On December 8, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported positive preliminary data from its ongoing open-label, single arm Phase 1 dose escalation study of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) (Press release, Curis, DEC 8, 2020, View Source [SID1234572401]). IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, and these pathways are frequently dysregulated in patients with AML and MDS. Third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with AML and MDS. A variety of drivers are believed to cause this, including specific spliceosome mutations.

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"We are highly encouraged by the breadth of clinical activity with CA-4948 seen with this early data, especially as this study is both monotherapy and in a late line, relapsed/refractory population. Historically, monotherapy studies in AML and MDS have proven underwhelming; monotherapy studies in a relapsed/refractory setting have been especially challenging," said James Dentzer, President and Chief Executive Officer of Curis. "We also have been pleased by the pace at which our trial partners have been able to enroll patients. We look forward to continuing to advance CA-4948 and reporting additional Phase 1 data in the second half of 2021."

"As a clinician intimately familiar with the treatment challenges faced by patients with AML or high-risk MDS, I am very encouraged by the early data coming out of this study," said Dr. Guillermo Garcia-Manero, Chief of the Section of Myelodysplastic Syndromes within the Department of Leukemia at The University of Texas MD Anderson Cancer Center. "While there have been important advancements in the development of new therapeutics for patients with previously untreated AML or MDS in recent years, relapsed and refractory patients are still in need of better treatment options. These preliminary data suggest, for the first time in a clinical setting, that successfully targeting the long isoform of IRAK4, which we know to be preferentially expressed in over half of AML and MDS patients, could be the first major breakthrough in over a decade for patients with these diseases."

The reported preliminary data are from Curis’s ongoing open-label, single arm Phase 1 dose escalation 3+3 study of orally administered CA-4948 monotherapy in adult patients with AML or high-risk MDS. A minimum of 3 patients will be enrolled in each cohort of the two-part study, starting with 200 mg BID, which was demonstrated to be well-tolerated, capable of achieving relevant levels of drug exposure and has demonstrated signs of biologic activity in Curis’s ongoing Phase 1 study of CA-4948 for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma. The primary objective of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for CA-4948 based on safety and tolerability, dose-limiting toxicities (DLT), and any biologic activity, pharmacokinetic and pharmacodynamic findings from the study trial population. Additional objectives include characterization of CA-4948’s pharmacokinetic parameters, and biomarker correlations. As of November 23, 2020, 4 AML patients and 3 high-risk MDS patients had been enrolled in the first 2 study cohorts and no DLTs had been observed. The data being reported from this ongoing trial are preliminary and subject to change.

Key findings include:

Marrow blast reductions observed in all evaluable patients (6 patients).
6 of 7 patients enrolled remain on study.
Patients enrolled experienced a median of 3 prior lines of treatment (range 1-4).
Two patients experienced a marrow complete response, one with blast count going from 23% pretreatment to 1% on treatment, and the other going from 11% pretreatment to 2% on treatment.
No DLTs observed in 7 DLT-evaluable patients in the 200 mg BID and 300 mg BID cohorts.
Enrollment has begun in the 400 mg BID cohort.
Webcast Event Information

Curis management will host a virtual KOL event today, December 8, 2020 at 8:00 am ET to discuss these results with Dr. Amit Verma, Professor of Medicine-Oncology at Albert Einstein College of Medicine, and Director of the MDS Program at Montefiore Medical Center located in Bronx, NY. To access the webcast, please visit the Events and Presentations section of the Curis website at View Source

On December 8, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has formally notified The Nasdaq Stock Market, Inc. of its intent to delist the Company’s common stock from the Nasdaq Global Select Market ("Nasdaq") (Press release, PDL BioPharma, DEC 8, 2020, View Source [SID1234572437]). PDL expects to file a Form 25 (Notification of Removal from Listing) with the Securities and Exchange Commission (the "SEC") and Nasdaq relating to the voluntary delisting of its common stock on or about December 28, 2020 and to suspend trading of its common stock on the Nasdaq Global Select Market prior to the opening of trading on December 31, 2020. PDL does not expect that a trading market will develop for its common stock following suspension of trading on Nasdaq. PDL intends to file a certificate of dissolution with the Delaware Secretary of State on or about January 4, 2021 and close its stock transfer books at the close of business on this date. The official delisting of PDL’s common stock will be effective on or about January 7, 2021 – 10 days after the filing of the Form 25.

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PDL also intends to file a Form 15 with the SEC as soon as practicable following the effectiveness of the delisting to indefinitely suspend its reporting obligations under the Securities Exchange Act of 1934, as amended. The suspension of PDL’s reporting obligations, including the obligation to file Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, will be effective upon filing the Form 15. PDL does however intend to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 in March 2021.

