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Cytocom, Inc. Announces Agreement to Reacquire Rights to Lead Drug Candidate CYTO-201 and CYTO-401 in Emerging Markets

On August 20, 2020 Cytocom, Inc. (Cytocom), a clinical-stage biopharmaceutical company developing novel immune modulating therapies based on proprietary platforms, reported the company and Immune Therapeutics, Inc. (OTC: IMUN; Immune) have entered into an agreement to reacquire the emerging market rights to distribute and market its late-stage investigational drug candidates CYTO-201 and CYTO-401 (Press release, Cytocom, AUG 20, 2020, https://www.prnewswire.com/news-releases/cytocom-inc-announces-agreement-to-reacquire-rights-to-lead-drug-candidate-cyto-201-and-cyto-401-in-emerging-markets-301115965.html [SID1234568903]). The agreement contemplates the execution of certain additional documents and consents in order to complete the assumption of various liabilities from noteholders and other creditors. The company does not anticipate any issues with the closing of this transaction, which is expected by the end of the third quarter 2020.

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As part of the 2014 spin off of Cytocom as a separate company, Immune licensed the rights to make and sell therapeutics containing CYTO-201 and CYTO-401 in over 80 countries, including Brazil and China. Cytocom is now reacquiring this license in exchange for the assumption of up to approximately $5 million of Immune liabilities.

"We are excited by this transaction and the opportunity to pursue the development of these products for indications such as cancer and HIV, not just in the U.S., but in other major markets such as Brazil and China," said Michael Handley, Cytocom CEO. "This agreement is consistent with our renewed strategic focus, and we look forward to advancing efforts to bring these potential new treatment options to patients as quickly as possible."

Cytocom’s lead investigational drug candidate, CYTO-201, an immune modulator, is now being studied in late-stage clinical trials for Crohn’s disease, fibromyalgia, multiple sclerosis and the human immunodeficiency virus (HIV), and is awaiting FDA clearance of an Investigational New Drug Application (IND) for a Phase 2 study in COVID-19. CYTO-401 is being developed as a cancer immunotherapy and antiviral therapy targeting HIV, as well as the H1N1 virus.

Admission to trading of Biofrontera’s 1.00% qualified subordinated mandatory convertible bond 2020/2021

On August 20, 2020 Biofrontera AG (shares of Biofrontera AG ISIN: DE 00 6046113) reported the successful placement of the 1.00% qualified subordinated mandatory convertible bond 2020/2021 with gross proceeds of EUR 7.9 million (Press release, Biofrontera, AUG 20, 2020, View Source [SID1234568551]). Within the scope of the issuance, 2,638,150 qualified subordinated mandatory convertible bearer bonds (the "Bond") were issued . The subscription price equaled 100% of the nominal value, corresponding to EUR 3.00 per Bond.

The mandatory convertible bond 2020/2021, with the German Securities Identification Number A3E454 / ISIN DE000A3E4548, matures on December 20, 2021 and has been admitted for trading on the Open Market of the Frankfurt Stock Exchange as of today, August 20, 2020.

According to Section 8 (2) of the terms and conditions of the mandatory convertible bond 2020/2021, the issuer Biofrontera AG, has, for an unlimited period of time, the right of "mandatory conversion" any time after the stock price of Biofrontera’s shares (ISIN: DE0006046113) has exceeded EUR 4.50 at least once ("Mandatory Conversion Trigger Price"). The relevant stock price shall be the daily volume-weighted average quotation of the issuer’s shares determined on the XETRA trading platform of the Frankfurt Stock Exchange within a continuous period of fifteen trading days. The Mandatory Conversion Trigger Price has already been exceeded as of today according to the calculation described above, and the relevant average price stands at EUR 4.8350. The issuer reserves the right to decide at what point in time it will exercise its right of mandatory conversion and will select the most appropriate time to do so after taking into account all foreseeable circumstances. According to Section 16 of the terms and conditions of the mandatory convertible bond, the request for mandatory conversion will be published in the Federal Gazette as well as via a corporate news release.

US FDA Awards Fast Track Designation (FTD) to Paxalisib for Glioblastoma

On August 20, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kazia’s paxalisib (formerly GDC-0084) for the treatment of glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, AUG 20, 2020, View Source [SID1234564080]).

