On August 17, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James F. Oliviero, President and Chief Executive Officer, will present a company overview and participate in a panel discussion at the Fortress Biotech Virtual Summit hosted by Mayank Mamtani, of B. Riley FBR, Inc., on Wednesday, August 19, 2020 at 1:50 p.m. ET (Press release, Checkpoint Therapeutics, AUG 17, 2020, View Source [SID1234563713]). A registration link and webcast information can be found below.

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The panel discussion will focus on cosibelimab, Checkpoint’s potentially best-in-class anti-PD-L1 antibody. Mr. Oliviero will be joined on the panel by David M. Miller, M.D., Ph.D., who will provide his insight on the use of immunotherapy in cutaneous squamous cell carcinoma ("cSCC") and the issues patients face when accessing available treatments. Dr. Miller is an Instructor in Dermatology and Medicine at Harvard Medical School and member of the Department of Dermatology and the Department of Medicine at Massachusetts General Hospital, where he is Director of the Center for Merkel Cell Carcinoma and Co-Director of the MGH-MEEI Non-Melanoma Skin Cancer Multi-Disciplinary Clinic.

Checkpoint will present updated interim safety and efficacy data from its ongoing registration-enabling clinical trial of cosibelimab in patients with metastatic cSCC at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020, to be held September 19-21, 2020. Checkpoint recently announced that the trial is over half enrolled, with full enrollment anticipated around year-end.

Registration link and webcast information:

Please click here to register for the event on Wednesday, August 19, 2020.
Following the event, the webcast will be available on the Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days.

On August 17, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported that the first patient has been dosed with Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597) (Press release, Precigen, AUG 17, 2020, View Source [SID1234563712]). HPV-associated cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

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The Phase I portion of the study will use 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with bintrafusp alfa as a neoadjuvant or induction therapy in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.

PRGN-2009 leverages Precigen’s proprietary UltraVector and AdenoVerse platforms to optimize HPV antigen design. Such design is differentiated from other therapies due to the gorilla adenovector’s large payload capacity and potential for repeat administration due to very low to no seroprevalence in the human population.

PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the laboratory of Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR), National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009. The Phase I/II clinical trial of PRGN-2009 is being conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB’s Clinical Trials Group, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, CCR, NCI. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

"We appreciate working in collaboration with such renowned partners at the NCI to achieve this important milestone in our efforts to develop a new off-the-shelf immunotherapy treatment option for patients with HPV-associated cancers," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are excited to investigate Precigen’s proprietary gorilla adenovector platform for the first time in a clinical setting and achieve this milestone during the COVID-19 global pandemic."

About HPV-associated Cancers
HPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in the United States each year. Of these, approximately 25,000 occur in women and 19,000 occur in men.2 HPV is considered responsible for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers.2 Recent studies indicate that about 70% of cancers of the oropharynx also may be related to HPV.2

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.

For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

References
1 HPV and Cancer, National Institutes of Health. Accessed in July 2020
2 HPV-Associated Cancer Statistics, Centers for Disease Control and Prevention. Accessed in July 2020

Trademarks
Precigen, AdenoVerse, UltraVector, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company’s business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company’s portfolio of therapies, the Company’s refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company’s non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company’s clinical trial might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

On August 17, 2020 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, reported a business and pre-clinical/clinical update for the second quarter ended June 30, 2020 (Press release, AIM ImmunoTech, AUG 17, 2020, View Source [SID1234563711]).

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Second Quarter 2020 Financial Highlights:

As of June 30, 2020, AIM had cash, cash equivalents and marketable securities of $40.3 million, as compared to $8.8 million as of December 31, 2019.
Research and development expenses for the second quarter ended June 30, 2020 were $1.46 million, compared to $1.10 million for the second quarter ended June 30, 2019.
General and administrative expenses for the second quarter ended June 30, 2020 were $1.72 million, compared to $1.94 million for the second quarter ended June 30, 2019.
The Company’s complete financial results are available in the Company’s June 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on August 14, 2020, which is available at www.sec.gov and on the Company’s website.

"AIM is engaged in extremely important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs such as COVID-19 and cancer-providing us ‘multiple shots on goal’ within large addressable markets. Given these multiple indications, AIM’s strategy to support these trials has been to maximize third-party, non-dilutive funding directly awarded to the clinical sites, which we have accomplished in many of our trials. In addition, we had more than $40 million in cash, cash equivalents, and marketable securities on our balance sheet as of June 30, 2020. As a result, we believe we are extremely well positioned to execute on our strategy going forward, which, in turn, we expect will drive significant value for stockholders," said AIM CEO Thomas K. Equels.

