2023 – Page 1086 – 1stOncology™: Cancer Intelligence Service

Johnson & Johnson to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference

On May 10, 2023 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the Goldman Sachs 44th Annual Global Healthcare Conference on Tuesday, June 13th, at the Waldorf Astoria Monarch Beach Resort & Club in Dana Point, CA (Press release, Johnson & Johnson, MAY 10, 2023, View Source [SID1234631419]). Biljana Naumovic, Worldwide Vice President, Oncology, and Peter Lebowitz, Global Therapeutic Head, Oncology, will represent the Company in a session scheduled at 4:20 p.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast replay will be available approximately 48-hrs after the live webcast.

SQZ Biotechnologies Reports First Quarter 2023 Financial Results and Recent Portfolio Updates

On May 10, 2023 SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies, reported its first quarter 2023 financial results and recent portfolio updates.

"The confirmed complete response in our first patient in the AAC trial has brought enthusiasm to our trial sites, and we are encouraged by the positive momentum for enrollment in both the AAC and eAPC clinical trials," said Howard Bernstein, M.D., Ph.D., Interim Chief Executive Officer and Member of the Board of Directors. "This is a crucial period for SQZ, and I am proud of our team’s unrelenting commitment to help our patients. We are excited to gather more data in our trials and look forward to sharing our findings later this year."

First Quarter 2023 and Recent Portfolio Updates

Clinical Programs:

SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Enrolling highest-dose cohort of monotherapy dose escalation trial
On track to report initial clinical data for the middle- and highest-dose monotherapy cohorts in the middle of 2023
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

A confirmed complete response (CR), by RECIST 1.1 criteria, was observed in the first patient in the lowest-dose cohort of the SQZ-AAC-HPV-101 Phase 1 clinical trial for HPV16+ solid tumors
In light of the response, the Company resumed patient enrollment in the SQZ-AAC-HPV-101 clinical trial
The Study Safety Committee recommended the Company move directly to the highest-dose cohort
Currently enrolling patients for the highest-dose cohort
Initial clinical data from the highest-dose cohort is anticipated in the fourth quarter of 2023
Earlier Stage Programs:

The Company will continue to explore partnerships and collaborations for its earlier stage assets and programs, including SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance
First Quarter 2023 Financial Highlights

Revenue for the quarter ended March 31, 2023, was $0.0 compared to $2.9 million for the same period in 2022
Research and development expenses for the quarter ended March 31, 2023, were $13.0 million compared to $17.0 million for the same period in 2022
General and administrative expenses for the quarter ended March 31, 2023, were $5.3 million compared to $6.9 million for the same period in 2022
Net loss for the quarter ended March 31, 2023, was $17.7 million, compared to $21.0 million for the same period in 2022
As of March 31, 2023, the Company had cash and cash equivalents of $39.9 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into 2024

Lunit to Present 16 Abstracts at the 2023 ASCO Annual Meeting

On May 10, 2023 Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer diagnostic solutions, reported the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago, Illinois, on June 2-6 (Press release, Lunit, MAY 10, 2023, View Source [SID1234631417]).

Since 2019, the company has been releasing groundbreaking findings based on its AI-powered tissue analysis platform, Lunit SCOPE, at the ASCO (Free ASCO Whitepaper) annual meeting. At this year’s ASCO (Free ASCO Whitepaper), Lunit plans to showcase the largest number of studies in the company’s history, including 10 poster presentations and 6 online publications. The studies will cover a range of topics, from predicting clinical outcomes to analyzing tumor microenvironments in various cancer types using the Lunit SCOPE suite.

Some of Lunit’s highlighted abstracts at ASCO (Free ASCO Whitepaper) 2023 include:

A study conducted in collaboration with the National Cancer Center Hospital East (NCCE) found a correlation between tumor-infiltrating lymphocyte (TIL) density change during chemoradiotherapy (CRT) and pathologic complete response (pCR) rate in locally advanced rectal cancer (LARC), indicating the potential of Lunit SCOPE IO to predict favorable outcomes
Lunit SCOPE IO analyzed TILs in head and neck squamous cell carcinoma (HNSCC) patients treated with durvalumab +/- tremelimumab, showing improved outcomes due to increased immune inflammation
Lunit SCOPE IO validated the efficacy of neoadjuvant HPV vaccine and immunotherapy of HPV+ head and neck squamous cell carcinoma (HNSCC) patients
A collaborative study led by Mayo Clinic predicted prognosis in patients with colon cancer by applying AI-derived immune phenotypes
A study showing how Lunit SCOPE IO predicts the efficacy of immunotherapy based on the patient’s Transforming growth factor-beta (TGFβ) level
The use of Lunit SCOPE IO to predict MET pathogenic mutations in non-small cell lung cancer
The use of Lunit SCOPE UIHC (Universal Immunohistochemistry) for exploring target cancer types and predicting response to novel tumor-associated antigens (TAA) targeted agents
Using AI to analyze the spatial arrangement of macrophages within tumor environments and how it relates to the Interferon Gamma (IFNG) signature and immune phenotype across different types of cancer
"We are thrilled to showcase the largest number of studies in the company’s history at ASCO (Free ASCO Whitepaper) 2023, demonstrating Lunit SCOPE’s efficacy," said Brandon Suh, CEO of Lunit. "Through our novel academic research using Lunit SCOPE suite across various cancer types and treatment settings, we aim to bring cutting-edge technology to the forefront of optimized cancer treatment for all patients."

Visit team Lunit at Booth IH21. Reach out to schedule a meeting at ([email protected]).

Lunit’s Abstracts at ASCO (Free ASCO Whitepaper) 2023

No.

Abstract No. #

Title

Type

3608

Predictive value of tumor-infiltrating lymphocyte (TIL) dynamics in the tumor microenvironment (TME) during preoperative chemoradiotherapy (CRT) on pathologic complete response (pCR) in microsatellite-stable (MSS) locally advanced rectal cancer (LARC)

Poster

2578

Dynamic change of immune phenotype assessed by artificial intelligence (AI)-powered tumor-infiltrating lymphocytes (TILs) analysis during neoadjuvant durvalumab with or without tremelimumab (D+/-T) in head and neck squamous cell carcinoma (HNSCC)

Poster

6075

Neoadjuvant pembrolizumab, GX-188E, and GX-I7 in patients with human papilloma virus-16- and/or 18-positive head and neck squamous cell carcinoma: single-arm, phase 2 trial with single cell transcriptomic analysis and artificial intelligence-powered spatial analysis

Poster

3542

Artificial Intelligence-Derived Immune Phenotypes for Prediction of Prognosis in Patients with Stage III Colon Cancer (NCCTG N0147) [Alliance]

Poster

2585

Tumor microenvironment (TME)-based histomic TGFβ signature (TGFBs) reveals stromal fibroblast recruitment and exclusion of immune cells as immunotherapy resistance mechanisms

Poster

e13578

Deep learning-based ensemble model using hematoxylin and eosin (H&E) whole slide images (WSIs) for the prediction of MET mutations in non-small cell lung cancer (NSCLC)

Online Publication

3135

Exploring expression levels of HER2, HER3, MET, Claudin18.2, and MUC16 across 16 cancer types using an artificial intelligence-powered immunohistochemistry analyzer

Poster

2621

Artificial intelligence (AI) –powered spatial analysis of macrophages in tumor microenvironment and its association with interferon-gamma (IFNG) signature and immune phenotype (IP) in pan-cancer dataset

Poster

e20520

Artificial intelligence (AI) –powered H&E whole-slide image (WSI) analysis of tertiary lymphoid structure (TLS) correlates with immune phenotype and related molecular signatures in non–small-cell lung cancer

Online Publication

1049

Artificial intelligence–powered tumor-infiltrating lymphocytes analyzer to reveal distinct immune landscapes in breast cancer by molecular subtype and HER2 score

Poster

e21179

Immune phenotype-driven treatment outcome of IO-only versus chemo-IO in PD-L1-high, first-line, advanced non-small cell lung cancer (NSCLC)

Online Publication

4162

Artificial intelligence (AI) –powered spatial analysis of tumor-infiltrating lymphocytes (TILs) for prediction of prognosis in resectable pancreatic adenocarcinoma (PDAC)

Poster

6100

Artificial intelligence (AI) analysis of tumor-infiltrating lymphocytes (TILs) in hematoxylin and eosin (H&E) slides to explore immune phenotypes in papillary thyroid cancer

Poster

e14657

Correlation of fragmented pattern of tumor mass captured by artificial intelligence (AI)-powered whole-slide image (WSI) analysis with biased fibroblast expansion over tumor growth and distinct mutational signatures

Online Publication

e13553

Performance validation of an artificial intelligence-powered PD-L1 combined positive score analyzer in six cancer types

Online Publication

e13546

Effect of an artificial intelligence–powered programmed death-ligand 1 combined positive score analyzer in urothelial cancer on inter-observer and inter-site variability

