On December 10, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with tumors that express human epidermal growth factor 2 (HER2) (Press release, Bellicum Pharmaceuticals, DEC 10, 2020, View Source [SID1234572614]). BPX-603 is Bellicum’s first dual switch GoCAR-T product candidate that incorporates the company’s iMC activation and CaspaCIDe safety switch technologies.

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"Initiation of this Phase 1/2 dose escalation clinical trial for BPX-603 denotes an important achievement for Bellicum and represents our second GoCAR-T program to enter the clinic," stated Rick Fair, President and CEO. "This program may provide further validation of our technology’s ability to enhance both the efficacy and safety of immune cell therapy against solid tumors. We are excited to advance this potentially life-saving treatment approach into the clinic."

BPX-603 Phase 1/2 Clinical Trial Design

This Phase 1/2, open-label, multicenter, non-randomized study will investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid. The trial will enroll patients with previously treated, locally advanced or metastatic solid tumors with HER2 amplification or overexpression. The initial dose escalation phase of the trial is designed to evaluate safety and identify the Phase 2 dose of BPX-603 administered with rimiducid at a fixed dose of 0.4 mg/kg per infusion. The Phase 2 portion of the trial will assess the safety, pharmacodynamics, and clinical activity of BPX-603 in various HER2+ solid tumors. Tumor types that may be studied include gastric, breast, ovarian, endometrial, and colorectal.

About BPX-603

HER2 is a validated antigen for cancer therapies and academic CAR-T cell clinical studies have shown evidence of modest antitumor activity. BPX-603 was designed to improve upon these efforts, primarily through incorporation of the inducible co-activation domain MyD88/CD40, or "iMC". MC signaling is believed to boost effector cell proliferation and survival, enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment, and stimulate the cancer patient’s own immune system. Additionally, Bellicum’s dual-switch technology—which enables the clinician to either activate or eliminate GoCAR-T cells with the administration of small molecules—is designed to enhance real-time control of both efficacy and safety.

On December 10, 2020 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China (Press release, Antengene, DEC 10, 2020, View Source [SID1234572630]).

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The trial is a randomized, controlled, open-label, multicenter, Phase 3 trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to three prior lines of therapy. A total of 150 patients will be randomized in a 2:1 ratio to receive SVd or Vd treatment.

ATG-010 is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it is now the first and only drug approved by the Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma. In China, Antengene is conducting a registrational Phase 2 clinical trial of ATG-010 for rrMM (MARCH). The trial is expected to complete enrollment by the end of 2020.

"The result of the BOSTON study has demonstrated that the SVd regimen reduced the risk of disease progression or death with lower doses of bortezomib and dexamethasone in the triplet combination when compared to the standard Vd regimen. Addition of ATG-010 to Vd may be more convenient and provides a more significant therapeutic effect in patients with rrMM." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "This planned Phase 3 trial, which is the registrational study based on BOSTON, is going to validate the SVd regimen’s efficacy and safety in Chinese population."

About ATG-010 (selinexor, XPOVIO)

ATG-010 (selinexor, XPOVIO) is a first-in-class and only-in-class oral selective inhibitor of nuclear export compound, developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA) approved ATG-010 in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved ATG-010 as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 is so far the first and only oral SINE compound approved by the FDA. ATG-010 is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm Therapeutics, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral ATG-010 versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed planned interim futility analysis and that Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 in China for relapsed refractory multiple myeloma (MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

On December 10, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported the pricing of its previously announced underwritten public offering of 4,761,904 shares of its common stock at a price to the public of $21.00 per share (Press release, Protagonist, DEC 10, 2020, View Source [SID1234572710]). Gross proceeds to Protagonist from the offering are expected to be $100 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Protagonist. In addition, Protagonist has granted the underwriters a 30-day option to purchase up to 714,285 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 15, 2020, subject to satisfaction of customary closing conditions.

