On May 23, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without Ta or T1 disease (Press release, ImmunityBio, MAY 23, 2022, View Source [SID1234614948]). The BLA is supported by the results of ImmunityBio’s studies in bladder cancer including the pivotal QUILT 3032 study (NCT03022825), where 71% of patients who had failed on previous therapies showed an over 50% increase in both response and median duration compared to the FDA-approved alternatives Valrubicin and Pembrolizumab, a systemic checkpoint inhibitor therapy for this indication.1

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The FDA previously granted N-803 Breakthrough Therapy and Fast Track designations when used in combination with Bacillus Calmette-Guerin (BCG) for the treatment of BCG-unresponsive NMIBC CIS. If approved by the FDA, N-803 plus BCG would be the first new immunotherapy for this indication in 23 years that can be delivered directly to the bladder (intravesically) to induce natural killer cells and T cells, providing a new treatment option for patients with this form of bladder cancer. The results of the pivotal Phase 2/3 clinical trial demonstrated the therapeutic combination gives patients a greater chance to avoid removal of the bladder itself—a surgical procedure referred to as radical cystectomy. This surgery is one of the last remaining options for many patients that do not respond to other therapies, but is costly to the healthcare system and comes with a high risk of mortality and complications that affect patient quality of life.

"This immunotherapy represents a potential new option for bladder cancer patients who fail to respond to BCG, the current standard of care. The results of the study of N-803 plus BCG indicate that this combination provides a durable response with a reduced need for a cystectomy," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "We believe that the durable responses seen in this study provide further support for our hypothesis that by orchestrating natural killer cells, T cells and memory T cells, long-term durable remissions can be achieved in patients suffering from cancer. The results from the QUILT series of ongoing trials across multiple tumor types, including pancreatic, lung and other solid tumors, could lead to a paradigm shift in cancer therapy that ImmunityBio is developing. We are hopeful that this combination immunotherapy of BCG acting as a prime and N-803 as the boost to the immune system will not only provide a new path for these patients, but also help us continue to broaden our understanding of how we might apply this novel mechanism of action to other difficult-to-treat diseases."

The BLA submission for BCG-unresponsive NMIBC is based on data from 171 subjects from Phase I and 2 trials in bladder cancer and on 84 subjects treated in ImmunityBio’s Pivotal Phase 2/3 QUILT 3032 study of the combination of N-803 and BCG. The combination had a well-tolerated profile and the full results of this study will be presented at an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting to be held June 3-7 in Chicago.

ImmunityBio’s IL-15 superagonist N-803 (Anktiva)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

N-803 is currently being evaluated for adult patients in two clinical NMIBC trials. QUILT 2005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT 3032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease.

Mechanism of Action & Contribution of N-803 and BCG for Bladder Cancer

Trained immunity is a recently discovered immune system response triggered by BCG. Natural Killer (NK) and T cells are activated by BCG resulting in bladder cancer cell death. When an appropriate secondary stimulus is administered along with BCG, that trained immune response is enhanced to induce immune memory resulting in a prolonged duration of immunological response. N-803, an IL-15 superagonist which proliferates NK and T cells, serves as this enhancing secondary boost and augments the immunological response when given in combination with BCG. ImmunityBio believes this mechanism of action of inducing trained innate immune memory, through the combination of N-803 and BCG, contributes to the high complete response rate and prolonged 24-month durable complete response reported in this trial.

On May 23, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") reported that it is the recipient of the 2022 Vanguard Award presented by the Triple Negative Breast Cancer (TNBC) Foundation (Press release, OncoSec Medical, MAY 23, 2022, View Source [SID1234614949]). OncoSec’s Head of Patient Advocacy, Kimberly Irvine, will accept the award on behalf of the Company at the Foundation’s gala titled, "No One Fights Alone," on May 25, 2022.

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"On behalf of OncoSec, I want to thank the TNBC Foundation for this distinguished honor and recognition," said Kimberly Irvine, Head of Patient Advocacy. "Our efforts aiming to provide much needed therapies to patients with metastatic TNBC (mTNBC) is one key pillar of our mission to help patients with cancer who don’t respond to currently available treatments. As a two-time breast cancer survivor, myself, I understand the unmet need. We look forward to continuing our research and working with the TNBC patient community to learn about their experiences and how we can better meet their needs."

