On March 6, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that it will host a virtual Research and Development (R&D) Day on Wednesday, March 22, 2023 at 4:30 pm ET/1:30 pm PT (Press release, Kezar Life Sciences, MAR 6, 2023, View Source [SID1234628224]).

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Kezar’s R&D Day will provide an extensive overview of the Company’s pipeline, reviewing next steps on zetomipzomib, including the trial design for the Phase 2b portion of the lupus nephritis development program, as well as on its Protein Secretion Inhibition platform. The event will also highlight the recently announced autoimmune hepatitis (AIH) PORTOLA study, including a presentation on the unmet need in AIH and treatment landscape from key opinion leader Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine and Executive Director of the Autoimmune Hepatitis Association.

Presenters:

John Fowler, Chief Executive Officer, Co-Founder
Noreen Roth Henig, M.D., Chief Medical Officer
Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine, and Executive Director of the Autoimmune Hepatitis Association
Neel Anand, D. Phil. (Ph.D.), Senior Vice President, Research and Drug Discovery
To register for this event, please visit the Events & Presentations page of Kezar’s website. On the day of the event, a live webcast and conference call will be accessible from the Events & Presentations page of Kezar’s website. Additionally, a replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About KZR-261 and the Inhibition of Protein Secretion

KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.

Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.

On March 6, 2023 Freenome, a privately held biotech company, reported a subject population analysis from PREEMPT CRC, a study for the detection of colorectal cancer (CRC) at the Western Colorectal Cancer Consortium Conference in Portland, Oregon (Press release, Freenome, MAR 6, 2023, View Source [SID1234628223]).

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According to the American Cancer Society, colorectal cancer is the second-leading cause of cancer-related death. Despite evidence that CRC screening reduces cancer incidence and mortality, screening rates continue to remain below recommended guidelines.

Freenome is in the final stages of development of its blood-based screening test for colorectal cancer. The test uses Freenome’s multiomics platform, which combines tumor and non-tumor signals with machine learning to detect cancer in the earliest, most treatable stages using a standard blood draw. The test is intended to offer an accessible and convenient option for CRC screening.

PREEMPT CRC is the largest prospective study for CRC using a blood-based screening test in the average-risk population and is Freenome’s clinical validation study for the use of its test.

The study’s focus was to enroll subjects that reflected the demographics of the intended use population for a colorectal cancer screening test: average-risk adults between the ages of 45 and 85 across urban and rural communities in the United States. The study enrolled subjects between May 2020 and March 2022. Several mitigations for the impact of COVID-19 were developed and incorporated into overall study plans.

To ensure representation, Freenome integrated forward-thinking enrollment strategies into its clinical study design. The company offered options of virtual enrollment, electronic consenting and mobile phlebotomy that enabled home blood draws for participants who were not geographically close or able to visit a hospital or other study site.

"Our tests are designed for everyone, which means our clinical studies need to demonstrate that representation," said Lance Baldo, M.D. and chief medical officer for Freenome. "Screening saves lives, and our goal is to make screening for CRC easier and more convenient for everyone."

Analysis of results demonstrate enrollment strategies were effective in recruiting an intended-use population. For example, of the study’s participants, 25% enrolled virtually and 7% used the mobile phlebotomy team. Additionally, racial diversity was above historical clinical study participation[1] with approximately 11% Black, 11% Hispanic or Latino and 7% Asian participants.

"From the onset, we wanted this study to be representative of the people of the United States. Making participation convenient was key to drive enrollment, especially during a pandemic. The results of our efforts show it’s possible to have meaningful diversity in clinical trials," said Aasma Shaukat, M.D., study co-lead, professor of medicine and director of outcomes research for the Division of Gastroenterology and Hepatology at NYU Langone Health.

For more information about PREEMPT CRC, visit Freenome’s clinical studies webpage.

On March 6, 2023 AstraZeneca and Daiichi Sankyo reported positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients (Press release, AstraZeneca, MAR 6, 2023, View Source [SID1234628222]).