COVID-19 General Updates:

Following the FDA’s authorization of an IND on May 11, 2020, AIM entered into a clinical trial agreement on July 6, 2020, with Roswell Park Comprehensive Cancer Center to support Roswell Park’s Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19, the disease caused by SARS-CoV-2. The trial is on track to commence patient enrollment soon.
AIM signed a trilateral material transfer and research agreement with Japan’s National Institute of Infectious Diseases and Shionogi & Co., Ltd., a leading global pharmaceutical company headquartered in Japan, in order to test Ampligen as a potential vaccine adjuvant for COVID-19. Ampligen has been shipped to Japan, to be followed up with an additional shipment.
AIM is currently collaborating with Shenzhen Smoore, the world’s largest vaping device manufacturer, to research the use of their innovative inhalation technology for enhaced delivery of Ampligen deep into the lungs at the first signs of COVID-19. The Company believes this approach may initiate a robust, therapeutic TLR3 response against the SARS-CoV-2 virus throughout the upper and lower respiratory system. Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China import regulatory requirements.
Ampligen has been shipped to Utah State University to support the University’s Institute for Viral Research in its pre-clinical testing againast SARS-CoV-2 and testing is underway.
COVID-19-induced Chronic Fatigue-like Illness Update:

Ampligen has proven to be a powerful drug conferring protective survival in SARS-CoV-1 animal experiments. Ampligen has also shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome (CFS) patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the first drug approved for severe CFS in the world. AIM is preparing to test Ampligen as a potential therapy for a SARS-CoV-2-induced chronic fatigue-like illness. AIM believes Ampligen may play an important role in addressing this multifaceted disease, including the potential post-infection debilitating aspects.
"There is a significant risk that SARS-CoV-2, the virus that causes COVID-19, will trigger a large number of chronic fatigue-like cases, similar to what occured in the prior SARS-CoV-1 epidemic," said Equels. "Ampligen’s strong history of preclinical outcomes with the SARS-CoV-1 virus gives AIM hope for the drug’s potential as a prophalaxis, as a vaccine adjuvant and as an early-onset treatment for the SARS-CoV-2 virus and for COVID-19-induced chronic fatigue-like illness. This potential therapy may be especially important for cancer patients, who face significantly increased risk of severe symptoms or death from COVID-19."

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Update:

AIM received clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen to Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. AIM has shipped Ampligen to its partner in Argentina, GP Pharm, which is required for testing and ANMAT release. Once final approval by ANMAT is obtained, the commercial launch of Ampligen in Argentina is planned. Further, AIM continues to pursue its Ampligen New Drug Application, or NDA, for the treatment of traditional CFS with the FDA.
Immuno-oncology Update: Equels further noted, "Given the advances in our third-party funded, investigator-sponsored cancer clinical trials, we believe there is real potential for AIM to become a powerhouse in oncology, as clinical data is reported in these trials. The fact that tens of millions of dollars in grants have been provided to world-class investigator/oncologists at top national cancer centers, from such esteemed organizations as Merck, the U.S. Department of Defense and the National Cancer Institute, clearly supports my faith in Ampligen."

Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center have both received "Breakthrough Awards" from the U.S. Department of Defense in Brain Metastatic Breast Cancer. Together, these separate-but-parallel proposed clinical trials are receiving approximately $15 million in federal funding in part with a significant focus upon Ampligen as a potential synergistic agent in combination with several other immunotherapies, including pembrolizumab (Keytruda) and Intron A.
The National Cancer Institute issued an award of $14.5 million to Roswell Park Comprehensive Cancer Center to fund five clinical trials in melanoma, colorectal and ovarian cancers. These trials will test chemokine modulation incorporating Ampligen as an immuno-modulator, as part of a strategy to turn "cold" tumors into "hot" tumors.
Advanced Recurrent Ovarian Cancer – This Phase 1/2 study of Ampligen as an intraperitoneal therapy in advanced recurrent ovarian cancer has completed 12 subjects in Phase 1; the Phase 1 portion established intraperitoneal safety sufficient to proceed with a larger Phase 2 study (See below). (View Source) We are awaiting publication of results. View Source
Advanced Recurrent Ovarian Cancer – Based upon the above, a 45-subject follow-up Phase 2 study of advanced recurrent ovarian cancer is underway principally funded via a Merck grant and using cisplatin, pembrolizumab and Ampligen. Enrollment commenced in January 2019 and numerous patients are now well into treatment. View Source (View Source)
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. All patients have been treated or are near completion of treatment. View Source
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as
component of chemokine modulatory regimen on colorectal cancer metastatic to liver; the majority of the 12 planned patients enrolled and treated. View Source
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. View Source
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization; the objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy; the goal of this approach is to increase survival. This study is recruiting and is designed for up to 24 patients. View Source
A study of Ampligen as a drug for late-stage pancreatic cancer is complete and the research team at Erasmus M.C. is currently compiling the final data from this early access approval-based study. We are enthusiastically awaiting the publication of these results.
With the nation’s health care system increasingly focused on the COVID-19 pandemic – and with cancer patients especially at risk for the disease – AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and subsequent reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. However, AIM intends to move forward without delay and we believe the teams at all of the clinical sites are eager to keep forward momentum.