Hayley Dinerman, Executive Director at TNBC Foundation, added, "Triple negative breast cancer accounts for up to 15% of breast cancers in the U.S., but many patients have never heard of TNBC. As the leading advocacy group for the TNBC community, it’s our goal to educate and support patients battling this disease, and to recognize academic, pharmaceutical and biotech industry partners who work to improve patient outcomes. The TNBC Foundation is thrilled to recognize OncoSec as the 2022 Vanguard Award recipient for its unrelenting dedication to cancer research and to patients struggling with TNBC. We are excited to see new developments from the company as it progresses its TNBC program."

The Triple Negative Breast Cancer Foundation’s Vanguard Award for Excellence in Oncology Research was previously awarded to Immunomedics (acquired by Gilead Sciences, Inc.) in 2019, Eisai Co., Ltd. in 2018, and Hackensack University Medical Center in 2017.

To learn more about the Vanguard Award and the TNBC Foundation visit, tnbcfoundation.org.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

On May 23, 2022 AstraZeneca reported that advances its ambition to redefine cancer care with new data to be presented across its diverse and industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 3 to 7 June 2022 (Press release, AstraZeneca, MAY 23, 2022, View Source [SID1234614930]).

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A total of 18 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts, including nine oral presentations and a plenary presentation of the DESTINY-Breast04 Phase III trial for Enhertu (trastuzumab deruxtecan) in HER2-low metastatic breast cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our five leading Oncology medicines have each set new standards for patient outcomes across many cancers. Our data at ASCO (Free ASCO Whitepaper) will showcase our continued investment in driving innovation with these medicines as well as their long-term impact in real-world settings. In particular, the groundbreaking data from DESTINY-Breast04 will show the potential of Enhertu to treat patients with HER2-low metastatic breast cancer who have never before been eligible for HER2-targeted treatments."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "At AstraZeneca, we are pioneering new biomarkers and novel therapeutic modalities in our ambition to attack cancer from every angle and deliver personalised medicines to more patients. The results from DESTINY-Breast04 support the potential for Enhertu to redefine the classification and treatment of breast cancer across the spectrum of HER2 expression. We are also excited to share promising clinical data for our bispecific PD1-CTLA4 antibody MEDI5752 in advanced renal cell carcinoma, designed to have both of these clinically validated checkpoint targets in one molecule, delivering efficacy with an improved tolerability profile."

Leading through disruption in breast cancer
A late-breaking plenary presentation will highlight the potentially practice-changing results of the DESTINY-Breast04 trial of Enhertu in patients with HER2-low metastatic breast cancer. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status compared to standard-of-care chemotherapy.

Additionally, data from a retrospective study will estimate the prevalence of HER2-low breast cancer and describe its clinical and pathological characteristics, to help identify patients with HER2-low expressing tumours who may benefit from HER2-targeted therapy.

Further results will be shared from dose-finding and dose-expansion studies of Enhertu in combination with other anti-cancer agents in patients with advanced or metastatic HER2-positive breast cancer (DESTINY-Breast07) and HER2-low breast cancer (DESTINY-Breast08).

Data will also be presented from a safety follow-up of the DESTINY-Breast03 Phase III trial of Enhertu in the treatment of patients with unresectable or metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane. Enhertu was recently approved in the US for patients in this setting.

Revealing the full potential of an industry-leading portfolio and pipeline
Beyond breast cancer, AstraZeneca will share results from multiple trials highlighting its focus on delivering life-changing cancer medicines for patients with high unmet need. Data will also support the Company’s commitment to realising the full potential of its leading medicines with ongoing analyses, real-world data and research into novel combinations.

· MEDI5752 – An oral presentation will share safety and clinical activity results for MEDI5752 in patients with advanced renal cell carcinoma as a monotherapy treatment. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.

· Calquence (acalabrutinib) – Updated data from the ELEVATE-TN and ASCEND Phase III trials will highlight long-term safety and efficacy results of Calquence in patients with chronic lymphocytic leukaemia (CLL) regardless of line of therapy.

Presentations include updated data with approximately five-years of median follow-up from the ELEVATE-TN trial, which has demonstrated sustained clinical benefit of Calquence either in combination with obinutuzumab or as monotherapy compared to obinutuzumab plus chlorambucil, providing flexibility to tailor treatment for adults with treatment-naïve CLL.

