On November 1, 2021 Compass Therapeutics, Inc. (the "Company"), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported that it has priced an underwritten public offering to sell 35,715,000 shares of common stock at a public offering price of $3.50 per share (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594047]). All of the shares of common stock are being offered by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 5,357,250 shares of common stock at the public offering price, less the underwriting discount. In connection with the offering, the Company also announced that its common stock will begin trading on the Nasdaq Capital Market under the symbol "CMPX" at the opening of trading on November 2, 2021, following its previously announced approval to list its common stock on the Nasdaq Capital Market. The gross proceeds to the Company from the public offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $125.0 million.

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The offering is expected to close on November 4, 2021, subject to customary closing conditions. The Company intends to use the net proceeds from the public offering, together with its existing cash and cash equivalents, for funding of ongoing operations including clinical trials for the programs noted in the preliminary prospectus supplement, which may change based on clinical and preclinical results.

SVB Leerink is acting as book-running manager for the offering. Raymond James & Associates, Inc., Wedbush Securities and H.C. Wainwright & Co. are acting as passive book-running managers and The Benchmark Company and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-257821) that was declared effective by the Securities and Exchange Commission on July 20, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, 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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On November 1, 2021 Compass Therapeutics, Inc. (OTC:CMPX) reported an update on the clinical development of CTX-009 (also known as ABL001), a dual anti-angiogenic bispecific antibody targeting DLL4 and VEGF-A (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594046]).

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A Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. (KOSDAQ: 002390) in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. The study has been enrolling patients who have unresectable advanced, metastatic, or relapsed BTC’s who have received one or two prior systemic therapies. The Phase 2a design was informed by the CTX-009 Phase 1b study, where CTX-009 in combination with either paclitaxel or irinotecan led to an overall response rate of 23.5% and a clinical benefit rate of 76.5%, including two confirmed and durable partial responses among four patients with advanced cholangiocarcinoma (clinicaltrials.gov Identifier: NCT04492033).

The Phase 2a study utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the study is three or more partial responses observed in 21 patients. So far, there have been five partial responses observed among the first 17 patients evaluated, which is an overall response rate of 29%, and accordingly, the criteria to advance to the second part of the study has been met. In the second part of the Phase 2a study, 45 additional patients will be enrolled. The preliminary adverse event profile of CTX-009 in this Phase 2a study is consistent with prior studies of CTX-009 with hypertension and neutropenia being the most common events related to CTX-009 and paclitaxel, respectively. Handok initiated the study in Q1 2021 at four leading medical centers in South Korea. Compass plans on submitting an IND for CTX-009 in the United States later this quarter and subject to the IND going into effect with the FDA, plans on initiating a Phase 2 study in the United States in Q2 2022.

"Patients with cholangiocarcinoma have limited treatment options following front line combination chemotherapy. In the Phase 1b and Phase 2a studies, we have seen a total of seven partial responses in 21 total patients evaluated. Impressively, there have been measurable tumor declines in 19 of the 21 advanced patients treated across both studies. We are looking forward to filing our IND in the United States this quarter and pursuing the global development of CTX-009," said Thomas Schuetz, M.D., Ph.D., CEO and scientific founder of Compass. Compass holds the global rights to CTX-009 with the exception of South Korea rights, which are held by Handok, and China rights, which were out-licensed to Elpiscience Biopharma.

About CTX-009

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and dose expansion study. Phase 1b and Phase 2a combination studies are ongoing.

On November 1, 2021 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that it will release third quarter 2021 financial results after the market closes on Monday, November 8, 2021 (Press release, Xencor, NOV 1, 2021, View Source [SID1234594045]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 5536153. A live webcast of the conference call will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. The webcast will be archived on the company website for 30 days.

On November 1, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022 (Press release, Legend Biotech, NOV 1, 2021, View Source [SID1234594044]). Cilta-cel is a BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The Biologics License Application (BLA) was submitted by Legend Biotech’s collaboration partner Janssen Biotech, Inc. (Janssen).

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"We are working closely with Janssen and the FDA to facilitate an efficient and thorough review of the BLA for cilta-cel," said Ying Huang, Ph.D., Chief Executive Officer and Chief Financial Officer at Legend Biotech. "We remain confident that cilta-cel has shown great promise in patients with relapsed and refractory multiple myeloma, and we are focused on making this therapy available to them in the US as soon as possible."

The FDA notified Janssen on October 28, 2021 of the extension of the PDUFA date to allow sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request. Legend and Janssen met with the FDA on November 1. No additional clinical data have been requested.

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies.

In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In December 2020, Legend announced initiation of rolling submission of Biologics License Application to the FDA seeking approval of cilta-cel for the treatment of relapsed and/or refractory multiple Myeloma, which was accepted under Priority Review in May 2021. Cilta-cel was previously granted Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, and Orphan Drug Designation in February 2019.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.1 Although treatment may result in remission, unfortunately, patients will most likely relapse.2 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.3 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.4,5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses

On November 1, 2021 Imugene Ltd ("Imugene") (ASX: IMU), a clinical stage immuno-oncology company, and Eureka Therapeutics, Inc. ("Eureka"), a clinical-stage biotechnology company developing novel T-cell therapies to treat solid tumours, reported a strategic collaboration to evaluate Imugene’s CD19 oncolytic virus onCARlytics technology in combination with Eureka’s anti-CD19 ARTEMIS T-cell therapy for the treatment of solid tumours (Press release, Imugene, NOV 1, 2021, View Source [SID1234594043]).

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Oncolytic viruses in combination with T-cell therapies represent a novel and promising approach to treat solid tumours. In preclinical studies conducted by the City of Hope Comprehensive Cancer Center, scientists combined CAR-T therapy with an oncolytic virus to eliminate solid tumours in mice. The virus enters the tumour cells and forces them to express the CD19 protein on the cell surface, presenting a target for anti-CD19 T-cells to pursue and kill. Imugene licensed the patents covering City of Hope’s oncolytic virus technology in May 2021.

"By combining oncolytic virus and CAR T-cell therapies, we have developed a ‘mark and kill’ approach to treating solid tumours with T-cell therapies," said Saul Priceman, Ph.D., Assistant Professor in the Department of Hematology and Hematopoietic Cell Transplantation at City of Hope and co-inventor of the platform. "In our animal studies, we were able to express CD19 in triple-negative breast, pancreatic, prostate, ovarian, and head and neck cancer, as well as brain tumours."

"T-cell and CAR-T therapies have not achieved much success in solid tumours in part because of a lack of tumour-specific targets. By using our proprietary oncolytic technology to force the tumour to express the CD19 target, we now have the ability to address this shortcoming. We believe the synergy between our onCARlytics platform and Eureka’s anti-CD19 ARTEMIS T-cells has the potential to shift the cellular medicine paradigm in treating solid tumours," said Leslie Chong, Managing Director & Chief Executive Officer of Imugene.

"We are delighted to be working with Imugene on tackling solid tumours using this innovative approach," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "We believe our ARTEMIS T-cell platform to be the ideal one to evaluate this combination. In head-to-head pre-clinical studies against CAR-T cells, our ARTEMIS T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion. In the clinical context, our ARTEMIS T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokine-related toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach."