On November 9, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported that it has successfully manufactured and shipped its first research use only quantity of self-amplifying mRNA (saRNA) template generated by its Linea DNA platform (the "Platform") to an unidentified preclinical therapeutic mRNA developer (Press release, Applied DNA Sciences, NOV 9, 2023, View Source [SID1234637350]).

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saRNA is a promising new form of mRNA therapy engineered to possess a self-replicating capability. Unlike conventional non-amplifying mRNA, saRNA carries the machinery necessary for its replication, resulting in a higher therapeutic index at a lower dose. Due to these advantages, interest in saRNA is rapidly growing, as evidenced by 10 active saRNA vaccine clinical trials as of Jan. 20231 and numerous companies engaged in preclinical studies to use saRNA to treat indications ranging from cancer to protein replacement therapies. Like mRNA, saRNA is also produced from a DNA template.

The manufacturing of saRNA, however, has proven to be challenging due to the large size and complexity of saRNA and its associated DNA IVT templates. The DNA templates for saRNA are often 3x-5x larger than the DNA templates for conventional non-amplifying mRNA. saRNA can also be challenging to produce efficiently in DNA plasmids, often leading to heterogeneous DNA sequences, low yields, and long manufacturing timelines.

In contrast, the Company’s Platform can rapidly and efficiently enzymatically produce the challenging DNA sequences necessary to produce saRNA with high levels of homogeneity, particularly in challenging sequences such as the poly(T) homopolymers required to produce saRNA. Due to these Platform advantages, the Company is working with additional customers to produce preclinical saRNA IVT templates.

"RNA technology is today central to the development of biologics for human health, and DNA is its manufacturing starting point," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Development pipelines are beginning to see an uptake of saRNA for next-generation mRNA therapies. We believe our Platform’s ability to enzymatically produce the challenging and large DNA sequences needed to manufacture saRNA at scale puts us at the forefront of template manufacturing for this promising and growing mRNA modality."

On November 9, 2023 Aeglea BioTherapeutics, Inc. ("Aeglea" or the "Company") (NASDAQ:AGLE), a biotechnology company advancing a pipeline of antibody therapeutics with the potential to transform the treatment of inflammatory bowel disease ("IBD"), reported its third quarter 2023 financial results and provided program and corporate updates (Press release, Aeglea BioTherapeutics, NOV 9, 2023, View Source [SID1234637349]).

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"We have made significant progress in our first quarter following the Spyre acquisition towards our goal of creating new, best-in-class medicines for patients with IBD. We believe that our combination strategy and pipeline, including SPY001, an extended half-life anti-α4β7 antibody, and SPY002 a dual monomer / trimer anti-TL1A antibody with picomolar affinity and extended half-life, offer the potential to meaningfully improve both efficacy and convenience relative to today’s standard of care," said Cameron Turtle, D.Phil., Chief Operating Officer of Aeglea. "In addition to progressing our portfolio towards first-in-human studies next year, we have built out our team with passionate and experienced biotechnology leaders."

Development Pipeline Overview and Update

With its acquisition of Spyre Therapeutics, Inc. ("Spyre") in June 2023, Aeglea shifted its disease focus to IBD. The Company’s approach combines best-in-class antibody engineering, rational therapeutic combinations, and precision immunology with the goal of maximizing efficacy, safety, and convenience of its IBD treatments under development. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract,

including two main disorders: ulcerative colitis ("UC") and Crohn’s disease ("CD"). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD.

The Company has four product candidates in preclinical development, three of which are validated targets in IBD. The fourth product candidate is a novel, undisclosed target.

SPY001 – a highly potent and selective anti-α4β7 monoclonal antibody engineered with half-life extension technology and formulated for high concentration, convenient dosing.

•SPY001 is currently progressing through IND-enabling studies and is expected to enter first-in-human ("FIH") studies in the first half of 2024.
•Interim data from a healthy volunteer study are expected by the end of 2024. The Company expects pharmacokinetic data to demonstrate proof of concept for its ability to potentially reach an every-eight-week or every-twelve-week dosing interval.