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Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy and safety of Enhertu in patients with locally advanced, unresectable, or metastatic previously treated, HER2-expressing solid tumours not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers. The primary endpoint of the trial is investigator-assessed confirmed ORR and investigator-assessed duration of response (DoR) is a key secondary endpoint.

The data will be presented at an upcoming medical meeting and shared with global regulatory authorities.

HER2 is a tyrosine kinase receptor protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.1,2 In some cancer cells, HER2 expression is amplified or the cells have activating mutations.1,3 While HER2-directed therapies have been used to treat breast, gastric and lung cancers, more research is needed evaluating their potential role in treating other HER2-expressing tumour types.2,4-6

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said, "Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumour settings with significant unmet need are very encouraging. The DESTINY-PanTumor02 results mark an important step forward in our understanding of the potential role of Enhertu across multiple HER2-expressing tumour types."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, "The clinically meaningful responses seen in the DESTINY-PanTumor02 trial reaffirm our belief in the potential of Enhertu across multiple HER2-expressing cancers. The results seen so far across multiple cohorts of the trial will inform next steps of our broad development programme as we look to bring this important medicine to as many patients as quickly as possible."

The safety profile observed in patients treated with Enhertu in the DESTINY-PanTumor02 trial was consistent with that seen in other trials of Enhertu with no new safety signals identified.​

Notes

DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the treatment of HER2-expressing tumours, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer and rare tumours.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DoR, disease control rate, progression-free survival, overall survival, safety, tolerability and pharmacokinetics.

DESTINY-PanTumor02 has enrolled 268 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive global development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

On March 6, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Baptist Health Miami Cancer Institute, part of Baptist Health Cancer Care, the largest cancer program in South Florida, reported that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter for the Miami Cancer Institute’s investigator initiated clinical trial to assess the safety and effectiveness of azeliragon combined with stereotactic radiosurgery in patients with brain metastases (Press release, Cantex, MAR 6, 2023, View Source [SID1234628221]).

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"Brain metastases are a devastating diagnosis for many people in their cancer journey," said Rupesh Kotecha, M.D., the principal investigator of the trial and Chief of Radiosurgery in the Department of Radiation Oncology and Director of the Central Nervous System Metastasis program at Miami Cancer Institute. "At Miami Cancer Institute, we are fortunate in that we have the latest radiotherapy technologies used to treat brain metastases. Stereotactic radiosurgery allows the radiation oncologist to deliver an intense, precisely targeted dose of radiation to tumor cells inside the brain while sparing healthy surrounding tissues including the brain itself, arteries, nerves and other important structures. Typically, patients receive corticosteroids along with the treatment to reduce the risk of peri-tumoral edema and inflammation. The clinical trial of azeliragon, with its differentiated mechanism of action, will offer patients a unique approach to the treatment of brain metastases that may protect against inflammation as well as potentiate radiation response in the tumor. This clinical trial represents a novel way of enhancing the effectiveness of radiation therapy of cancer."

Cantex’s azeliragon is an orally administered small molecule, taken as a pill once daily, that is being studied as a treatment for glioblastoma, brain metastases, and other cancers. Azeliragon inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the cancer microenvironment. S100A9, a protein released from cells within the microenvironment of brain metastasis, binds to RAGE receptors on the surface of cancer cells, making them resistant to the effectiveness of radiation treatments. Azeliragon blocks the interaction of S100A9 with RAGE, potentially restoring sensitivity to radiation therapy. In addition, interaction of RAGE with proteins that bind to it, trigger inflammatory responses, which may worsen brain swelling associated with radiation therapy. The Miami Cancer Institute’s investigator-initiated trial is designed to determine whether azeliragon, when administered in combination with stereotactic radiosurgery, can prevent or eliminate the need for a powerful steroid, dexamethasone, to control brain swelling as well as improve the effectiveness of radiation therapy to treat brain metastases.

