On August 30, 2022 Alpha Tau Medical Ltd. (Nasdaq: DRTS) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the Company will participate in person at three upcoming investor conferences in September 2022 (Press release, Alpha Tau Medical, AUG 30, 2022, View Source [SID1234618764]).

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Event: Citi’s 17th Annual BioPharma Conference
Date: Wednesday, September 7,2022
Location: Boston, MA
Format: 1:1 Meetings

Event: Cantor Oncology, Hematology & HemeOnc Conference
Date: Wednesday, September 28th, 2022
Location: New York, NY
Format: Group Panel and 1:1 Meetings

Event: Ladenburg Thalmann Annual Healthcare Conference
Date: Thursday, September 29th, 2022
Location: New York, NY
Format: Company Presentation and 1:1 Meetings

Additional information can be found on the Events and Presentations section of Alpha Tau’s investor website, www.alphatau.com/events. If you would like to schedule a 1:1 meeting, please contact the appropriate institutional representative.

On August 30, 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 clinical development collaborator, Roswell Park Comprehensive Cancer Center ("Roswell Park"), in a clinical trial fully funded by the National Cancer Institute (NCI), has commenced patient enrollment in its Phase 2 study in subjects with primary PD-1/PD-L1 resistant melanoma (Press release, AIM ImmunoTech, AUG 30, 2022, View Source [SID1234618763]). The Phase 2 study will evaluate type-1 polarized dendritic cell (αDC1) vaccine in combination with tumor-selective chemokine modulation ("CKM") comprised of Interferon alpha 2b, Ampligen (rintatolimod) and Celecoxib.

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"The start of this NCI-funded clinical trial marks an important milestone for our Melanoma R&D program. Despite recent successes of immune checkpoint inhibitors in advanced-stage disease, only a minority of treated melanoma patients have a durable benefit, reinforcing the need to develop second-line therapies that are effective against checkpoint-refractory disease. Based on the data seen to-date, we believe Ampligen, in combination with Roswell’s polarized dendritic cell vaccine plus interferon, has an opportunity to fill this gap and potentially provide clinical benefit to melanoma patients in need," commented AIM Chief Executive Officer Thomas K. Equels.

Ampligen (rintatolimod) is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. 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 country.

The single-arm Phase 2 study plans to enroll up to 24 subjects. Subjects will be on active experimental treatment for 12 weeks. In the absence of disease progression, patients will be followed for progression-free survival (PFS) and overall survival (OS) within routine care. Patients with progressive disease at 12 months can, at the physician’s discretion, begin CTLA-4± PD-1/PDL1 inhibitor treatment and will be followed as per standard of care for this disease group. Patients will continue to be monitored for PFS and OS within standard care visits (every 3 months for up to 2 years). The primary endpoint of the study is objective response rate (ORR) at 12 weeks (only in participants who have completed the first 3 treatment cycles), which will be evaluated using RECIST 1.1 criteria.

The trial will be conducted at Roswell Park under the clinical leadership of Igor Puzanov, MD, MSCI, FACP, Chief of Melanoma at Roswell Park, and the overall scientific leadership of Pawel Kalinski, MD, PhD, Roswell Park Chair of Immunology. Enrollment of patients is underway.

"We are interested in further exploring the potential of rintatolimod for the treatment of refractory melanoma and appreciate AIM’s participation and collaboration in this study," said Dr. Kalinski. "Based on the pre-clinical data demonstrated, we believe that combining our vaccine approach with the rintatolimod-based modulation of the tumor microenvironment in a first-in-human trial has potential for converting checkpoint (PD1)-resistant ‘cold’ melanomas into PD1-sensitive ones. We look forward to getting this study underway and remain dedicated to evaluating the potential effectiveness of rintatolimod for this application."

On August 30, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, CEO of Aclaris, will virtually present a company overview at the H.C. Wainwright 24th Annual Global Investment Conference, which will be available on-demand beginning on Monday, September 12, 2022 at 7:00 a.m. ET (Press release, Aclaris Therapeutics, AUG 30, 2022, View Source [SID1234618762]). Management will be available September 12th throughout the day for virtual 1×1 meetings.

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A webcast of the presentation may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On August 30, 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 notified Curis that it may resume enrollment of additional patients in the monotherapy phase of the TakeAim Leukemia study (Press release, Curis, AUG 30, 2022, View Source [SID1234618757]).

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Previously, Curis announced that the FDA had placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April 2022. On August 18, 2022, Curis reported that the partial clinical hold on the TakeAim Lymphoma study was lifted. After review of the comprehensive data package submitted by Curis, the FDA has notified Curis that it may resume enrollment of additional patients in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study, in which the company has agreed to enroll at least nine additional patients at the 200mg dose level. The partial hold remains in place for the combination therapy phase (Phase 1b) and the expansion phase (Phase 2a) of the study until Phase 1a is complete and the FDA approves proceeding to the next phases of the study.

