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OncoNano Awarded $9.97 Million Grant from Cancer Prevention and Research Institute of Texas

On August 20, 2020 OncoNano Medicine, Inc. reported that it has been awarded $9.97 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to expand the application of its lead product, ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors, for imaging metastatic disease (Press release, OncoNano Medicine, AUG 20, 2020, View Source [SID1234563909]).

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This grant adds to the initial $6 million that the company received from CPRIT in 2014 for the advancement of ONM-100 to intraoperatively image tumors during surgical resection. ONM-100 was granted a Fast Track designation from the Food and Drug Administration (FDA) and is currently in Phase 2 clinical trials.

During these trials, researchers discovered that ONM-100 can also be used to image and stage metastatic disease, which represents 45-50% of all cancer diagnoses and is responsible for 90% of patient deaths. Improvement in visualization of metastatic disease, both preoperatively and during surgery, is critical for initial diagnosis, accurate staging, therapeutic choice and efficacy, and is closely tied to patient survival. The grant from CPRIT will enable the company to expand the application of ONM-100 to the identification of metastatic disease in the peritoneum, lymph nodes and pleural surfaces – areas that comprise 40% of metastatic disease and result from primary tumors originating from numerous cancer types.

"With limited tools available today that allow doctors to visualize tumors that have metastasized, especially small and disperse ones often characteristic of metastatic disease, the funding we received from CPRIT for our pH-sensitive micelle approach for imaging metastatic disease has the potential to solve a tremendous unmet need," said Ravi Srinivasan, Ph.D., CEO of OncoNano Medicine. "CPRIT has been our partner since our founding and we greatly appreciate their ongoing support as we bring our technologies through development to benefit patients."

In addition to the grants received for ONM-100, OncoNano was awarded $15.4 million from CPRIT in August 2019 to advance ONM-500, which leverages its proprietary pH-sensitive micelle technology to deliver antigens while activating innate immunity for the treatment of cancers caused by the human papilloma virus (HPV).

"CPRIT continues to be impressed with OncoNano Medicine’s outcomes using their unique micelle technology to detect metastatic cancer," said Cindy WalkerPeach, PhD, Chief Product Development Officer at CPRIT. "We’re looking forward to successful clinical trials that clearly demonstrate favorable impact to cancer patient care."

About the Cancer Prevention and Research Institute of Texas

To date, CPRIT has awarded $2.6 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 213 distinguished researchers, supported the establishment, expansion or relocation of 42 companies to Texas, and generated over $5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 6.6 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention.

About ONM-100

ONM-100 is OncoNano’s lead product candidate that utilizes the pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM‑100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag expression, making tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas.

Aptorum Group Appoints Dr. Herman Weiss as CEO of microbiome-based platform Claves Life Sciences and Dr. Robbie Majzner as scientific advisor to SACT-1 drug for Neuroblastoma and others

On August 20, 2020 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM), a biopharmaceutical company focused on the development of novel therapeutics to address certain global unmet medical needs, reported two appointments to its team (Press release, Aptorum, AUG 20, 2020, View Source [SID1234563908]).

Appointment of Dr. Herman Weiss MD as CEO and Executive Director of Claves Life Sciences

Dr. Herman Weiss, M.D., has been appointed as the Chief Executive Officer and Executive Director of Claves Life Sciences Limited ("Claves") and also senior medical advisor of Aptorum Group Limited ("Aptorum Group" or "Company"). Claves is one of Aptorum Group’s wholly-owned subsidiaries and is focused on microbiome-based approach to metabolic diseases. Going forward, Dr. Weiss will be leading the development of Claves’ business and drive Claves’ exciting microbiome-based research platform for treatments of metabolic diseases, and potentially other indications, to targeted clinical stages. Claves is a microbiome-based platform utilizing proprietary macromolecule-based technology to target major systemic metabolic diseases including microbiome modulator CLS-1 for treatment of obesity. Through Claves, the Company is also developing microbiome modulators CLS-2 and CLS-3, which target other metabolic diseases.