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J.P. Morgan Securities LLC, SVB Leerink LLC, Piper Sandler & Co. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. 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 related to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. The offering is being made only by means of a prospectus supplement and accompanying prospectus. Copies of the prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected]; from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities 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 December 10, 2020 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported it has commenced an underwritten registered public offering of shares of its Series A Cumulative Perpetual Preferred Stock, with liquidation preference of $25.00 per share (the "Preferred Stock") (Press release, Xoma, DEC 10, 2020, View Source [SID1234572615]). The Company expects to grant the underwriters a 30-day option to purchase additional shares of the Preferred Stock in connection with the offering.

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The Company expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding.

B. Riley Securities, Inc., Ladenburg Thalmann & Co. Inc., National Securities Corporation, and William Blair & Company are acting as joint book-runners for this offering. Aegis Capital Corp., Boenning & Scattergood, Inc., and Northland Capital Markets are acting as co-managers.

The offering of these securities is being made pursuant to an effective shelf registration statement on Form S-3, which was initially filed with the Securities and Exchange Commission (the "SEC") on March 7, 2018, and declared effective by the SEC on April 5, 2018. The offering will be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to these securities may be obtained, when available, from the website of the SEC at View Source or by contacting: B. Riley Securities, Inc., 1300 17th Street North, Suite 1300, Arlington, Virginia 22209, Attn: Prospectus Department, Email: [email protected], Telephone: (703) 312-9580.

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 December 10, 2020 LIPAC Oncology LLC and Huons Co., Ltd. reported the achievement of a major development milestone in their partnering agreement by finalizing its Clinical Study Report for a Phase 2A marker lesion clinical trial in patients with low-grade highly recurrent Non-Muscle Invasive Bladder Cancer (NMIBC) treated with LiPax (paclitaxel) (Press release, Lipac Oncology, DEC 10, 2020, View Source [SID1234572632]). LiPax, a proliposomal paclitaxel formulation in development for intravesical instillation in the treatment of NMIBC, demonstrated a 63 percent responder rate in highly recurrent and heavily pre-treated patients.

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"This is an important milestone for LIPAC as we prepare for our Type B meeting with the U.S. Food and Drug Administration in early January to validate our Phase 2B/3 clinical study approach," said TR Thirucote, Ph.D., Chairman and CEO of LIPAC.

In September 2019, LIPAC and Huons announced that they entered into an exclusive licensing agreement to develop, manufacture, and commercialize LiPax for all indications in South Korea. This is the first milestone payment to LIPAC based on specific development, regulatory and commercial milestones and royalty payments based on sales.

"We are delighted to have reached this milestone in our agreement with LIPAC that brings us a step closer to making this essential therapy available to thousands of patients in Korea," said Mr. Key An UM, CEO of Huons. "Our interest in LiPax extends well beyond NMIBC as we continue our collaboration with LIPAC in additional orphan-designated programs for Upper Tract Urothelial Carcinoma, Ovarian Cancer, Mesothelioma, and Malignant Plural Effusion for Breast Cancer."

"Non-Muscle Invasive Bladder Cancer is difficult to treat and highly recurrent. By pairing a simple outpatient procedure (Transurethral Resection of Bladder Tumor or TURBT) with LiPax, we have an opportunity to substantially improve both clinical outcomes and quality of life for patients globally," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. "We were also pleased to present our Phase 2A data at the Society of Urological Oncology meeting earlier this month."

Based on a patient’s biopsy results obtained from TURBT, NMIBC is stratified into three risk categories: low, intermediate, and high risk. To reduce recurrence and prevent progression, the American Urological Association NMIBC guidelines recommend intravesical therapy after TURBT. The low to intermediate risk category targeted by LiPax is estimated to comprise 90,000 Americans, yet no intravesical agent is approved by the U.S. Food and Drug Administration for this disease.

About LiPax
LiPax is a novel, investigational formulation of paclitaxel in Phase 2 development for the treatment of NMIBC. LIPAC Oncology’s proprietary formulation utilizes their proliposomal technology platform to enhance the persistence and penetration of bladder tissue by paclitaxel. LiPax is designed to enhance the standard of care of outpatient endoscopic tumor removal through a histological risk assessment followed by intravesical instillation using a standard urinary catheter. LIPAC Oncology completed a Phase 2A clinical trial in August 2020 and intends to advance the program to a pivotal study to further investigate LiPax in the treatment of this condition.