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 Seagen Inc. (Nasdaq:SGEN) reported positive topline results from the pivotal phase 2 MOUNTAINEER clinical trial investigating TUKYSA (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC) (Press release, Seagen, MAY 23, 2022, View Source [SID1234614946]). Data from this trial will form the basis of a planned supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) under the FDA’s Accelerated Approval Program. Merck, known as MSD outside the U.S. and Canada, is commercializing TUKYSA in regions outside of the U.S., Canada and Europe and plans to discuss these results with health authorities as it continues to accelerate the filing of TUKYSA in its territory.

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Results showed a 38.1% confirmed objective response rate (cORR) [95% Confidence Interval (CI): 27.7, 49.3] per blinded independent central review (BICR). The median duration of response (DoR) per BICR was 12.4 months [95% CI: 8.5, 20.5]. The combination of tucatinib and trastuzumab was generally well-tolerated, and the most common (greater than or equal to 20%) treatment-emergent adverse events were diarrhea, fatigue, nausea and infusion-related reaction, which were primarily low-grade.

Please see Important Safety Information at the end of this press release for further safety information regarding tucatinib.

"People with HER2-positive previously treated metastatic colorectal cancer have a significant unmet need for new therapies. We are excited by the potential for this tucatinib combination to help patients based on the excellent anti-tumor activity with durable responses and a tolerable safety profile," said Roger Dansey, M.D., interim CEO and Chief Medical Officer, Seagen. "Based on the strength of these data, we are planning to engage in regulatory discussions with the FDA with the intent to submit a supplemental New Drug Application for TUKYSA."

Full data from the MOUNTAINEER trial will be presented by John H. Strickler, M.D., Duke University Medical Center, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain from June 29 through July 2, 2022.

About MOUNTAINEER

MOUNTAINEER is a U.S. and European multicenter, open-label, phase 2 clinical trial of tucatinib in combination with trastuzumab or as a single agent in 117 patients with HER2-positive metastatic or unresectable colorectal cancer following previous standard-of-care therapies. The primary endpoint of the trial is confirmed objective response rate by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria per blinded independent central review in patients receiving the combination of tucatinib and trastuzumab. Duration of response, progression-free survival, overall survival and safety and tolerability of the combination regimen are secondary objectives.

About Colorectal Cancer

Colorectal cancer is the third leading cause of cancer-related deaths in the U.S. and is anticipated to lead to about 52,580 deaths in 2022.1 Approximately 22% of U.S. patients with colorectal cancer are diagnosed at the advanced stage.2 Human epidermal growth factor receptor 2 (HER2) is overexpressed in 3-5% of patients with metastatic colorectal cancer.3,4 There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

TUKYSA is approved in 36 countries. It was approved by the U.S. FDA in April 2020 and by the European Medicines Agency and the UK Medicines and Healthcare Products Regulatory Agency in February 2021. Merck, known as MSD outside the U.S. and Canada, has exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.

U.S. Indication and Important Safety Information

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

Warnings and Precautions

Diarrhea – TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. In HER2CLIMB, 81% of patients who received TUKYSA experienced diarrhea, including 12% with Grade 3 diarrhea and 0.5% with Grade 4 diarrhea. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. The median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to dose reductions of TUKYSA in 6% of patients and discontinuation of TUKYSA in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.

If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Hepatotoxicity – TUKYSA can cause severe hepatotoxicity. In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to dose reduction of TUKYSA in 8% of patients and discontinuation of TUKYSA in 1.5% of patients.

Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Embryo-Fetal Toxicity – TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for at least 1 week after the last dose.
Adverse Reactions

Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in ≥2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in ≥1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in ≥2% of patients were hepatotoxicity (8%) and diarrhea (6%).

The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

Strong CYP3A or Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
Use in Specific Populations

Lactation: Advise women not to breastfeed while taking TUKYSA and for at least 1 week after the last dose.
Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

On May 23, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells in vivo for patients with solid and hematologic malignancies, and Lupagen, Inc., a gene therapy company developing first-in-class gene delivery technologies for CAR-T, gene editing and immunotherapy products, reported they have entered into a collaboration to evaluate extracorporeal in vivo delivery as a potential additional route of administration for Umoja’s VivoVec particles using Lupagen’s Side CAR-T technology (Press release, Umoja Biopharma, MAY 23, 2022, View Source [SID1234614945]). Lupagen’s patient connected extracorporeal Side CAR-T delivery system is expected to enable efficient and highly controlled viral vector targeting of T cells in a convenient bedside procedure without requirements for lymphodepleting chemotherapy.

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"Today’s cellular therapies are often hampered by lengthy delays to patient treatment with a weeks-to-months wait for cell manufacturing and release. Pairing Lupagen’s technology with Umoja’s in vivo therapeutics offers a compelling solution to one of the greatest challenges to receiving cellular therapies today," said David Fontana, Ph.D., Chief Business and Strategy Officer at Umoja. "Putting patients first is not just about building better therapies, it’s about reimagining the patient experience by giving more control to the patients and providers to enable timely and controlled delivery."

