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) .

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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.

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]).

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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

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]).

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"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.

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]).

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"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.

On March 8, 2024 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 it has streamlined its executive leadership to further focus on advancing the Company’s clinical programs while optimizing resource allocation (Press release, Sellas Life Sciences, MAR 8, 2024, View Source [SID1234640969]). As part of this effort, Senior Vice President, Chief Commercial Officer, Robert Francomano and Executive Vice President, General Counsel and Corporate Secretary, Barbara Wood, will be departing the Company.

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"As part of our efforts to rapidly advance our clinical pipeline, we continue to streamline our operations to effectively and efficiently deliver on our key business objectives," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "As I mentioned on the January shareholder call, our focus remains on shareholder value through the development of our assets and tight financial stewardship and exploration of commercial partnerships with the assistance of Stifel Financial Corp. I am confident that SELLAS has the right leadership in place to drive forward all of our clinical programs and I look forward to upcoming interim analysis of the Phase 3 REGAL trial of GPS in AML and reporting topline data from our Phase 2a SLS009 r/r AML trial this quarter and additional data in the second quarter, and topline data from the Phase 1b/2 study of SLS009 in PTCL in the second quarter. Additionally, we made significant strides in commercial market access, pricing strategies, and reimbursement initiatives positioning SELLAS for continued success in the Phase 3 REGAL trial of GPS and its potential as a new treatment for AML patients."

Dr. Stergiou continued: "I would like to thank Robert and Barbara for their leadership, dedication, and unwavering contributions to help bring SELLAS to this point of development. I wish them the very best in their future endeavors."

In line with the Company’s commitment to maintaining operational excellence, SELLAS is engaging the expertise of a seasoned commercial consultant with a proven track record of success, including launching Venetoclax. Stacy Yeung, recently promoted to Vice President, Associate General Counsel, and Head of Compliance, with 20 years of relevant experience will lead the Company’s legal and compliance functions.