Brain metastases occur when cancer spreads from their original location. Brain metastases are the most common type of cancer in the brain, with over 150,000 people each year developing brain metastasis from their primary cancer (most commonly lung and breast cancer).

"We are excited to receive FDA authorization to proceed with this trial. With this approval, Cantex expands the cancer indications for which azeliragon is being investigated, including glioblastoma, breast cancer, and pancreatic cancer, furthering our work to better understand azeliragon as a treatment of very aggressive and difficult to treat cancers," said Stephen G. Marcus, M.D., Chief Executive Officer of Cantex. "The team of renowned oncologists at Miami Cancer Institute is committed to expanding innovative, cutting-edge tools for cancer treatment as indicated by their interest in RAGE inhibition and treatment of brain metastases."

Cantex recently announced that the FDA had provided the company with a "Study May Proceed" letter to assess azeliragon for the treatment of glioblastoma, the most common primary brain cancer. Azeliragon was also recently granted FDA Orphan Drug Designation for the treatment of glioblastoma.

About Azeliragon
Azeliragon, previously known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation end products (RAGE) licensed by Cantex from vTv Therapeutics Inc. (NASDAQ:VTVT). vTv Therapeutics discovered azeliragon and carried out phase 3 clinical trials for Alzheimer’s disease. Although these trials did not demonstrate efficacy in Alzheimer’s disease, clinical safety data from these trials, involving over 2000 patients dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. A broad range of evidence suggests that RAGE—ligand interactions play a critical role in cancer and its complications as well as in a range of inflammatory diseases.

On March 6, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it has formed a wholly-owned subsidiary, Starlight Therapeutics Inc. ("Starlight"), to develop drug candidate LP-184’s central nervous system (CNS) and brain cancer indications – including glioblastoma (GBM), brain metastases (brain mets.), and several rare pediatric CNS cancers (Press release, Lantern Pharma, MAR 6, 2023, View Source [SID1234628220]). Starlight will refer to the molecule LP-184, as it is developed in CNS indications, as "STAR-001". Combined, STAR-001’s targeted treatment indications are estimated to represent an annual global market potential of approximately $6.0 billion (USD) and over 500,000 global cases each year.

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Starlight plans on establishing a leading CNS oncology franchise to develop the unique drug candidate STAR-001 for some of the most malignant and unaddressed primary and secondary CNS cancers. The programs being developed by Starlight were born from the analysis of billions of oncology-focused data points and by using Lantern’s AI platform, RADR. STAR-001’s powerful anti-tumor mechanism of action, synthetic lethality, and collaborations with internationally recognized institutions, including the Kennedy Krieger Institute at Johns Hopkins and the Greehey Children’s Cancer Research Institute at UT Health – San Antonio, make it well positioned to advance in targeted and efficient clinical development programs. Starlight intends to pursue human clinical trials for multiple CNS indications starting in late 2023, building on prior IND-enabling studies and the Phase 1 clinical testing that will be conducted by Lantern.

"The formation of Starlight allows Lantern to put extreme focus on advancing STAR-001 through targeted clinical trials and dedicate increased time, resources, and personnel to progress one of the most promising drug candidates for CNS cancer patients in decades," stated Panna Sharma, Lantern’s CEO and President. "Additionally, establishing Starlight as a wholly-owned subsidiary will increase the potential to partner with other biopharma companies who are looking to develop a franchise in CNS cancers and to further accelerate the progression of STAR-001 towards changing patient outcomes in this devastating set of diseases," continued Sharma. "Since our initial discovery, in which we used large-scale, multi-omic network analysis from our RADR AI platform, to validate that GBM was sensitive to LP-184 and that LP-184 had excellent blood-brain barrier permeability, our team has found, validated, and published on several additional pediatric and adult brain cancers that have shown early promise to LP-184, now STAR-001, in CNS cancers," stated Sharma. "Our portfolio of opportunities and pipeline in CNS cancers has grown five-fold and includes multiple indications lacking any accepted standard-of-care. We believe that by focusing our efforts via Starlight Therapeutics we can accelerate and deepen our commitment to the CNS cancer patient community, while also creating the potential for meaningful additional upside for our investors," concluded Sharma.