Appointment of Dr. Robbie Majzner as scientific advisor of Aptorum Group

Dr. Robbie Majzner has been appointed as a scientific advisor of Aptorum Group Limited. In particular, Dr. Majzner will provide scientific advice and support for certain targeted clinical development aspects of Aptorum Group’s repurposed drug candidate SACT-1 for the treatment of neuroblastoma, a rare type of solid tumor cancer that develops predominantly in infants and young children, as well as other potential cancer indications.

"We are delighted that Dr. Weiss and Dr. Majzner are joining the Aptorum Group family. as the Chief Executive Officer of Claves, Dr. Weiss, who served at Juniper Pharmaceuticals Inc., which was previously listed on Nasdaq and was subsequently acquired in 2018 by Catalent Inc (NYSE: CTLT), brings with him significant clinical development experience which will be critical in driving R&D of Claves’ microbiome-based drug candidates to the next targeted development milestones. We are also delighted to have Dr. Majzner, a world-class hematologist and oncologist, on board in supporting the development of our SACT-1 and related programs." said Mr. Ian Huen, the Chief Executive Officer and Executive Director of Aptorum Group.

Dr. Weiss has over 20 years of experience in the medical field. He is currently a Physician at Maccabi and Meuchedet Kuppot Health System and Chairman of the Board of Directors of Todos Medical in Israel. Dr. Weiss previously held senior roles at both Juniper Pharmaceuticals, as Head of Clinical Development and Medical Affairs, and at Teva Pharmaceuticals, as Global Medical Director. He has also consulted for various medical device and biotech companies. He owns multiple patents and is the author of numerous publications in the area of women’s health/gynecology. Dr. Weiss received his MBA from the George Washington University, his M.D. from the Ohio State University College of Medicine and his B.A. from Ramapo College of New Jersey.

Dr. Majzner is an Assistant Professor of Pediatrics in the Division of Hematology and Oncology at the Stanford University Medical Center. Prior to joining Stanford, he worked in the laboratory of Dr. Crystal Mackall at the National Cancer Institute. His research interests lie in the optimization of chimeric antigen receptor (CAR) T cell therapies for sarcomas and other solid tumors. Dr. Majzner received his M.D. from Harvard Medical School, and completed his pediatric residency at Columbia University and fellowship in pediatric hematology-oncology at the joint program of Johns Hopkins University and the National Cancer Institute.

Kintara Therapeutics (Formerly DelMar Pharmaceuticals) Announces Completion of Merger with Adgero Biopharmaceuticals and Closing of $19.6 Million Private Placement Priced At-The-Market

On August 20, 2020 Kintara Therapeutics, Inc. (formerly DelMar Pharmaceuticals, Inc.) ("Kintara" or the "Company") (Nasdaq: KTRA) reported that it has completed its merger with Adgero Biopharmaceuticals Holdings, Inc. (Adgero) (Press release, DelMar Pharmaceuticals, AUG 20, 2020, View Source [SID1234563907]). Commencing today, August 20, 2020, the combined company will operate as Kintara Therapeutics, Inc. and its shares of common stock will commence trading on the Nasdaq Capital Market under the ticker symbol "KTRA." Kintara is a diversified biopharmaceutical company with multiple oncology product candidates in development, including VAL-083 for the treatment of drug-resistant solid tumors such as glioblastoma multiforme (GBM) and REM-001 for the treatment of cutaneous metastatic breast cancer (CMBC).

Concurrent with the closing of the merger, the Company closed its previously announced private placement with investors providing for the sale and issuance of 19,587 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market. The Preferred Stock is convertible into shares of the Company’s common stock at a conversion price of $1.16 per share. The offering resulted in gross proceeds to the Company of approximately $19.6 million.

