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Castle Biosciences to Present New Data Highlighting the Clinical Value of its Dermatologic Tests for Patients with Skin Cancer at the 2024 American Academy of Dermatology (AAD) Annual Meeting

On March 8, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will share data across its dermatologic portfolio of gene expression profile (GEP) tests via oral and electronic poster presentations at the 2024 AAD Annual Meeting, taking place March 8-12 in San Diego (Press release, Castle Biosciences, MAR 8, 2024, View Source [SID1234640975]).

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"Our presentations at the 2024 AAD Annual Meeting add to the growing body of evidence supporting the use of our tests in guiding improved, personalized care for patients with skin cancers," said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. "In collaboration with leading dermatologists dedicated to advancing patient care, we are excited to share our latest findings which highlight how our tests are empowering both clinicians and patients with meaningful, clinically actionable information that can refine risk and inform important treatment decisions."

Castle will present the following abstracts at AAD. Abstract content will be available throughout the meeting in the online viewing portal and at the on-site viewing stations, and will also be published online in the Fall 2024 Journal of the American Academy of Dermatology (JAAD) supplement.

DecisionDx-Melanoma

Oral Poster Presentation Title: 31-GEP testing is associated with improved melanoma-specific survival relative to untested patients: an analysis of patients <65 years old
Presenter and Lead Author: Michael Tassavor, M.D., Skin Cancer Center, Cincinnati
Abstract Number: 51667
Date: March 9, 2024
Time: 4:50-4:55 p.m. Pacific Time
Location: San Diego Convention Center (Upper Level, Sails Pavilion, Poster Center 1)
Summary: For patients with CM, the median age at diagnosis is 66 years old, suggesting that almost half of newly diagnosed patients are younger than 65. In this large study of unselected, clinically tested patients with CM who were under 65 (n=5,183), the DecisionDx-Melanoma (31-GEP) test identified patients at higher risk of melanoma-specific death who may benefit from more aggressive management, including imaging surveillance. In the study, use of the DecisionDx-Melanoma test was associated with improved melanoma-specific survival relative to untested patients. This is clinically significant, as identifying high-risk patients allows for earlier detection of recurrence, while the tumor burden is lower, which has been shown to lead to better response to therapy.

DecisionDx-SCC

Oral Poster Presentation Title: Consistent utilization of the 40-gene expression profile (40-GEP) test in high-risk cutaneous squamous cell carcinoma (cSCC) by clinicians according to intended use indications
Presenter and Lead Author: Jane Yoo, M.D., Icahn School of Medicine at Mount Sinai, New York
Abstract Number: 54153
Date: March 9, 2024
Time: 10:30-10:35 a.m. Pacific Time
Location: San Diego Convention Center (Upper Level, Sails Pavilion, Poster Center 2)
Summary: This study provides summary metrics regarding DecisionDx-SCC (40-GEP) test results and patient risk factors for tumor samples clinically tested in the first three years of the test’s availability between September 2020 and August 2023 (n=16,930). The study data demonstrate that clinicians are utilizing the DecisionDx-SCC test appropriately for patients with high-risk cutaneous squamous cell carcinoma (SCC). These patients are at a higher risk of poor outcomes compared to the general SCC patient population, yet over 70% of patients received a Decision-SCC Class 1 test result, indicating they are at a lower biological risk for metastasis. Each DecisionDx-SCC Class result was present in the various subgroupings of risk factors in the study (patients with 1-2, 3-4 and more than 5 risk factors), demonstrating that the test provides independent risk assessment from clinicopathological presentation. These data support incorporating the test’s results into clinical practice to improve the accuracy of risk predictions to guide more personalized treatment plans for patients.

MyPath Melanoma

ePoster Title: Enabling access to prognostic gene expression profile (GEP) testing for invasive melanoma by leveraging RNA-based testing in the diagnostic workflow
Abstract Number: 52819
Summary: Reaching a definitive diagnosis of melanoma can be challenging. Ancillary testing can provide clarity and a definitive diagnosis for problematic lesions. The MyPath Melanoma (23-GEP) diagnostic test returns accurate results quickly, with approximately 80% of cases tested receiving an actionable result in a median of four business days. Between March 1 and July 31, 2023, approximately 60% of ambiguous lesions tested with MyPath received a benign test result, potentially reducing overdiagnosis and overtreatment for diagnostically challenging lesions. Lesions that receive a malignant test result (approximately 20% of lesions tested with MyPath in the five-month study timeframe) can be tested with the DecisionDx-Melanoma risk stratification test, using the same extracted tumor material when available, to inform risk-aligned decisions about sentinel lymph node biopsy, surveillance imaging and patient follow-up schedules. Approximately 80% of clinically tested lesions with a malignant MyPath result have sufficient biopsy tumor content for DecisionDx-Melanoma testing.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2023, DecisionDx-Melanoma has been ordered more than 150,000 times for patients diagnosed with cutaneous melanoma.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

