Uncategorized – Page 1654 – 1stOncology™: Cancer Intelligence Service

Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights

On November 13, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the third quarter of 2024 and its recent business highlights (Press release, Sutro Biopharma, NOV 13, 2024, View Source [SID1234648288]).

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With its lead program, luveltamab tazevibulin (luvelta), Sutro recently initiated a registrational trial for a rare form of pediatric leukemia, a clinical trial for non-small cell lung cancer (NSCLC), and presented expansion data in combination with bevacizumab. The randomized portion of Sutro’s registrational trial for patients with advanced ovarian cancer is underway. Sutro expects to provide an update following alignment with the U.S. Food & Drug Administration (FDA) on the selected dose for the pivotal portion of this trial around the end of the year.

Recognizing the potential patient benefit and commercial opportunity for luvelta, Sutro engaged Lazard to assist in its efforts to identify a partner for luvelta who can provide financial resources and expertise for the multi-indication development and commercialization of luvelta.

Additionally, Sutro showcased at a recent Research Forum a portfolio of emerging next-generation ADCs, made possible by our unique cell-free platform, which are expected to drive value creation beyond luvelta. During the event, Sutro announced three planned IND filings over the next three years for wholly owned programs, including STRO-004, a tissue-factor targeting ADC, featuring a DAR8 exatecan payload and site-specific linker design, which is expected to enter the clinic next year.

Recent Business Highlights and Select Anticipated Milestones

Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise:

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Sutro presented updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, demonstrating a 56% response rate at the recommended Phase 2 dose of luvelta (4.3 mg/kg) for this study. An expansion study of this combination is ongoing, with data expected in the first half of 2025.
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Part 2 (randomized portion) of the Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), is ongoing.
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REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is underway.

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A Phase 2 trial for the treatment of NSCLC is underway, with initial data expected in 2025.
Additional Pipeline Development and Collaboration Updates:

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In October 2024, Sutro hosted a Research Forum highlighting next-generation ADC innovation and near-term pipeline milestones, including:
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STRO-004, a tissue factor-targeting ADC, which features a drug-antibody-ratio (DAR) of eight exatecan payloads and site-specific linker design, demonstrated greater anti-tumor activity and lower toxicities than a tissue factor benchmark ADC in preclinical models. Sutro anticipates filing an IND for STRO-004 in the second half of 2025.
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Dual-payload ADCs (ADC2) provide therapeutic benefits compared to standard ADCs, including potential to overcome tumor resistance mechanisms, and show increased anti-tumor activity and desirable properties in preclinical models.
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iADCs provide a novel mechanism of action, bridging innate and adaptive immunity to enable broad protection in a single molecule, and show increased and durable anti-tumor activity in a preclinical model compared to standalone ADCs or immune-stimulating antibody conjugates.
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Sutro’s proprietary and partnered preclinical ADC portfolio has potential across a broad range of tumor types and the Company plans to deliver three INDs over the next three years.
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Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $975 million in payments through September 30, 2024, including equity investments.
Upcoming Events: Sutro plans to participate in three upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events.

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Jefferies London Healthcare Conference, November 19-21, 2024, in London
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The Citizens JMP Hematology and Oncology Summit, December 2, 2024, Virtual
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Piper Sandler 36th Annual Healthcare Conference, December 3-5, 2024, in New York
Third Quarter 2024 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2024, Sutro had $388.3 million in cash, cash equivalents and marketable securities.

Realized Gain on Sale of Vaxcyte Common Stock

Included in non-operating interest and other income (expense), net, on the Statement of Operations for the nine months ended September 30, 2024 was a realized gain of $32.1 million from the sale of approximately 0.7 million shares of Vaxcyte common stock, with net proceeds of approximately $74.0 million. As of September 30, 2024, Sutro does not hold any shares of Vaxcyte common stock.

Revenue

Revenue was $8.5 million for the quarter ended September 30, 2024, as compared to $16.9 million for the same period in 2023, with the 2024 amount related principally to the Astellas collaboration and the Vaxcyte agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the quarter ended September 30, 2024 were $76.4 million, as compared to $60.9 million for the same period in 2023. The 2024 quarter includes non-cash expenses for stock-based compensation of $6.5 million and depreciation and amortization of $1.8 million, as compared to $6.0 million and $1.7 million, respectively, in the comparable 2023 period. Total operating expenses for the quarter ended September 30, 2024 were comprised of research and development expenses of $62.1 million and general and administrative expenses of $14.3 million.

Vergent Bioscience Completes Enrollment in Phase 2 VISUALIZE Trial Evaluating Potential of Abenacianine for Injection (VGT-309) to Improve Tumor Visualization During Cancer Surgery

On November 13, 2024 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported completion of patient enrollment in the company’s Phase 2, multi-center VISUALIZE trial, evaluating the efficacy and safety of abenacianine for injection (VGT-309) in patients with cancer in the lung. Abenacianine for injection is a novel, investigational tumor-targeted fluorescent imaging agent designed to improve the visibility of difficult-to-find and previously undetected tumors during minimally invasive and robotic-assisted surgical procedures (Press release, Vergent Bioscience, NOV 13, 2024, View Source [SID1234648312]).

