On July 28, 2022 Novartis and the University of California, Berkeley reported that they have extended their research-based collaboration to develop new technologies for the discovery of next-generation therapeutics, following its successes over the last five years (Press release, Novartis, JUL 28, 2022, View Source [SID1234617107]). The combined research team is pursuing a vast number of disease targets in cancer and other illnesses that have eluded traditional small-molecule compounds and drug discovery strategies.

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"One of the biggest challenges facing drug discovery is that the majority of proteins are currently still considered ‘undruggable,’" said covalent chemoproteomics expert Daniel Nomura, Director of the Institute and Professor of Chemistry, Molecular and Cell Biology in the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology at UC Berkeley. "Most proteins do not possess well-defined binding pockets or ‘ligandable hotspots’ that can be pharmacologically and functionally targeted for therapeutic benefit. Tackling these undruggable proteins requires the development of innovative technologies for ligand discovery and the discovery of novel therapeutic modalities to functionally manipulate these intractable proteins for therapeutic benefit."

This research collaboration allows UC Berkeley scientists to work with their scientific peers at Novartis Institutes for BioMedical Research (NIBR) to find new cures for debilitating illnesses. The second phase of the research collaboration is the Novartis-Berkeley Translational Chemical Biology Institute, and is based at UC Berkeley. The Berkeley team includes Professors Nomura, F. Dean Toste, Thomas Maimone, Ziyang Zhang, and James Olzmann. The science and strategy underpinning the research collaboration aim to harness covalency, coupled with chemoproteomics technology, to enable the discovery of small-molecule compounds that could ultimately form the basis of proximity-based therapeutics.

"I am thrilled to be able to help build off the momentum gained during the past five years and equally excited to synergize with new colleagues," said Maimone, Associate Professor of Chemistry at UC Berkeley. "With expanded scientific expertise, increasingly sophisticated chemistries, and new envisioned therapeutic modalities, the next several years will be exhilarating."

The inaugural research collaboration, the Novartis-Berkeley Center for Chemistry and Proteomics Technologies, led to multiple groundbreaking discoveries, including the development of several novel recruiters of E3 ubiquitin ligases that can be exploited in the degradation of disease causing proteins; the development of new chemistry that can be used to enhance the scope of covalent chemoproteomic technologies; and the creation of a new therapeutic platform called Deubiquitinase Targeting Chimeras (DUBTACs) for stabilizing the levels of proteins that are aberrantly degraded. This work has led to several publications and patents and facilitated the training of emerging scientists. The DUBTAC platform is also the basis of a spinout company, Vicinitas Therapeutics, focused on developing DUBTACs into a unique, potential, proximity-based therapeutic modality for cancer, genetic disorders, and other indications.

"We joined forces with Berkeley five years ago because we knew that many compelling targets in disease biology remain beyond reach – and that no one team or discipline could tackle the toughest among them alone," said Jay Bradner, President of NIBR. "Today, we recommit to working shoulder-to-shoulder to make these so-called ‘undruggable’ targets druggable."

Moving forward, the alliance will continue to develop new chemistries and chemical technologies for targeting undruggable proteins, expand upon emerging therapeutic modalities such as targeted protein degradation (TPD) that exploit the cell’s natural protein disposal system to destroy disease-causing proteins, and develop new therapeutic modalities that enable access into larger swaths of the undruggable protein landscape.

On July 28, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3-related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 30 June 2022 (Q4 FY22) (Press release, Immutep, JUL 28, 2022, View Source [SID1234617126]).

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Efti Development Program for Cancer

AIPAC – clinical trials

New biomarker and multivariate analysis data from the Phase IIb AIPAC trial was reported at ESMO (Free ESMO Whitepaper)’s Breast Cancer Congress in May 2022. The AIPAC trial evaluated efti in combination with paclitaxel chemotherapy in 227 patients with HER2-negative/HR positive metastatic breast cancer (HR+ MBC). While the final Overall Survival results from this trial were reported in November 2021, the biomarker analysis reported highly valuable additional insights.

The analysis showed a statistically significant increase in innate and adaptive immune response biomarkers (monocyte and CD8+ T cell counts and serum CXCL10 levels) and absolute lymphocyte count (ALC) was observed in the efti group, but not in the placebo group. These improved immune parameters correlated with improved overall survival of the patients, confirming efti is activating the immune system and helping patients live longer.

