On February 11, 2021 Cyteir Therapeutics, a leader in the discovery and development of next-generation synthetic lethal therapies for cancer, reported the close of an oversubscribed $80 million Series C financing (Press release, Cyteir Therapeutics, FEB 11, 2021, View Source [SID1234577663]). The company will use the new funds to advance its lead compound, the first-in-class inhibitor of RAD51-mediated DNA repair, CYT-0851, into phase 2 monotherapy trials in hematologic cancers and solid tumors, to initiate trials combining CYT-0851 with other cancer therapies, and to expand preclinical research to identify and advance additional novel cancer therapies.

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RA Capital Management led the round with Janus Henderson Investors, Acuta Capital Partners, Ally Bridge Group, Avidity Partners, Ample Plus Fund, and CaaS Capital Management, joined by existing investors Novo Holdings, Venrock, Lightstone Ventures, DROIA Ventures, Osage University Partners (OUP), and another undisclosed U.S.-based, healthcare-focused fund. Cyteir has now raised over $140 million in total to support its novel, synthetic lethal approach to cancer therapy.

"Our unique approach to inhibiting RAD51-mediated DNA repair allows us to potentially target hematologic cancers as well as solid tumors with reduced toxicity as compared to other DDR inhibitors," said Markus Renschler, M.D., Cyteir president and CEO. "This advantage and the speed at which we’ve advanced our lead program from discovery to the clinic has enabled us to secure interest and investment from multiple, high-tier healthcare investors. We’re grateful for their support, which will fund phase 2 studies of CYT-0851 monotherapy scheduled to begin later this year, as well as clinical studies beginning mid-year that will further explore its potential in combination with other cancer therapies."

CYT-0851 is an oral, once daily, first-in-class small-molecule inhibitor of RAD51-mediated DNA repair. Preclinical and early clinical findings support the broad potential for CYT-0851 to selectively target various cancers, including B-cell malignancies such as non-Hodgkin lymphoma, and solid tumors. The findings also suggest there is significant potential to combine CYT-0851 with other therapies that target or induce DNA damage, such as PARP inhibitors and chemotherapy. CYT-0851 is currently being evaluated in the dose-escalation portion of a Phase 1/2 monotherapy trial enrolling approximately 200 patients with solid tumors and hematologic malignancies at leading U.S. cancer centers. Cyteir expects to enter phase 2 later this year.

"We are intrigued by the potential of RAD-51 inhibition, particularly due to early findings suggesting it could be helpful in treating lymphomas and other hematologic malignancies," said Derek DiRocco, Ph.D., partner, RA Capital Management. "This promising mechanism, coupled with the demonstrated efficiency and expertise of Cyteir’s leadership team, inspired us to support the next stages of their exciting development program."

Cyteir is leveraging its expertise in DNA damage response (DDR) to create a pipeline of novel, first-in-class drugs that selectively target a key cancer vulnerability. Cancer cells are acutely reliant on DNA damage repair for their survival and growth; inhibiting key DNA-repair pathways causes them to become overwhelmed by their own damage and self-destruct, a validated scientific approach known as synthetic lethality. Cyteir is pursuing a novel application of synthetic lethality based on the discovery that many tumors rely on a specific DNA-repair pathway that is dependent on the protein RAD51 to repair breaks in DNA.

Beyond CYT-0851, Cyteir is actively identifying, prioritizing and evaluating DDR pathway targets based on their role in cancer and whether they have an identifiable patient population that could be predicted to benefit from targeted therapy. The company will use a portion of the Series C financing to initiate IND-enabling studies for CYT-1853, a second-generation RAD51 inhibitor. Cyteir also plans to initiate IND-enabling studies in 2023 for an undisclosed discovery compound targeted for the treatment of solid tumors.

Finally, Cyteir is developing a companion diagnostic assay to identify patients whose tumors overexpress certain cytidine deaminases, which may suggest that their cancer is more susceptible to CYT-0851. The company has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration to begin evaluating this companion diagnostic in patients.

On February 11, 2021 Q’Apel Medical, Inc., an innovative neurovascular company specializing in developing and commercializing novel access device technology for vascular interventions, reported it has raised $22 Million in Series C funding (Press release, Research Corporation Tech, FEB 11, 2021, View Source [SID1234576194]). The round included River Cities Capital, Soleus Capital, and incumbent investor Research Corporation Technologies (RCT). Scott Huennekens, former Chairman, CEO and President of Verb Surgical, and Carter McNabb, Managing Director, River Cities Capital, will join the Board of Directors.

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"With our three-pronged approach that involves increasing manufacturing, expanding into newer geographies, and developing innovative products, Q’Apel is perfectly poised to become the preferred catheter technology vendor across the healthcare sector. In addition, having Scott Huennekens and Carter McNabb join our Board of Directors will be extremely valuable. Both Scott and Carter bring extensive experience, especially in high-growth medical device companies, building businesses both in the U.S. and internationally." said King Nelson, CEO of Q’Apel Medical.

