On August 18, 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 the commencement of its Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer ("LAPC") (AMP-270) following receipt of Institutional Review Board ("IRB") approval for the trial protocol (Press release, AIM ImmunoTech, AUG 18, 2022, View Source [SID1234618476]).

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AIM Chief Executive Officer Thomas K. Equels commented, "We are pleased to reach this important step in the development of Ampligen. Receiving IRB approval for our Phase 2 study of Ampligen for the treatment of LAPC is the pivotal precursor to the recruitment, enrollment and treatment of patients with locally advanced pancreatic cancer. We look forward to providing further updates on the development of this important therapy."

The Company’s Phase 2 study Investigational New Drug ("IND") application was previously cleared by the U.S. Food and Drug Administration ("FDA"). An IRB is a group that operates under FDA regulations and ensures, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

The AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in the Netherlands are expected to be the primary study sites.

"We expect study sites to be open and recruiting patients in late Q3/early Q4 of 2022, with every hope of first dose in the first patient by the end of Q4 2022," commented Kazem Kazempour, Ph.D., President and CEO of Amarex Clinical Research, LLC, AIM’s Contract Research Organization for AMP-270.

For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697.

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 See: AIM Press Release July 20, 2022.

About Ampligen

Ampligen is AIM’s dsRNA product candidate 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 success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently 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 country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

On August 18, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing the comprehensive data package submitted by Curis (Press release, Curis, AUG 18, 2022, View Source [SID1234618474]).

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"We are excited to announce that FDA has completed its review of the TakeAim Lymphoma study and has lifted the partial clinical hold. We are working with our clinical sites to quickly resume enrollment of new patients in this study in the third quarter," said James Dentzer, President and Chief Executive Officer of Curis.

Previously, Curis announced that the FDA had placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies on April 4 and April 11, 2022, respectively. The partial hold on the TakeAim Leukemia study was issued by the FDA Division of Hematologic Malignancies 1 (DHM1), which regulates clinical studies in leukemia. The partial hold on the TakeAim Lymphoma study, and the lifting of that hold, was issued by the FDA Division of Hematologic Malignancies 2 (DHM2), which regulates clinical studies in lymphoma. The partial clinical hold was lifted following agreement with the FDA on Curis’s strategy for rhabdomyolysis identification and management, as well as on the enrollment of at least nine additional patients at the 200 mg dose level of emavusertib in combination with ibrutinib.

With the partial clinical hold lifted on the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from this study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib, including alignment on optimal dose and development path, with DHM2 for the TakeAim Lymphoma study.

About Emavusertib (CA-4948)

Emavusertib is an IRAK4 kinase inhibitor and IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-kB protein complex. Additionally, third parties have recently discovered that the long form of IRAK4 (IRAK4-L) is oncogenic and preferentially expressed in over half of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The overexpression of IRAK4-L is believed to be driven by a variety of factors, including specific spliceosome mutations such as SF3B1 and U2AF1. In addition to inhibiting IRAK4, emavusertib was also designed to inhibit FLT3, a known oncologic driver, which may provide additional benefit in patients with AML and MDS.

About TakeAim Leukemia

The TakeAim Leukemia study (NCT04278768) is a Phase 1/2 open-label dose escalation, dose expansion clinical trial investigating emavusertib as a monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory (R/R) AML or high risk MDS. After dose escalation in both monotherapy and combination therapy to determine the recommended Phase 2 dose (RP2D), we plan to expand five cohorts: monotherapy in AML patients with spliceosome and FLT3 mutations, monotherapy in patients with MDS and spliceosome mutations and combination therapy with azacitidine or venetoclax in patients without spliceosome or FLT3 mutations. The goals of the study are to determine several parameters including safety, maximum tolerated dose (MTD), RP2D and signals of activity.

About TakeAim Lymphoma

The TakeAim Lymphoma study (NCT03328078) is a Phase 1/2 open-label, dose escalation, dose expansion clinical trial investigating emavusertib as monotherapy and in combination with ibrutinib in patients with R/R hematologic malignancies, such as non-Hodgkin’s lymphoma and other B cell malignancies. After dose escalation in both monotherapy and combination therapy to determine the RP2D, we plan to expand four cohorts for combination treatment: marginal zone lymphoma, activated b-cell diffuse large b-cell lymphoma, primary CNS lymphoma, and patients developing adaptive resistance to ibrutinib monotherapy. The goals of the study are to determine several parameters including safety, MTD, RP2D and signals of activity.

On August 18, 2022 The European Medicines Agency (EMA) reported that it had adopted a positive opinion regarding the application for conditional approval of Kinpeygo for the treatment of IgA nephropathy, and on July 15th the European Commission issued the market authorization for Kinpeygo in the European Economic Area (EEA) (Press release, Calliditas Therapeutics, AUG 18, 2022, View Source [SID1234618473]).

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This is the first time that any drug has achieved approval for this rare disease in Europe and we are delighted that we can contribute a piece of the puzzle in the broader effort to improve care for patients with orphan diseases. We have now initiated the transfer of our market authorization to our partner, STADA, and look forward to seeing Kinpeygo being launched in Europe. Having now received approval in both the US and

Europe we are looking forward to the regulatory process in China, where our partner, Everest Medicines, plans to file for approval with the NMPA in the second half of this year.