Online Publication

Photocure ASA: Results for the first quarter of 2023

On May 10, 2023 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 105.9 million in the first quarter of 2023 (Q1 2022: NOK 81.4 million) and EBITDA of minus NOK 1.2 million (NOK -13.9 million) (Press release, PhotoCure, MAY 10, 2023, View Source [SID1234631416]). Total revenues increased 30% year over year, and 30 high-definition blue light towers were installed in the first quarter (18 new and 12 upgrades). Photocure reiterates its guidance for 2023 and expects to deliver new Saphira blue light tower installations in the U.S. in the range of 65 to 75, consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

"Photocure delivered strong results in the first quarter of 2023, with revenue in both our North America and European territories rebounding significantly from the unusually soft fourth quarter last year. Hexvix/Cysview sales increased 30% year over year driven by higher unit sales, price increases and foreign exchange. Sequentially, product sales were up 12% from Q4 2022. Typically, the first quarter is seasonally lower than the preceding fourth quarter, however the recent pattern is indicative of unusual circumstances," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 106.2 million in the first quarter of 2023 (NOK 81.6 million), and an EBITDA* of minus NOK 1.2 million (NOK -13.9 million), driven by a combination of unit growth, price increases and positive effects of foreign currency exchange. The Hexvix/Cysview revenues ended at NOK 105.9 million in the quarter (Q1 2022: NOK 81.4 million). The EBIT was NOK -7.7 million (NOK -19.9 million) and the cash balance at the end of the period was NOK 246.0 million.

At the end of the first quarter of 2023, the installed base of blue light cystoscopy (BLC) systems in the U.S. was 388, an increase of 20% or 64 units since the first quarter of 2022. The installed base in the U.S. includes 69 flexible BLC systems.

"In the U.S., we achieved a record first quarter with each month of Q1 2023 marking a new historic high. The installed base of blue light capital equipment expanded once again, with 30 new Saphira tower installations in Q1 – 18 new placements and 12 upgrades. Upgrading accounts is a key initiative in 2023, in addition to new account growth. Importantly, 4 accounts that purchased new high-definition equipment moved their legacy standard-definition towers to another location creating additional blue-light enabled facilities. Our flexible BLC business continued to perform in Q1. Given Karl Storz’s decision to cease supporting flexible blue light equipment when parts are no longer available, we will increasingly focus on the rigid cystoscopy segment during the year. Flexible BLC kit sales represent approximately 5% of our total annual revenue, and we will work to offset the phase down of blue light surveillance revenue with kit sales in the surgical segment. Demand for rigid BLC equipment remains strong, and we continue to expect a record year for new blue light tower installations in the U.S.," Schneider adds.

Ongoing healthcare staffing shortages and inflationary pressures leading to hospital budget tightening, as well as the anticipated phase down of flexible BLC equipment in the coming quarters present challenges in 2023 for Photocure’s business. Considering these challenges, Photocure has issued the following guidance: In 2023, the company expects new Saphira blue light tower installations in the range of 65 to 75, a consolidated product revenue growth above 20%, and positive EBITDA excluding business development spending.

"Our business is on the upswing with several initiatives to drive growth this year such as BLC system and image quality upgrades, and new account growth in North America and in Europe. Other events and activities to watch include the potential for re-classification of BLC equipment in the U.S., the pursuit of a solution to develop and commercialize new flexible BLC cystoscopes, and anticipated Phase 3 results from our partner Asieris for both Hexvix in China and Cevira later this year. 2023 promises to be an exciting year for Photocure, and we look forward to executing on our business plan and creating value for our stakeholders," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2023 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20230510_9/

The presentation is scheduled to conclude at 14:45 CEST.

Aadi Bioscience Announces Financial Results and Operational Update for the First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial

On May 10, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes, reported financial results for the first quarter of 2023 and provided an initial update on the tumor-agnostic PRECISION 1 trial, a registration-directed Phase 2 study of nab-sirolimus in patients with solid tumors with pathogenic inactivating alterations in TSC1 or TSC2 genes (Press release, Aadi Bioscience, MAY 10, 2023, View Source [SID1234631415]).

"We are excited about the uptake of FYARRO and its continued sales growth after our first year on the market and believe we are operating from a position of strength with solid cash balances into 2025," said Scott Giacobello, Interim CEO and President and CFO of Aadi. "We are also encouraged by initial PRECISION 1 enrollment data, indicating more than 15 different tumor types on study, shaping the foundation for a truly tumor agnostic trial. We believe in the potential of this study and given the importance of maintaining its integrity, we will provide the results of an efficacy analysis later in the year when response data is unblinded in conjunction with a pre-planned interim analysis on 40 patients with appropriate follow-up."