STAR-001 is a unique blood-brain barrier permeable small molecule that utilizes its powerful mechanism of action, synthetic lethality, to exploit common vulnerabilities in CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of STAR-001 has been demonstrated across an extensive number of in-vitro and in-vivo CNS cancer models, including GBM, brain mets., and atypical teratoid rhabdoid tumors (ATRT), and has been presented at leading conferences and publications including, the Society for Neuro-Oncology annual meeting, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, and the Frontiers in Drug Discovery Journal. Highlights of STAR-001’s promising preclinical results from these presentations and publications are included below:

Pharmacokinetic studies have shown STAR-001 to have 2X the bioavailability in brain tumors, compared to normal brain tissue, and to have 2X the bioavailability in brain tumors compared to the bioavailability of temozolomide (TMZ), the GBM standard-of-care (SOC) agent. Additional details from these experiments can be found here.
In mice implanted with subcutaneous GBM cell-derived xenograft (CDX) tumors from models of the two major GBM subtypes, known as MGMT methylated and MGMT unmethylated, STAR-001 treatment resulted in 107% tumor growth inhibition in both tumor types. In these experiments, 75% of mice with tumors from the MGMT unmethylated GBM model and 30% of mice with tumors from the MGMT methylated GBM model were entirely tumor-free after STAR-001 treatment. Additional details from these experiments can be found here.
STAR-001 has the potential for combination with the FDA-approved agent spironolactone to enhance STAR-001’s anti-tumor potency. In in-vitro GBM models with different MGMT methylation states, STAR-001 treatment with spironolactone significantly decreased STAR-001’s IC50 by 3-6X, resulting in IC50s in the low nanomolar range of 34-94nM. Additional details from these experiments can be found here.
STAR-001 has been demonstrated to have nanomolar potency in brain mets. cell lines that originated from non-small cell lung cancer, melanoma, and breast cancer (HER2- and Triple Negative). Additional details from these experiments can be found here.
STAR-001 treatment of mice implanted with ATRT CDX tumors, at either 2 mg/kg or 4 mg/kg doses (I.V.), showed near complete tumor growth inhibition between 82-91%, respectively. Additional details from these experiments can be found here.
Based on STAR-001’s demonstrated anti-tumor potential in CNS cancers, the FDA has granted STAR-001 Orphan Drug Designations (ODD) for malignant gliomas (including GBM) and ATRT. Additionally, STAR-001 was granted a Rare Pediatric Disease Designation for ATRT, which occurs in 60-70 pediatric patients a year in the US.

Starlight’s clinical development strategy will initially focus on progressing STAR-001 through early-stage clinical trials for adult recurrent high-grade gliomas (HGGs), including GBM. There have been no effective single-agent treatment options approved for GBM in nearly two decades. The current GBM standard-of-care agent, TMZ, is ineffective in MGMT unmethylated patients, who represent over 65% of all GBM patients. Starlight is planning several additional clinical programs for STAR-001 including adult and pediatric CNS cancers and combination regimens.

Commencing in mid-2023, Lantern is anticipating a Phase 1A basket trial for LP-184 (STAR-001), in a range of solid tumors including: recurrent brain cancers (including GBM and HGGs), metastatic CNS cancers (brain mets.), pancreatic cancer, and solid tumors with DDR deficiencies. The clinical development of STAR-001 in CNS cancers beyond the Phase 1A trial will be conducted exclusively by Starlight. Following the launch of Starlight, Lantern will continue to advance LP-184’s preclinical and clinical development for non-CNS indications (including pancreatic cancer and other solid tumors) and will also provide AI-driven bioinformatic and computational biology support to Starlight.