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.

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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]).

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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.

Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA

On June 30, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Company has initiated the submission of its Biologics License Application ("BLA") for omburtamab under the U.S. Food and Drug Administration’s ("FDA") Rolling Review process. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types (Press release, Y-mAbs Therapeutics, JUN 30, 2020, View Source [SID1234561600]). The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.

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The non-clinical portion and a part of the CMC portion of the rolling BLA were submitted during June 2020, and completion of the BLA submission is currently expected to take place over the next four to six weeks. The clinical submission will be based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present later this year.

"As the father of a long-term high-risk neuroblastoma survivor with CNS/Leptomeningel metastasis, I know how important this potentially is for families faced with brain metastasis from high-risk neuroblastoma and I am excited to see the initiation of Y-mAbs’ second BLA submission this year in neuroblastoma. We believe this is a key milestone for families facing CNS/leptomeningeal metastases from neuroblastoma and for Y-mAbs. We are very grateful to all clinical sites involved in developing omburtamab, and especially to our employees in the development team." stated Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We look forward to working with the Agency to bring omburtamab to appropriate patients. We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastases from neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.

The EndBrainCancer Initiative Announces Partnership with GT Medical Technologies, Creators of GammaTile Therapy for Patients with Brain Tumors

On June 30, 2020 The EndBrainCancer Initiative (EBCI) reported that GT Medical Technologies, manufacturers of GammaTile Therapy for Brain Cancer Patients, has joined EBCI’s roster of corporate partners (Press release, The End Brain Cancer Initiative, JUN 30, 2020, View Source [SID1234561599]). According to the EndBrainCancer Initiative, GT Medical Technologies is dedicated to improving the lives of patients with brain tumors through a promising new intervention in the treatment of brain cancer, GammaTile Therapy. Part of EBCI’s business model is to partner with other companies that are also offering promising new treatment options to treat brain cancer including metastatic disease to the brain.

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GammaTile Therapy is an FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant and recurrent brain tumors including primary and metastatic tumors. The small, bioresorbable GammaTile:

Is placed directly and surgically at the tumor site after the tumor is surgically removed.
Provides immediate radiation treatment to remaining tumor cells before they can replicate while preserving healthy tissue.
Means no additional trips to the hospital or clinic for standard radiation therapy
Allows patients to receive radiation treatment while going about their daily lives.
According to the EndBrainCancer Initiative, the partnership with will result in:

Education, Awareness & Outreach about GammaTile Therapy to a National audience of patients with brain tumors, their caregivers, medical practitioners, industry, and the general public with a total annual reach of over 18,000,000.
Patients facing surgery and radiation who contact EBCI’s "Direct Connect" Patient Services Program and Referral Clinic being provided with information about GammaTile Therapy
IMMEDIATE ACCESS to brain tumor specialists and cancer centers across the country where GammaTile Therapy is offered for those patients who express interest (to get connected please fill out a Patient Advocacy & Inquiry Form or call 425.445.2215).
"We are proud to welcome GT Medical Technologies as an EBCI Corporate Partner," commented Dellann Elliott Mydland, EBCI President & CEO. "Representing a breakthrough in delivering radiation, GammaTile Therapy is a triple win for patients with brain cancer that it:

Has been shown to delay brain tumor recurrence, potentially extending survival
Minimizes side effects and eliminates all those trips to the hospital or clinic that standard radiation requires.
Allows patients and their caregivers to focus on healing, doing those things that are important to them as well as time to explore all of their treatment options, which also include Standard of Care (SOC), advanced treatments, clinical trials and the Optune device."
"We look forward to bringing on additional Corporate Partners who share EBCI’s commitment to improving the lives and extending survivorship for this patient population and who are ‘moving the dial’ through making available new options for treating this disease." To become a Corporate Partner, please contact Dellann Elliott Mydland directly at [email protected], 425-785-8489 or fill out our Partnership Inquiry Form.

Nordic Nanovector to Amend PARADIGME Trial Protocol to Expand Eligible Patient Population

On June 30, 2020 Nordic Nanovector ASA (OSE: NANO) reported that it will amend the trial protocol for its PARADIGME trial to broaden the inclusion criteria and expand the pool of eligible patients with the aim of increasing the present rate of enrolment (Press release, Nordic Nanovector, JUN 30, 2020, https://www.prnewswire.com/news-releases/nordic-nanovector-to-amend-paradigme-trial-protocol-to-expand-eligible-patient-population-301085578.html [SID1234561598]). This decision has been made based on the company’s reviewed discussions with the US Food and Drug Administration (FDA).

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PARADIGME is the company’s ongoing pivotal, global, randomised Phase 2b trial investigating Betalutin (177Lu-lilotomab satetraxetan) as a single administration in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL) patients. The trial aims to enrol 130 patients into two arms to compare different dosing regimens; 51 patients were enrolled as of 25th May 2020 – Q1 report.

One of the measures to improve the recruitment rate into PARADIGME is to allow for FL patients who have undergone stem cell transplant (SCT) to be included in the trial. In some countries, for example UK, Italy, Turkey, Israel and Spain, SCT is frequently used for treating R/R FL and patients who have had a SCT make up the majority of 3L FL patients. This and other ways to broaden the inclusion criteria will, when implemented, substantially expand the pool of patients eligible for recruitment into PARADIGME.

As soon as practicable, Nordic Nanovector will seek approvals for the protocol amendments from the regulators in each of the 25 countries in which PARADIGME is active. It is anticipated that it will take 2-3 months to gain approval for these protocol amendments in all countries. Until the amendments have been approved, the company will continue to enrol patients under the existing protocol.

A close collaboration with the company’s Clinical Research Organisation (CRO) will be prioritised to ensure smooth implementation of the new protocol and maximise enrolment once the new protocol is approved in each country.

The company expects that expanding the pool of eligible patients will significantly improve the present enrolment rate. During August, the company will provide updated timelines for PARADIGME based on more clarity on the impact of COVID-19 and after the completion of the interim analysis.

In the Phase 1/2 LYMRIT 37-01 study, a single administration of Betalutin demonstrated encouraging anti-tumour activity, with a 65%, overall response rate (ORR) and 28% complete responses (CR) in the subset of FL patients (n=57). The median duration of response (mDoR) was over one year (13.6 months) for all responders and nearly three years (32.0 months) for complete responders.

The LYMRIT 37-01 study also showed that Betalutin was safe and well tolerated in these fragile patients with advanced stage disease, who have few remaining options available.

Jean Pierre Bizzari, MD, Chair of Nordic Nanovector’s Clinical Committee, said: "We are extremely encouraged by the preliminary data we are seeing both in terms of efficacy and safety profile. This novel ‘one-time` treatment in this underserved resistant/refractory patient population is especially important in these frail elderly patients for whom other treatment options are too toxic. We are confident that the protocol amendments the company is implementing to expand the eligible pool of FL patients will significantly increase the rate of enrolment into PARADIGME."

Dominic Smethurst, MD, interim Chief Medical Officer, commented: "We are very happy that we can now start to implement these important protocol amendments to PARADIGME. As soon as the amendments are made, we will implement a plan with our CRO to gain approval in all currently active countries as soon as possible. We intend to provide an updated timeline for PARADIGME once we have more clarity on the impact of the easing of the COVID-19 restrictions and the completion of the interim analysis."

"We are also very pleased to have received Fast Track designation for Betalutin in marginal zone lymphoma (MZL), another form of non-Hodgkin’s lymphoma for which new treatments are urgently needed and against which Betalutin has already demonstrated encouraging data. We are evaluating this new opportunity within the context of PARADIGME and will provide an update when we have made a decision on our development plans in this indication."