On September 9, 2024 Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, reported the publication of an abstract regarding PRT3789 at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 taking place in Barcelona, Spain September 13-17, 2024 (Press release, Prelude Therapeutics, SEP 9, 2024, View Source [SID1234646438]). The abstract can be found on the ESMO (Free ESMO Whitepaper) 2024 website Registration | ESMO (Free ESMO Whitepaper) Congress 2024

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"We are excited for the opportunity to share the first ever clinical data of a novel, highly-selective SMARCA2 degrader," stated Jane Huang, M.D., President and Chief Medical Officer of Prelude. "Patients whose cancer has a SMARCA4 mutation have limited treatment options and generally very aggressive disease. Although PRT3789 as a first-in-class molecule targeting a novel mechanism is early in its development, we are highly encouraged by the safety profile, target engagement and clinical activity we have seen to date."

PRT3789 is a potent and highly selective, first-in-class SMARCA2 degrader, in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation by year end 2024 and identify a recommended Phase 2 dose. In addition, enrollment of patients into back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations is ongoing. Objectives for this first Phase 1 clinical study are to establish the safety and tolerability profile of PRT3789 as both monotherapy and in combination with docetaxel, evaluate activity, pharmacokinetics and pharmacodynamics and determine a dose and potential indications for advancement into a registrational clinical trial.

Oral presentation title: First Clinical Results from a Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation.

Observations in the abstract include:

•
As of the March 7, 2024 data cutoff date, 40 pts had been enrolled (NSCLC [18], pancreatic [5], breast [3], esophageal [2], other [12]; 55% have loss-of-function mutations;

•
Dose escalation had proceeded through 6 levels, from 24-212 mg, with 2 backfill cohorts opened;
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No DLTs or study drug-related SAEs have been reported;
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The most common AEs reported, of any grade or relatedness, are nausea (25%), constipation and dyspnea (each 17.5%), decreased appetite and fatigue (each 15%), and anemia (12.5%);
•
Dose-related increases in AUC were observed;
•
Dose-dependent decreases in SMARCA2 levels were seen at all doses with a trend for increasing depth and duration with increasing doses;
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Minimal effects on SMARCA4 levels were seen;
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Clinical activity of PRT3789 therapy noted to date includes RECIST partial responses, tumor shrinkage and prolonged stable disease (longer than response to most recent therapy) in patients with advanced, heavily pretreated esophageal cancer and NSCLC.

Updated data will be presented at ESMO (Free ESMO Whitepaper).

Investor Conference Call and Webcast Information

Prelude Therapeutics will host a conference call, live webcast with slides and a Q&A on Friday, September 13, 2024 at 12:00 PM EST. A live webcast of the presentation will be available at Events & Presentations – Prelude Therapeutics (preludetx.com). A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 60 days following the call. The Company will be posting its updated corporate presentation shortly after 10:00 AM EST on its website at Events & Presentations – Prelude Therapeutics (preludetx.com).

On September 9, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara") a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported all stockholders to vote at the upcoming Special Meeting of Stockholders (the "Special Meeting") to allow for completion of the proposed merger (the "Merger") with TuHURA Biosciences, Inc. ("TuHURA") (Press release, Kintara Therapeutics, SEP 9, 2024, View Source [SID1234646436]). As previously announced, Kintara entered into a definitive agreement (the "Merger Agreement") for an all-stock transaction with TuHURA to form a company combining expertise and resources to advance a risk diversified late-stage oncology pipeline.

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The Special Meeting will be held virtually on Friday, September 20, 2024, at 9:00 a.m., Eastern Time via live audio webcast. In order to attend, register in advance at www.viewproxy.com/kintarasm/2024 by 11:59 p.m., Eastern Time, on September 19, 2024.

Under the terms of the Merger Agreement, subject to stockholder approval, on a pro forma basis, pre-Merger Kintara equityholders are expected to collectively own up to approximately 2.85% (or approximately 5.45% including the shares underlying the contingent value rights (CVR) to be received by certain of Kintara’s equityholders as set forth in the Merger Agreement), of the common stock of post-Merger combined company on a pro forma fully diluted basis. Pre-Merger TuHURA equityholders are expected to collectively own approximately 97.15% (or 94.55% after giving effect to the issuance of the CVR shares), of the common stock of combined company on a pro forma fully diluted basis. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market under the ticker "HURA." The transaction is subject to customary closing conditions, including stockholder approval of both companies, and is expected to close in the third quarter of 2024.

For more information, please see the definitive proxy statement and final prospectus filed by Kintara with the Securities and Exchange Commission (the "SEC") on August 19, 2024.

Stockholders must ACTIVELY VOTE by 11:59 p.m., Eastern Time, on September 19, 2024, for their vote to count. Stockholders as of the close of business on August 14, 2024, are entitled to vote, even if they no longer own the shares. Stockholders who have previously submitted their proxy or otherwise voted and who do not want to change their vote need not take any action.

