On August 15, 2022 AIM ImmunoTech Inc. (NYSE: American AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the second quarter 2022 and provided a business update (Press release, AIM ImmunoTech, AUG 15, 2022, View Source [SID1234618371]).

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"As the second quarter results demonstrate, we believe we are closer than ever to unlocking Ampligen’s commercial potential," commented Thomas K. Equels, Chief Executive Officer of AIM. "Notably, we have recently seen the publication of positive clinical data regarding several unmet medical needs in highly lethal malignancies. We have a strong clinical development program, sufficient operating capital and enough Ampligen to support new clinical trials. Despite ongoing headwinds for the biotech sector, we believe we are well-positioned to take advantage of the value-driving catalysts across our pipeline and look forward to generating near- and long-term shareholder value. Finally, we remain focused on delivering sufficient data on Ampligen in oncology, which we believe could contribute to significant value creation."

Recent Highlights

Reported positive follow-on patient data from a Single-Center Named Patient Program evaluating Ampligen as maintenance therapy for advanced pancreatic cancer indicating additional progression-free and overall survival over previously published data.
Provided a summary of Ampligen data supporting synergistic potential with checkpoint blockade therapies. See: "Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer."
Provided an update on advancement of Ampligen clinical development program for the treatment of pancreatic cancer and announced the engagement of Amarex Clinical Research LLC, a world-renowned CRO, to conduct the upcoming Phase 2 study.
Reported positive data from Phase 2a study evaluating Ampligen as a component of a chemokine modulatory (CKM) regimen for the treatment of colorectal cancer metastatic to the liver.
Reported positive data from a Phase 1 study evaluating Ampligen for the treatment of stage 4 metastatic triple negative breast cancer.
Reported positive preliminary pilot study data from its ongoing Expanded Access Program (AMP-511) evaluating Ampligen as a therapeutic for "Long COVID." The preliminary data from this uncontrolled clinical trial found that patients reported significant improvements in fatigue symptoms after treatment with Ampligen compared to baseline, which the investigators considered a clinically significant decrease in fatigue-related measures. Based on these early results, AIM is working to move forward with a Phase 2 controlled trial.
Secured new state-of-the-art facility for product development and testing to advance research and development of Ampligen to treat multiple types of cancers, immune disorders, and viral diseases.
Bolstered intellectual property portfolio for Ampligen with issuance of new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products for use in COVID-19 treatment or prevention.
Clinical Program Update

Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system

Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies – in advanced recurrent ovarian cancer and triple negative breast cancer – that indicate that the drug may have similar anti-tumor activity in humans.

Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the U.S.. Ampligen is also being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Immuno-Therapy Targeting Multiple Cancers with High Unmet Need

Locally Advanced Pancreatic Cancer ("LAPC") – The Company recently reported new, positive data following evaluation of the initial data reported from the single-center named patient program at Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and those data show high statistical significance, a small cohort of five (5) LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy following FOLFIRINOX. The overall survival from the start of FOLFIRINOX therapy of two (2) of the patients was 34 and 43 months and one patient was still surviving at the last reported checkup in April 2022 at 54 months. The Company’s Phase 2a study Investigational New Drug ("IND") application was cleared by the U.S. Food and Drug Administration ("FDA") and is on track to commence in Q3 2022. The study will compare the efficacy of Ampligen following FOLFIRINOX versus a control group that previously received FOLFIRINOX but no Ampligen for subjects with locally advanced pancreatic adenocarcinoma. Approximately 90 subjects expected to be enrolled across up to 30 centers in the U.S. and Europe.
Advanced Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1 portion was completed. The Phase 2 portion of the study is planned to be conducted in the future. ClinicalTrials.gov: NCT02432378
Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver was completed and met primary endpoint, evidenced by increased CD8a expression post-treatment (p=0.046).; 15 patients were treated and 12 patients were evaluable for the primary endpoint. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. The data from the Phase 2a study was presented in April 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met primary endpoint. Positive data from this proof-of-concept study demonstrate that short-term systemic CKM followed by pembrolizumab is well-tolerated and selectively enhances local cytotoxic T-lymphocyte (CTL) infiltration in the tumor microenvironment (TME). The data from the Phase 1 study was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April 2022. ClinicalTrials.gov: NCT03599453
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. ClinicalTrials.gov: NCT03899987
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 and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. Investigators are currently analyzing data. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)

Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.

