On October 10, 2023 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the presentation of 9 studies featuring its AI pathology research at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Congress, scheduled to be held in Madrid, Spain, from October 20 to October 24, 2023 (Press release, Lunit, OCT 10, 2023, View Source [SID1234635824]).

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This year’s collection of abstracts delves into multifaceted research, including the use of AI-powered analysis to predict treatment outcomes in different cancer types, assess HER2 expression in breast and biliary tract cancer, and streamline clinical workflows for treatment decisions in lung cancer, all utilizing the Lunit SCOPE suite.

The highlighted abstracts for ESMO (Free ESMO Whitepaper) 2023 include:

Lunit investigates AI’s potential to predict multiple druggable mutations in non-small cell lung cancer from H&E stained images, paving the way for more efficient clinical workflows and treatment decisions.
In a collaborative study, Lunit SCOPE IO distinguishes MMR-D (Mismatch repair deficiency) from MMR-P (Mismatch repair proficiency) colon cancers by analyzing features in whole slide images, offering insights with implications for prognosis and subtype-based interventions.

Lunit evaluates the efficacy and safety of avelumab plus gemcitabine in leiomyosarcoma patients who failed first-line chemotherapy, demonstrating encouraging results in terms of response rates, duration of response, and overall survival.

Analyzing HER2 expression with Lunit SCOPE HER2 in breast cancer cases proves effective in predicting FISH (Fluorescence In Situ Hybridization) positivity and therapy response, offering valuable insights for targeted therapy.
In another study utilizing Lunit SCOPE HER2, Lunit assesses HER2 expression and TIL (Tumor-infiltrating lymphocyte) density in biliary tract cancer, providing valuable insights into the tumor microenvironment’s role in treatment strategies.

Lunit’s AI-powered spatial analysis of TIL in advanced biliary tract cancer patients, who are planning to be treated with anti-PD-1 therapy, demonstrates the potential of immune phenotypes to predict therapy outcomes.
Using Lunit SCOPE IO, a study explores the predictive role of immune phenotypes and Inflamed Score in metastatic colorectal cancer patients, providing insights into immunogenicity as a biomarker.
Lunit’s AI-powered TIL density analysis in recurrent/metastatic head and neck squamous cell carcinoma patients treated with ICI reveals favorable treatment outcomes, especially in those with higher intratumoral TIL density.
"These groundbreaking abstracts showcase the power of the Lunit SCOPE suite in unraveling complex insights across various cancer types, from distinguishing tumor subtypes to predicting treatment responses," said Brandon Suh, CEO of Lunit. "We’re on our way towards making the Lunit SCOPE suite an essential biomarker for cancer immunotherapy – contributing to the advancement of personalized oncology through innovative AI solutions."

For inquiries or to schedule a meeting with the Lunit team, please contact [email protected].

On October 10, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported that Lantern management will be presenting at the ThinkEquity Conference on Thursday, October 19, 2023, at the Mandarin Oriental in New York, NY (Press release, Lantern Pharma, OCT 10, 2023, View Source [SID1234635823]).

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Lantern Pharma is scheduled to present at the conference at 1:30 p.m. ET on October 19.

Webcast Link: View Source
Conference Registration Link: View Source
Lantern Pharma management will be available for one-on-one meetings to be held throughout the conference.

On October 10, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that the company plans to report new and updated data from the global randomized Phase 1b/2 combination study of TPST-1120 with atezolizumab and bevacizumab in first-line treatment of hepatocellular carcinoma (HCC) in a premarket press release on Wednesday, October 11, 2023, followed by a webcasted conference call with associated slide presentation at 8:30 a.m. ET on Wednesday, October 11, 2023 (Press release, Tempest Therapeutics, OCT 10, 2023, View Source [SID1234635820]).

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To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and audio archive of the presentation may be accessed on the investor section of the Tempest website at View Source The webcast will be available for replay for 30 days.

On October 10, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, a novel and highly selective CDK9 inhibitor, for the treatment of acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, OCT 10, 2023, View Source [SID1234635819]).

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"We are honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity. With the support of this ODD, we look forward to accelerating SLS009 clinical development and bringing new hope to those suffering from this devastating disease."