On September 9, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) presented interim results from the randomized NeoCOAST-2 (NCT05061550) Phase 2 platform study during the 2024 World Conference on Lung Cancer on September 8, 2024 (Press release, Innate Pharma, SEP 9, 2024, View Source [SID1234646435]).
The NeoCOAST-2 platform study is intended to assess the safety and efficacy of neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer (NSCLC), followed by adjuvant treatment with durvalumab with or without the novel agents. The preliminary data of three arms were presented at WCLC, namely:

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•Arm 1: oleclumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus oleclumab in the adjuvant setting;
•Arm 2: monalizumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus monalizumab in the adjuvant setting and;
•Arm 4: datopotamab deruxtecan in combination with durvalumab and single agent platinum chemotherapy in the neoadjuvant setting, and durvalumab alone in the adjuvant setting.

In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of 26.7% [95% CI; 16.1–39.7] and a major pathological response rate of 53.3% [95% CI; 40.0–66.3] which are numerically higher than the durvalumab plus platinum doublet approved regimen. Treatment in Arm 2 showed manageable safety profile and no impact on surgical rate.

The presentation will be available on Innate’s website, in the publications section.

"We’re pleased to see the preliminary results from the NeoCOAST-2 Phase 2 trial presented at WCLC and the encouraging clinical outcomes for patients with early-stage non-small cell lung cancer across all treatment arms," said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. "Monalizumab is the first checkpoint inhibitor targeting the inhibitory receptor NKG2A on NK cells and CD8 T cells. Based on these preliminary results, we remain excited about the potential of extending the clinical benefit of durvalumab in the neoadjuvant/adjuvant setting with the addition of monalizumab in patients with non-small cell lung cancer. We look forward to the final analysis and the translation of these preliminary data to Event Free Survival (EFS) data in due course."

About NSCLC:

In 2022, an estimated 2.5 million people were diagnosed with lung cancer worldwide1. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC2,3,4 Stage III NSCLC represents approximately one quarter of NSCLC incidence5.
Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally.

About Monalizumab

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.
NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells and may enhance the cytotoxic potential of other therapeutic antibodies6.
AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in NSCLC and other malignancies.

On September 9, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported that it will hold its first Ovarian Cancer R&D Day on September 18, 2024 at the Harvard Club (35 West 44th Street) in New York City (Press release, IMUNON, SEP 9, 2024, View Source [SID1234646434]). The event will feature presentations and updates on the development program for IMNN-001, Imunon’s investigational therapy currently in development for the treatment of ovarian cancer. Presentations from KOLs including clinical study investigators, immunology and biostatistics experts and company management will take place from 10:00 a.m. to 12:00 p.m. Eastern time, followed by lunch and informal conversations with presenters from 12:00 p.m. to 1:00 p.m. Eastern time.

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Plans for the Ovarian Cancer R&D Day event follow IMUNON’s recent announcement of positive topline data from its randomized Phase 2 OVATION 2 Study of IMNN-001 showing that treatment was associated with an 11.1 month increase in median OS in the intent-to-treat population, representing a 35% improvement in survival among patients with advanced disease.

The R&D Day program will include insights from thought leaders with expertise in ovarian cancer and immunology and principal investigators from IMNN-001 clinical studies. The agenda will include a review of the OVATION 2 Study results, assessments of oncology clinical trial endpoints and a discussion of the potential role of IMNN-001 in the treatment of advanced ovarian cancer. In addition, IMUNON management will review next steps in the development program for IMNN-001 and the potential impact treatment could have on standard of care.

Presenters during the R&D Day event will include (listed in order of presentations):

Sid Kerkar, M.D., T cell biology review editor, Frontiers in Immunology. Dr. Kerkar will discuss the important role of IL-12 in treating cancer.
William Bradley, M.D., Professor, Obstetrics and Gynecology, Gynecologic Oncology, Medical College of Wisconsin. Dr. Bradley will discuss the data highlighting the safety and efficacy of IMNN-001.
L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health. Dr. Wei will discuss the opportunity to combine PFS and OS to provide a clinically interpretable evaluation of the IMNN-001 treatment effect.
Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Jazaeri will discuss the ongoing Phase 1/2 study of IMNN-001 in combination with bevacizumab in advanced ovarian cancer, for which he serves as principal investigator, including the importance of minimal residual disease and early translational insights.
Premal Thakker, M.D, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Chief of Gynecologic Oncology, Interim Director of Gynecologic Oncology Clinical Research, Professor of Gynecologic Oncology, Washington University School of Medicine, and the OVATION 2 Study Chair. Dr. Thaker will discuss the OVATION 2 topline results and their clinical significance beyond the reported topline results.
IMUNON executives at the R&D Day event will include:

Stacy R. Lindborg, Ph.D., President and CEO, will provide an overview of treatment for women newly diagnosed with ovarian cancer and discuss how IMNN-001 has the potential to change the paradigm as well as planning for a Phase 3 registration study.
Khursheed Anwar, Ph.D., Chief Scientific Officer, will review the company’s TheraPlas technology platform, among other topics.
IMUNON strongly encourages in-person attendance to facilitate networking and direct engagement with speakers and management. For those unable to attend in person, a webcast will be available using the same registration link as above.

