Cullgen Announces Publication of Small Molecule BRAF Protein Degraders in Journal of Medicinal Chemistry

On April 7, 2020 Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, reported that the company’s internal program to develop selective degraders that target key BRAF mutant proteins has been accepted for publication by the Journal of Medicinal Chemistry (Press release, Cullgen, APR 7, 2020, View Source [SID1234556181]). BRAF protein, which is necessary for normal cell signaling and cell growth function, is also one of the most frequently mutated genes in human cancers, including melanoma, colorectal, and thyroid cancers. The first-in-class degraders developed by Cullgen efficiently degrade mutated, disease causing forms of the BRAF protein and subsequently inhibit cancer cell growth.

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According to the National Cancer Institute, over 96,000 new cases of melanoma were reported in the USA in 2019. Colorectal cancer is the fourth most common type of cancer diagnosed each year in the USA, with over 145,000 new cases and 51,000 deaths reported in 2019. Patients with BRAF-driven mutations of these cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.

"This seminal publication exemplifies the strength of our uSMITE technology to identify and develop novel and highly selective degraders for the treatment of important and debilitating diseases such as cancer," stated Dr. Ying Luo, Chairman and President of Cullgen. "In addition to our multiple oncology degrader programs which are advancing smoothly through pre-clinical studies, we have also utilized our uSMITE platform to discover novel E3 ligands which we will use to develop completely new classes of targeted protein degraders."

Journal of Medicinal Chemistry is a peer-reviewed science and medical journal published by a division of the American Chemical Society (ACS). The journal publishes innovative studies that contribute to an understanding of the relationship between molecular structure and biological activity or mode of action.

Blaze Bioscience Announces FDA Has Granted Fast Track Designation to BLZ-100 (tozuleristide) for Pediatric Central Nervous System Tumors

On April 7, 2020 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients through development and commercialization of products for fluorescence guided surgery, reported that its clinical program evaluating tozuleristide (BLZ-100) for pediatric brain tumors, has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) (Press release, Blaze Bioscience, APR 7, 2020, View Source [SID1234556180]).

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BLZ-100 (tozuleristide) is a tumor-targeting optical imaging agent, designed to provide real-time, high-resolution visualization of cancer cells during surgery, potentially enabling more effective removal of cancerous tissue while sparing healthy tissue. Greater precision in surgery can be curative or improve downstream treatment options for people with cancer. BLZ-100 and the high-sensitivity Canvas Imaging System are currently being tested in a Phase 2/3 clinical trial enrolling patients from age 0-30 undergoing surgery for pediatric central nervous system tumors.

Fast track is a designation granted by the FDA that is intended to facilitate and expedite development and review of new drugs to address an unmet medical need in the treatment of a serious life threatening condition and for which nonclinical or clinical data has demonstrated the potential to address this unmet medical need. Developers of drugs that receive Fast Track designation benefit from access to FDA expertise, and Fast Track drugs that meet FDA criteria are eligible for priority review and accelerated approval. The designation allows for expedited regulatory review of clinical data, with the goal to speed promising therapies to market.

"Receiving Fast Track designation is an important recognition of the importance of our pediatric brain cancer surgery program and the promise of tozuleristide in this patient population," said Dr. Dennis Miller, Blaze Bioscience Executive Vice President of Development. "Pediatric brain tumors remain the leading cause of cancer-related death among children and adolescents. We look forward to our continued collaborative relationship with FDA as we work to complete the clinical and other product development work needed to speed the product to approval."

About BLZ-100 (tozuleristide)

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of a targeting peptide and a fluorescent dye, which emits light in the near-infrared (NIR) range. Tumor Paint products are designed to provide real-time, high-resolution intraoperative visualization of cancer cells throughout surgery, potentially enabling more precise, complete resection of cancer while sparing normal adjacent tissue. BLZ-100 has been tested in four Phase 1 clinical trials and has demonstrated clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. BLZ-100, an investigational agent, is being evaluated in a pivotal Phase 2/3 clinical study in pediatric central nervous system tumors (NCT03579602). More details about ongoing trials are available at www.clinicaltrials.gov.

