On October 26, 2020 INOVIO (NASDAQ: INO) reported that third quarter 2020 financial results will be released after the market close on November 9, 2020 (Press release, Inovio, OCT 26, 2020, View Source [SID1234569054]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s ongoing vaccine developments for COVID-19.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

About INOVIO’s DNA Medicines Platform

INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

INOVIO’s DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO’s proprietary hand-held smart device called CELLECTRA. The simple-to-use CELLECTRA device provides a brief electrical pulse to reversibly open small pores in the local skin area cells resulting in more than a hundred-fold increase in product delivery providing dose sparing and consistency. Once inside the cell, the DNA plasmids instruct the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers specific T cell and antibody-mediated immune responses. Administration with the CELLECTRA device, which takes only a few seconds, is designed to ensure that the DNA medicine is efficiently delivered directly into the body’s cells, where it can go to work to drive the immune responses. INOVIO’s DNA medicines are transient, and do not interfere with or change in any way an individual’s own DNA. The advantages of INOVIO’s DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the consistent immune response, safety profile, and tolerability that have been observed in clinical trials with multiple products.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

On October 26, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it has completed a successful pre-submission meeting with the European Medicines Agency ("EMA") for Vicineum1 for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") in Europe (Press release, Sesen Bio, OCT 26, 2020, View Source [SID1234569053]).

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During the meeting, the EMA addressed product-specific, legal, regulatory and scientific topics related to Vicineum. The information and insights gained from the meeting will help to facilitate the validation of the Marketing Authorization Application ("MAA") and support a smooth evaluation. The agency also provided guidance on various administrative topics which helps to clarify the regulatory path forward.

"We are very pleased to be managing the regulatory process with the EMA efficiently and effectively despite the pandemic. We have conducted productive virtual interactions allowing us to stay on track for regulatory filings in Europe," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Europe represents one of the largest regions in terms of unmet need for patients with NMIBC, and we appreciate the agency’s guidance and confidence in Sesen Bio to pursue an MAA submission for approval of Vicineum."

This successful pre-submission meeting with the EMA follows the critical milestone of written notice from the EMA that Vicineum has received confirmation of eligibility to file an MAA under the agency’s centralized procedure. Confirmation of eligibility was given in response to the submission of a letter of intent, which notified the EMA that Sesen intended to file an MAA.

The success of the pre-submission meeting, in addition to the receipt of centralized procedure eligibility confirmation from the EMA, are significant milestones toward the Company’s regulatory path forward in Europe and reaffirms the Company’s intent to complete all necessary pre-submission activities with the EMA by the end of 2020.

1The proprietary brand name, Vicineum is a corporate trademark which has been conditionally approved by the FDA. Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process in Europe for oportuzumab monatox.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate currently in the follow-up stage of a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive NMIBC. In December 2019, the Company initiated the Biologics License Applictation ("BLA") submission for Vicineum to the FDA under Rolling Review. Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin ("BCG") and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

About Non-Muscle Invasive Bladder Cancer

There are approximately 440,000 new cases of bladder cancer each year globally, and approximately 80 percent of patients have non-muscle invasive bladder cancer ("NMIBC"). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin ("BCG") immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. Additionally, there is an ongoing chronic, global shortage of BCG, which puts a tremendous pressure on doctors, patients and the FDA. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.

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.