"The VISUALIZE trial will provide additional, valuable insights illuminating the potential of our novel imaging agent to address existing deficits in tumor visualization during lung surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. "Completing enrollment in the trial is an exciting milestone that reflects our team’s dedication, as well as the commitment of the VISUALIZE clinical investigators and study participants. We look forward to sharing the results of this study."

Data from previous clinical studies of abenacianine for injection suggest the agent allowed surgeons to see tumor tissue during minimally invasive surgery (MIS), including robotic-assisted surgical procedures, providing "molecular sight" and potentially increasing their confidence in MIS.

For the Phase 2 VISUALIZE trial, investigators at six sites in the United States and Australia enrolled 89 patients with cancer in the lung, all of whom received 0.32mg/kg abenacianine for injection as a short infusion 12 to 36 hours prior to surgery. Following data readout from the VISUALIZE trial, Vergent intends to advance the agent into a Phase 3 study. Assuming positive Phase 3 results, the company will file a new drug application (NDA) for abenacianine for injection for cancer in the lung.

About Lung Cancer Surgery

Approximately 25% of all U.S. lung cancer patients undergo lung cancer surgery, which can be a curative treatment if lung cancer is diagnosed early, and all tumor tissue is removed.1 MIS and robotic-assisted surgery methods are increasingly utilized in lung cancer resection because these approaches are associated with shorter hospital stays, smaller incisions, less blood less, and decreased post-operative complications. While these are important advantages, MIS and robotic-assisted surgery often compromise surgeons’ sight and ability to feel tissue during procedures, making it difficult for them to distinguish tumors from normal tissue and ensure all tumor tissue is removed.

About the VISUALIZE Clinical Trial

The Phase 2, multi-center, open-label VISUALIZE study (NCT06145048) was designed to evaluate the efficacy and safety of abenacianine for injection in patients undergoing surgery for proven or suspected cancer in the lung. Each of the 89 patients in the study received 0.32mg/kg abenacianine for injection 12 to 36 hours prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators used a commercially available near-infrared (NIR) endoscope to assess the presence of tumor tissue, which was then confirmed by pathology. Primary efficacy endpoints included visualization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

About Abenacianine for Injection (VGT-309)

Abenacianine for injection is a tumor-targeted fluorescent imaging agent designed to enable a complete solution for optimal tumor visualization during open, minimally invasive and robotic-assisted surgical procedures. Abenacianine for injection is delivered to patients via a short intravenous infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach, if successful, would provide distinct clinical advantages and position abenacianine for injection as an ideal tumor imaging agent. Abenacianine for injection’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is a preferred dye to minimize confounding background autofluorescence.

Photocure ASA: Results for the third quarter of 2024

On November 13, 2024 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 120.1 million in the third quarter of 2024 (Q3 2023: NOK 107.3 million), and EBITDA of NOK 5.0 million (NOK 3.3 million) for the Company (Press release, PhotoCure, NOV 13, 2024, View Source [SID1234648214]). Photocure reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses.

"We delivered solid performance in the third quarter, generating 12% Hexvix/Cysview revenue growth and NOK 5.0 million in EBITDA. Year-to-date, we have reported 9% growth in product revenues. Our business segments in North American and Europe both generated positive contributions during the quarter, and we made progress on key initiatives that we are pursuing to accelerate our growth going forward," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 120.2 million in the third quarter of 2024 (NOK 107.5 million), and EBITDA* of NOK 5.0 million (NOK 3.3 million), driven by revenue growth in North America and Europe. Hexvix/Cysview revenues ended at NOK 120.1 million in the quarter (Q3 2023: NOK 107.3 million). The EBIT was NOK -2.2 million (NOK -3.9 million) and the cash balance at the end of the period was NOK 291.1 million.

At the end of the third quarter of 2024, the installed base of rigid BLC systems in the U.S. was 387, up 13% since Q3 2023. This includes 18 mobile towers owned by ForTec Medical. Photocure estimates that 25 flexible BLC towers remain in the U.S. market. Photocure also entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation flexible blue light cystoscope based on Richard Wolf’s system blue technology with the goal to reintroduce and grow the use of BLC with Cysview/Hexvix in the surveillance setting.

"We are also positioning for the future with our Richard Wolf partnership to develop and commercialize a state-of-the-art flexible high-definition blue light system. This partnership is focused on ensuring that physicians and patients have reliable access to high quality BLC equipment in the surveillance setting. The development project is well underway, with the goal to bring a new flexible BLC system to patients globally as soon as possible. Additionally, the Karl Storz’ Citizen’s Petition to have BLC equipment reclassified in the U.S. from Class 3 to Class 2 is another significant opportunity that we continue to monitor and pro-actively support," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Photocure reiterates its 2024 guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency, positive EBITDA excluding business development expenses, and new and upgraded Saphira installations in the U.S. in the range of 55 to 70 towers.