On August 17, 2020 Mateon Therapeutics (OTC.QB: MATN), a leading developer of TGF-β therapeutics, reported financial results for the second quarter ended June 30, 2020 (Press release, Mateon Therapeutics, AUG 17, 2020, View Source [SID1234563710]). Unless otherwise stated, all comparisons are for the second quarter of 2020 compared to the second quarter of 2019.

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We recorded services revenue of $1.4 million during the three months ended June 30, 2020 as compared to no revenues during the same period ended in 2019. The revenue of $0.9 million was recorded from services provided to Golden Mountain Partners (GMP) during the period ended June 30, 2020 in connection with the development of OT-101 for COVID-19. We also recorded $0.5 million in revenues from Autotelic Bio (ATB) upon the successful completion of the in-vivo efficacy studies of OT-101 combination with IL-2 based on the ATB Agreement.

Research and development ("R&D") expenses increased by approximately $0.1 million for the three months ended June 30, 2020 compared to the same period in 2019. The higher R&D cost was primarily due to by higher amortization of intangibles of $0.1 million. The financial information presented does not include any R&D activity for PointR for the period ended June 30, 2019. General and administrative ("G&A") expenses increased by approximately $0.1 million for the three months ended June 30, 2020 compared to the three months ended June 30, 2019, primarily due to increases of approximately $0.1 million due to increase in legal and professional expenses.

As a result of our mergers with Oncotelic and PointR, we expect to increase R&D and G&A expenses, including the initiation of new clinical trials including those for COVID-19, and therefore believe that research and development expenses will increase for the remainder of 2020 compared to research and development expenses in 2019.

"We are pleased to announce that despite the challenges presented by the COVID-19 situation, we were able to achieve revenue of $1.4 million," said Amit Shah, CFO of Mateon. "Additionally, 2020 Financing has resulted in gross proceeds of $2.5 million to the Company. Coupled with the $2.0 million in debt funding by GMP specifically for the COVID-19 trial, the company is in a position to execute on its objectives, including the spinoff of Edgepoint in the coming months and the development of OT-101 and Artemisinin. Overall, the company has raised over $6.0 million between revenues and financing in 1H20."

"Based on the approval accorded by the shareholders of Mateon, we anticipate the name change of the Company to Oncotelic Inc. (Oncotelic) on or before the end of September. The change in name reflects the acquisition of Mateon by Oncotelic back in April 2019", said Dr. Vuong Trieu, CEO of Mateon. "In addition, the assets of the Company, in OT-101 and Artemisinin, are both Oncotelic assets and the Company has been developing them to create shareholder value. The legacy Mateon assets are being repositions as therapeutics for rare pediatric oncology and may be spun off in the future. Over the past year, the Company has been working on development of OT-101, as an Oncology therapeutic as well for COVID-19, as well as Artemisinin for COVID-19. We expect that the development of these drugs will enhance significant shareholder value for the Company. We are also developing technologies within the artificial intelligence space (AI) through our AI division in EdgePoint Inc. (EdgePoint). The Company will develop these technologies in-house and at the appropriate time, consider how to monetize of spin-off of these assets and technologies. We are confident our efforts will create significant shareholder value similar to companies within the similar space.

We expect the EdgePoint spinoff to be completed on or before year end. We are confident that the EdgePoint spinoff will be successful given the early involvement of luminaries such as IBM, Balaji Baktha – Leading Silicon Valley VC, and Dr. Sanjay Jha- the former CEO of Motorola and COO/President of Qualcomm.

On August 16, 2020, Immune Therapeutics, Inc. (the "Company" or "Immune") and Cytocom, Inc. ("Cytocom") reported that closed on an agreement for the Company to sublicense Lodonal ("LDN") and Methionine Enkephalin ("MENK") for emerging markets (Filing, 8-K, TNI BioTech, AUG 16, 2020, View Source [SID1234563748]). Under the terms of the agreement, Cytocom will assume approximately $5,200,000 in the Company’s note, loan and other financial obligations. Separate from the sublicensing agreement, the Company owns an equity stake of approximately 15% in Cytocom.

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Pursuant to the sublicensing agreement, Cytocom will assume the following approximate obligations of the Company: $1,051,000 in accrued liabilities and accounts payable, $3,038,000 in notes and loans payable, and $1,111,000 in obligations owed to former Immune employees.

The Company’s Board of Directors believes that despite the difficulty of the decision to take these actions, they are in the clear best interest of the Company and its shareholders and consistent with the Company’s forward-looking transition strategy of improving Immune’s financial position.