On October 26, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that one patient‘s experience on the Phase 1 trial of MB-105, a prostate stem cell antigen (PSCA) chimeric antigen receptor (CAR) T administered systemically to patients with PSCA-positive metastatic castration-resistant prostate cancer (mCRPC), was presented at the virtual 27th Annual Prostate Cancer Foundation Scientific Retreat (Press release, Mustang Bio, OCT 26, 2020, View Source [SID1234569052]).

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Tanya Dorff, M.D., City of Hope Associate Clinical Professor, Department of Medical Oncology & Experimental Therapeutics and Head of its Genitourinary Cancer Program and the trial’s principal investigator, presented a description of the correlative science from the ongoing Phase 1 open-label clinical trial of MB-105, one of the first CAR T trials for prostate cancer in the nation. In a 73-year-old male patient with PSCA-positive mCRPC who was treated with MB-105 and lymphodepletion (a standard CAR T pre-conditioning regimen) after failing eight prior therapies, MB-105 demonstrated on day 28 a 94 percent reduction in prostate-specific antigen (PSA), near complete reduction of measurable soft tissue metastasis by computerized tomography, and improvement in bone metastases by magnetic resonance imaging. The therapy was associated with cytokine release syndrome, which was clinically managed with tocilizumab (anti-IL-6 receptor antibody), and hemorrhagic cystitis requiring transfusion which clinically resolved in 30 days.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are encouraged by the initial data presented by City of Hope from the ongoing Phase 1 trial of Mustang’s CAR T cell therapy MB-105. We see potential for this PSCA-targeted CAR T in the treatment of prostate cancer, as well as other difficult-to-treat solid tumor cancers. We look forward to the continued progression of this trial and anticipate providing further data in the second half of 2021."

According to the American Cancer Society (ACS), prostate cancer is the most common cancer in American men, excluding skin cancer. ACS estimates 191,930 new cases of prostate cancer in the U.S. will be diagnosed this year, and roughly one out of every nine men will be diagnosed with prostate cancer during his lifetime. The median survival for men with CRPC is less than two years, according to the American Urological Association.

About MB-105 (PSCA CAR T technology)
MB-105 was developed in the laboratory of Saul Priceman, Ph.D., assistant professor in City of Hope’s Department of Hematology & Hematopoietic Cell Transplantation and associate director of translational sciences in the T Cell Therapeutics Research Laboratory led by Stephen Forman, M.D., leader of City of Hope’s Hematologic Malignancies and Stem Cell Transplantation Institute and the laboratory’s director.

The Phase 1 clinical trial of MB-105 will continue to enroll up to 33 patients. Its primary endpoints are to define safety and optimal dosing of PSCA CAR T cells in treating patients with PSCA-positive mCRPC. Secondary endpoints include assessing the expansion and persistence of PSCA CAR T cells, the clinical response based on Prostate Cancer Working Group 3 (PCWG3) criteria, survival outcomes and serum cytokine profiles in peripheral blood pre- and post-therapy, as well as describing the PSCA expression level on tumor cells prior to CAR T cell infusion and the relationship it may have with disease response and associated toxicities. For more information on this Phase 1 trial, please visit www.clinicaltrials.gov using identifier NCT03873805.

On October 26, 2020 Turning Point Therapeutics, Inc. (Nasdaq: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell $400,000,000 of shares of its common stock (Press release, Turning Point Therapeutics, OCT 26, 2020, View Source [SID1234569051]). In connection with the offering, Turning Point expects to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. 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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Goldman Sachs & Co. LLC, SVB Leerink and Guggenheim Securities are acting as joint bookrunning managers for the offering. Wedbush PacGrow and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by Turning Point pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (the "SEC") on May 15, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132 or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at 212-518-5548, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On October 26, 2020 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance to the Company for three new DRP biomarker patents in conjunction with use of several of its clinical pipeline drugs (Press release, Allarity Therapeutics, OCT 26, 2020, View Source [SID1234569050]).

