On March 22, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that Michael Amoroso, Executive Vice President, Chief Operating Officer (COO) and principal executive officer at Abeona, has been promoted to President, Chief Executive Officer (CEO) and a member of the company’s Board of Directors, effective immediately (Press release, Abeona Therapeutics, MAR 22, 2021, View Source [SID1234576959]).

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"Michael’s promotion to CEO reflects his unwavering commitment and outstanding operational leadership during a period of important transition for the company, and the Board fully supports him and the Abeona senior management team," said Steven H. Rouhandeh, Chairman of Abeona’s Board of Directors. "Under Michael’s stewardship, Abeona has remained focused on the strategy of providing our novel gene and cell therapies to patients who currently have no approved treatment options, delivering on meaningful milestones across our three clinical development programs during the last six months."

Most recently, Mr. Amoroso has been responsible for overseeing the operational management of Abeona, including research and clinical development, regulatory, medical, commercial, corporate affairs and business development as COO and principal executive officer. Mr. Amoroso joined Abeona in 2020, bringing extensive experience in leading teams across clinical development, regulatory and medical affairs, corporate affairs, and commercial, both in the U.S and globally, with direct operational experience in major world markets. For 20 years, he has led and been part of teams responsible for launches and delivering profit and loss results for major biopharmaceutical products across most therapeutic areas. Mr. Amoroso has worked with companies in the small molecule, biologic, and cell and gene therapy spaces, with his deepest areas of expertise in rare oncological diseases.

Prior to joining Abeona, Mr. Amoroso held various senior level executive positions at leading biopharmaceutical companies, including Kite, Eisai Inc., Celgene Corporation (now a subsidiary of Bristol-Myers Squibb Company), and began his biopharmaceutical career at Aventis (now Sanofi). Mr. Amoroso earned his Executive M.B.A. in Management from the Stern School of Business, New York University, and his B.A. in Biological Sciences, summa cum laude, from Rider University.

On March 22, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the presentation of clinical data from its Phase 2 clinical trial of DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological malignancies at the Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer, being held as a virtual meeting from March 19-25, 2021 (Press release, Leap Therapeutics, MAR 22, 2021, View Source [SID1234576958]). DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, leading to the activation of the innate immune system in the tumor microenvironment and anti-tumor activity.

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"DKN-01 demonstrated objective responses, including a monotherapy complete response continuing now for over 2 and a half years, and durable tumor reductions as a single agent and in combination with paclitaxel in the advanced gynecologic cancer patients treated in the study," said Rebecca Arend, M.D., MSPH, Associate Professor, University of Alabama at Birmingham O’Neal Comprehensive Cancer Center. "The disease control rate and progression-free survival were strongest in patients whose tumors express high levels of DKK1 (DKK1-high), which is a group that real world evidence has shown to have poorer outcomes on other therapies."

"The activity of DKN-01 in this study was comparable to the monotherapy data from other widely-used immuno-oncology or targeted therapies." Dr. Arend continued. "As DKN-01 was extremely well tolerated, additional studies of DKN-01 as a monotherapy and in combination with anti-PD-1 antibody therapy are warranted in endometrial cancer patients with DKK1-high tumors."

The P204 Study in Advanced Gynecologic Cancers

The P204 study was a Phase 2 basket study evaluating DKN-01 as a monotherapy or in combination with paclitaxel in groups composed of epithelial endometrial cancer (EEC), epithelial ovarian cancer (EOC), or carcinosarcoma (MMMT) patients. The primary endpoint of the P204 study was overall response rate (ORR), and secondary endpoints include disease control rate (DCR) and progression-free survival (PFS). In each group, at least fifty percent (50%) of patients were required to have specified Wnt signaling pathway alterations, a subgroup of which (Wnt activating mutations) are known to drive high tumoral DKK1 expression. Tumoral DKK1 expression was determined retrospectively by RNAscope chromogenic in situ hybridization and correlated with clinical outcomes.

Key Findings from the P204 Study

One hundred-eleven patients were enrolled in the study, including 29 EEC patients in a DKN-01 monotherapy group, 24 EEC patients in a DKN-01 plus paclitaxel group, 14 EOC patients in a DKN-01 monotherapy group, 19 EOC patients in a DKN-01 plus paclitaxel group, 9 MMMT patients in a DKN-01 monotherapy group, and 16 MMMT patients in a DKN-01 plus paclitaxel group. The key findings from the study were:

·EEC patients and patients with Wnt activating mutations express higher levels of DKK1: EEC patients expressed higher levels of DKK1 and had a higher frequency of Wnt activating mutations than patients with EOC. Within EEC, patients with endometrioid histology had higher DKK1 expression than those with non-endometrioid histology. Patients whose tumors had Wnt activating mutations expressed 14.4 times higher levels of DKK1.

·DKN-01 has enhanced activity in patients whose tumors express high levels of DKK1: In the group of 22 EEC patients treated with DKN-01 monotherapy for whom DKK1 expression data was available, patients with DKK1-high tumors (n=7) had greater ORR (14% vs. 0%), DCR (57% vs. 7%), and median PFS (3.0 months vs. 1.8 months [HR 0.39; 95% CI: 0.14, 1.1]) compared to patients with DKK1-low tumors (n=15). Additionally, seven patients did not have DKK1 expression results available, of whom one had a complete response (14%) and five (72%) had a best response of stable disease, including three patients with Wnt activating mutations.