Additionally, updated results from the ASCEND Phase III trial with approximately four years of median follow-up will highlight the sustained reduction of disease progression or death for Calquence compared to idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed or refractory CLL, as well as a maintained safety profile.

· Imfinzi (durvalumab) – Patient-reported outcomes from the HIMALAYA trial will highlight quality of life for patients treated with a single priming dose of tremelimumab added to Imfinzi in 1st-line unresectable liver cancer (STRIDE regimen). HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS versus sorafenib in this setting. Tremelimumab with Imfinzi was recently accepted under Priority Review in the US by the Food and Drug Administration (FDA) based on this trial.

Patient-reported outcomes will also be presented from the TOPAZ-1 trial of Imfinzi plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line advanced biliary tract cancer. TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination versus chemotherapy alone in this setting.

An additional regional subgroup analysis for the TOPAZ-1 trial will compare efficacy outcomes, including OS, for Asian patients with other geographies. Imfinzi plus chemotherapy was recently granted Priority Review in the US by the FDA based on this trial.

Further clinically relevant safety data from the positive POSEIDON Phase III trial of Imfinzi, tremelimumab and chemotherapy in 1st-line metastatic non-small cell lung cancer (NSCLC) will also be presented.

· Lynparza (olaparib) – Data from the PROpel Phase III trial will further reinforce the safety profile of Lynparza plus abiraterone in the treatment of 1st-line metastatic castration-resistant prostate cancer (mCRPC). These data build on PROpel efficacy data, which demonstrated that this combination significantly delayed disease progression versus standard-of-care abiraterone in 1st-line mCRPC in patients with or without homologous recombination repair gene mutations. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent versus abiraterone alone in this setting.

· Tagrisso (osimertinib) – Results will be shared from the externally sponsored OPAL Phase II trial in previously untreated EGFR-mutated (EGFRm) NSCLC that evaluated whether the addition of platinum-based chemotherapy to Tagrisso can improve patient outcomes. This combination is also being tested in the ongoing FLAURA2 Phase III trial.

Real-world data will also be presented to better inform unmet needs and treatment strategies among patients with resectable early-stage NSCLC, providing valuable insights into EGFRm disease prevalence and rates of recurrence, despite adjuvant chemotherapy, in this population. Tagrisso is approved for the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC based on the ADAURA Phase III trial.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 2022

Lead author

Abstract title

Presentation details

Antibody drug conjugates

Modi, S

Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study.

Abstract #LBA3

Plenary Session

5 June 2022

2:17pm (CDT)

Hamilton, EP

Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive (HER2+) unresectable and/or metastatic breast cancer (mBC): Safety follow-up of the randomized, phase 3 study DESTINY-Breast03.

Abstract #1000

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

1:15pm (CDT)

Andre, F

Dose-finding and -expansion studies of trastuzumab deruxtecan in combination with other anti-cancer agents in patients (pts) with advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer (BC).

Abstract #3025

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

5 June 2022

8:00am (CDT)

Immuno-Oncology

Cho, BC

Durvalumab (D) +/- tremelimumab (T) + chemotherapy (CT) in first-line (1L) metastatic (m) NSCLC: AE management in POSEIDON.

Abstract #9035

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Sangro, B

Patient-reported outcomes from the phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

Abstract #4074

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Burris III, HA

Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

Abstract #4070

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Vogel, A

Regional subgroup analysis of the phase 3 TOPAZ-1 study of durvalumab (D) plus gemcitabine and cisplatin (GC) in advanced biliary tract cancer (BTC).

Abstract #4075

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Özgüroğlu, M

Adverse events self-reported by patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with durvalumab (D) plus platinum-etoposide (EP) or EP in the CASPIAN study.

Abstract #8571

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6 June 2022

8:00am (CDT)

Albiges, L

Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renal cell carcinoma (RCC): Preliminary results from an FTIH trial.

Abstract #107

Clinical Science Symposium Bispecifics: Are Two Better Than One?

5 June 2022

10:33am (CDT)

DNA damage response

Pignata, S

Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.

Abstract #5519

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Thiery-Vuillemin, A

Tolerability of abiraterone (abi) combined with olaparib (ola) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Further results from the phase III PROpel trial.