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The USPTO has issued Notices of Allowance to the Company on the following three patent applications:

U.S. Patent Application No.: 16/444,881, "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – Directed to a DRP biomarker for the Company’s cancer drug Dovitinib, which biomarker is in development by Company as a companion diagnostic to select high likely responders for Dovitinib.
U.S. Patent Application No.: 15/858,703, "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – Directed to a DRP biomarker for Cisplatin, including the Company’s cancer drug LiPlaCis, which biomarker is in development by Company as a companion diagnostic to select high likely responders for LiPlaCis.
U.S. Patent Application No.: 15/978,655, "METHODS FOR PREDICTING DRUG RESPONSIVENESS IN CANCER PATIENTS" – Directed to DRP biomarkers for anthracyclines, including doxorubicin, epirubicin, and the Company’s cancer drug 2X-111, which biomarker is in partnered development by Smerud Medical Research International as a companion diagnostic to select high likely responders for 2X-111.
The allowance and imminent issuance of these three new DRP biomarker patents further expands Allarity’s patent portfolio on unique, drug-specific DRP biomarkers developed with its best-in-class and highly validated DRP platform technology. The Company has now gained allowance and/or issuance of patents on more than 60 different DRP biomarkers.

Dovitinib, originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of renal cell carcinoma and is a potential therapeutic alternative to sorafenib. Allarity is currently preparing to file its first new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of dovitinib as a treatment for renal cell carcinoma (RCC), using its Dovitinib DRP as a companion diagnostic to select and treat high likely responder patients. Dovitinib also has promising potential as a monotherapy in a number of other indications, including metastatic estrogen receptor (ER) positive breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.

LiPlaCis is an advanced, targeted liposomal formulation of cisplatin, one of the world’s most widely used chemotherapies, being developed in partnership with Smerud Medical Research International AS for the treatment of metastatic breast cancer, using the Cisplatin DRP as a companion diagnostic to select and treat high likely responder patients. The specific LiPlaCis formulation allows delivery of the drug directly at tumor site, thereby increasing drug targeting at the tumor and reducing negative, off-target drug effects. LiPlaCis has previously shown promising results in a Phase 2 study in DRP-selected patients with late-stage metastatic breast cancer (mBC). In August 2019, the U.S. FDA approved an investigational device exemption (IDE) application for use of the Company’s LiPlaCis DRP companion diagnostic in a planned pivotal Phase 3 study in mBC.

2X-111 is an advanced, targeted liposomal formulation of doxorubicin, one of the world’s most widely used chemotherapies, being developed in partnership with Smerud Medical Research International AS for the treatment of glioblastoma multiforme (GBM), using the Doxorubicin DRP as a companion diagnostic to select and treat high likely responder patients. The specific 2X-111 formulation allows delivery of the drug across the blood-brain barrier (BBB) directly at the brain tumor site, thereby increasing drug targeting at the tumor and reducing negative, off-target drug effects. 2X-111 has previously shown promising results in a Phase 2 study in both GBM patients and patients with brain metastases of breast cancer.

Steve Carchedi, CEO of the Company, noted "We see the allowance of these patents from the USPTO as further validation of the inventive importance of our core DRP platform and its resulting, drug-specific companion diagnostics, which we believe will help bring the promise of personalized medicine to cancer patients. The issuance of these new patents on our dovitinib, LiPlaCis, and 2X-111 programs solidifies our competitive advantage as we advance these promising cancer therapeutics to the market and to patients, and underscores our global leadership in the development and use of best-in-class companion diagnostics that are designed to match the right cancer patient to the right drug."

Steen Knudsen, Ph.D., CSO and Co-Founder of the Company, further stated, "I am pleased to see the USPTO’s recognition of these three novel and valuable DRP biomarkers, through allowance of these patents, as Allarity continues to develop and utilize such DRP biomarkers as companion diagnostics to advance our therapeutic pipeline, including dovitinib, LiPlaCis, and 2X-111 towards approval and to improve treatment options for cancer patients."

About the Drug Response Predictor – DRP Companion Diagnostic

Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On October 26, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, reported healthcare industry veteran with proven operational skills Richard Adcock as its Chief Executive Officer, effective immediately (Press release, NantKwest, OCT 26, 2020, View Source [SID1234569049]). Adcock brings extensive leadership experience to NantKwest as the company advances rapidly in the development of natural killer cell-based immunotherapies for cancer and serious infectious diseases. Rich will assume the role of CEO from Dr. Patrick Soon-Shiong, who will become Executive Chairman of the Board. Dr. Soon-Shiong remains the largest shareholder in NantKwest.