About the Canvas Imaging System

The Canvas Imaging System is an investigational medical device designed to provide high-sensitivity detection of NIR light in the operating room under ambient light conditions. The Canvas Imaging System was developed and is manufactured by Teal Light Surgical, Inc. (a wholly owned subsidiary of Blaze Bioscience, Inc.). The first Canvas Imaging System under development is adapted for use with surgical microscopes and detects both BLZ-100 and indocyanine green (ICG).

Gilead Completes Acquisition of Forty Seven, Inc.

On April 7, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported the completion of the previously announced transaction for Toro Merger Sub, Inc., a wholly owned subsidiary of Gilead ("Purchaser"), to acquire Forty Seven, Inc. (Nasdaq: FTSV) for $95.50 per share, net to the seller in cash, without interest, or approximately $4.9 billion in the aggregate (Press release, Gilead Sciences, APR 7, 2020, View Source [SID1234556179]).

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On March 2, 2020, Gilead and Forty Seven announced that Forty Seven, Gilead and Purchaser had signed a definitive merger agreement pursuant to which a tender offer would be made. Pursuant to the merger agreement, Gilead and Purchaser commenced a tender offer on March 10, 2020, to acquire all outstanding shares of Forty Seven at a price of $95.50 per share, net to the seller in cash, without interest. On April 7, 2020, Gilead successfully completed the tender offer for all outstanding shares of common stock of Forty Seven and accepted for payment all shares validly tendered and not withdrawn as of the expiration time of the tender offer, and Gilead will promptly pay for such shares, which shares represented approximately 93.48% of Forty Seven’s outstanding shares (including 2,133,813 shares delivered through Notices of Guaranteed Delivery, representing approximately 4.42% of the shares outstanding). Pursuant to the terms of the merger agreement, Purchaser merged with and into Forty Seven on April 7, 2020. All outstanding shares of common stock of Forty Seven, other than (i) shares owned by Gilead, Purchaser or any of their direct or indirect wholly owned subsidiaries, (ii) shares owned by Forty Seven (or held in Forty Seven’s treasury) and (iii) shares held by Forty Seven stockholders who properly demand appraisal for their shares under Delaware law, were cancelled and converted into the right to receive cash equal to the $95.50 price per share.

As a result of the completion of the merger, Forty Seven has become a wholly owned subsidiary of Gilead and the common stock of Forty Seven will no longer be listed for trading on the Nasdaq Global Select Market, which is expected to take effect as of the close of market on April 7, 2020.

"We will now work together to accelerate the progress of magrolimab and advance Gilead’s work in immuno-oncology," said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. "I am delighted to welcome the Forty Seven team, whose unique expertise will be of great value as we grow our clinical pipeline and work to help more patients with some of the toughest forms of cancer."

Citi and J.P. Morgan acted as joint financial advisors to Gilead. Centerview Partners LLC acted as the exclusive financial advisor to Forty Seven. Skadden, Arps, Slate, Meagher & Flom LLP acted as legal counsel to Gilead and Cooley LLP acted as legal counsel to Forty Seven.

Selecta Biosciences to Present at the 19th Annual Needham Virtual Healthcare Conference

On April 7, 2020 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform, ImmTOR, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will present at the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14 at 10:40 a.m. Eastern Time (Press release, Selecta Biosciences, APR 7, 2020, View Source [SID1234556177]). A live webcast and a copy of the presentation will be available on the Investors & Media section of the Selecta website at www.selectabio.com.

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Curis to Present at 19th Annual Needham Virtual Healthcare Conference

On April 7, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer of Curis, will present at the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2020 at 12:00 p.m. ET (Press release, Curis, APR 7, 2020, View Source [SID1234556176]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for 90 days following the event.