Before lifting the restriction on patient enrollment, the FDA reviewed additional data provided by the company related to the risk of rhabdomyolysis, a side effect also associated with statins, as well as with cancer medications such as Odomzo and Cotellic. The FDA also reviewed the company’s strategy for utilizing objective laboratory measurements, similar to those used with Odomzo and Cotellic, to identify rhabdomyolysis, as well as the company’s strategy for managing rhabdomyolysis, if it is detected.

"We are pleased to announce the results of the FDA’s review and to have addressed potential concerns about the identification and management of rhabdomyolysis," said James Dentzer, President and Chief Executive Officer of Curis. "We are working with our clinical sites to quickly resume enrollment of additional patients."

Similar to the TakeAim Lymphoma study, the Company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from the TakeAim Leukemia study in 2023. In addition, Curis is proactively discussing the clinical plans for emavusertib in leukemia, including alignment on optimal dose and development path, with the FDA’s leukemia division.

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 monotherapy to determine the recommended Phase 2 dose (RP2D) and assuming the partial hold for the phase 1b cohort dose escalation in combination to determine the RP2D is lifted, 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 30, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported a reprioritization of its clinical and research initiatives, an acceleration of discussions related to potential strategic corporate and program-based partnerships, and a restructuring of operations to support a streamlined set of priorities (Press release, Codiak Biosciences, AUG 30, 2022, View Source [SID1234618756]).

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"We are focused on positioning Codiak for success in the current capital markets environment, prioritizing engEx platform programs which we believe are well-positioned to generate compelling new clinical and preclinical data in the near term. We are also accelerating strategic and collaborative discussions at both the corporate level and for specific clinical candidates and engEx platform programs," said Douglas E. Williams, Ph.D., President and CEO of Codiak. "The preclinical and human clinical data generated to date validate our initial vision for this broad platform and support the tolerability and predictable pharmacology of exosome therapeutic candidates with early signs of clinical activity."

Program Updates

exoASO-STAT6 is Codiak’s first systemically administered exosome-based drug candidate, and its third candidate to enter clinical trials. exoASO-STAT6 is engineered to selectively deliver antisense oligonucleotides to disrupt STAT6 signaling in tumor associated macrophages (TAMs) and induce an anti-tumor immune response. Preclinical studies of exoASO-STAT6 showed single agent anti-tumor activity in models of aggressive hepatocellular carcinoma (HCC). Enrollment continues in the Phase 1 clinical trial of exoASO-STAT6 in patients with advanced HCC, liver metastases from primary gastric cancer and colorectal cancer where high STAT6 transcript levels correlate with poor prognosis for patients. Data is expected during the first half of 2023.
Codiak announced last month a new partnership with CEPI (Coalition for Epidemic Preparedness Innovations) to advance its exoVACC pan betacoronavirus program. As part of the partnership, CEPI is providing seed funding of up to $2.5 million, which Codiak anticipates will fund the completion of preclinical development and identification of a clinical candidate by early next year.
Preclinical data presented at ASGCT (Free ASGCT Whitepaper) earlier this year on the Company’s engEx-AAV discovery program, demonstrated efficient incorporation of AAV capsids inside exosomes where they were not subject to neutralization by antibodies against AAV. These engineered constructs efficiently transduce target cells and support the idea of engEx-AAV for repeat dosing of gene delivery constructs. Codiak’s team will continue to advance this program toward generation of in vivo proof-of-concept data later this year.
Codiak is pausing plans to initiate Phase 2 trials of exoSTING and exoIL-12. Platform-validating data from Phase 1 trials for both programs were reported in June, demonstrating potential for best-in-class profiles, and Codiak identified a recommended Phase 2 dose for each candidate.
Codiak is prioritizing discussions related to establishing potential new strategic and collaborative initiatives for the Company, including program-based partnerships. Codiak’s existing research and business partnerships with Lonza and Jazz Pharmaceuticals are continuing, with resources committed to attain key goals.
Organizational Updates
Codiak BioSciences has aligned the organization to reflect its smaller, refocused pipeline. The Company’s workforce will be reduced by 37%, to 53 full-time employees, to support the priority programs mentioned above.

Dr. Williams added, "We’re incredibly proud of the work of our team having created, manufactured and brought into the clinic the first engineered exosomes. I would like to personally thank every Codiak employee for their trailblazing work, particularly those who are impacted by today’s announcement. Together we have made great strides toward making this new modality a reality for patients, and we remain strongly committed to realizing this important goal."

Financial Overview
As of June 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $41.8 million. An essential component of the Company’s strategic corporate and partnering discussions and other initiatives is exploring prospective opportunities to provide funding to enable extension of Codiak’s cash runway and the potential to resource additional programs.