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"I’m excited to have Rich, with his extensive experience and unwavering commitment to innovation and operations, at the helm of NantKwest at a crucial time for the company and for the entire healthcare industry," said Dr. Soon-Shiong. "Not only is Rich uniquely qualified to take on this role, but having worked with him for several years, I am confident that he is the right leader to advance NantKwest and its mission. As established leaders in the natural killer cell therapy space, we will leverage Rich’s unique combination of engineering and operational skills, as well as his understanding of the complex needs of health systems in cell therapy, to propel us forward. I intend to work closely with him and continue to maintain an active role in achieving NantKwest’s mission to harness the power of natural killer cells and the human immune system to transform the treatment of cancers and serious infectious diseases."

"I am thrilled to be joining Dr. Soon-Shiong and the NantKwest team on the quest to cure cancer and infectious diseases using natural killer cell therapy," said Richard Adcock. "I look forward to using my experience in healthcare research and delivery to help accelerate NantKwest’s growth."

Adcock was most recently CEO of Verity Health Systems, a California-based nonprofit healthcare system that he steered through a successful restructuring event. Prior to joining Verity Health, Adcock served as Executive Vice President and Chief Innovation Officer for Sanford Health, the largest rural nonprofit healthcare system in the U.S. with more than 382 locations and 28,000 employees. While at Sanford, he was responsible for leading the healthcare company’s growth and innovation, in addition to direct operational oversight of related entities including Sanford Research, Sanford Health Plan, Sanford Foundation and Sanford Frontiers. During his time at Sanford he learned firsthand how essential it is to keep the patient at the center of all healthcare decisions, this was even more important as Sanford Health brought forth many new exciting treatments, therapies and medical devices from their own research efforts. Earlier in his career, Adcock was director of engineering and a Six Sigma Master Black Belt for GE Medical Systems. He began his career in the medical field as co-owner and vice president of research and development at medical equipment supplier Micro Medical Systems.

As Executive Chairman, Soon-Shiong will continue to play a key, active role in NantKwest’s business and in the development of the company’s long-term business strategy.

On October 26, 2020 eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, reported that data presented over the weekend at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium (ENA 2020), showed that zotatifin, the company’s product candidate targeting eIF4A, downregulates key cancer-driving proteins including receptor tyrosine kinase (RTK) proteins (HER2, FGFR1, and FGFR2), as well as cell cycle protein Cyclin D1 (Press release, eFFECTOR Therapeutics, OCT 26, 2020, View Source [SID1234569048]). These data also show that the downregulation of these oncoproteins correlates with apoptosis (programmed cell death) and tumor regression in vivo. Further, vertical inhibition of the PI3K-AKT-mTOR-eIF4F pathway through combination of zotatifin with other agents acting in the pathway provided a synergistic effect in RTK-driven tumors. The data were presented in a poster titled "Dissection of cancer therapy combinations in RTK driven tumors using Zotatifin (eFT226), a potent and selective eIF4A inhibitor," in the New Drugs poster session, abstract 196. The poster can be found in the on the company’s website.

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"These studies not only confirm zotatifin’s specific activity of blocking expression of key oncoproteins and cell cycle targets leading to tumor regressions as a single agent, but also highlight the attractiveness of vertical inhibition within the very important PI3K-mTOR-eIF4F oncogenic pathway," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "These data informed our selection strategy for monotherapy and combination clinical expansion cohorts anticipated to start in early 2021."

A Phase 1/2 clinical trial of zotatifin in patients with KRAS- or RTK-mutant solid tumors is ongoing [NCT04092673]. The trial is enrolling patients with activating mutations, amplifications or fusions in HER2, ERBB3, FGFR1, or FGFR2 receptor tyrosine kinases, or any KRAS mutation subtype. The primary objectives of the trial include safety and tolerability of zotatifin as monotherapy. Secondary objectives include antitumor activity and survival, as well as pharmacokinetics of the drug. Exploratory objectives include pharmacodynamics of zotatifin.

About Zotatifin

Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor 4A (eIF4A) mediated translation. Zotatifin is designed to inhibit the translation of mRNAs encoding several important oncogenes and survival factors, including several RTKS, KRAS, Cyclin D, CDK4/6, MYC, MCL1 and BCL-2 resulting in potent in vivo tumor regression in multiple tumor models dependent on these factors, including breast cancer, non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma and B cell lymphomas. Since zotatifin inhibits the translation of mRNA encoding KRAS and RTK, it is not limited to any mutation subtypes. The product candidate is currently being evaluated in a Phase 1/2 clinical trial in patients with solid tumors.