SLS009 is a highly selective CDK9 inhibitor, currently being evaluated in an open-label, single-arm, multi-center Phase 2a study in patients with relapsed or refractory AML. The primary objectives of the trial are to evaluate safety, tolerability, and efficacy at two dose levels of SLS009 (once weekly at 45 mg and at the recommended Phase 2 dose, 60 mg) in combination with azacitidine and venetoclax (aza/ven). Top-line data are expected by the end of this year.

The ODD designation was supported by data from the Phase 1 study of SLS009 which met all key study objectives: anti-tumor activity (cell killing) of up to 77.3% bone marrow blast reduction, durable complete remission (CR) with no minimal residual disease (MRD), desired 24 hours > IC90 peripheral blood concentrations after the first infusion, with IC90 concentrations resulting in up to 97% cancer cell killed, achievement of desired levels of MCL1 and MYC suppression in peripheral blood with decrease in MCL1 or MYC observed in 97% (66/68) of analyzed patients; and, with regard to safety, no dose limiting toxicities, no higher grade non-hematologic toxicities of any kind and some hematologic toxicities difficult to determine in patients with hematologic cancers but short in duration and reversible.

The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

On October 10, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported a portfolio update, including both increased focus on its ex vivo cell therapy product candidates and an IND submission for SC291 in autoimmune diseases (Press release, Sana Biotechnology, OCT 10, 2023, View Source [SID1234635818]). Sana is positioned to generate clinical proof of concept from multiple programs in 2023 and 2024, with a goal of better understanding its allogeneic HIP CAR T programs in blood cancers, allogeneic HIP CAR T program in autoimmune diseases, and HIP pancreatic islet cells in type 1 diabetes. The company will reduce near-term spend on its fusogen platform for in vivo gene delivery, which postpones the planned SG299 IND and decreases its expected forward operating burn.

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"We have increased confidence in the potential of our HIP platform, and near-term, we are increasing focus on three therapeutic areas that utilize this platform and have the potential to address large unmet needs with curative intent – allogeneic CAR T cells in oncology, allogeneic CAR T cells in autoimmune diseases, and pancreatic islet cell transplantation in type 1 diabetes. We plan to present clinical data in these areas at various times across 2023 and 2024," said Steve Harr, President and CEO of Sana. "The SC291 IND submission for the treatment of autoimmune diseases positions us to move into the rapidly emerging opportunity of utilizing CAR T cells in these large and underserved populations, leveraging the investments we have made to date in the HIP platform, T cell therapeutics, and scaled manufacturing that can produce hundreds of patient doses per run. We need to ensure that we have a financeable cost structure with these emerging opportunities factored in, and this strategic re-positioning enables us to deliver significant clinical data across multiple drug candidates with the current balance sheet. These changes unfortunately mean that many talented and valued colleagues will depart the company, and we thank them for their contributions and commitment to our mission."

Select Program Review

SC291 Oncology (HIP-modified CD19-directed allogeneic CAR T): Enrollment continues in Sana’s ARDENT Phase 1 study for the treatment of B-cell lymphomas and leukemias with clinical data expected in 2023 and 2024.

SC291 Autoimmune (HIP-modified CD19-directed allogeneic CAR T): Sana submitted an IND for the treatment of multiple autoimmune diseases, with preliminary clinical data expected across multiple indications in 2024.

SC262 (HIP-modified CD22-directed allogeneic CAR T): Sana expects to submit an IND in 4Q 2023 for the treatment of B-cell lymphomas and leukemias in patients who have failed CD19-directed CAR T therapies, with preliminary clinical data expected in 2024.

HIP-modified primary islet cells for the treatment of type 1 diabetes: A CTA has been submitted for an investigator sponsored trial exploring the potential of HIP modifications to allogeneic primary islet cells to enable immune evasion and overcome transplant rejection in type 1 diabetes; proof of concept data expected in 2023 and 2024.

SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Sana will continue its focused research on this innovative platform but not submit an IND at this time as previously planned.

2024 Operating Burn Guidance

Sana expects 2024 operating cash burn to be below $200 million, allowing the current cash position to extend further into 2025. The strategic re-positioning will reduce headcount by 29% while allowing the company to invest in clinical capabilities across multiple indications in oncology, autoimmune diseases, type 1 diabetes, and central nervous system disorders. Sana will leverage its existing allogeneic manufacturing expertise and continue development of its GMP manufacturing facility in Bothell, Washington.