About MyPath Melanoma

MyPath Melanoma is Castle’s gene expression profile test designed to provide an accurate, objective result to aid dermatopathologists and dermatologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately two million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. For these cases, the treatment plan can also be uncertain. Obtaining accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, MyPath Melanoma is designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

TransThera Announced Global Phase 3 Clinical Trial for Cholangiocarcinoma Authorized in the European Union and Orphan Drug Designation for Tinengotinib to Treat Biliary Tract Cancer Granted by European Medicines Agency

On March 8, 2024 TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, reported that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region (Press release, TransThera Biosciences, MAR 8, 2024, View Source [SID1234640974]). Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) .

Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO (Free ESMO Whitepaper) and 2024 ASCO (Free ASCO Whitepaper) GI conferences. The FRIST-308 clinical trial is enrolling to further confirm the efficacy and safety of tinengotinib in CCA. In December 2023, first patient was dosed in the United Sates (US).

"We are very delighted to have achieved the significant regulatory progresses for tinengotinib in global development at various countries and regions. These milestones are not only the recognition by global regulatory authorities of the potential clinical benefit of tinengotinib to treat CCA patients, but also a reflection of the company’s international regulatory capabilities and unwavering commitment to bringing innovative therapies to global patients," said Jean Fan, M.D., Chief Medical Officer of TransThera Sciences. "Leveraging the regulatory agency’s support from the EU in addition to the US and other countries and regions, we will continue to expedite the global clinical development and commercialization of tinengotinib. We are hopeful that these efforts will enable us to bring this novel drug to patients around the world as quickly as we can."

About ODD in EU

The term "orphan medicines" refers to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions affecting less than 5 in 10,000 people in the EU. The EMA offers a range of incentives to encourage the development of designated orphan medicines. This Orphan Drug Designation for tinengotinib qualifies it for great regulatory supports in the subsequent clinical development and commercialization in the EU, including protocol assistance, fee reductions, and most importantly, 10 years of market exclusivity upon approval.

About tinengotinib

Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells proliferation, angiogenesis and immune-oncology pathways by inhibiting the cytokine signaling and angiogenesis (FGFRs and VEGFRs), mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation (BTD) by NMPA in China. In March 2024, tinengotinib was granted the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA.

Mabwell to Present the Clinical Data of 9MW2821 in Cervical Cancer as Focused Plenary Oral Presentation at 2024 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer

On March 8, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported that it will present the clinical study results on the efficacy and safety of the novel Nectin-4-targeting ADC 9MW2821 for patients with recurrent or metastatic cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on women’s cancer to be held in San Diego, USA, from March 16-18, 2024 (Press release, Mabwell Biotech, MAR 8, 2024, View Source [SID1234640973]).

The American Society of Gynecologic Oncology (SGO) is a leading non-profit medical organization in the world dedicated to the study, treatment, and education of gynecologic cancers.

Focused Plenary Oral Presentation

Focused Plenary ll: Encore & More: Cutting Edge Gyn Onc Care in Cervical Cancer

Abstract Title: Efficacy and safety of 9MW2821, an antibody-drug conjugate targeting Nectin-4, monotherapy in patients with recurrent or metastatic cervical cancer: A multicenter, open-label, phase I/II study

Abstract Plenary Presenter: Huijuan Yang (Fudan University Shanghai Cancer Center)

Location: Ballroom 20AB

Date/time: March 16, 2024, 3:00 PM PDT

About 9MW2821

9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform.The drug achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells. Mabwell is conducting multiple clinical studies evaluating the efficacy of 9MW2821 in various indications, including urothelial carcinoma and cervical cancer. Mabwell is the first Chinese enterprise to advance 9MW2821 into Phase 3 clinical trials for the treatment of urothelial carcinoma, making it the second globally in terms of progress. 9MW2821 is also the first therapeutic drug in the world with the same target to disclose clinical efficacy data for indications of cervical cancer and esophageal carcinoma

Onconova Therapeutics’ Rigosertib Poster Selected For AACR 2024

On March 8, 2024 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will present an abstract related to preclinical studies conducted by the Company and its collaborators to further characterize the mechanism of rigosertib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (AACR 2024), taking place April 5-10, 2024 in San Diego, CA (Press release, Onconova, MAR 8, 2024, View Source [SID1234640971]).

