On February 2, 2023 Instil Bio, Inc. ("Instil" or the "Company") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing next-generation tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported an extension of its previously reported reduction-in-force to a team of approximately 15 employees in the U.S. to lead global business operations, including the consolidation of clinical manufacturing and trial operations of its CoStAR-TIL to its active Manchester, U.K. operations (Press release, Instil Bio, FEB 1, 2023, View Source [SID1234626784]). Instil’s Manchester, U.K. operations have extensive experience and success in the manufacture and development of TIL and other cell therapy products since 2011. With these changes, Instil expects cash resources to provide runway beyond 2026 and continues to expect initial clinical data from the ITIL-306 program in 2023. Instil is also evaluating opportunities for a potential sale of the Tarzana manufacturing site which would further extend the cash runway.

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"I am confident in the ability of our Manchester team to progress ITIL-306 in the clinic, building on more than a decade of proven experience in manufacturing TIL, including our historical compassionate use program in metastatic melanoma," said Bronson Crouch, CEO of Instil Bio. "The consolidation we announce today, while difficult, is consistent with our responsibilities as an early clinical phase company. We look forward to presenting initial clinical data in 2023 and continuing to progress the CoStAR-TIL platform."

On February 1, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in polymerase chain reaction ("PCR")-based technologies, reported that it will release financial results for the three months ended December 31, 2022, after the market closes on Thursday, February 9, 2023 (Press release, Applied DNA Sciences, FEB 1, 2023, View Source;id=253561&p=2256785&I=1206939-c7Z3G6f3m8 [SID1234626751]). The Company will host a conference call for the investment community to discuss its results and answer questions at 4:30 p.m. ET.

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Date & Time: Thursday, February 9 @ 4:30 p.m. ET

Dial In (ask to be joined into the Applied DNA Sciences call):

Domestic callers (toll free): 844-887-9402
Canadian callers (toll free): 866-605-3852
International callers: 412-317-6798
Live webcast: View Source
A telephonic replay of the conference call will be available for 1 week following the conclusion of the live call:

Replay for domestic callers (toll free): 877-344-7529, replay access code 2079390
Replay for Canadian callers: 855-669-9658, replay access code 2079390
An archived webcast replay of the conference call will be available for 1 year following the conclusion of the live call: View Source

An accompanying slide presentation will be embedded in the webcast (live and replay) and can also be accessed in the ‘Company Events’ section of the ‘News & Events’ tab of the Applied DNA investor relations website at View Source

On February 1, 2023 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Eli Lilly to be a specialty pharmacy partner for JAYPIRCA (pirtobrutinib), which is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi) (Press release, Onco360, FEB 1, 2023, View Source [SID1234626750]). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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"Onco360 is excited to announce our partnership with Eli Lilly and become a specialty pharmacy provider for JAYPIRCA patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of patients battling relapsed/refractory mantle cell lymphoma which has failed prior lines of systemic therapy across the United States."

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 80,470 new cases of Non-Hodgkin Lymphoma (NHL) will be diagnosed in 2022 in the United States with a corresponding 20,250 deaths in 2022.1 According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of B-Cell Lymphomas, 3-5% of annual new NHL diagnoses are mantle cell lymphoma (MCL) cases. MCL is thought to possess the unfavorable characteristics of both indolent and aggressive NHL subtypes owing to the incurability of disease with conventional chemotherapy and a typically more aggressive disease course compared to indolent lymphomas. The five-year overall survival (OS) for MCL ranges from 50-70% dependent upon stage of disease.2

JAYPIRCA, a non-covalent BTKi, is commercialized by Eli Lilly. The FDA approval of JAYPIRCA is based on results Phase I/II BRUIN trial (NCT03740529), which was an open-label, single-arm study that, in part, evaluated the efficacy/safety of JAYPIRCA in 120 patients with relapsed/refractory MCL who were previously treated with BTKi therapy. JAYPIRCA administration resulted in a 50% overall response rate (ORR) in the aforementioned patient population. The most common adverse reactions (> 15%) in patients with MCL are fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising.3

On February 1, 2023 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for EP0042, a dual FLT-3 and Aurora kinase inhibitor (Press release, Ellipses Pharma, FEB 1, 2023, View Source [SID1234626749]).