SPY002 – a highly potent and selective anti-TL1A monoclonal antibody engineered with half-life extension technology. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications.

•The Company’s extensive discovery campaign has identified lead clones which bind both TL1A monomers and trimers with picomolar affinity and have in vitro potency and pharmacokinetic half-lives that exceed all clinical-stage TL1A antibodies.
•The Company expects to begin FIH studies of the SPY002 program in the second half of 2024 with healthy volunteer interim data expected in the first half of 2025.

SPY003 – a highly potent and selective monoclonal antibody targeting the p19 subunit of IL-23 engineered with half-life extension technology.

•The Company continues preclinical development efforts on a potential best-in-class IL-23 monoclonal antibody. Recent data from the Phase 3 SEQUENCE study of risankizumab versus ustekinumab in Crohn’s disease validates the Company’s targeting of the p19 subunit as it demonstrated superiority to targeting the p40 subunit of IL-23.
•An IND/CTN is expected in 2025.
Corporate Updates

•In October 2023, the Company filed a definitive proxy statement regarding the Special Meeting of Stockholders to be held on November 21, 2023 (the "Special Meeting"). At the Special Meeting, stockholders are expected to vote on four proposals, including the conversion of the Company’s Series A Preferred Stock to common stock and an increase to the Company’s authorized shares.
•In September 2023, the Company strengthened its leadership team with the appointments of industry veterans Scott Burrows, as Chief Financial Officer, and Heidy Abreu King-Jones, as Chief Legal Officer and Corporate Secretary.
•In September 2023, the Company completed a reverse stock split of all outstanding shares of common stock at a ratio of 1-for-25, with trading on a split-adjusted basis on the Nasdaq Capital Market beginning on September 8, 2023.
•In July 2023, the Company sold the global rights to pegzilarginase to Immedica Pharma AB ("Immedica") for $15 million in upfront cash proceeds and up to $100 million in contingent milestone payments. In November 2023, holders of the Company’s contingent value rights (CVRs) are expected to receive a payment representing the Immedica sale proceeds net of expenses and adjustments pursuant to the CVR agreement entered into in connection with Aeglea’s acquisition of Spyre.

Third Quarter 2023 Financial Results
Cash Position: As of September 30, 2023, Aeglea had available cash and cash equivalents, marketable securities, and restricted cash of $204.9 million.
Research and Development (R&D) expenses: R&D expenses totaled $24.7 million for the third quarter of 2023 and $12.0 million for the third quarter of 2022. This increase was primarily related to increases in preclinical development and manufacturing expenses for the Company’s IBD pipeline, partially offset by a decrease in expenses associated with the legacy Aeglea rare disease pipeline.
General and Administrative (G&A) expenses: G&A expenses totaled $8.6 million for the third quarter of 2023 and $7.0 million for the third quarter of 2022. This increase was primarily due to an increase in legal and employee separation costs.
Gain on Sale of In-Process Research & Development Asset: During the third quarter of 2023, the Company recognized a $14.6 million gain on the sale of the global rights of pegzilarginase to Immedica.
Other Income and Expenses: Other Income and Expenses were a net $21.8 million expense in the third quarter of 2023, primarily driven by a $25.4 million non-cash forward contract liability expense related to an increase in fair value of the underlying Series A Preferred Stock between June 30, 2023 and the forward contract’s settlement on July 7, 2023.
Net Loss: Net loss totaled $40.1 million and $18.2 million for the third quarter of 2023 and 2022, respectively, which includes non-cash stock compensation expense of $4.8 million and $1.6 million for the third quarter of 2023 and 2022, respectively.

On November 9, 2023 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended September 30, 2023 (Press release, Adaptive Biotechnologies, NOV 9, 2023, View Source [SID1234637348]).

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"We have two compelling businesses in MRD and Immune Medicine, which continue to make significant progress in divergent ways," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Given the advancements achieved to date by each business and their respective investment needs, we are conducting a review of strategic alternatives to maximize value for our patients and shareholders."