In addition, an observed early rise in ALC in patients treated with efti may provide clinicians with a potential predictor of improved survival, helping them to determine early on if continued treatment with efti is beneficial. The exploratory analysis also identified six patient subgroups that showed improvements in Overall Survival (OS). These subgroups are therefore relevant for patient population selection for future late-stage studies in breast cancer.

Regulatory interactions are ongoing for the further clinical development program for efti in MBC, including with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). This follows feedback from the EMA regarding the efti program received in October 2021 and the FDA in March 2022. In light of the exciting 1st line NSCLC data from TACTI-002 (discussed below) Immutep is reviewing clinical plans for MBC and NSCLC in order to potentially prioritize one indication.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial

New data from 1st line NSCLC patients (Part A) from TACTI-002 was reported in a prestigious Oral Presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting in June 2022. The data showed TACTI-002 met its primary objective for 1st line NSCLC patients in this PD-L1 all-comer trial.

Immutep reported an Overall Response Rate of 38.6% to the combination of efti plus pembrolizumab and favourable anti-tumour activity. Encouraging responses were demonstrated in all PD-L1 status groups, including patients who were PD-L1 negative or PD-L1 low, both groups were less likely to respond to anti-PD-1 monotherapy. Immutep also reported improving secondary endpoints, Disease Control Rate (DCR) and interim median Progression Free Survival (PFS), across all PD-L1 expression levels. Efti continues to be safe and well tolerated, with a safety profile consistent with previously reported studies for pembrolizumab monotherapy. The results are supportive of continued late-stage clinical development of efti in 1st line NSCLC.

New interim data from 2nd line NSCLC patients (Part B) has been selected for a poster presentation at the IASLC 2022 World Conference on Lung Cancer (WCLC 2022) taking place in August 2022 in Vienna, Austria. WCLC is the world’s largest international gathering of clinicians, researchers and scientists in the field of lung cancer and thoracic oncology.

TACTI-003 – Phase IIb clinical trial

Recruitment is ongoing for 1st line head and neck squamous cell carcinoma (HNSCC) patients for Immutep’s TACTI-003 trial, with 39 patients out of approximately 154 enrolled to date across the now 24 active trial sites.

TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial. It was granted fast track designation for 1st line HNSCC by the US FDA in 2021. Immutep presented the trial design for TACTI-003 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting held in June. Recruitment and trial updates are expected to be reported throughout the remainder of 2022 and into 2023.

INSIGHT-003 – triple combination

Patient recruitment is ongoing for the INSIGHT-003 investigator-initiated trial, with 13 out of a total of 20 patients already enrolled. INSIGHT-003 focuses on a patient population with NSCLC adenocarcinomas and evaluates a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin, pemetrexed) and an anti-PD-1 therapy. Interim results from the study are expected to be reported in Q4 2022. The trial is being conducted by the Institute of Clinical Cancer Research (IKF) at Northwest Hospital, Frankfurt, Germany.

Potential new trials for efti in cancer

Due to the positive data from efti presented at ASCO (Free ASCO Whitepaper) 2022 and other conferences, Immutep has been approached for potential new investigator-initiated trials as well as other potential collaborations for efti in various indications and combinations; we are currently assessing these opportunities. It is very encouraging to see the increased level of industry interest and willingness to support and fund further trials for efti in cancer because of the growing body of positive data generated from efti clinical trials thus far.

At this stage, discussions with various parties are incomplete and still subject to negotiation. Once an agreement is reached, the Company will provide further details in a market announcement.

IMP761 Development Program for Autoimmune Disease

Preclinical development steps are continuing for IMP761, prior to advancing the candidate into clinical trials. This includes development of a GMP-compliant manufacturing process for IMP761. The GMP manufacturing at 200 litre scale is ongoing. IMP761 is Immutep’s immunosuppressive agonist antibody to LAG-3 which will be tested to treat the causes of autoimmune disease, such as inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis, rather than merely treating the symptoms.

Partnering Updates

CYTLIMIC

Immutep signed clinical collaboration, service and supply agreements with the Japanese biotech, CYTLIMIC (an affiliate of NEC) in 2019 to support its development of a therapeutic cancer vaccine. CYTLIMIC has been conducting studies of CYT001, its lead cancer vaccine which comprises peptides designed using artificial intelligence from the HSP70 and GPC-3 proteins, plus two adjuvants, efti and Hiltonol. Based on a comprehensive business evaluation, CYTLIMIC has determined to dissolve the company and to transfer its own patents and licensing rights to NEC accordingly. Investigations into CYT001 will not be continuing whilst NEC assesses the future of this cancer vaccine program.