First Quarter 2023 Updates and Recent Operational Highlights

Based on initial information from the PRECISION 1 trial, enrollment is well-balanced, and the trial is accruing evenly between the TSC1 and TSC2 arms. More than 15 discreet tumor types have been enrolled with no more than three of any type, supporting the thesis that TSC1 and TSC2 alterations occur broadly across different solid tumors. A pre-planned interim analysis on 40 patients with appropriate follow-up is expected by the end of 2023.
FYARRO net product sales were $5.9 million in the first quarter, continued double-digit growth of 12% quarter-over-quarter.
The appointment of Mohammad Hirmand, M.D., to Board of Directors. Dr. Hirmand, previously Chief Medical Officer of Turning Point Therapeutics prior to its acquisition by BMS, is the co-founder of Avenzo Therapeutics, Inc., and serves as executive vice president and chief medical officer of this privately held biotechnology company focused on oncology therapeutics.
Multiple presentations at AACR (Free AACR Whitepaper) Annual Meeting 2023. Aadi presented an encore trials-in-progress (TIP) poster for the ongoing PRECISION 1 trial; results on the anti-tumor activity of nab-sirolimus in combination with KRASG12C inhibitors in xenograft models; and results of a biomarker analysis from AMPECT correlating response to nab-sirolimus with TSC1 and TSC2 inactivating alterations. The AACR (Free AACR Whitepaper) posters can be found here on the Aadi website.
Multiple presentations at SGO Annual Meeting 2023. Aadi presented a TIP poster for the ongoing PRECISION 1 trial and additional data with nab-sirolimus from its AMPECT trial at SGO 2023. The SGO posters can be found here on the Aadi website.
Upcoming presentations at ASCO (Free ASCO Whitepaper) Annual Meeting 2023. Aadi will present a company-sponsored TIP update from the PRECISION 1 Phase 2 study and combination data of nab-sirolimus and pazopanib (PAZO) from an ongoing Investigator Initiated Trial at ASCO (Free ASCO Whitepaper) 2023, taking place June 2-6, 2023, in Chicago. Following Aadi’s presentation at ASCO (Free ASCO Whitepaper), the posters will be made available on the investor relations page of the Aadi website at www.aadibio.com.
Initiation of Phase 1/2 trial in KRASG12C is expected to begin with first patient dosing in the second quarter of 2023. The study will evaluate the combination of adagrasib with nab-sirolimus in collaboration with Mirati Therapeutics. The open-label Phase 1/2 trial is intended to determine the optimal dose and recommended Phase 2 dose in patients with KRASG12C mutant solid tumors.
First Quarter 2023 Financial Results

Total revenue resulting from sales of FYARRO for the quarter ended March 31, 2023 was $5.9 million. This compares to the prior year period of $2.3 million and $5.2 million in the fourth quarter 2022.
Cash, cash equivalents and short-term investments as of March 31, 2023 were $151.2 million as compared to $172.6 million as of December 31, 2022, which is expected to fund operations into 2025 based on current plans.
Net loss for the three months ended March 31, 2023 was $15.2 million as compared to $13.9 million for the three months ended March 31, 2022.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the first quarter 2023.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic registrational clinical trial of nab-sirolimus. This tumor agnostic study will evaluate approximately 60 mTOR inhibitor naïve patients in each of two independent study arms, or approximately 120 in total, comprised of patients with solid tumors harboring pathogenic inactivating alterations in either TSC1 or TSC2 genes. In November 2022, the FDA granted Fast Track designation to evaluate nab-sirolimus for this patient population.

nab-Sirolimus 100 mg/m2 is given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle. The primary endpoint is overall response rate per independent radiographic review (IRR) using RECIST v1.1. Other endpoints include duration of response, time to response, progression-free survival by IRR, overall survival, patient-reported quality of life, and safety.

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Year: 2023

Johnson & Johnson to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference

SQZ Biotechnologies Reports First Quarter 2023 Financial Results and Recent Portfolio Updates

Lunit to Present 16 Abstracts at the 2023 ASCO Annual Meeting

Photocure ASA: Results for the first quarter of 2023

Aadi Bioscience Announces Financial Results and Operational Update for the First Quarter 2023 and Provides Update on PRECISION 1 Tumor Agnostic Trial