On July 28, 2022 Modifi Biosciences reported that the journal Science has published a critical study validating the company’s novel oncology platform based on new classes of molecules that exploit tumor-associated DNA repair defects through direct cancer cell DNA modification (Press release, , JUL 28, 2022, View Source [SID1234629035]). The company closed a $6.4M seed round, which will support IND-enabling studies and expansion of the platform to target cancers with other DNA repair defects. Key investors in this round include HighCape Capital; Connecticut Innovations; Ironwood Capital; the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society; and Yale Ventures.

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"This approach redefines the rules on how to selectively kill cancer cells via direct DNA modification and positions our company as a leader in this emerging field of oncology drug development," said study co-lead author and Modifi Bio co-founder, Ranjit Bindra, MD, PhD. Bindra is the Harvey and Kate Cushing Professor of Therapeutic Radiology at Yale School of Medicine and Scientific Director of the Yale Brain Tumor Center at Smilow Cancer Hospital. "As a brain tumor doctor treating patients for over a decade, my colleagues and I have seen gliomas take the lives of too many patients. Our discovery represents a major step forward in changing the treatment paradigm for this devastating disease, as well as for many other cancers with intrinsic DNA repair defects."

The technology bypasses conventional approaches that indirectly target proteins in cancer cells and demonstrates robust anti-tumor activity in glioma, one of the deadliest forms of brain cancer, while sparing normal tissue. In the Science publication, the group’s new class of molecules were found to be exquisitely active and selective against cancer cells that lack expression of a key DNA repair protein called MGMT (O6-methylguanine methyl transferase).

Approximately half of all glioblastomas and up to 80% of gliomas lack MGMT. Emerging research indicates that MGMT deficiency is seen in many other tumor types, suggesting broad applicability for this strategy in treating cancer.

Modifi Bio is creating a new class of molecules, based on research conducted at Yale, that fragment in cells and induce DNA modifications, which are irreparable in cancer cells with DNA repair defects. Modifi Bio’s compounds are designed to be orally bioavailable and possess favorable drug-like properties, which will allow them to rapidly file an Investigative New Drug application with the U.S. Food and Drug Administration in anticipation of Phase I clinical trials in 2024.

"These molecules are particularly promising as therapeutics because of their ability to directly modify DNA of cancer cells, which we believe will not only be effective in fighting cancer but will also allow us to overcome key resistance mechanisms," said Seth Herzon, PhD, study co-lead author, Modifi Bio co-founder, and the Milton Harris ’29 PhD Professor of Chemistry in Yale’s Faculty of Arts and Sciences.

"Novel treatments for these types of brain cancer are urgently needed. I am enthusiastic that this paradigm-shifting discovery may lead to the first clinically meaningful pharmacological advances in the treatment of glioma in over two decades," said Roger Stupp, MD, a member of the Modifi Bio Scientific Advisory Board, Paul C. Bucy Professor of Neurological surgery, and Chief of Neuro-oncology at Northwestern University. Stupp first published the pivotal studies over 20 years ago, which define the current standard of care for glioma.

The research was conducted at Yale University and the co-first authors of the Science study are Kingson Lin and Susan Gueble. Co-authors are Ranjini Sundaram and Eric Huseman. The technology highlighted in the research has been exclusively licensed to Modifi Bio with support from Yale Ventures. Co-founders of Modifi Bio include Herzon, Bindra, Lin, and Kevin Rakin.

Funding for the research came, in part, from the National Institutes of Health and the Yale Cancer Center. Additionally, Bindra received CureSearch for Children’s Cancer’s Catapult Award. CureSearch’s mission is to end childhood cancer by driving targeted and innovative research with measurable results in an accelerated time frame.

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.

On July 28, 2022 CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States reported that the first patient has been dosed in a Phase 1 clinical trial evaluating CYTO-102, a novel cellular therapy consisting of PD-L1-positive tumor-reactive TRACK-NKTM cells (Press release, CytoImmune Therapeutics, JUL 28, 2022, View Source [SID1234617108]). The trial is assessing CYTO-102 as a monotherapy and in combination with atezolizumab in patients with relapsed/refractory non-small cell lung cancer (NSCLC).

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This innovative therapy is generated by genetically modifying NK cells to secrete high levels of soluble IL-15, an immune-signaling molecule crucial for optimal antitumor responses with the patient’s own immune system. The engineered NK cells are primed with cytokines IL-12 and IL-18 along with other signals during manufacturing to induce PD-L1 expression. The PD-L1-positive TRACK-NKTM cells are naturally directed to the tumor microenvironment where they are designed to kill the cancer cells as well as to coordinate the adaptive or T cell response by the patient’s own immune system.

"We are thrilled to initiate patient dosing with CYTO-102, in partnership with City of Hope, which marks our transition into a clinical-stage company and brings us an important step closer to understanding the potential our tumor-reactive NK cell-based therapies may have for treating patients with cancer," said Christina Coughlin, M.D., Ph.D., chief executive officer of CytoImmune. "We’ve engineered CYTO-102 to be an off-the-shelf cell therapy that can directly kill cancer cells, broadly stimulate the body’s own endogenous immune system, and enhance tumor killing through generation of a highly effective immune response ultimately leading to improved patient outcomes. We look forward to advancing this trial in an effort to bring the next generation of cellular therapies to patients in need."

"City of Hope is committed to making a difference in the lives of patients with cancer with a goal of transforming the future of cancer care," said Michael Caligiuri, M.D., president of City of Hope National Medical Center, Deana and Steve Campbell Physician-in-Chief Distinguished Chair and CytoImmune’s scientific founder. "NSCLC continues to be a challenging cancer to treat and despite advancements, too many patients are left without durable and effective options. We are pleased to advance this novel cellular therapy together with CytoImmune, which could offer patients with NSCLC a promising new treatment option."

The Phase 1, dose escalation clinical trial will evaluate the safety and tolerability, as well as key biologic endpoints of CYTO-102, including NK cell persistence and trafficking, tumor microenvironment changes and endogenous T and NK cell recruitment by CYTO-102, as both a monotherapy and in combination with atezolizumab, a PD-L1 inhibitor. The trial will enroll approximately 21 patients with relapsed or difficult-to-treat NSCLC. Details regarding the study can be found here.