EAT COVID

Conducted and funded by the University Hospital Pilsen, Czech Republic, the Phase II EAT COVID study was evaluating the Company’s lead product candidate efti in hospitalised patients with COVID-19. The study aimed to boost a patient’s immune response to prevent development of severe COVID-19 symptoms that require intensive care and can lead to respiratory failure and death. While independently reviewed safety run-in data prompted the Company to initiate enrolment for the randomised portion of the study in January 2021, recruitment into the trial has been slow. Accordingly, Immutep has decided to discontinue the supply of efti for this trial and to terminate the collaboration with the University Hospital Pilsen. Immutep only incurred minimal costs for this investigator-initiated trial.

Intellectual Property

During the quarter, Immutep and its partner Novartis AG were granted a new patent for ieramilimab (Novartis code: LAG525), a humanised LAG-3 antagonist antibody derived from Immutep’s IMP701 antibody, by the Eurasian Patent Office. The patent protects ieramilimab in the member states of the Eurasian Patent Convention, namely Armenia, Azerbaijan, Belarus, Kirgizstan, Kazakhstan, Moldova, Russia, Tajikistan and Turkmenistan. The expiry date of the new patent is 13 March 2035.

Corporate Update

Clinical Advisory Board

Immutep was delighted to welcome four world leading oncologists to its Clinical Advisory Board (CAB) during the quarter:

Scott Antonia, M.D., Ph.D. of the Duke Cancer Institute Center for Cancer Immunotherapy

Leisha A Emens, M.D., Ph.D. Professor of Medicine at the UPMC Hillman Cancer Center

Martin Forster, M.D., Ph.D., Associate Professor at University College London (UCL)

Hans Wildiers, M.D., Ph.D. of the University Hospital Leuven, Belgium

The CAB serves as a strategic resource for advancing Immutep’s pipeline of LAG-3 programs, including efti, especially in NSCLC and MBC.

Financial Summary

Overall, the financial performance for the quarter ended 30 June 2022 (i.e. Q4 FY22) was very pleasing. Cash receipts from customers Q4 increased to $96k, compared to $8k in the previous quarter (i.e. Q3 FY22).

The net cash used in G&A activities in the quarter was $361k compared to $1.6 million in Q3 FY22. The decrease compared with the last quarter is mainly due to the inclusion of certain annual expense prepayments in the previous quarter.

Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $189k in payment of Non-Executive Director’s fees and Executive Director’s remuneration.

The net cash used in Research and Development activities in the quarter was $7.62 million, compared to $8.13 million in Q3 FY22. The lower cash outflows in Q4 FY22 were mainly due to the decrease of efti and IMP761 contract manufacturing payments. The cash outflow for clinical trial activities increased compared with Q3 FY 22 and were in line with increased activity in TACTI-003. Total net cash outflows used in operating activities in the quarter was $9.28 million compared to $10.95 million in Q3 FY22.

The Company’s cash and cash equivalent balance as at 30 June 2022 was approximately $80 million compared to a balance of $87 million as at 31 March 2022. Immutep’s higher than planned cash balance continues to put the Company in a strong financial position with an expected cash reach based on current estimates of early calendar 2024. The company will continue to manage its strong cash balance carefully as it reviews its overall clinical strategy, particularly in light of the various potential opportunities for the development of efti in cancer.

A copy of the Appendix 4C – Quarterly Cash Flow Report for the quarter is attached.

On July 28, 2022 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported a corporate and financial update for the second quarter ended June 30, 2022 (Press release, Athenex, JUL 28, 2022, View Source [SID1234617059]).

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"Our team has made significant progress advancing our new strategy this quarter. I am proud of our operational execution in the first half of 2022 and pleased to say we are continuing this momentum into the second half of the year," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "By monetizing non‑core assets, we have paid down a significant amount of our senior secured debt and extended our cash runway. Athenex remains focused on advancing our NKT cell therapy platform during this transformational period and is highly encouraged by the clinical trial data to date demonstrating the potential of CAR‑NKT cells to offer a more durable, safe, and effective cell therapy option for patients with advanced solid tumors or hematological malignancies."