"The ability to impact multiple targets is an important characteristic of Onconova’s two lead clinical programs, rigosertib and narazaciclib. We are pleased to present new preclinical studies that explore the molecular targets for rigosertib, in clinical development through a series of investigator initiated studies (IIS)," commented Steven Fruchtman, M.D., President and Chief Executive Officer of Onconova. "The studies provide additional prospective on the main cellular pathways impacted by rigosertib, including RAS-MAPK signaling and reactive oxygen species (ROS)-related proteins. In addition, the studies highlight rigosertib’s impact on the tumor microenvironment through the activation of inflammation–related targets, such as an NLRP3. We hope to apply this translational science to help guide the clinical program to enable the potential use of rigosertib in difficult-to-treat cancers."

Poster Information:
Poster Title:
Rigosertib promotes anti-tumor activity of cancer cells via CETSA revealed novel targets and activates NLRP3-dependent inflammatory responses (2033/16)
Session: Microenvironment, Immunity, and DNA Repair in Therapeutic Response (PO.ET05.02)
Date/Time: Monday, April 8 9:00a-12:30p PT

Brief Overview: Onconova and its collaborators conducted a series of biochemistry and molecular and cell biology assays to study rigosertib’s molecular and inflammation-based targets. The team used a specialized mass spectrometry assay (a Cellular Thermal shift Assay or CETSA-MS) as one of the tools to identify new targets which were then validated as novel targets of rigosertib.

Conclusions: This work identified a series of cellular and inflammatory targets that may be affected by rigosertib. In particular, the research highlighted target activity through RAS-MAPK signaling, ROS-mediation JNK activation, and tumor microenvironment reprogramming through NLRP3 activation, which may contribute to preclinical and clinical synergistic effects with checkpoint inhibitors. The identification of these targets and signaling pathways may be helpful in the design of clinical trials to address difficult-to-treat cancers.

XOMA Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent and Upcoming Events Expected to Drive Shareholder Value

On March 8, 2024 XOMA Corporation (Nasdaq: XOMA), the biotech royalty aggregator, reported its fourth quarter and full year 2023 financial results and highlighted portfolio activities expected to drive long-term shareholder value (Press release, Xoma, MAR 8, 2024, View Source [SID1234640970]).

"Over the course of 2023, we continued to build the foundation for future growth, spearheaded by the $140 million royalty-backed financing of VABYSMO in the fourth quarter," stated Owen Hughes, Chief Executive Officer of XOMA. "We entered 2024 with the strongest cash position in the Company’s history, several key upcoming clinical and regulatory events, including the potential approvals of Day One’s tovorafenib and Zevra Therapeutics’ arimoclomol NDAs, and a growing pipeline of asset opportunities."

Key Fourth Quarter Events

Partner

Event

Day One Biopharmaceuticals
• Tovorafenib NDA accepted by U.S. Food and Drug Administration (FDA), resulting in XOMA’s receipt of a $5 million milestone payment from Viracta

• Tovorafenib data presented at the Society of Neuro-Oncology Annual Meeting and published in Nature Medicine

Zevra Therapeutics Resubmitted the arimoclomol NDA with FDA
Medexus Pediatric label expansion application for IXINITY accepted for review by FDA
Rezolute
• Launched RZ358 Phase 3 study

• Received Priority Medicines (PRIME) eligibility from European Medicines Agency

AstraZeneca Launched and dosed first patient in rilvegostomig Phase 3 study
LG Chem (AVEO Oncology) Launched ficlatuzumab Phase 3 study
Organon Announced intent to terminate ebopiprant License Agreement
Anticipated 2024 Events of Note

Partner

Event

Day One Biopharmaceuticals April 30, 2024 – FDA action date for tovorafenib NDA
Zevra Therapeutics September 21, 2024 – FDA action date for arimoclomol NDA
Medexus FDA decision regarding IXINITY pediatric label expansion
Financial Results

XOMA recorded total revenues of $1.8 million and $4.8 million for the fourth quarter and full year of 2023, respectively. In 2023, XOMA recognized $2.5 million in milestone payments received from two partners, whereas the Company reported revenues of $6.0 million in 2022, of which $4.0 million were milestone payments received from four partners.