Recent Highlights

•
Strategic review underway with Goldman Sachs to maximize the value of the MRD and Immune Medicine businesses.
•
Revenue for the third quarter 2023 was $37.9 million, representing a 21% decrease from the third quarter 2022 driven primarily by a 61% reduction in GNE amortization and a 14% decrease in MRD pharma services and IM pharma services largely due to biopharmaceutical industry headwinds.
•
clonoSEQ test volume in the third quarter 2023 grew 56% to 15,072 tests delivered versus the third quarter of prior year.
•
Immune Medicine achieved a key milestone with the discovery of a novel target in multiple sclerosis, which validates our target discovery approach in autoimmune disorders.
•
Operating expenses, excluding cost of revenue, for the third quarter 2023 decreased 11% versus the same period last year as a result of continued operating efficiencies efforts.
Third Quarter 2023 Financial Results

Revenue was $37.9 million for the quarter ended September 30, 2023, representing a 21% decrease from the third quarter in the prior year. Immune Medicine revenue was $13.3 million for the quarter, representing a 52% decrease from the third quarter in the prior year. MRD revenue was $24.7 million for the quarter, representing a 24% increase from the third quarter in the prior year.

Operating expenses were $88.9 million for the third quarter of 2023, compared to $93.3 million in the third quarter of the prior year, representing a decrease of 5%. Interest expense from our revenue interest purchase agreement was $3.7 million for the third quarter of 2023, compared to $0.7 million in the third quarter of the prior year.

Net loss was $50.3 million for the third quarter of 2023, compared to $45.3 million for the same period in 2022.

Adjusted EBITDA (non-GAAP) was a loss of $29.8 million for the third quarter of 2023, compared to a loss of $25.9 million for the third quarter of the prior year.

Cash, cash equivalents and marketable securities was $371.1 million as of September 30, 2023.

2023 Financial Guidance Update

In light of the strategic review and evolving focus of Immune Medicine as a drug discovery business, Adaptive Biotechnologies is updating full year 2023 revenue guidance to exclude revenue from the Immune Medicine business.

MRD business full year 2023 revenue to be in the range of $100 million to $105 million.

Total company operating expenses, including cost of revenue, for full year 2023 to be around $375 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its third quarter 2023 financial results after market close on Thursday, November 9, 2023 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On November 9, 2023 Daiichi Sankyo’s (TSE: 4568) reported the VANFLYTA (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive (Press release, Daiichi Sankyo, NOV 9, 2023, View Source [SID1234637289]).

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VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.

The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet. In QuANTUM-First, VANFLYTA combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival was 31.9 months for patients receiving VANFLYTA (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

"This approval of VANFLYTA represents an important advancement for frontline treatment of patients with FLT3-ITD positive acute myeloid leukemia, an aggressive and historically difficult-to-treat subtype," said Richard F. Schlenk, MD, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany. "VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3-ITD positive AML."

"This approval of VANFLYTA is very welcome news for eligible patients diagnosed with FLT3-ITD positive AML each year," said Samantha Nier, Network Director, Acute Leukemia Advocates Network (ALAN). "New medicines and treatment approaches are needed to help patients with this difficult type of leukemia live longer, and we look forward to VANFLYTA becoming available in countries throughout the EU."

The safety profile of VANFLYTA in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed. The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%). QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation. Ventricular arrhythmia events with VANFLYTA were uncommon. Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

"With the approval of VANFLYTA in the European Union, patients diagnosed with FLT3-ITD positive acute myeloid leukemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype," said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. "VANFLYTA is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer."

About QuANTUM-First
QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating VANFLYTA in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant (HSCT), and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive VANFLYTA or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance.

The primary study endpoint was overall survival. Secondary endpoints include event-free survival, postinduction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR also were evaluated.

QuANTUM-First enrolled 539 patients at 193 study sites in 26 countries across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.3 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.4,5 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients.6,7

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.8 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival.1,2 FLT3-ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%.1,2

About VANFLYTA
VANFLYTA is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3-ITD mutations and has been specifically developed for patients with FLT3-ITD positive AML.

