On January 25, 2022 SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, reported that it has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for SNIPR001 (Press release, SNIPR Biome, JAN 25, 2022, View Source [SID1234606793]). SNIPR001 is the company’s first development candidate targeting E. coli in patients with hematological malignancy at risk of neutropenia. This announcement comes only a few weeks after the FDA approved the Investigational New Drug (IND) Application paving the way initiating the first clinical trial in humans.

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"At SNIPR BIOME, we are extremely proud to have been granted Fast Track designation by the FDA. It underlines SNIPR001’s potential to be a game-changer for hematological cancer patients at increased risk of life-threatening bloodstream infections caused by E. coli" says Dr. Christian Grøndahl, Co-founder & CEO and continues, "E. coli was recently highlighted as one of the leading pathogens associated with anti-microbial-resistance (AMR) and death in a systematic review published by the scientific journal The Lancet, so there is an urgent need for new medicines targeting E. coli."

Fast Track is an FDA process designed to facilitate the development, and expedite the review, of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.

Dr. Milan Zdravkovic, Chief Medical Officer and Head of R&D at SNIPR Biome, adds: "With the FDA’s Fast Track designation, we have reached yet another milestone and we are very pleased, that the FDA shares our view on the need to target AMR. Now, all our attention is directed towards initiating our first clinical trial, which is expected in H1 2022."

SNIPR001 is being developed in collaboration with the non-profit organisation CARB-X. The aim is to target E. coli bacteria in the gut, and thereby prevent translocation of these bacteria from the gut into the bloodstream, while leaving the commensal bacteria in the patient’s microbiome unaffected.

This precision medicine approach is harnessing a novel application of SNIPR BIOME’s proprietary CRISPR/Cas technology, hereby potentially transforming the way E. coli infections are prevented and treated, especially in the cancer ward.

Today, there are no approved therapies for prophylactic therapy in this setting.  

On January 25, 2022 ViewRay, Inc. (NASDAQ: VRAY) reported that the Company will participate in the B. Riley Securities Oncology Conference. Scott Drake, President and Chief Executive Officer, and Zach Stassen, Chief Financial Officer, will participate in a fireside chat at 1:00 p.m. Eastern Time on Friday, January 28, 2022 (Press release, ViewRay, JAN 25, 2022, View Source [SID1234606792]).

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An audio webcast of the Company’s presentation will be available on the investor relations section of ViewRay’s website at View Source A replay of the webcast will be available for 7 days after the date of the presentation.

On January 25, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for Pidnarulex, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations (Press release, Senhwa Biosciences, JAN 25, 2022, View Source [SID1234606791]).

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"We are excited to receive Fast Track Designation and look forward to working closely with the US FDA to accelerate the development of Pidnarulex, aiming to bring a meaningful treatment to patients with breast and ovarian cancer whose tumors have BRCA1/2. PALB2, or other HRD mutations," said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences. FTD expedites the review of new drugs for serious conditions to fill an unmet medical need. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA.

Currently, Pidnarulex is tested in a Phase 1b Open-label, Multi-center Expansion Study (in both US and Canada) to determine a tolerable dose in patients with selected solid tumors (such as Breast Cancer, Ovarian Cancer, Pancreatic Cancer and Prostate Cancer) with BRCA2 and PALB2, and Ovarian Cancer with BRCA1 and other HR gene mutations. This dose will be used in future Phase II trials.

In a previous Phase 1 trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with BRCA1/2, and PALB2 mutations and that were also resistant to platinum and other chemotherapeutics. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, PARPi resistance is not uncommon in clinical use. According to an article published on Molecular Cancer in 2020, more than 40% of BRCA1/2 deficient patients fail to respond to PARPi alone.

Addressing treatment resistant tumors continues to be an unmet medical need in cancer treatment. Pidnarulex has proven human efficacy across certain tumor types by accelerating dsDNA breaks. By targeting the G-quadruplex DNA structure instead, Senhwa’s Pidnarulex has great potential as an alternative treatment for patients who have developed resistance to PAPRi or other chemotherapies.

About Pidnarulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported that it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606788]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may also be obtained, when available, by contacting 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 Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.

On January 25, 2022 Gilead Sciences Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms (Press release, Gilead Sciences, JAN 25, 2022, View Source [SID1234606787]). While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

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During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab."

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.

The studies impacted by this partial clinical hold include:

Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
Phase 1b study in MDS (NCT03248479)
Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts
The studies not impacted include:

Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
Phase 2 study in multiple myeloma (NCT04892446)
Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
Phase 2 study in solid tumors (NCT04827576)
Phase 2 study in triple-negative breast cancer (NCT04958785)
Phase 2 study in colorectal cancer, planned and not currently recruiting
About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don’t eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.

More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.