"With our business continuing to show steady growth, industry trends in our favor, and a number of initiatives underway that can enable Hexvix/Cysview to grow faster, I believe that Photocure is well-positioned to deliver value to patients and our shareholders in the coming quarters," 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 third quarter 2024 financial report on page 23.

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

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/20241113_5/

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

Enterome to host webinar on new clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of lead programme, EO2463

On November 13, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, reported that it will be holding a webinar to run through new clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, for the treatment of patients with either newly diagnosed, previously untreated follicular lymphoma (FL) [EO2463 monotherapy], or FL and marginal zone lymphoma relapsed/refractory disease [EO2463 in combination with lenalidomide/rituximab] (Press release, Enterome, NOV 13, 2024, View Source [SID1234648268]).

The data is being presented in two posters at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Conference by Jose Caetano (JC) Villasboas Bisneto, MD, PhD, principal study investigator at the Mayo Clinic, and Stephen Smith, MD, hematologist and medical oncologist at the Fred Hutchinson Cancer Center.

Poster details

Abstract #1616 – EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab

Abstract #4395 – EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
Webinar details are as follows:

Date: 12 December 2024

Time: 9.30am-10.35am PT / 12.30pm-1.35pm ET / 5.30pm-6.35pm UK / 6.30pm-7.35pm CET

Presenters:

Pierre Belichard PhD, CEO, Enterome

Laurent Chene PhD, Head of Drug Discovery, Enterome

Jose Caetano (JC) Villasboas Bisneto, MD, PhD, Mayo Clinic

Jan Fagerberg, MD, PhD, CMO of Enterome will also be present for the Q&A session following the presentation.

To attend, please register your details at [email protected] .

Questions can be submitted at any time during the presentation.

Daiichi Sankyo to Showcase TURALIO® Research in Patients with Tenosynovial Giant Cell Tumor at CTOS

On November 13, 2024 Daiichi Sankyo (TSE: 4568) reported that it will highlight new clinical research and real-world data from seven abstracts for TURALIO (pexidartinib) at the Connective Tissue Oncology Society (#CTOS2024) 2024 Annual Meeting (Press release, Daiichi Sankyo, NOV 13, 2024, https://www.businesswire.com/news/home/20241113520939/en/Daiichi-Sankyo-to-Showcase-TURALIO%C2%AE-Research-in-Patients-with-Tenosynovial-Giant-Cell-Tumor-at-CTOS [SID1234648313]).

TURALIO is the first and only oral systemic therapy approved in the U.S. for adult patients with tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TGCT is a rare and typically non-malignant tumor that affects small and large joints.1,2,3

Data at CTOS will highlight ongoing TURALIO research, including two analyses from the ENLIVEN phase 3 trial. One analysis evaluates the efficacy of TURALIO according to surgical history and the feasibility of surgery following treatment with TURALIO. The other is an exploratory analysis examining the dose of TURALIO at the time of objective response and the first timepoint response of progressive disease in relation to adverse events.

"These latest data being presented at CTOS continue to support the role of TURALIO as a treatment option for certain patients with tenosynovial giant cell tumor," said Dan Switzer, Head of U.S. Oncology Business, Daiichi Sankyo, Inc. "As a leader in TGCT research and development, Daiichi Sankyo has made significant progress in transforming the treatment landscape for patients with this rare, debilitating tumor and we remain committed to educating the medical community on identifying appropriate patients who may be eligible for treatment with TURALIO."

Additional TURALIO data at CTOS include health-related quality of life (HRQOL) outcomes from a phase 4 trial evaluating the discontinuation and re-treatment in patients with TGCT previously treated with TURALIO and a trial-in-progress of a phase 4 trial evaluating the risk of idiosyncratic cholestatic hepatoxicity associated with TURALIO treatment.

Other clinical research includes interim results from an investigator-initiated phase 1 trial evaluating the safety and tolerability of TURALIO in pediatric patients and young adults with TGCT, a case study reporting the use of TURALIO as an upfront treatment strategy for TCGT and results of a real-world assessment evaluating symptom change in patients with TGCT receiving TURALIO.

An overview of TURALIO data to be presented at CTOS includes:

Presentation Title

Author

Presentation (PST)

Pexidartinib use in patients with tenosynovial giant cell tumor: an analysis of the phase 3 randomized ENLIVEN clinical trial according to surgical history

J. Healey

Oral Presentation
Saturday, November 16
3:30 – 4:30 pm

Tumor response and regrowth in relation to clinical events among pexidartinib-treated subjects in the phase 3 ENLIVEN trial

J. Desai