Key Points

Fast Track Designation (FTD) is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions
FTD provides Kazia with substantially enhanced access to FDA, including opportunities for face-to-face meetings and written consultation throughout the remaining development of paxalisib
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval
FTD also allows for ‘rolling review’, whereby Kazia may submit completed sections of the paxalisib NDA as they become available, rather than at the end of development
Kazia consequently plans to begin initial preparatory activities for NDA filing for paxalisib in CY2021
Kazia CEO, Dr James Garner, commented, "in awarding Fast Track Designation to paxalisib, FDA has recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement. The opportunities that Fast Track Designation creates, as we move towards an NDA filing, are of great value and have the potential to substantially accelerate the commercialisation of paxalisib. In particular, the ‘rolling review’ process enables Kazia to complete and submit substantial sections of our NDA filing in advance, saving time and reducing risk for the product. We look forward to working closely with FDA as we move into the final stage of development for paxalisib."

The specific indication for which FTD has been approved is "for the treatment of patients with newly diagnosed glioblastoma with unmethylated O6-Methylguaninemethyltransferase (MGMT) promotor status who have completed initial radiation with concomitant temozolomide." This language precisely reflects the patient population studied in the ongoing phase II study, and is the primary proposed population for the GBM AGILE pivotal study, and is the intended indication at commercial launch.

Kazia announced on 7 August 2020 that FDA had granted paxalisib Rare Pediatric Disease Designation (RPDD) for DIPG, an aggressive childhood brain cancer. For clarity, this granting of FTD for glioblastoma is not specifically connected to the prior granting of RPDD in DIPG.

Fast Track Designation

Introduced under the FDA Modernization Act (1997), Fast Track Designation (FTD) may be awarded by FDA to investigational drugs which treat a serious or life-threatening condition, and which fill an unmet medical need. FDA notes that ‘the purpose [of the Fast Track program] is to get important new drugs to the patient earlier.'[1] FTD must be requested by the sponsor company and must be accompanied by a detailed review of both preclinical and clinical data. To be awarded FTD, drugs must generally be able to show some potential advantage over existing therapies, either in terms of safety or efficacy.

The key benefits of FTD comprise enhanced access to FDA, with regular and more frequent opportunities for consultation and discussion. In addition, drugs with FTD may be eligible for Accelerated Approval, in which a new medicine is approved prior to the availability of definitive data, and Priority Review, in which the standard 12-month review process is reduced to six months. Drugs with FTD may also enter a ‘rolling review’ of their NDA submission, in which sections are submitted and reviewed as they become available, substantially expediting the approval process.

Next Steps

Kazia completed recruitment to its phase II clinical trial of paxalisib in newly diagnosed glioblastoma in February 2020, and interim clinical data was presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020. Overall survival was calculated at 17.7 months, which compares favourably to a historical figure of 12.7 months for temozolomide, the existing FDA-approved standard of care.

Kazia expects to present further data from this study in 2H CY2020, and to conclude the study in early CY2021.

Paxalisib has been selected to join the international GBM AGILE pivotal study in glioblastoma, and recruitment is expected to begin in 2H CY2020.

Targovax ASA: second quarter and first half 2020 results

On August 20, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its second quarter and first half 2020 results (Press release, Targovax, AUG 20, 2020, View Source [SID1234564007]).

An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

HIGHLIGHTS FOR THE SECOND QUARTER AND FIRST HALF 2020
Data
Announced encouraging clinical and immune data in mesothelioma combining ONCOS-102 and chemotherapy demonstrating that ONCOS-102 activates patients’ immune system far more extensively than chemotherapy
Presented interim data from safety lead-in cohort in the ovarian and colorectal (peritoneal metastasis) trial at ASCO (Free ASCO Whitepaper)
Presented pre-clinical data from Next Generation ONCOS at AACR (Free AACR Whitepaper)
Completed enrollment in the melanoma trial
Collaborations
Entered into a collaboration with Merck to test ONCOS-102 in combination with Keytruda and chemotherapy in mesothelioma
Entered into a collaboration with Leidos to equip ONCOS viruses with genetic elements encoding for small peptides with checkpoint inhibitor functionality
Entered into an option agreement with IOVaxis Therapeutics for a TG mutant RAS vaccine license agreement in Greater China and Singapore
Entered into a collaboration to develop mutant RAS neoantigen coating of ONCOS viruses using Valo Therapeutic’s PeptiCRAd technology
Entered into a collaboration with Oblique Therapeutics to target mutant RAS cancers by combining both companies’ technology platforms
Corporate
Completed a private placement, raising NOK 101 million (USD 11.2 million)
Announced election of Damian Marron as Chairman of the Board
Appointed Dr Victor Levitsky, MD, PhD as CSO
Øystein Soug, CEO commented: "Targovax had a highly productive second quarter this year. Most importantly, we reported 12-month immune and efficacy data for ONCOS-102 in mesothelioma, our lead indication, in combination with standard of care chemotherapy (SoC). Based on the promising findings so far, we have started preparations for a subsequent randomized phase II trial where we will add a checkpoint inhibitor to the ONCOS-102 and chemotherapy combination. We are very pleased to have secured a clinical collaboration agreement with Merck for this trial, who will provide Keytruda and valuable scientific and clinical support for the trial. Additionally, three new innovative collaborations, of which two of them were RAS collaborations, were signed during the quarter, indicating a high interest in Targovax."