The FDA has authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518

Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler

The Company is currently sponsoring an ongoing, FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813) expanded access program (EAP) for ME/CFS patients in the United States. AIM has enrolled four post-COVID patients with new onset ME/CFS following acute COVID-19. Following at least 12 weeks of Ampligen treatment, each of these four patients indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.002), despite the small number of patients. Based in part on these early positive data, AIM is working toward filing an IND application with the FDA for a Phase 2 study of Ampligen for the treatment of post-COVID conditions.

Recent Ampligen Data Publications

Presented data at the prestigious American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022:
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod
Initial results of a phase II study evaluating a chemokine-modulatory (CKM) regimen in patients with colorectal cancer metastatic to the liver
Systemic Rintatolimod and Interferon-α2b selectively reprogram local tumor microenvironment in patients with metastatic triple negative breast cancer for enhanced influx of cytotoxic T-lymphocytes but not regulatory T-cells
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer
Presented Rintatolimod: a potential therapeutic molecule for human pancreatic cancer cells expressing Toll-Like Receptor 3 at the 15th Annual International Hepato-Pancreato-Biliary Association (IHPBA) World Congress.
Summary of Financial Highlights for Second Quarter 2022

As of June 30, 2022, AIM reported cash and cash equivalents of $34.5 million, compared to $32.1 million as of December 31, 2021.
Research and development expenses for the three months ended June 30, 2022 were $2.5 million, compared to $XX1.3 million for the same period in 2021.
General and administrative expenses were $2.2 million for the three months ended June 30, 2022, compared to $2.1 million for the same period in 2021.
The net loss from operations for the three months June 30, 2022 was $4.9 million, or $0.10 per share, compared to $5.9 million, or $0.12 per share, for the three months ended June 30, 2021.

On August 15, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported a clinical trial supply agreement with Novartis to evaluate tislelizumab, an anti-PD-1 immune checkpoint inhibitor, in combination with HiFiBiO’s HFB200301, an investigational first-in-class monoclonal anti-TNFR2 agonist antibody for the potential treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform (Press release, HiFiBiO Therapeutics, AUG 15, 2022, View Source [SID1234618370]).

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HFB200301 is currently being evaluated as a single agent in the first-in-human dose escalation and expansion clinical trial (NCT05238883), with the intention of following up with a combination of HFB200301 and tislelizumab.

"Immuno-oncology therapies have significantly improved the way we treat cancers. Unfortunately, they are not effective in every patient, and many individuals are still left with few options. Combination immunotherapy approaches have become a promising solution for harder to treat cancers," said Luigi Manenti, M.D., Chief Medical Officer at HiFiBiO Therapeutics. "HFB200301 has the potential to reenergize the immune system to fight against cancers, both as a single agent and in combination. We are excited to explore whether HFB200301 in combination with tislelizumab can further improve patient outcomes in DIS selected cancers."

"HiFiBiO is proud to highlight the potential of our DIS platform to rapidly advance novel therapeutics like HFB200301 from targets to patients. Additionally, this collaboration showcases our continuing commitment to Open Innovation for the benefit of cancer patients with high unmet needs," said Liang Schweizer, Ph.D., Founder, Chairperson and CEO at HiFiBiO Therapeutics.

Under the terms of the agreement, HiFiBiO Therapeutics will maintain control of the HFB200301 program, including global R&D and commercial rights. Novartis has agreed to supply tislelizumab for use in combination with HFB200301.

HFB200301

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select indications that may benefit the most from HFB200301 treatment. HFB200301 is an investigational agent. Safety and efficacy have not been established. There is no guarantee that HFB200301 will become approved and commercially available anywhere globally.

Tislelizumab
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

On August 15, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended June 30, 2022 and provided a corporate update (Press release, Tempest Therapeutics, AUG 15, 2022, View Source [SID1234618369]).

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"In the second quarter, we presented promising trial results from TPST-1120, our novel PPARα antagonist, at the ASCO (Free ASCO Whitepaper) Annual Meeting. This was the first presentation of clinical data from a Tempest program: a significant milestone for the company that was enhanced by its selection for a podium presentation," said Stephen R. Brady, chief executive officer of Tempest. "In addition to progress on our other programs, we closed a financing with support from both a new, top-tier investor and our founding investor that extended Tempest’s runway into the first quarter of 2024, providing additional stability during this turbulent time in the biotech capital markets."

