On March 5, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer and lung disease, reported accelerating growth of 375% in CyPath Lung tests ordered and processed over the past three months as compared to the previous three months. CyPath Lung is a noninvasive test to detect early-stage lung cancer (Press release, BioAffinity Technologies, MAR 5, 2024, View Source [SID1234640800]).

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bioAffinity Technologies is on target to meet its sales forecast for the previously announced limited test market launch in Texas designed to refine future positioning and strategic insight for CyPath Lung in preparation for expanding to the national market.

"The introduction of our reimbursement code, completion of our branding, and expansion of our sales force have markedly contributed to the growing physician interest and adoption of our innovative, noninvasive CyPath Lung test. Increasing physician satisfaction and adoption have also been driven by the successful integration and efficient operation of our commercial laboratory, Precision Pathology Laboratory," bioAffinity Technologies’ President and CEO Maria Zannes said. "Importantly, our sales growth has been in line with our expectations and bolsters our confidence in our ability to capitalize on the lung cancer diagnostics market projected to reach $4.7 billion by 2030."

Pulmonologists and other lung health specialists understand the critically important role of screening and early diagnosis in improving outcomes for those diagnosed with lung cancer and providing peace of mind for individuals at elevated risk of developing the disease. bioAffinity Technologies’ commitment to noninvasive cancer detection is poised to reshape the landscape of lung health management by increasing early detection and treatment.

bioAffinity Technologies will release financial results for the fourth quarter and full year ended December 31, 2023, on April 1, 2024.

About CyPath Lung

CyPath Lung uses advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, TCPP, that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage cancer can improve outcomes and increase patient survival.

On March 5, 2024 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will present three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place in San Diego, CA, from April 5 – 10, 2024 (Press release, Vincerx Pharma, MAR 5, 2024, View Source [SID1234640797]). Vincerx will also share clinical data for VIP236 at the conference.

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"We are extremely pleased to highlight the continued development of our next-generation VersAptx bioconjugation platform in these three abstract/poster presentations," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "In addition to the preclinical results of our VersAptx platform, our SMDC poster (#3197) will also present, for the first time, early clinical results for VIP236. To date, 20 patients with relapsed/refractory advanced or metastatic solid tumors have been treated with two different dosing schedules of VIP236. The poster will summarize preliminary safety, efficacy, and pharmacokinetic results from this first-in-human, dose-escalation study (NCT05712889)."

Virtual Investor Event:

Vincerx will host a virtual investor event featuring company management and key opinion leaders on Monday, April 8, 2024. The event will be webcast live, and details can be accessed in the Investor Calendar section of the Vincerx website on March 27, 2024. An archived replay will be available shortly after the conclusion of the live event.

Poster presentation details:

Title: Activity of VIP943 on AML patient-derived leukemic blasts and healthy donor-derived bone marrow hematopoietic stem cells
Abstract Number: 629
Session Category: Experimental and Molecular Therapeutics
Session Title: Mechanisms of Drug Action
Session Date and Time: Sunday, April 7, 2024, 1:30 PM – 5:30 PM PT
Location: Poster Section 26; Poster Board Number 6
Presented by Beatrix Stelte-Ludwig, Ph.D., Vincerx Pharma

Title: Innovations in ADC technology platform with legumain-cleavable KSP-inhibitor payloads adaptable to various aspects of cancer biology
Abstract Number: 2051
Session Category: Experimental and Molecular Therapeutics
Session Title: New Technologies
Session Date and Time: Monday, April 8, 2024, 9:00 AM – 12:30 PM PT
Location: Poster Section 28; Poster Board Number 8
Presented by Hans-Georg Lerchen, Ph.D., Vincerx Pharma

Title: Addressing drug metabolism and pharmacokinetics (DMPK) challenges of small molecule-drug conjugates (SMDCs)
Abstract Number: 3197
Session Category: Experimental and Molecular Therapeutics
Session Title: Cancer Immunotherapy and Drug Delivery
Session Date and Time: Monday, April 8, 2024, 1:30 PM – 5:00 PM PT
Location: Poster Section 23; Poster Board Number 14
Presented by Anne-Sophie Rebstock, Ph.D., Vincerx Pharma

A copy of the presentation materials can be accessed on the Investors section of the Company’s website at View Source once each presentation has concluded.

About VIP236

VIP236, the first-in-class small molecule drug conjugate (SMDC) from our VersAptx Platform, consists of an αvβ3 integrin binder, a neutrophil elastase linker cleaved in the tumor microenvironment, and a camptothecin payload optimized for high permeability and low efflux. VIP236 was designed to deliver its payload to advanced/metastatic tumors that express αvβ3. Preclinical data show enhanced efficacy, independent of HER2 status, in patient-derived and cell line-derived gastric cancer models compared with ENHERTU, an approved ADC. VIP236 is being evaluated in a Phase 1 dose-escalation trial treating patients with advanced or metastatic solid tumors (NTC05371054). As VIP236 is a first-in-class drug, the Phase 1 trial is evaluating various dosing schedules. To date, 20 patients with advanced or metastatic disease that has relapsed or is refractory to standard of care have received VIP236.