Abstract #5019

Poster Discussion Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

5:26pm (CDT)

Armstrong, AJ

Olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer: Pharmacokinetics data from the PROpel trial.

Abstract #5050

Poster Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

1:15pm (CDT)

Eskander, RN

Real-world effectiveness of first-line maintenance olaparib in women with BRCA-mutated advanced ovarian cancer: U.S. retrospective cohort study.

Abstract #5518

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Tumour drivers and resistance

Jones, RH

Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor–positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis.

Abstract #1005

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

2:39pm (CDT)

Nakamura, A

A phase II study of osimertinib in combination with platinum plus pemetrexed in patients with EGFR-mutated, advanced non–small cell lung cancer: The OPAL study (NEJ032C/LOGIK1801).

Abstract #9097

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Haematology

Sharman, JP

Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN.

Abstract #7539

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

4 June 2022

8:00am (CDT)

Notes

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On May 23, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has initiated the first in a series of studies to test the ability of its pancreatic cancer therapy to treat malignant ascites (Press release, PharmaCyte Biotech, MAY 23, 2022, View Source [SID1234614951]). The initiation of this first study was made possible after PharmaCyte’s successful production of a Master Cell Bank as well as the demonstration that the Master Cell Bank is adventitious agent free.

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In PharmaCyte’s initial study, it aims to establish a mouse model of malignant ascites to serve as a basis for further CypCaps plus ifosfamide efficacy studies. This study involves inoculating the peritoneal space of genetically susceptible mice with radiolabelled mouse colon carcinoma cells. Study parameters include survival, clinical signs, body weight, assessment of tumor spread using fluorescence imaging and indexing of total tumor volume.

The planned series of studies will build on previous data obtained by Prof. Matthias Löhr of the Karolinska Institute in Stockholm, Sweden, and his colleagues that showed PharmaCyte’s treatment for pancreatic cancer can slow the production and accumulation of malignant ascites. Heidelberg Pharma Research, a leading German biotechnology company focused on cancer therapies, will conduct the study.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The expansion of our oncology program is continuing with the pursuit of a treatment for malignant ascites. This patient population is dealing with advanced cancer, and malignant ascites only compounds the problems these patients must endure at a very difficult time. The establishment of a reliable malignant ascites animal model is a critical step on the path to create a first-ever treatment for malignant ascites and represents our desire to address unmet medical needs and the patient’s quality of life."

Ascitic fluid is normally produced in the peritoneum, a sheet of tissue that covers the organs in the abdomen; however, the presence of cancer can cause the peritoneum to produce too much ascitic fluid when cancer cells irritate the peritoneum, which causes the abdomen to swell as fluid accumulates. This is known as malignant ascites. It is more likely to develop in patients who have ovarian, uterine, cervical, colorectal, stomach, pancreatic, breast and liver cancers. In most patients, development of malignant ascites is a sign of advanced disease and poor prognosis.

Malignant ascites can result in impairment to the quality of life of a cancer patient. In addition to abdominal distention, pain and difficulty breathing, it may also cause nausea, vomiting, early satiety, lower extremity edema, weight gain and reduced mobility. These symptoms can interfere with a patient’s ability to eat, to walk and to perform daily activities. They also reduce a patient’s ability to withstand anti-cancer therapies, potentially reducing survival.

As a supportive or palliative measure, malignant ascites can be drained by paracentesis, percutaneously implanted catheters, peritoneal ports or peritoneovenous shunts. These treatments are invasive, can be painful and are expensive. PharmaCyte expects its treatment to offer cancer patients a therapy that slows down or eliminates the production and accumulation of malignant ascites fluid. There is currently no such treatment on the market.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On May 23, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces that its CEO, Pierre Belichard, will provide a company update (in person) at the Jefferies Healthcare Conference in New York City, US which will take place June 8-10, 2022 (Press release, Enterome, MAY 23, 2022, View Source [SID1234614931]).

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In his presentation, Dr. Belichard will provide an overview of the progress the Company has made with its advanced OncoMimics pipeline, including its first-in-class off-the-shelf therapeutic cancer vaccine, EO2401, as well as its other fully owned EndoMimics pipeline for immune diseases using its Mimicry drug discovery platform.