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) presented data from the monotherapy and combination therapy arms of the TPST-1120 Phase 1 study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting; (ii) hosted a well-attended investor event at ASCO (Free ASCO Whitepaper) during which multiple key thought leaders discussed Tempest’s programs; and (iii) continued enrollment in a first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented a "trials in progress" poster for the ongoing TPST-1495 Phase 1 monotherapy and combination therapy clinical trial at ASCO (Free ASCO Whitepaper); and (iii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Financing: closed $15 million private investment in public equity (PIPE) financing with new investor, EcoR1 Capital, and founding investor, Versant Venture Capital.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): early data from the first 40 patients in the first-line randomized global Phase 1b/2 study in patients with HCC under a collaboration with F. Hoffmann La Roche expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023, with planned presentation of the combined data in 2023.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2022 with $51.6 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $15.5 million offset by proceeds from the PIPE financing of $14.5 million (net of issuance costs).
Net loss and net loss per share for the second quarter of 2022 were $9.2 million and $0.79, respectively, compared to $7.1 million and $7.63, respectively, for the second quarter of 2021.
Research and development expenses for the second quarter of 2022 were $5.7 million compared to $4.2 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and higher compensation expenses due to an increase in employee headcount.
General and administrative expenses for the second quarter of 2022 were $3.1 million compared to $2.6 million for the same period in 2021. The increase of $0.5 million was primarily due to higher professional and consulting fees and insurance expense as a result of operating as a publicly-traded company.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2022 was $15.5 million.
Net loss and net loss per share for the six months ended June 30, 2022 were $17.7 million and $1.88, respectively, compared to $12.4 million and $17.30, respectively, for the same period in 2021.
Research and development expenses for the six months ended June 30, 2022 were $10.8 million compared to $7.8 million for the same period in 2021. The $3.0 million increase was primarily due to expanded research and development efforts and higher personnel-related costs.
For the six months ended June 30, 2022, general and administrative expenses were $6.2 million compared to $4.1 million for the same period in 2021. The increase of $2.1 million was primarily due to an increase in professional and consulting fees and higher insurance expense as a result of operating as a publicly-traded company.

On August 15, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported Brian M. Culley, Lineage’s Chief Executive Officer, will present at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference, in a fireside chat hosted by Joseph Pantginis, Ph.D., Director of Research; Managing Director, Equity Research, H. C. Wainwright & Co. LLC (Press release, Lineage Cell Therapeutics, AUG 15, 2022, https://investor.lineagecell.com/news-releases/news-release-details/lineage-present-hc-wainwright-co-2nd-annual-virtual [SID1234618368]). The fireside chat will be available to investors on demand, starting on August 17th, 2022 at 7am ET.

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Interested parties can register to view on-demand replay on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

On August 15, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide, reported a strategic agreement with Ontada, a McKesson business with leading provider technology and actionable real-world research, education, and evidence in oncology, to improve U.S. community oncology care through the development of real-world evidence (RWE) data, tools, and insights to help increase access to affordable, cutting-edge therapies (Press release, BeiGene, AUG 15, 2022, View Source [SID1234618367]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The partnership will be led by Ontada and focus on accelerating the development and implementation of RWE to improve community education on the financial impact and value of oncolytics as well as improve patient access to oncology medicines.

"BeiGene is excited to work with Ontada to advance our shared vision of improving patient access, affordability, and value for community oncology stakeholders and key partners working at the intersection of clinical practice and real-world evidence," said Josh Neiman, Chief Commercial Officer, North America and Europe, at BeiGene. "Working together, BeiGene and Ontada will generate novel oncology insights through real-world data, tools, and technologies that will facilitate the acceleration of precise decision-making in support of community oncology practices whose ultimate mission is to improve patient outcomes."

As part of the collaboration, the companies will optimize the use of RWE to communicate value across key stakeholders including patients, providers, and payers; develop timely education on emerging science and therapeutic differentiation; and collaborate to advance use of RWE in healthcare and regulatory decision making to increase timely and affordable patient access to life-saving oncology therapies.

"BeiGene aims to bring 10 molecules per year to the clinic starting in 2023 and, as this research advances, we’re delighted to form this strategic partnership with McKesson, which shares the same vision as BeiGene for improving the care of cancer patients," said Christiane Langer, M.D., Senior Vice President of Global Medical Affairs, Ex-China, at BeiGene. "This collaboration will leverage Ontada’s technology platform and deep understanding of the experiences of patients treated in community oncology clinics to help accelerate both the development of the BeiGene portfolio and expand access to treatment options."

"As a leader in real-world research, Ontada is uniquely positioned to support complex research that uncovers deeper patient insights and perspectives that advance cancer care," said Susan Shiff, Ph.D., president of Ontada. "We are excited to announce this unique partnership with BeiGene and look forward to developing a stronger understanding of how to better treat oncology patients through the use of real-world data and evidence."