General and administrative ("G&A") expenses were $7.3 million for the fourth quarter and $25.6 million for the full year of 2023. In the fourth quarter and full year of 2022, G&A expenses were $7.6 million and $23.2 million, respectively. The increase of $2.4 million between the two full-year periods was primarily due to a $5.5 million increase in stock-based compensation, partially offset by a $2.1 million decrease in consulting and legal expenses, and a $0.9 million decrease in salaries and related expenses.

In the fourth quarter of 2023, G&A expenses included $2.6 million in non-cash stock-based compensation expense, compared with $1.0 million in the fourth quarter of 2022. For the full year of 2023, G&A expenses included $9.1 million in non-cash stock-based compensation, compared with $3.6 million for the full year of 2022.

XOMA received cash payments of approximately $5.7 million from royalties and milestone payments in the fourth quarter of 2023, as compared to $0.8 million in the comparable period in 2022. During the full year of 2023, the Company received cash payments of approximately $15.5 million from royalties and milestone payments, as compared to $7.2 million in 2022. XOMA’s net cash used in operations during the fourth quarter of 2023 was $3.9 million and $18.2 million for the full year, as compared with $3.9 million used during the fourth quarter of 2022 and $12.9 million used for the full year of 2022.

XOMA incurred one-time arbitration settlement costs of $4.1 million in 2023, related to an arbitration proceeding settlement with one of its licensees.

For the year ended December 31, 2023, XOMA recorded $15.8 million in impairment charges, as a result of the discontinuation of operations at Bioasis ($1.6 million) and Organon’s decision to terminate its License Agreement for ebopiprant ($14.2 million).

Other income, net was $1.6 million for the full year of 2023 and $0.3 million for the full year of 2022. The increase in other income, net between periods is primarily due to an increase in investment income.

In 2023, net loss for the fourth quarter and year ended December 31, 2023, was $20.1 million and $40.8 million, respectively. In 2022, the net loss for the fourth quarter was $6.0 million and $17.1 million for the full year.

On December 31, 2023, XOMA had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). In 2023, XOMA’s royalty interests generated cash payments of $7.3 million from Roche related to VABYSMO sales and $1.7 million from Medexus related to IXINITY sales. The Company also received a $5.0 million milestone payment from Viracta related to the FDA’s acceptance of Day One Pharmaceuticals’ NDA for tovorafenib. These cash receipts from royalty and milestone acquisitions reduced XOMA’s short-term royalty and commercial payment receivables by $14 million. On October 16, 2023, the Company paid total cash dividends of $1.4 million on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and on the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO). In December 2023, XOMA drew $130.0 million from its royalty-backed loan with certain funds managed by the credit platform of Blue Owl Capital. On December 31, 2022, the Company reported cash of $57.8 million. Based upon the cash flows XOMA expects to receive from VABYSMO, DSUVIA, and IXINITY sales in addition to its current cash position, the Company continues to believe its current cash position will be sufficient to fund XOMA’s operations for multiple years.

Subsequent Events

On January 2, 2024, the Company announced a stock repurchase program of up to $50 million through January 2027.

On January 7, 2024, Owen Hughes was appointed as Chief Executive Officer and Jack Wyszomierski was named Chairman of the Board of Directors.

On January 18, 2024, XOMA acquired an economic interest in DSUVIA (sufentanil sublingual tablet) from Talphera, Inc., for $8 million. DSUVIA is commercialized by Alora Pharmaceuticals. XOMA will receive 100 percent of all royalties and milestones related to DSUVIA sales until it receives $20 million. Thereafter, XOMA will receive a 15 percent royalty associated with DSUVIA commercial sales, a 37.5 percent royalty on DoD purchases and 50 percent of the remaining $116.5 million in potential milestone payments due from Alora Pharmaceuticals.

On February 16, 2024, XOMA announced its intention to acquire Kinnate Biopharma for between $2.3352 and $2.5879 in cash per share plus a contingent value right (CVR). XOMA anticipates it will add approximately $9.5 million to its cash balance at the closing of the acquisition, which is expected to occur in April 2024.