Second Quarter 2022 and Recent Business Highlights

Business Updates

APD/APS division delivered new product launches and generated 26% growth in product revenues during the second quarter of 2022 versus the prior year
Announced sale of revenues from U.S. and European royalty and milestone interests in Klisyri (tirbanibulin) for a total transaction value of $85 million in June
Entered into an agreement in July to sell China API Business for approximately $19 million
Appointed Darrel P. Cohen, MD, PhD as new Chief Medical Officer of Cell Therapy
Entered a clinical collaboration with Merck to support the expansion of the Phase 1 clinical trial to evaluate Oral Paclitaxel plus KEYTRUDA (pembrolizumab) in patients with non-small cell lung cancer (NSCLC)
Clinical Programs

NKT Cell Therapy

Presented early Phase 1 ANCHOR dose escalation data for KUR-502, an allogeneic CD19 CAR-NKT therapy at the American Society of Transplantation and Cellular Therapy (ASTCT)/Center for International Blood & Marrow Transplant Research (CIBMTR) Tandem Meetings in April 2022. Data demonstrated a 60% ORR and 6-month CR rate of 40% in 5 patients from the Non-Hodgkin’s Lymphoma (NHL) cohort, including 1 ongoing CR at 34 weeks. Encouraging response rates were observed at low doses, including 2 durable responses in patients who failed prior autologous CAR-T cell therapy. KUR-502 remains well-tolerated without cytokine release syndrome (CRS) in the NHL cohort, immune effector cell-associated neurotoxicity syndrome (ICANS), or graft versus host disease (GvHD).
Presented early Phase 1 GINAKIT2 dose escalation data for KUR-501, an autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting in May 2022. Study demonstrated expansion of CAR-NKT cells in all patients and dose response, with 2 out of 3 responses observed at the 1×108 cells/m2 dose level, including a durable complete response lasting at least 12 months. Analysis of results found that responses correlated with CD62L+ NKT cell expression as well as CAR‑NKT cell area under the curve (AUC). Treatment remains well-tolerated without any dose-limiting toxicity, no ICANS, and 1 case of Grade 2 CRS.
Presented pre-clinical data for KUR-503, an allogeneic GPC3 CAR-NKT cell therapy, at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2022. Study demonstrated CAR-NKT cells overexpressing BATF3 enhanced NKT cell proliferation, long-term tumor control, and survival compared to IL-15 CAR-NKT cells.
Made the strategic decision to deprioritize development of AX-TCRT-001 and plan to close the Phase 1 open-label study of TCRT-ESO-A2 autologous T cells expressing TCR specific for NY-ESO-1 in patients with advanced solid tumors.
Commercial Update

Specialty Pharmaceutical Business

Athenex Pharmaceutical Division (APD) currently markets a total of 31 products with 57 SKUs.
Athenex Pharma Solutions (APS) currently markets 6 products with 16 SKUs.
Key Anticipated Milestones

Oral Paclitaxel:
Phase 2 data from I-SPY 2 trial evaluating Oral Paclitaxel in combination with dostarlimab in neoadjuvant breast cancer expected in 2H 2022
Regulatory interactions with UK MHRA for Oral Paclitaxel in advanced breast cancer in UK remain on track with responses to questions expected later this quarter
KUR-501: autologous GD2 CAR-NKT cell therapy for relapsed/refractory high-risk neuroblastoma
Ongoing enrollment of additional patients in single-institution Phase 1 dose escalation GINAKIT2 study at the 2 highest dose levels (DL5: 3×108 cells/m2; DL6: 1×109 cells/m2)
Next data update from the ongoing GINAKIT2 study expected in 2023
KUR-502: allogeneic CD19 CAR-NKT cell therapy for relapsed/refractory B-cell malignancies
Ongoing multicenter expansion of Phase 1 dose escalation ANCHOR study
Next clinical trial data update from the ongoing ANCHOR study anticipated in 4Q 2022 or 1Q 2023
KUR-503: allogeneic GPC3 CAR-NKT cell therapy for hepatocellular carcinoma
IND filing for KUR-503 in GPC3-expressing hepatocellular carcinoma planned in 2023
Second Quarter 2022 Financial Highlights

Revenues from product sales increased to $25.8 million for the three months ended June 30, 2022, from $20.4 million for the three months ended June 30, 2021, an increase of $5.4 million or 26%. This increase was primarily attributable to an increase in APD specialty product sales, which increased by $4.2 million as the result of increases in shortage product sales and product launches during 2022.

License fees and other revenue for the three months ended June 30, 2022, was $5.7 million, compared to $0.3 million for the same period in 2021, an increase of $5.4 million. This increase was primarily due to the recognition of $5.0 million of license revenue pursuant to the 2017 Almirall License Agreement upon the commencement of a line extension trial for Klisyri in the U.S.