In the US we continue to have significant success in our early commercial efforts. Net revenues from TARPEYO grew by over 250% when compared to Q1, resulting in net revenues of SEK 63.6 million ($6.6m) from TARPEYO for Q2. This reflects the continued strong interest from nephrologists, with unique prescribers growing from 111 in Q1 to 314 prescribers during Q2 with enrolments growing significantly from 134 in Q1 to 315 in Q2. This is a testament both to the unmet medical need perceived by nephrologists for this patient group as well as significant interest from prescribers generated due to the strong proteinuria and eGFR data associated with our product.

We are thrilled to be another step closer to bringing the first approved medication in IgAN to patients around the world, and look forward to continuing to expand access for patients with an unmet medical need for the rest of the year and beyond."

CEO Renée Aguiar-Lucander

Summary of Q2 2022
April 1 – June 30
Net sales amounted to SEK 64.0 million, whereof TARPEYO net sales amounted to SEK 63.6 million, for the three months ended June 30, 2022. No net sales were recognized for the three months ended June 30, 2021.
Operating loss amounted to SEK 209.8 million and SEK 159.4 million for the three months ended June 30, 2022 and 2021, respectively.
Loss per share before and after dilution amounted to SEK 3.62 and SEK 3.22 for the three months ended June 30, 2022 and 2021, respectively.
Cash amounted to SEK 846.8 million and 709.3 million as of June 30, 2022 and 2021 respectively.
Significant events during Q2 2022, in summary
In May 2022, Calliditas announced that the first patient had been randomized in the Group’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib.
In May 2022, Calliditas announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a conditional marketing authorisation for Kinpeygo for the treatment of IgA nephropathy.
In May 2022, the Annual General Meeting of Calliditas was held and, among other things, the meeting decided on the election of Henrik Stenqvist and Elisabeth Björk to the Board of Directors and the establishment of a U.S. At-the-Market framework, pursuant to which Calliditas may, at its option, sell American Depositary Shares ("ADSs") in the United States.
Significant events after the reporting period
In July 2022, Calliditas announced that the European Commission (EC) granted conditional marketing authorization for Kinpeygo for the treatment of IgA nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Kinpeygo is an orphan medicinal product and became the first and only approved treatment for IgAN in Europe. Kinpeygo will be marketed in the European Economic Area (EEA) exclusively by STADA Arzneimittel AG.
Investor Presentation August 18, 2022 14:30 CET
Audio cast with teleconference, Q2 2022

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on August 18, 2022 at 07:00 a.m. CET.

On August 18, 2022 Vivesto reported that it will publish its Q2 report for 2022 on August 25, 2022, at 08.00 am CEST (Press release, Vivesto, AUG 18, 2022, View Source [SID1234618472]). The company will hold a conference call and an online presentation on the same day at 10.00 am CEST. The call will be hosted by Acting CEO Christer Nordstedt and Acting CFO Robert Maiorana. The presentation will be in English and followed by a question-and-answer session.

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On August 18, 2022 Immedica Pharma AB reported that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency), presented earlier by our valued partner PharmaMar (see full press release below) (Press release, Immedica Pharma, AUG 18, 2022, View Source [SID1234618471]).

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Anders Edvell, CEO says: "To be awarded an Innovation Passport under the new Innovative Licensing and Access Pathway means a lot to us. We are excited about engaging with UK healthcare system stakeholders through this new pathway to explore the opportunities for bringing Lurbinectedin to patients as quickly as possible".

The pressrelease from PharmaMar, follows below.

AUGUST 5, 2022

PharmaMar has announced today that Zepzelca (lurbinectedin) has received the Innovation Passport (Innovative Medicine Designation) by the MHRA (UK Medicines and Healthcare products Regulatory Agency).

The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. The ILAP comprises as the first step an "Innovation Passport" designation which supports innovative approaches to the safe, timely and efficient development of medicines to improve patient access. The criteria for the innovation passport include where the condition is life-threatening or seriously debilitating, or where there is a significant patient or public health need and where the medicinal product has the potential to offer benefits to patients (improved efficacy or safety, improved patient care or quality of life as compared to alternative therapeutic options).

Ali Zeaiter, M.D., VP Clinical Development & Regulatory Affairs of PharmaMar, said:

"Lurbinectedin is an innovative medicine that showed clinical benefit for patients with relapsed Small Cell Lung Cancer (SCLC) and obtained provisional approvals in a number of countries (including USA, Canada and Australia) and is being developed in other clinically significant indications. SCLC represents an unmet medical need in the UK and worldwide, and our objectives are aligned with those of the UK public health authorities to facilitate and improve patients access to medicines such as lurbinectedin," and added: "We believe that the innovation passport designation is an important step towards facilitating SCLC patients’ access to a new treatment option."

On May 4th 2022, PharmaMar announced it had submitted a conditional marketing authorization application to the UK’s MHRA for the treatment with lurbinectedin in adult patients with metastatic Small Cell Lung Cancer who have progressed following prior platinum-based chemotherapy based on data from the Phase II basket trial with lurbinectedin in monotherapy. PharmaMar expects a response to such application by the end of this year or first quarter of 2023. In addition, the LAGOON Phase III trial could be used as a confirmatory trial.

On 2020 PharmaMar and Immedica Pharma AB signed an agreement for the exclusive distribution and marketing of lurbinectedin for the UK and other territories.

Legal warning
This news release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.