OVATION 2 Study Topline Results

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT.

As announced on July 30, 2024, highlights from patients treated with IMNN-001 plus standard-of-care in a first-line treatment setting include:

An 11.1 month increase in median overall survival (OS) compared with standard-of-care alone in the intent-to-treat population (ITT).
A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival.
Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival.
For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm.
About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumor in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On September 9, 2024 Immunotherapy innovator ImmunityBio, Inc. (NASDAQ: IBRX), reported positive results from its QUILT 3.055 trial demonstrating long-term extended survival of 14 months to as much as five years for patients with advanced non-small cell lung cancer (NSCLC) being treated with checkpoint inhibitors (CPI) (Press release, ImmunityBio, SEP 9, 2024, View Source [SID1234646433]). An oral presentation of the data was presented by John Wrangle, M.D., MPH, Associate Professor, Medical University of South Carolina, at the World Congress on Lung Cancer in San Diego on Sunday, September 8 in the session titled "Novel Immunotherapy Strategies and Combinations."

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The phase 2b study of ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with checkpoint inhibitors KEYTRUDA or OPDIVO in multiple tumor types including NSCLC who failed CPI showed long-term overall survival of 57 percent (49/86) and 34 percent (29/86) at 12 and 18 months respectively, exceeding the current standard of care.

"Most NSCLC patients experience progression following checkpoint inhibitors, with average survival well under a year when checkpoint inhibitor-based therapies fail our patients," said Dr. Wrangle. "The QUILT-3.055 study enrolled patients relapsed after CPI and CPI in combination with chemotherapy and showed that, regardless of prior therapy, adding the IL-15-based superagonist ANKTIVA to their therapy could rescue checkpoint activity likely through activation of NK cells, CD4+, CD8+, and memory T cells. The survival rate in these patients on their 2nd or 3rd line of cancer therapy is impressive and exceeds what you might expect from the current standard of care."

About the QUILT-3.055 Study

Non-small cell lung cancer occurs when malignant cells form in the lung’s tissue and it accounts for approximately 85% of all lung cancer cases. Lung cancer is by far the leading cause of cancer death in the U.S., accounting for about 1 in 5 of all cancer deaths, according to the American Cancer Society.

The QUILT-3.055 study examined overall survival in 86 patients with 2nd and 3rd line+ NSCLC who were previously treated and failed either CPI alone or failed CPI in combination with chemotherapy. These patients had received no intervening therapy. Patients received ANKTIVA 15 mcg/kg subcutaneously every 3 weeks in combination with the same checkpoint inhibitor they previously received and on which they had progressed.

The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with survival ranging up to 58 months. Overall survival for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 16.2) versus PDL1-ve (N=33) of 15.8 months (95% CI 11.5, 24.0). The ANKTIVA adverse event profile was consistent with CPI alone with no cytokine release syndrome observed. Only 10% of participants had any grade ≥3 ANKTIVA-related adverse events. The study demonstrates long-term survival at ≥12 and ≥18 months of 49/86 (57%) and 29/86 (34%) patients respectively.

ANKTIVA plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of ANKTIVA to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median overall survival of 57% and 34% at 12 and 18 months, respectively, exceeding the standard of care.

Based on the results of the QUILT 3.055 study and other trials involving ANKTIVA with checkpoint inhibitors, ImmunityBio is opening Phase 3 trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1st and 2nd line NSCLC.

"The clinical trial protocol was designed such that the duration of experimental therapy with ANKTIVA plus CPI was 24 months, and thereafter no further ANKTIVA doses were administered. Despite this, the results demonstrated that 27% of the participants survived beyond the 2-year therapy period, indicating the potential benefit of ANKTIVA to activate memory T cells and prolonged therapeutic benefit after study treatment was completed," said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. "Based on this study, the ResQ studies have been activated as randomized Phase 3 trials in both 1st. and 2nd line NSCLC by combining ANKTIVA with pembrolizumab or nivolumab versus standard of care. The current results presented at World Congress on Lung Cancer confirm that by activating the body’s natural immune system and proliferating natural killer cells, killer T cells, and memory T cells, this IL-15 superagonist boosts, or rescues, the checkpoint inhibitor likely by reactivating MHC1 expression on the tumor. We are excited at the potential of converting a MHC-ve cold tumor to a MHC+ve hot tumor and evolving the field of immunotherapy beyond T cells."

About ANKTIVA

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response.

ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.

ANKTIVA was recently approved by the FDA for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit Anktiva.com.

Indication and Important Safety Information

INDICATION AND USAGE

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS

Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION

For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS

The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia.

For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com. You are encouraged to report negative side effects of prescription drugs to FDA.

Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482)