On January 26, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, reported the completion of the chPD1 licensing agreement with Longwood University (Press release, Kiromic, JAN 26, 2021, View Source [SID1234574310]).

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PD-1 has always been a challenge for CAR-T development.
PD-1 is the brakes of the immune system, inhibiting immune cells from killing tumor cells. Traditional PD-1 inhibitors block the PD-1 receptor, "removing the brakes" of T-cell activity.
Kiromic’s chPD1 not only "removes the brakes" but also engages the PD-1 receptor to "accelerate" T-cell activity.
Upon interaction with the PD-1 ligand, the chPD1 receptor activates CD3 zeta (the main activating intracellular domain for T cells), and Dap10 (costimulatory domain). The activation of these two intracellular domains induces T cell activation, cytokine secretion, and tumor cell lysis.
"Longwood University is proud to have completed this chPD1 licensing agreement with Kiromic. We believe that Kiromic has a strong Allogenic Off-The-Shelf CAR-T program which will be even stronger with chPD1. The role that chPD1 plays in the modulation of the tumor micro-environment (TME) can never be underestimated when treating solid tumors," says Dr. Amorette Barber, PhD, Associate Professor of Biology and Director of the Office of Student Research at Longwood University.

"The completion of the licensing agreement for chPD1 marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.

"We believe that the licensing agreement of chPD1 from Longwood will make Kiromic the only CAR-T development program with a built-in capability to meet other CAR-T programs head-on who do not have a bundled chPD1 CAR-T. We believe that the licensing agreement will place Kiromic in a solid position to begin first in-human in solid tumors," says Mr. Gianluca Rotino, Chief of Strategy and Innovation of Kiromic BioPharma.

On January 26, 2021 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, reported the pricing of an underwritten public offering of 15,243,903 shares of its common stock, at a price to the public of $2.05 per share (Press release, Apricus Biosciences, JAN 26, 2021, View Source [SID1234574291]). In addition, the Company granted the underwriters a 30-day option to purchase up to 2,286,585 additional shares of its common stock to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by Seelos.

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BTIG is acting as the sole book-running manager for the offering.

Seelos anticipates the aggregate net proceeds from the offering will be approximately $29.1 million, after deducting the underwriting discounts and commissions and estimated offering expenses payable by Seelos, but excluding any exercise of the underwriters’ option to purchase additional shares of common stock. Seelos intends to use an aggregate of $3.3 million of the net proceeds from the offering for the partial repayment of certain outstanding convertible promissory notes and the remainder for general corporate purposes and to advance the development of its product candidates. This offering is expected to close on or about January 28, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by Seelos pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-251356) previously filed with the Securities and Exchange Commission (the "SEC") on December 15, 2020, amended on December 22, 2020, and declared effective by the SEC on December 23, 2020. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by calling (212) 593-7555 or by e-mail at [email protected].

This press release does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On January 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported that it has commenced an underwritten public offering of $150.0 million of its common stock (Press release, Personalis, JAN 26, 2021, View Source [SID1234574311]). In addition, Personalis expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common stock on the same terms and conditions.

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The offering is subject to market 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.

Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on December 30, 2020, and was declared effective on January 8, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source When available, electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the proposed public offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; BofA Securities, Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-833-297-2926.

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 under the securities laws of any such state or jurisdiction.

On January 26, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of onvansertib in metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, Cardiff Oncology, JAN 26, 2021, View Source [SID1234574292]).

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This Phase 2 clinical trial is designed to assess the safety and preliminary efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), 5-FU and leucovorin as a second-line treatment in patients with metastatic PDAC who have failed first-line gemcitabine-based therapy. The trial is expected to enroll approximately 40 patients across six sites in the U.S. including the three Mayo Clinic Cancer Centers (Arizona, Minnesota and Florida), Emory University, Kansas University Medical Center and Inova Schar Cancer Institute.

"We are excited about the potential of onvansertib in PDAC and originally proposed this trial to Cardiff Oncology because of the results we are seeing in patients treated in our ongoing Phase 1b/2 trial in KRAS-mutated mCRC, which is also evaluating onvansertib in combination with nanoliposomal irinotecan and 5-FU," said Dr. Daniel H. Ahn, medical oncologist at the Mayo Clinic Cancer Center (Arizona), principal investigator for the Phase 2 PDAC trial and lead investigator for the Phase 1b/2 KRAS-mutated metastatic colorectal cancer (mCRC) trial. "These data show promising response rates with impressive durability across several KRAS variants following treatment. We believe these clinical benefits can be extended to PDAC, as approximately 95% have a KRAS mutation and onvansertib inhibits the proliferation and survival of KRAS-mutated tumor cells. We are looking forward to starting this important trial and providing our PDAC patients with a new second-line therapy with the potential to change the course of this devastating cancer."

"The FDA’s clearance of our Investigational New Drug application for a Phase 2 clinical study in patients with metastatic pancreatic cancer is an important milestone for onvansertib and represents a significant step forward in our development of a potential new treatment in an indication where current therapeutic options are limited and patient prognosis is poor," said Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology. "By parlaying the known synergy between onvansertib and standard-of-care nanoliposomal irinotecan and 5-FU therapy, we believe we can offer a promising new treatment option that has the potential to improve patient outcomes."
About the Phase 2 Trial of Onvansertib in Metastatic PDAC
This trial is a multi-center, open-label, single-arm study designed to assess the safety and efficacy of onvansertib in combination with nanoliposomal irinotecan (Onyvide), leucovorin,

and 5-FU as a second-line treatment in patients with metastatic PDAC. The trial is expected to enroll approximately 40 patients with histologically confirmed measurable and metastatic PDAC who have failed treatment with one prior line of gemcitabine-based chemotherapy. Patients will receive nanoliposomal irinotecan, leucovorin, and 5-FU on Day 1 of 14-day cycles, plus 12 mg/m2 onvansertib on Days 1-10, or 15 mg/m2 onvansertib on Days 1-5 of each 14-day cycle. The study will be conducted at six clinical trial sites across the U.S.: Mayo Clinic (Arizona, Minnesota, Florida), Emory University, Kansas University Medical Center and Inova Schar Cancer Institute. The primary endpoint will be overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Key secondary and exploratory endpoints include duration of response, median overall survival, ORR in patients receiving greater than two treatment cycles, disease control rate (defined as complete response, partial response or stable disease by RECIST v1.1 over the entire treatment period), and assessment of KRAS allelic burden in liquid biopsies as measured by circulating tumor DNA (ctDNA).

On January 26, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported the pricing of its previously announced underwritten public offering of 3,950,000 shares of its common stock at a price to the public of $38.00 per share (Press release, Personalis, JAN 26, 2021, View Source [SID1234574312]). Gross proceeds to Personalis from the offering are expected to be $150.1 million, before deducting underwriting discounts and commissions and estimated offering expenses.

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In addition, the underwriters have been granted a 30-day option to purchase up to an additional 592,500 shares of common stock from Personalis on the same terms and conditions.

Morgan Stanley, BofA Securities, Citigroup and Cowen are acting as joint book-running managers. BTIG is acting as co-manager.

A shelf registration statement relating to the shares being sold in this offering was filed with the U.S. Securities and Exchange Commission on December 30, 2020, and was declared effective on January 8, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and are available for free on the SEC’s website located at View Source When available, electronic copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; BofA Securities, Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-833-297-2926.

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 under the securities laws of any such state or jurisdiction.