Cost of sales for the three months ended June 30, 2022, totaled $23.1 million, an increase of $4.0 million, or 21%, as compared to $19.1 million for the three months ended June 30, 2021. The increase was primarily due to an increase of $1.3 million in cost of APD product sales and an increase of $2.7 million in cost of 503B product sales.

R&D expenses totaled $13.1 million for the three months ended June 30, 2022, a decrease of $7.6 million, or 37%, as compared to $20.6 million for the three months ended June 30, 2021. This decrease was primarily due to a decrease in Oral Paclitaxel product development and medical affairs costs, costs of clinical and regulatory operations, compensation costs, and costs of preclinical operations.

SG&A expenses totaled $17.2 million for the three months ended June 30, 2022, a decrease of $0.5 million, or 3%, as compared to $17.6 million for the three months ended June 30, 2021. The decrease was primarily due to a $2.5 million decrease of costs for preparing to commercialize Oral Paclitaxel as significant pre-launch activities occurred in 2020 and a $0.2 million decrease in compensation related costs. These decreases were partially offset by a $2.2 million increase in operating costs.

Interest expense totaled $4.3 million and $5.6 million, respectively, for the three months ended June 30, 2022, and 2021. Interest expense in both periods was incurred from the Senior Credit Agreement with Oaktree, and the decrease in 2Q 2022 was due to principal repayments made to the Agreement.

Income tax benefit for the three months ended June 30, 2022, amounted to less than $0.1 million, compared to an $11.0 million benefit for the same period in 2021. The income tax benefit in 2Q21 was the result of a taxable temporary difference due to the deferred tax liability recognized for the indefinite lived intangible assets acquired in connection with the acquisition of Kuur’s IPR&D. We did not record a provision for U.S. federal income taxes for the three months ended June 30, 2022, because we expect to generate a loss for the year ending December 31, 2022.

Net loss attributable to Athenex for the three months ended June 30, 2022, was $32.2 million, or ($0.28) per diluted share, as compared to a net loss of $34.3 million, or ($0.33) per diluted share, for the same period in 2021.

For further details on the Company’s financial results, including the results for the three months ended June 30, 2022, refer to the Form 10Q filed with the SEC.

2022 Financial Guidance

Athenex continues to expect product sales from continuing operations growth to be in the range of 20-25% over the prior year period.

Cash Conservation Update

As of June 30, 2022, the Company had cash and cash equivalents, restricted cash, and short-term investments of $37.1 million. The Company is implementing cost savings programs and monetizing non-core assets, and as the Company completes such activities, the Company plans to extend its cash runway into next year.

Conference Call and Webcast Information

Athenex will host a conference call and live audio webcast today, Thursday, July 28, 2022, at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:

The live conference call and replay can also be accessed via audio webcast here and on the Investor Relations section of the Company’s website under "Events and Presentations", located at View Source

On July 28, 2022 ImmunityBio, Inc reported that The FDA accepted for review a Biologics License Application (BLA) for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023.

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This combination of N-803 with BCG is ImmunityBio’s first BLA to reach this stage of FDA acceptance for review. This marks an important milestone in the pursuit of ImmunityBio’s vision of transforming how cancer patients are treated without high-dose chemotherapy, but instead by activating the patient’s innate immune system. If approved, N-803 plus BCG would be the first immunotherapy combination for this indication in 23 years that can be delivered directly to the bladder (intravesically) to induce natural killer cells and T cells. It represents an essential step in the clinical demonstration of the Nant Cancer Vaccine hypothesis proposed by ImmunityBio’s founder, Patrick Soon-Shiong, M.D. of "Quantum oncotherapeutics: a longitudinal spatiotemporal orchestration towards immunogenic cell death".

N-803 has a unique mechanism of action that leads to the proliferation of NK and T cells that are cells of the adaptive and innate immune system. Through this action, N-803 provides a secondary boost to the immunological response generated by BCG for bladder cancer, or by a checkpoint inhibitor for other indications. In the QUILT 3.032 study, 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.

"This BLA acceptance brings us a very important step closer to being able to offer this promising combination therapeutic to more people living with NMIBC and, ultimately, reduce the incidence of cystectomies," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "This is a compelling example of the power of inducing trained innate immune memory to potentially provide long-term, durable effects against serious, life-threatening diseases."