"Q’Apel’s technology has the ability to revolutionize vascular access and improve patient care. There is no better team to lead this effort; between strong existing physician relationships and a deep understanding of the neurovascular market, this team will execute effectively and efficiently," said Carter McNabb.

"I admire Q’Apel Medical for its highly innovative products and dynamic leadership team, and I’m honored to be joining their board. I have tremendous respect for King, Chris and the other board members, and I look forward to working with them," said Scott Huennekens

Q’Apel Medical products are already being utilized in over 130 hospital systems nationwide. In 2021, Q’Apel plans to significantly increase its manufacturing capacity, add additional head count and expand their product portfolio. At the same time, the company is in the process of acquiring CE certification, which will allow Q’Apel to expand into Europe later this year.

On February 11, 2021 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Corvus Pharmaceuticals, FEB 11, 2021, View Source [SID1234576180]). All of the shares to be sold in the offering will be offered by Corvus. In addition, Corvus expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in the offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Corvus currently expects to use the net proceeds from this offering to fund its Phase 3 clinical trial of CPI-006 and development of its other product candidates, with any remaining proceeds for working capital and general corporate purposes.

Cantor Fitzgerald & Co. and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

A shelf registration statement on Form S-3 relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 19, 2020. The offering of these securities is being made only by means of a prospectus forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on February 11, 2021 and is available on the SEC’s website at www.sec.gov. A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6TH Floor, New York, NY 10022 or by email at [email protected] or H.C. Wainwright & Co., LLC, 430 Park Avenue, 3RD Floor, New York, NY 10022, by telephone at (646) 975-6996 or by email at [email protected].

This press release shall not constitute an offer to sell or the 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 of these securities under the securities laws of any such state or jurisdiction.

On February 11, 2021, Applied Therapeutics, Inc. (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Cowen and Company, LLC and UBS Securities LLC as representatives (the "Representatives") of the several underwriters named therein (the "Underwriters"), relating to the issuance and sale pursuant to an underwritten public offering (the "Offering") of an aggregate of 3,000,000 shares (the "Shares") of its common stock, par value $0.0001 per share (the "Common Stock"), and up to 450,000 additional shares of Common Stock at the Underwriters’ option (Filing, 8-K, Applied Therapeutics, FEB 11, 2021, View Source [SID1234575200]). The Shares were sold at a public offering price of $23.00 per share, less underwriting discounts and commissions, as described in the prospectus supplement, dated February 11, 2021, filed with the Securities and Exchange Commission (the "Commission") on February 12, 2021. The offering of Common Stock closed on February 17, 2021.

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On February 11, 2021 Artios Pharma Limited ("Artios"), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, reported the start of a clinical trial of its small-molecule ATR inhibitor, ART0380, in patients with advanced or metastatic solid tumors (Press release, Artios Pharma, FEB 11, 2021, View Source [SID1234575054]). ART0380 was originally in-licensed from The University of Texas MD Anderson Cancer Center and ShangPharma Innovation in 2019. The molecule was jointly developed as part of a collaboration between ShangPharma and MD Anderson’s Therapeutics Discovery Division.

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The clinical trial of the ATR (Ataxia telangiectasia and Rad3-related kinase) inhibitor is an open-label, multi-center, Phase I/IIa study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART0380 as a monotherapy and in combination with gemcitabine in patients with advanced or metastatic solid cancers. The study will enroll up to 180 patients and will be conducted at multiple oncology centers across the USA, UK, and Europe. Full details can be found at www.clinicaltrials.gov under the identifier NCT04657068.

Niall Martin, Chief Executive Officer at Artios Pharma, said: "Our vision is to build on the success of PARP inhibition to enable more patients to benefit from DDR targeting medicines. By using insights gained from our longstanding experience in this field, we believe that our approach will address the challenges of resistance to targeted therapy, identify patients with sensitive cancers, and optimize the therapeutic index. We have done extensive preclinical work to characterise and differentiate our lead candidates and will have two programs, ART0380 and ART4215, a first in class Pol theta inhibitor, in the clinic by end of 2021. Following the recent strategic collaboration with Merck KGaA, Darmstadt, Germany, taking ART0380 into the clinic is another major milestone for Artios in the development of next generation DNA Damage Response treatments for hard-to-treat cancers."

Melissa Johnson, MD, Program Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, Principal Investigator for the trial, said: "We have a strong heritage in developing novel cancer therapies. We see DDR as an exciting and promising area of research and are excited to collaborate with Artios on this important clinical trial."

ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of ATR. ATR is an important signalling protein in the cellular DNA damage response to replication stress and DNA double-strand breaks that occur as cells multiply.

ART0380 is being developed as an oral anti-cancer agent for the treatment of patients with cancers harbouring defects in DNA repair and in combination with agents including established and novel agents that cause DNA damage and/or suppress a cancer’s ability to repair DNA damage.