About VIP943

VIP943, the first ADC from our VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with our CellTrapper technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is in a Phase 1 dose-escalation trial evaluating patients with relapsed/refractory acute myeloid leukemia, myelodysplastic syndrome, and B-cell acute lymphoblastic leukemia who have exhausted standard therapeutic options (NCT06034275). Preliminary pharmacokinetic data from the first cohort shows low levels of unconjugated payload (VIP716) in circulation, as predicted from preclinical experiments. Reduced nonspecific release of payload is one of many features engineered into VIP943 to increase the therapeutic index compared with existing technologies. We expect to expand into additional CD123-positive indications, including TP53 mutated AML, both as monotherapy and in combination, as safety and efficacy data are generated. Preliminary Phase 1 data are expected in mid-2024.

About VersAptx Platform

VersAptx is our versatile and adaptable next-generation bioconjugation platform. The modular nature of this innovative platform allows us to combine different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies. With this platform, (i) antibodies and small molecules can be used to target different tumor antigens, (ii) linkers can be designed to reduce non-specific release of the payload, cleave intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for release in the tumor microenvironment. The VersAptx platform allows us to optimize these technologies to a specific target and develop bioconjugates designed to address the safety and efficacy challenges of many ADCs and the needs of cancer patients.

On March 5, 2024 Turnstone Biologics presented its corporate presentation (Presentation, Turnstone Biologics, MAR 5, 2024, View Source [SID1234640796]).

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On March 5, 2024 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the fourth quarter and year ended December 31, 2023 (Press release, Tracon Pharmaceuticals, MAR 5, 2024, View Source [SID1234640795]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We are on track to complete enrollment of 80 patients treated with single agent envafolimab in the ongoing pivotal ENVASARC trial later this quarter. We expect to report updated response rate data shortly thereafter and before the end of this quarter, with final data anticipated in the second half of 2024," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We also expect to leverage our Product Development Platform to generate non-dilutive capital through either an additional license or by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our costs using a pay for performance model."

Recent Corporate Highlights

•
In December, we announced updated interim data from the ENVASARC Phase 2 pivotal trial in the initial 46 patients treated with single agent envafolimab. The objective response rate (ORR) was 15% by investigator review and 8.7% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR by BICR in nine of 80 patients (11.25%) treated with envafolimab and median duration of response of greater than six months is a key secondary endpoint.

•
In November, we licensed our Product Development Platform (PDP) to a clinical stage biotech company for an upfront payment of $3.0 million.

Expected Upcoming Milestones

•
Complete accrual of the ENVASARC pivotal trial this quarter and report updated response rate data shortly thereafter and before the end of the quarter.

•
Report final data from ENVASARC pivotal trial in the second half of 2024.

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Continue to leverage TRACON’s cost-efficient, CRO-independent PDP to generate non-dilutive capital.

Fourth Quarter 2023 Financial Results

•
Cash, cash equivalents and restricted cash were $8.6 million at December 31, 2023, compared to $17.5 million at December 31, 2022.

•
License revenue for the fourth quarter of 2023 was $3.0 million and was due to the license of our PDP to a clinical stage biotech company.

•
Research and development expenses for the fourth quarter of 2023 were $1.5 million, compared to $3.9 million for the fourth quarter of 2022. The decrease was primarily related to enrollment into only cohort C in the ongoing ENVASARC pivotal trial.

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General and administrative expenses for the fourth quarter of 2023 were $1.1 million, compared to $2.0 million for the fourth quarter of 2022. The decrease was primarily attributable to lower legal expenses.

•
Net income for the fourth quarter of 2023 was $0.4 million, compared to a net loss of $7.0 million for the fourth quarter of 2022.

Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC Phase 2 pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON is enrolling patients in ENVARSAC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

On March 5, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported that collaborators at the Beth Israel Deaconess Medical Center (BIDMC) at Havard Medical School will present a poster with preclinical data supporting the advancement of TPST-1120 as a potential treatment for renal cell carcinoma (RCC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 5-10, 2024 in San Diego, CA (Press release, Tempest Therapeutics, MAR 5, 2024, View Source [SID1234640794]).

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Poster presentation details:

Title: PPAR-α Antagonist Enhances Immunotherapy and Anti
Angiogenic Therapy to Inhibit Murine Renal Cancer
Abstract Number: 3045
Date & Time: Monday, April 8, 2024; 1:30 – 5:00 p.m. PT
Session Title: Oncogenic Transcription Factors
Location: Poster Section 18

All regular abstracts are available for viewing via AACR (Free AACR Whitepaper)’s online itinerary planner, located here.