitaxel (Press release, Sun BioPharma, JUN 30, 2020, View Source [SID1234561621]).

One of FDA’s Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs. Programs with Fast Track Designation may benefit from more frequent meetings with and written communications from FDA, in addition to being eligible for accelerated approval and priority review if certain criteria are met. Fast Track Designation also provides eligibility for a rolling review of a New Drug Application (NDA), which allows for completed sections of an NDA to be submitted for FDA review. Usually NDA review does not begin until the company has submitted the entire application to the FDA.

"Fast Track Designation is important for Sun BioPharma because it enhances our ability to develop SBP-101 as efficiently as possible," said Suzanne Gagnon, M.D., Chief Medical Officer of Sun BioPharma. Michael T. Cullen, M.D., MBA, Co-Founder, Executive Chairman, and CEO, added "There is an urgent need for new therapeutic options for patients with pancreatic cancer, and we look forward to working closely with FDA as we continue to advance our development program of SBP-101 for patients with metastatic PDA."

SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. For more information please visit clinicaltrials.gov.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to be a first-in-class product to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.