The voluntary delisting and deregistration are part of PDL’s previously announced voluntary Plan of Dissolution that was approved by the Board of Directors in February 2020 and at the Annual Meeting of the Company’s stockholders on August 19, 2020. The Company’s Board of Directors considered a number of factors in determining to delist and deregister PDL’s common stock, including the costs and expenses associated with being a publicly traded company, the auditing, legal and other costs associated with continuing to make SEC filings, and the burdens placed on Company management to comply with the continued listing and reporting requirements, all in light of the Company’s planned dissolution and liquidation.

On December 8, 2020 Paige, a global leader in AI-based digital diagnostics, reported it received a CE mark for Paige Breast, its breast cancer detection software that indicates suspicious areas for further review to pathologists evaluating breast biopsies (Press release, Paige AI, DEC 8, 2020, View Source [SID1234572453]). The company also received a CE mark for Paige Prostate Grading & Quantification, a digital diagnostic that offers slide level information for primary and secondary Gleason patterns and tumor size to inform treatment planning. With these CE marks, both products are now available for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK.

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"The CE mark in breast cancer represents an important regulatory validation for our computational pathology products as we broaden our applications in oncology, while the CE mark in prostate cancer adds valuable grading and quantification features for our existing CE marked Paige Prostate offering," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "We continue to rapidly advance new products that improve pathology workflow and improve diagnostic confidence for some of the most prevalent cancers including breast cancer. I am incredibly grateful to all the Paige team members and our physician colleagues worldwide who have helped advance this technology in order to ultimately optimize patient outcomes."

Paige Breast Enables Slide and Case Level Predictions on Breast Cancer Presence

For pathologists diagnosing breast cancer – the most commonly diagnosed cancer among women in European countries1 – the potentially large volume of breast tissue slides to be reviewed can pose challenges for workload management and pathologist productivity. Paige Breast is designed to draw pathologists’ attention to concerning features on a breast tissue slide and provides slide and case level predictions about the presence of cancer. This functionality enables pathologists to more easily, efficiently and confidently identify small foci of cancer that can be easily missed.

"By reducing inter-observer variability, uncertainty, and time, this technology will enable pathologists to drive informed treatment more efficiently, helping to ensure patients receive the best care," said Matthew Hanna, M.D., Director of Digital Pathology Informatics at Memorial Sloan Kettering Cancer Center. "These technologies have the potential to increase physician productivity while minimizing burnout, particularly for diseases with high incidence, such as breast cancer, where hospitals may be faced with a large volume of patient cases."

Paige continues to enhance functionality for Paige Breast, including quantification and subtyping functionality, for future deployment.

Streamlining Prostate Cancer Diagnosis Through AI-based Grading and Quantification

Grading and quantification of prostate tissue are time consuming tasks that are often subjective with high inter-observer variability as part of the diagnosis process. With the addition of the new grading and quantification functionality, Paige Prostate can enhance diagnostic confidence for the pathologist while increasing consistency and standardization.

Paige Prostate Grading & Quantification provides slide level information for primary and secondary Gleason patterns, tumor length and tumor percentage. The product provides visual overlays that indicate the specific regions of the slide corresponding to each Gleason pattern, which can reduce the time it takes a pathologist to determine and measure a grade. Furthermore, Paige Prostate Grading & Quantification exhibits high concordance with sub-specialized pathologists which means the technology has the potential to decrease a pathologist’s need to defer cases for additional review without compromising diagnostic accuracy. This technology thereby streamlines workflows to decrease turnaround time for the patient and clinician.

On December 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share and, to certain investors, pre-funded warrants to purchase 2,040,816 shares of its common stock at a purchase price of $24.4999 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, DEC 8, 2020, View Source [SID1234572525]). The aggregate gross proceeds from the offering are expected to be approximately $175.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and Roth Capital Partners is acting as manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On December 8, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported the pricing of an underwritten public offering of 5,102,041 shares of its common stock at a price to the public of $24.50 per share and, to certain investors, pre-funded warrants to purchase 2,040,816 shares of its common stock at a purchase price of $24.4999 per pre-funded warrant share, which represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of each such pre-funded warrant share (Press release, Atara Biotherapeutics, DEC 8, 2020, View Source [SID1234574479]). The aggregate gross proceeds from the offering are expected to be approximately $175.0 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by Atara Biotherapeutics. The offering is expected to close on or about December 11, 2020, subject to customary closing conditions. In connection with the offering, Atara Biotherapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,071,428 shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Citigroup, Evercore ISI and Mizuho Securities are acting as joint book-running managers for the offering. Canaccord Genuity is acting as lead manager and Roth Capital Partners is acting as manager for the offering.

The securities described above are being offered by Atara Biotherapeutics pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Atara Biotherapeutics with the Securities and Exchange Commission (the "SEC") and that became automatically effective on February 27, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 800-831-9146; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected]; or Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, by telephone 212-205-7600, or by email: [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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.