VANFLYTA is approved in the EU in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed AML that is FLT3-ITD positive.

VANFLYTA is approved in the U.S. in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive as detected by an FDAapproved test. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

VANFLYTA also is approved in Japan for the treatment of AML that is FLT3-ITD mutation positive, including for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy for adult patients with newly diagnosed FLT3-ITD positive AML and as a monotherapy for relapsed/refractory AML that is FLT3-ITD positive as detected by an approved test. VANFLYTA is an investigational medicine in all countries outside of Europe, Japan and the U.S.

About the VANFLYTA Clinical Development Program
The VANFLYTA clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3-ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center.

On November 9, 2023 Astrazeneca reported that Positive high-level results from the EMERALD-1 Phase III trial showed Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolisation (Press release, AstraZeneca, NOV 9, 2023, View Source [SID1234637288]). The trial continues to follow the secondary endpoint of overall survival (OS).

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Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death with an estimated 900,000 people worldwide diagnosed each year.1,2 Approximately 20-30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can also deliver chemotherapy or radiation therapy directly to the liver.3-9 Despite being the standard of care in this setting, most patients who receive embolisation experience rapid disease progression or recurrence.10-14

Dr. Riccardo Lencioni, Professor and Director of the Cancer Imaging Program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Pisa, Italy, and principal investigator in the trial, said: "Patients with liver cancer eligible for embolisation experience high rates of progression or recurrence and do not have the opportunity for early intervention with effective systemic therapy. These results for durvalumab plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to TACE significantly improves progression-free survival."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These positive results for Imfinzi-based treatment in EMERALD-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients."

The safety profiles for Imfinzi and TACE plus bevacizumab were consistent with the known profile of each medicine, and there were no new safety findings.

The data will be presented at a forthcoming medical meeting and shared with regulatory authorities.

AstraZeneca has an extensive clinical development programme further assessing Imfinzi across multiple gastrointestinal (GI) cancer settings, including in combination with bevacizumab in adjuvant HCC (EMERALD-2) and in combination with Imjudo (tremelimumab), lenvatinib and TACE in embolisation-eligible HCC (EMERALD-3).

Notes

Liver cancer
Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1-2 Asia holds more than 70% of the world’s new liver cancer cases.15 About 75% of all primary liver cancers in adults are HCC.1 Between 80-90% of all patients with HCC also have cirrhosis.16 Chronic liver diseases such as cirrhosis are associated with inflammation that over time can lead to the development of HCC.16 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.17

EMERALD-1
EMERALD-1 is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial of Imfinzi plus TACE concurrently, followed by Imfinzi with or without bevacizumab until progression versus TACE alone in a total of 616 patients with unresectable HCC eligible for embolisation.

The trial was conducted in 157 centres across 18 countries, including in North America, Australia, Europe, South America and Asia. The primary endpoint was PFS for Imfinzi and TACE plus bevacizumab versus TACE alone, and secondary endpoints include PFS for Imfinzi plus TACE, overall survival, patient-reported outcomes and objective response rate.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable HCC in the US, EU, Japan and many other countries based on the TOPAZ-1 and HIMALAYA Phase III trials, respectively.

In addition to its indications in GI cancers, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN Phase III trial. Additionally, Imfinzi is approved in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. Imfinzi is approved in previously treated patients with advanced bladder cancer in a small number of countries.

Since the first approval in May 2017, more than 200,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer and other solid tumours. In 2023, AstraZeneca announced positive results for Phase III trials including combinations with Imfinzi in ovarian (DUO-O) and endometrial (DUO-E) cancers, as well as in resectable NSCLC (AEGEAN).

In addition to the EMERALD programme across multiple liver cancer settings, AstraZeneca has ongoing registrational trials investigating Imfinzi in resectable gastric and gastroesophageal junction cancers (MATTERHORN) and in locally advanced oesophageal cancer (KUNLUN). In June 2023, Imfinzi added to standard-of-care neoadjuvant chemotherapy met a key secondary endpoint of pathologic complete response in the MATTERHORN Phase III trial.