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.

On August 30, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the Company’s CEO & President, Panna Sharma, will be speaking at H.C. Wainwright’s 24th Annual Global Investment Conference, which is being held September 12-14, 2022 in New York, NY (Press release, Lantern Pharma, AUG 30, 2022, View Source [SID1234618776]).

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Further information on this conference, including registration links, can be found below:

H.C. Wainwright’s 24th Annual Global Investment Conference
September 12-14, 2022 @ Lotte New York Palace Hotel – New York, NY
Presentation Information: Lantern Pharma’s on-demand presentation will be live starting on Monday, September 12, 2022 at 7:00am EDT
Presenter: Panna Sharma, CEO & President, Lantern Pharma Inc.
Registration Link: www.hcwevents.com/annualconference
Webcasting Link: View Source

On August 30, 2022 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported a collaboration with Pfizer and Myovant Sciences to fund research projects seeking to improve cardiovascular management of patients with prostate cancer being treated with androgen-deprivation therapy (ADT) (Press release, NCCN, AUG 30, 2022, View Source [SID1234618792]).

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"Cardiovascular disease is an important comorbid condition in many patients living with prostate cancer, especially in those receiving ADT," said Crystal S. Denlinger, MD, FACP, Senior Vice President, Chief Scientific Officer, NCCN. "Congratulations to all of these inspiring investigators. We hope their work can advance the management of cardiovascular risk to improve overall health of this patient population."

The selected research projects are:

Zhaoping Li, MD, PhD, David Geffen School of Medicine at UCLA

Contribution of Race to Nutritional Approach to Lower Cardiovascular Risk Factors in Men Undergoing Androgen Deprivation Therapy

Alicia Morgans, MD, MPH, Dana-Farber Cancer Institute

CV CARE: Cardiovascular Care of Androgen Related Effects in Prostate Cancer Patients

Vivek Narayan, MD, MSCE, University of Pennsylvania, Abramson Cancer Center

The Cardiovascular Risk Evaluation in Men with Prostate Cancer (CARE-PC): Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation

Camille Ragin, PhD, MPH, and Daniel Geynisman, MD, Fox Chase Cancer Center

Investigating the Role of African Genetic Ancestry in Cardiovascular Complications and Cardiotoxicity among Prostate Cancer Patients Post Treatment with Androgen Deprivation Therapy

Balaji Tamarappoo, MD, PhD, Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Personalized Medical Treatment of Coronary Atherosclerosis in Prostate Cancer Patients Guided by Plaque Assessment with Quantitative Coronary CT Angiography
Roughly half of the people treated for prostate cancer receive ADT, often for a prolonged duration. A majority of them may have pre-existing risk factors for cardiovascular disease, which is the primary cause of non-cancer death among people with prostate cancer. Data also shows that roughly a third of patients with uncontrolled risk factors for cardiovascular events are not on appropriate medications. The goal of this project is to improve the awareness, identification, and implementation of interventions for known modifiable risk factors (i.e. hypertension, dyslipidemia, diabetes) for cardiovascular disease.

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert clinicians and scientists from NCCN Member Institutions. The selected projects are set to be completed within three years. The total amount of grants awarded for this research is approximately $1.5 million.

The NCCN ORP fosters innovation and knowledge discovery that improve the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website, an informed consent database, and points to consider on the best practices for biorepositories, registries, and databases. For more information, visit NCCN.org/orp.

On August 30, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number 7116547) entitled "Combined Preparations for the Treatment of Cancer or Infection" by the Japanese Patent Office (Press release, Immutep, AUG 30, 2022, View Source [SID1234618810]).

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This new Japanese patent follows the grant of the corresponding Australian, European, United States and Chinese patents announced in 2018 through 2022.

The claims of the new patent protect Immutep’s intellectual property relating to combined therapeutic preparations comprising (a) its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321"), which is a LAG-3 fusion protein (LAG-3Ig), and (b) an anti-PD-(L)1 antibody. The claims are also directed to related methods of use in the treatment of cancer and infection.

In addition to broader style claims, the granted claims include narrower claims drawn to specific combinations of efti with various approved PD-(L)1 antibodies.

In all, the claims provide comprehensive coverage of both combination products and combination therapies comprising efti and an anti-PD-(L)1 antibody.

The patent expiry date is 8 January 2036.

Immutep CEO, Marc Voigt, noted: "We are pleased to see continued progress in building our global patent estate around efti. This is especially meaningful when coupled with the very promising data we have reported from TACTI-002 in three cancer indications, along with the initiation of TACTI-003 in the past 12 months. This Japanese patent, along with the equivalent patents granted in other key global markets, underpin the investments we have made to develop this unique candidate and give Immutep important strategic options."

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.