Presentation
As a consequence of the Corona situation, there will not be a physical presentation of the results. Instead, we invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

Moffitt Cancer Center Names Patrick Hwu, M.D., as President and CEO

On August 20, 2020 Moffitt Cancer Ctr reported that World-renowned tumor immunologist Patrick Hwu, M.D., has been appointed the new president and CEO of Moffitt Cancer Center (Press release, Moffitt Cancer Ctr, AUG 20, 2020, View Source [SID1234563959]). He joins Moffitt from The University of Texas MD Anderson Cancer Center, where he is the division head of Cancer Medicine. Hwu begins his new role at Moffitt on Nov. 10.

Patrick Hwu, M.D., president and CEO, Moffitt Cancer CenterPatrick Hwu, M.D., president and CEO, Moffitt Cancer Center
"Dr. Hwu is truly a cancer visionary ready to elevate Moffitt to even greater success," said Tim Adams, chair of Moffitt’s Institute Board of Directors. "Drawing from his innovative cancer research, quality patient care and extensive leadership experience, Dr. Hwu will no doubt continue to help Moffitt in our pursuit of dynamic growth and groundbreaking work."

"It is my distinct honor and privilege to be selected as the next president and CEO of Moffitt Cancer Center, which has made unprecedented strides in its 34 years in the prevention and treatment of cancer," Hwu said. "I look forward to bringing my years of experience as a cancer physician, researcher and leader to help advance the outstanding work already underway by the teams of cancer experts at Florida’s top-ranked cancer hospital. I’m confident that our collective efforts will further elevate Moffitt’s leadership in cancer patient care, research and education."

Hwu brings 33 years of oncology experience to Moffitt. He held various leadership roles during 17 years at MD Anderson, including chair of the Department of Sarcoma Medical Oncology and co-director of the Center for Cancer Immunology Research. He was the first chair of the Department of Melanoma Medical Oncology. Known for leading transformative research into the clinic, Hwu helped pioneer the field of gene modified T cells, publishing research on the first chimeric antigen receptor directed against cancer. His work focuses on vaccines, adoptive T-cell therapies and immune resistance. He is the principal investigator on a National Institutes of Health SPORE grant for melanoma and has more than 270 peer-reviewed publications.

Hwu is vice president/president elect at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), serves on the Melanoma Research Alliance Foundation Medical Advisory Panel in Washington, D.C., and is a member of numerous scientific advisory boards throughout the U.S.

Founder H. Lee MoffittFounder H. Lee Moffitt
"Dr. Patrick Hwu is a nationally respected physician-scientist with the vision to lead Moffitt into the future," said founder H. Lee Moffitt. "Coming from the largest cancer center in the country, where he has distinguished himself and produced incredible results, we expect he will successfully guide the Moffitt team through the next generation of cancer treatments and discoveries.

"I’m confident Dr. Hwu will inspire and continue our mission to contribute to the prevention and cure of cancer. Our impact on helping cancer patients will be felt worldwide and, in the process, continue to make Florida proud," Moffitt said.

Russell Reynolds Associates, a global leadership advisory and search firm, led the extensive and competitive national search.

Hwu earned his medical degree from The Medical College of Pennsylvania. He served as a house officer in Internal Medicine at The Johns Hopkins Hospital and completed a fellowship in oncology at the National Cancer Institute.