David Peritt, Ph.D., Chief Scientific Officer, and co-founder of Lupagen added, "Lupagen’s core focus is to make gene therapies broadly accessible using our extracorporeal in vivo gene delivery system. This partnership seeks to transform patient care by pairing Lupagen’s novel extracorporeal gene delivery technology with Umoja’s next-generation in vivo therapeutics to revolutionize cancer treatment. The familiarity of healthcare providers with extracorporeal bedside procedures will enable greater uptake and access to life-changing therapies across a wider range of patients. We look forward to working with Umoja to enhance the potential of their VivoVec particles with the highly controlled targeted delivery Lupagen’s technology can offer."

Under the terms of the agreement, both parties will collaborate to evaluate VivoVec delivery using the Side CAR-T system. Lupagen will not develop or commercialize the Side CAR-T device for the delivery of viral vectors in the field of oncology during the term of the agreement. Umoja retains the right to opt in to an exclusive, worldwide agreement to develop the Side CAR-T device in the field of oncology.

On May 23, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, reported it would resume its existing Stock Repurchase Program (Press release, Greenwich LifeSciences, MAY 23, 2022, View Source [SID1234614944]).

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Under the repurchase program previously authorized by the board of directors, Greenwich LifeSciences may repurchase its outstanding shares of common stock from time to time in open market or privately-negotiated transactions, including accelerated share repurchase transactions, block trades, or pursuant to 10b5-1 trading plans. Any repurchases will be at management’s discretion and will be subject to market conditions, the price of the Company’s shares and other factors. The stock repurchase program may be modified, suspended or terminated by the Board of Directors at any time.

The Company has approximately $4.5 million available under the current program. As of its most recently reported quarter-end March 31, 2022, the Company had 12,951,453 shares of common stock outstanding.

On May 23, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, MAY 23, 2022, View Source [SID1234614943]):

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We have completed the manufacturing of GP2, released 3 clinical lots, and started the stability testing program for these lots. Previously, the FDA informally asked us to allow them to review an updated chemistry and manufacturing section on drug product before initiating the Phase III trial as our manufacturing information for the final drug product was incomplete and the lots were being tested for the first time. Subsequently, we received a formal clinical hold letter. Greenwich has provided a response and is working with the FDA to resolve all outstanding issues. All hold issues are associated with manufacturing and pharmacy procedures.

We continue to work toward study initiation. We are scheduling site initiation visits to train clinicians, nurses, coordinators, and pharmacists to activate and open clinical sites. We, along with our CRO, continue to actively recruit and prepare sites for site initiation.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "We continue to make progress towards opening up our first sites. We just completed our first Data Safety Management Board (DSMB) meeting and are currently scheduling our initial Steering Committee Meeting with the lead clinicians of FLAMINGO-01. Our electronic data capture and inventory management systems are anticipated to go live in June. We are working to address all FDA issues rapidly so that the study can be initiated shortly."

Three abstracts and two posters were accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2022. The titles of the abstracts are as follows:

Abstract Number: LBA550; Poster Number: 322; Abstract Title: Evaluation of booster injections in maintaining peak immunity in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus GM-CSF alone after adjuvant trastuzumab in HER2 positive women with breast cancer.
Abstract Number: e12519; Abstract Title: Baseline GP2 immune response as an independent prognostic factor in a phase IIb study evaluating HER2/neu peptide GP2 (GLSI-100) versus. GM-CSF alone after adjuvant trastuzumab in HER2-positive women with breast cancer.
Abstract Number: TPS1110; Poster Number: 485b; Abstract Title: A randomized, multicenter, placebo-controlled, phase III study to evaluate the efficacy and safety of HER2/neu peptide GLSI-100 (GP2 + GM-CSF) in patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 (Co-authored with Baylor College of Medicine)
CEO Snehal Patel commented, "These abstracts and posters highlight the first steps to optimizing the use of GLSI-100. We are planning to study the peak immunity of GP2 and how to assess when to administer booster injections. The current methodology is to deliver 6 primary injections over the first 6 months and 5 booster injections 6 months apart, thus totaling 11 injections over 3 years. However, in the future, we envision using immune response and T-cell profiles to determine when boosters may be needed. This may allow GLSI-100 to protect breast cancer survivors over longer periods of time against recurring metastatic breast cancer. In addition, approximately 20% of patients in the Phase IIb trial had a GP2 immune response before being treated with GP2, possibly due to a potential impending recurrence. We found that some patients with baseline immune response to GP2 tended to recur at faster rates. We are planning to study this observation in the Phase III trial, which could lead us to being able to use GP2 immune response as an independent prognosticator for impending recurrence. This would allow doctors to detect recurrences sooner than current standard of care and to thus start aggressive treatments sooner with potentially better outcomes."

Mr. Patel further added, "This will be the first ASCO (Free ASCO Whitepaper) meeting in person since 2019, attended by oncologists from around the world. Greenwich is in discussions with 2 of the largest oncology networks in Europe for participation in FLAMINGO-01, and we look forward to expanding our outreach to potential international sites at ASCO (Free ASCO Whitepaper). In the US, we anticipate that the largest oncology network will provide one of the first sites to treat patients and that a second oncology network in the US may participate along side. We believe that the participation of clinical trial networks focused on cancer treatment will help to increase the enrollment rate in FLAMINGO-01 and expand the geographic footprint to allow more patients to participate."

About the ASCO (Free ASCO Whitepaper) Annual Meeting

Founded in 1964, ASCO (Free ASCO Whitepaper) is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.