The Company intends to use the net proceeds from the offering to fund the previously announced registration study for VAL-083 in newly diagnosed and recurrent GBM, the 15-patient REM-001 confirmatory lead-in study intended to continue seamlessly into a full Phase 3 pivotal study for CMBC, and for working capital. Also, as previously disclosed, the GBM trial will be executed through the Company’s partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in GBM.

The Preferred Stock accrues dividends payable in shares of the Company’s common stock on the first four anniversaries of the closing of the private placement as long as the Preferred Stock has not been converted, with percentages ranging from 10% in year one to 25% in year four.

The board of directors of Kintara is now comprised of Robert Hoffman, Laura Johnson, Rob Toth and Saiid Zarrabian, who are current directors of the Company, and John Liatos and Keith Murphy from Adgero.

The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Termination of a Material Definitive Agreement

On August 20, 2020, AnaptysBio, Inc. ("AnaptysBio") reported that sent a notice of breach to GlaxoSmithKline and TESARO, Inc., a wholly-owned subsidiary of GSK (collectively, "GSK"), stating that GSK is in breach of its obligations under the Collaboration and Exclusive License Agreement by and between TESARO, Inc. and AnaptysBio (the "GSK Agreement"), and notifying GSK that the GSK Agreement will terminate with regard to PD-1 antagonists, including dostarlimab, which will thereby revoke any licenses and rights granted pertaining to the program, if such breach is not cured within the 60-day time period required by the GSK Agreement (Filing, 8-K, AnaptysBio, AUG 20, 2020, View Source [SID1234563906]).

Pursuant to the GSK Agreement, GSK has a license to certain antibodies originally developed by AnaptysBio, including dostarlimab, a PD-1 antibody product candidate in the late-stages of clinical development, with FDA approval of an accepted biological license application (BLA) for a first indication anticipated during 2020 and regulatory submission for a second indication anticipated in the first half of 2021, according to GSK.

Under the terms of the GSK Agreement, GSK agreed that it would not conduct or participate in research, development, manufacturing or commercialization of any PD-1 antagonist other than those licensed by AnaptysBio to GSK. The GSK Agreement also provides that GSK will "use Commercially Reasonable Efforts to . . . (e) commercialize Products and attempt to obtain the optimum commercial return for each Product in all major markets throughout the world." In contravention of the exclusivity and diligence provisions of the GSK Agreement, GSK recently announced plans to begin a Phase 3 clinical trial involving a third-party anti-PD-1 antibody, Merck’s Keytruda, and GSK’s drug, Zejula in non-small cell lung cancer. The aforementioned Phase 3 trial is being initiated subsequent to previous proposals from Tesaro to waive PD-1 antagonist exclusivity terms under the GSK Agreement, which AnaptysBio has explicitly declined.

While we hope to resolve this matter amicably, we have also, as of August 20, 2020, filed a Verified Complaint (the "Complaint") in Delaware Chancery Court, requesting a preliminary injunction to enjoin GSK’s current planned clinical trial using GSK’s Zejula in combination with Keytruda, without the consent of AnaptysBio and in breach of the GSK Agreement. In addition to enjoining this planned clinical trial, AnaptysBio is seeking specific performance of return of all PD-1 antagonist related rights under the GSK agreement, including the dostarlimab program, across all clinical indications, to AnaptysBio, pursuant to the termination provision of the GSK Agreement. In addition to the Complaint, AnaptysBio also filed a Motion to Expedite Proceedings, requesting a court schedule to expedite trial to occur as soon as possible but no later than March 2021. Milestone and royalty payment obligations due to AnaptysBio pursuant to the GSK Agreement will continue during the proceedings.

Genmab Announces Janssen Granted U.S. FDA Approval for DARZALEX® (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma

On August 20, 2020 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy (Press release, Genmab, AUG 20, 2020, View Source [SID1234563905]). A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

"We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR study
The Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study
The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.