In the group of 24 EEC patients treated with DKN-01 plus paclitaxel, 72% of whom had received three or more prior systemic therapies, DKK1-high patients (n=11) had improved median PFS (5.4 months vs. 1.8 months [HR 0.34; 95% CI: 0.12, 0.97]) compared to DKK1-low patients (n=9). Four patients did not have DKK1 expression data available.

·Within EEC, DKN-01 activity strongest in endometrioid histology: In the pooled group of 27 patients with endometrioid histology for whom DKK1 expression data was available, patients with DKK1-high tumors (n=14) had greater DCR (57% vs. 15%) and median PFS (4.1 months vs. 1.8 months [HR 0.34; 95% CI: 0.14, 0.81]) than patients with DKK1-low tumors (n=13). Additionally, seven patients with endometrioid histology did not have DKK1 expression results available, of whom one (14%) had a complete response and five (72%) had a best response of stable disease, including two patients with Wnt activating mutations.

Conference Call Details

Leap will be hosting a conference call today at 8:30 a.m. Eastern Time with Dr. Arend and members of Leap’s management team to discuss the data. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 2077923. The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

About DKN-01

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which have an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.

On March 17, 2021 T-Cure Bioscience, Inc., a privately held company focused on developing T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has entered into a clinical research agreement with Rutgers, The State University of New Jersey, to fund a Phase I clinical study testing a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, and triple negative breast cancers (Press release, T-Cure Bioscience, MAR 22, 2021, View Source [SID1234576957]). T-Cure acquired the KK-LC-1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. The Principal Investigator who will conduct the clinical research is Christian S. Hinrichs, M.D., Chief of the Section of Cancer Immunotherapy and Co-Director of the Cancer Immunology and Metabolism Center of Excellence at Rutgers Cancer Institute of New Jersey. Dr. Hinrichs is an expert in cancer immunology and immunotherapy and was recruited from the NCI where he served as Senior Investigator at the Genitourinary Malignancies Branch. T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2021 at the NCI, with the clinical study responsibilities to be transferred to Rutgers in the second half of 2021.

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"I joined the Cancer Immunology and Metabolism Center of Excellence because I believe that Rutgers Cancer Institute can be a global leader in cancer and tumor immunology research and development. In support of that mission, I am excited to partner with T-Cure to launch the first cell therapy clinical trial targeting the KK-LC-1 antigen," stated Dr. Hinrichs. "I began collaborating with the T-Cure team on this T cell receptor therapy while at the NCI, and I am pleased to continue working with them to advance this therapy at Rutgers."

"We look forward to our partnership with Dr. Hinrichs at Rutgers as a continuation of the work we undertook with him and his team at the NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "The TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to a safely administered immunotherapy. Accordingly, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without being harmful to healthy tissue."

On March 22, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that a notice that a Clinical Use Patent for the drug candidate arfolitixorin will be approved in Europe (Press release, Isofol Medical, MAR 22, 2021, View Source [SID1234576956]). The patent covers a dose regimen for treating solid tumors, such as colorectal, stomach, breast and liver cancer and expires in 2038.

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The patent application that will be granted , EP18150457.2, includes a dose regimen involving two or more injections of arfolitixorin in combination with 5-fluorouracil (5-FU). These two agents may also be given in combination with other anticancer drugs, such as oxaliplatin, irinotecan and bevacizumab.

"It is most gratifying that we now have strengthened our patent rights in the European market as well. This patent, which has already been approved in USA, Japan and Korea will now be granted in Europe* as well. It is a clinical patent based on data derived from an earlier study (ISO-005) of arfolitixorin and 5-FU in metastatic colorectal cancer patients. The data have demonstrated superior activity of arfolitixorin and 5-FU compared to the standard of care therapy. The patented dose regimen covers the one used in the ongoing global Phase III study AGENT, a multicenter study in patients with metastatic colorectal cancer", said Ulf Jungnelius, M.D, CEO of Isofol.

* EPO, meaning that we may select it to cover up to 38 countries in Europe.

The information was submitted for publication, through the agency of the contact person set out above, at 11.00 CET on March 22, 2021.

About the AGENT study

The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On March 22, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa" or the "Company"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co. under which the underwriter has agreed to purchase on a firm commitment basis 1,904,762 shares of common stock of the Company at a public offering price of $5.25 per share, less underwriting discounts and commissions (Press release, Anixa Biosciences, MAR 22, 2021, View Source [SID1234576955]). The Company also has granted the underwriter a 30-day option to purchase up to an additional 285,714 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about March 25, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $10 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by the Company and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from this offering for general corporate purposes, including, but not limited to, ongoing research and pre-clinical studies, clinical trials, the development of new biological and pharmaceutical technologies, investing in or acquiring companies that are synergistic with or complementary to its technologies, and licensing activities related to current and future product candidates and working capital.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-232067) that was filed with the U.S. Securities and Exchange Commission ("SEC") on June 11, 2019 and declared effective on June 21, 2019. The shares of common stock may be offered only by means of a prospectus supplement forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when filed, may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (212) 856-5711.

This press release shall not constitute an offer to sell or a 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.