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EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome.1

This approval will allow Ellipses to expand its ongoing first in human phase 1/2 clinical trial, which is currently undergoing its dose ranging phase. Once a recommended Phase 2 dose is confirmed, Ellipses will continue to evaluate EP0042 as a monotherapy and explore EP0042 in combination with established standard treatments.

In December 2022, Ellipses presented preliminary data from this ongoing study at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which demonstrated that EP0042 had acceptable safety and tolerability with evidence of prolonged disease control in a number of heavily pre-treated patients.2

Dr Rajan Jethwa, Chief Executive Officer & Founder of Ellipses, commented:
"This FDA approval of EP0042’s Investigational New Drug application allows us to open additional trial sites in the world’s foremost pharmaceutical market. This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, whilst also allowing us to engage with key industry and academic partners. The data we presented in December at ASH (Free ASH Whitepaper), one of the leading conferences in our sector, demonstrated the potential of EP0042, and as a team we are now focused on doing all we can to progress this potential towards reality."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma commented:
"We are delighted to continue progressing through the regulatory pathway for EP0042, and this FDA IND approval is another successful milestone for our team. We will now work with our clinical partners to bring US sites online as quickly as possible as we look to continue this positive momentum in EP0042, and indeed across our broader portfolio."

EP0042’s ongoing clinical-stage study follows earlier drug discovery and development work led by The Institute of Cancer Research, London, which was funded by organisations including The Institute of Cancer Research, Breast Cancer Now and Cancer Research UK.

About EP0042

EP0042 is a dual FLT3 and Aurora kinase inhibitor under development as a new treatment for AML patients who have developed FLT3 inhibitor resistance. Dual inhibition of FLT3 and Aurora kinase has been shown to overcome acquired resistance to selective FLT3 inhibition both in vitro and in vivo.3

About acute myeloid leukaemia

Acute myeloid leukaemia (AML) is a cancer of the bone marrow, which begins to produce excess volumes of monocytes and granulocytes. It is one of the most common types of leukaemia in adults. Approximately 20,000 patients are diagnosed with AML in the US each year,4 and a further 18,000 patients in Europe, with around 40% of cases being diagnosed in people over the age of 75.5 The 5-year survival rate following an initial diagnosis is currently 15%.6

On February 1, 2023 Orbit Discovery Limited (Orbit), a leader in the discovery of therapeutic peptide hits, reported it has entered into a multi target Research Agreement with Endevica Bio Inc., (Endevica), a company dedicated to creating first-in-class therapeutics for cachexia caused by cancer and other chronic conditions, with its lead compound having proven safe and well-tolerated in its Phase 1 trials (Press release, Orbit Discovery, FEB 1, 2023, View Source [SID1234626748]). The collaboration aims to accelerate Endevica’s development of advanced G-protein coupled receptor (GPCR)-targeting therapeutics on receptor sets both novel and complimentary to its lead compound.

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Endevica’s technology platform allows for the modification of peptides to modulate activity of GPCRs behind the blood-brain barrier. The focus of this agreement is to identify peptide hits from selected library populations, derived from Endevica’s internal in silico and modelling tools, which will be applied directly to Orbit’s proprietary functional screening platform where agonism of proteins can be identified. The platform allows for millions of independent peptide sequences to be screened using a combination of bead-based DNA encoded libraries and microfluidic droplet screening. The peptide display engine is uniquely able to address soluble targets and targets in situ, both on and in cells, allowing for significantly faster discovery times of relevant peptide leads based on affinity screens and/or functional screens.

The agreement covers activities ranging from hit ID to development of cell-based assays, with an option for Endevica to further develop the peptide hits resulting from the screening activities.