"We are pleased the FDA has begun its review, and ImmunityBio is prepared to move rapidly to manufacturing and marketing should the Agency approve our therapeutic for this indication," said Richard Adcock, President and CEO of ImmunityBio.

The BLA submission is supported by the results from ImmunityBio’s bladder cancer trials including QUILT 3.032, an open-label, three cohort, multicenter Phase 2/3 study of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) that was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. Results of this trial were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2022). See link here to video presentation on UroToday.

ImmunityBio’s IL-15 superagonist N-803

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 has been studied in more than 700 patients in multiple Phase 1 and 2 trials in both liquid and solid tumors. It is currently being studied in trials for non-muscle-invasive bladder cancer, pancreatic cancer, non-small-cell lung cancer, non-Hodgkin’s lymphoma, and HIV.

N-803 has received both Breakthrough Therapy and Fast Track designations by the FDA for the treatment of BCG-unresponsive NMIBC CIS, as well as Fast Track designation for BCG-unresponsive NMIBC papillary and BCG-naïve NMIBC CIS. However, it is important to note such designations may not lead to a faster development process or regulatory review and may not increase the likelihood that a product candidate will receive approval. Seminal patents covering intravesical administration of BCG and N-803 were issued (US 11,173,191 B2 and US 9,925,247 B2) providing term coverage until 2035.

On July 28, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended July 2, 2022 (Press release, Thermo Fisher Scientific, JUL 28, 2022, View Source [SID1234617092]).

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Second Quarter 2022 Highlights

Second quarter revenue was $10.97 billion.
Second quarter GAAP diluted earnings per share (EPS) was $4.22.
Second quarter adjusted EPS was $5.51.
Delivered very strong financial results in the second quarter, with 13% Core organic revenue growth and $0.63 billion of COVID-19 testing revenue.
Launched a range of high-impact innovative new products including the Gibco CTS TrueCut Cas9 Protein to advance genomic research by delivering consistently higher editing efficiency across a wide range of gene targets and cell types, and the Phadia 2500+ series of instruments launched in the U.S., to provide high throughput testing for both allergy diagnostics and autoimmune diseases. At the American Society for Mass Spectrometry (ASMS) Conference, the company featured new instruments, workflows, software, and industry collaborations enabling customers to generate new analytical insights, enhance productivity, and accelerate next generation vaccine and therapy development. Highlights included the Thermo Scientific Direct Mass Technology which advances the capability to analyze the characteristics of biotherapeutics, and the Thermo Scientific AccelerOme Automated Sample Preparation Platform which significantly simplifies workflows for proteomic researchers by eliminating a range of previously manual steps.
Strengthened our unique customer value proposition with new capacity and capabilities to meet increasing global demand: in Grand Island, NY expanded cell culture media capacity to support research and drug production applications; and in Geel, Belgium expanded our European distribution center for our laboratory chemicals business.
Continued to leverage our scale in high growth and emerging markets, delivering excellent growth in China, driven by both our Core business and our role in supporting local COVID-19 testing.
Building on our environmental, social and governance priorities, we released our 2021 Corporate Social Responsibility Report reflecting our commitment to society and our stakeholders.
"We delivered another quarter of outstanding financial performance," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Our proven growth strategy and PPI Business System enabled us to deliver exceptional results across our business and we continue to see the benefit of our strategic investments to enhance our unique customer value proposition. The integration of our clinical research business is going very well, the business is performing at a high level and the outlook for long-term synergies is very compelling."

Casper added, "Our team continues to execute well and we’re in a very strong position at the halfway point of the year and on track to deliver another outstanding year for Thermo Fisher."

Second Quarter 2022
Revenue for the quarter grew 18% to $10.97 billion in 2022. Organic revenue growth was 3%; acquisitions increased revenue by 19% and currency translation decreased revenue by 4%. Core organic revenue growth was 13%. COVID-19 testing revenue was $0.63 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2022 was $4.22, versus $4.61 in the same quarter last year. GAAP operating income for the second quarter of 2022 was $2.00 billion, compared with $2.16 billion in the year-ago quarter. GAAP operating margin was 18.2%, compared with 23.3% in the second quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2022 was $5.51, versus $5.60 in the second quarter of 2021. Adjusted operating income for the second quarter of 2022 was $2.61 billion, compared with $2.69 billion in the year-ago quarter. Adjusted operating margin was 23.7%, compared with 29.0% in the second quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Daylight Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, July 28, 2022, at 8:30 a.m. Eastern Daylight Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The conference ID is 512129. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News & Events" through Friday, August 12, 2022.