On April 30, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported it is presenting new data about its lead product candidate, PH-762, an INTASYL compound (Press release, Phio Pharmaceuticals, APR 30, 2024, View Source [SID1234642476]).

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PH-762 is currently being studied in a US clinical trial to assess safety and efficacy in specific skin cancers. (NCT 06014086). This open-label Phase 1b clinical study (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of IT PH-762 in Stages 1,2 and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma. Stages 1 and 2 cSCC represent 77% of all new cSCC annually. There are no drug products approved for treatment of Stages 1 and 2 cSCC.

The data will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to be held in Chicago, Illinois.

Title: INTASYL PH-762: PD-1 Intratumoral Immunotherapy for Cutaneous Carcinoma

Poster Number: TPS9620
Topic: Melanoma/Skin Cancer
Presenting Author: Mary Spellman, M.D.
Date and Time: June 1, 2024: 1:30-4:30 PM CDT

On April 30, 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 that the randomized portion (Part 2) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and the planned 50 patients in Part 1 of the trial have been enrolled (Press release, Sutro Biopharma, APR 30, 2024, View Source [SID1234642475]). Luvelta is a novel Folate Receptor-α (FRα) targeting ADC with the potential to benefit 8 out of 10 PROC patients, including addressing high unmet medical need in patients with low-medium FRα expression.

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"We are pleased to announce the initiation of the Phase 3 portion of our global, registration-directed clinical trial of luvelta, in patients with platinum-resistant ovarian cancer," said Anne Borgman, M.D., Sutro’s Chief Medical Officer. "The speed with which we were able to enroll Part 1 of the trial speaks to the continued demand for a targeted therapy for patients that are not well supported by the standard of care. With evidence of clinical activity seen in all tumor types that have been tested with luvelta, we look forward to providing a promising treatment option to patients in need, including those with ovarian cancer and beyond."

REFRaME-O1 is a global registration-directed study evaluating the efficacy and safety of luvelta versus chemotherapy in women with PROC with FRα expression ≥25% Tumor Proportion Score (TPS), defined as at least 25% or greater of tumor expressing FRα, at any intensity (1+,2+,3+). In Part 2, approximately 500 patients will be enrolled and randomized 1:1 to the selected luvelta dose or investigators’ choice of chemotherapy. The trial includes a planned interim analysis to support a potential application for accelerated approval.

About Luveltamab Tazevibulin
Luveltamab tazevibulin, abbreviated as "luvelta" and formerly known as STRO-002, is a FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. Developed and manufactured with Sutro’s cell-free XpressCF platform, luvelta is a homogeneous ADC with four hemiasterlin cytotoxins per antibody, precisely positioned to efficiently deliver to the tumor while ensuring systemic stability after dosing. REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer is ongoing. The Company has additional ongoing trials in patients with endometrial cancer and in combination with bevacizumab in patients with ovarian cancer. The Company expects to file an Investigational New Drug (IND) Application for the initiation of a non-small cell lung cancer study in the first half of 2024 and expects to initiate REFRαME-P1, a Phase 2/3 registration-directed study for patients with CBF/GLIS2 acute myeloid leukemia, a rare subtype of pediatric cancer, in the second half of 2024. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS2 Pediatric AML.

On April 30, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, APR 30, 2024, View Source [SID1234642474]):

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BofA Securities Health Care Conference on Tuesday, May 14 at 11:20am Pacific Time
RBCCM Global Healthcare Conference on Wednesday, May 15 at 10:30am Eastern Time
Jefferies Global Healthcare Conference on Wednesday, June 5 at 11:00am Eastern Time
Goldman Sachs Annual Global Healthcare Conference on Wednesday, June 12 at 1:20pm Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation

On April 30, 2024 SynOx Therapeutics Limited ("SynOx" or the "Company"), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other diseases, reported it has entered into a $35m loan facility with Hercules Capital, Inc. (NYSE:HTGC) ("Hercules") (Press release, SynOx Therapeutics, APR 30, 2024, View Source [SID1234642470]).

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The transaction strengthens the Company’s balance sheet as it executes TANGENT, a registrational Phase 3 study of emactuzumab, SynOx’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of TGCT.

This loan facility provides SynOx with flexibility to fund additional clinical work in TGCT to augment TANGENT, activities to support the successful registration and commercialisation of emactuzumab in TGCT, and potentially to explore the use of emactuzumab in other CSF-1 driven and macrophage-mediated diseases.

The term loan facility provides up to $35m, in total, in four tranches. The initial tranche was drawn on signing, with subsequent tranches available over the medium term and upon achievement of certain clinical milestones.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: "This funding will provide SynOx with additional capital to fulfil its mission of establishing emactuzumab as a best-in-class drug, to address significant unmet medical needs and greatly improve the quality of life for as many patients as possible. We are grateful for the support from Hercules, which together with the $75m we raised recently in our Series B round, puts SynOx on a strong financial footing."

R. Bryan Jadot, Senior Managing Director and Group Head – Life Sciences, Hercules, said: "We have been impressed by the quality of data SynOx has already generated on emactuzumab, which demonstrate it to be highly differentiated from other CSF-1 inhibiting drugs in development. Emactuzumab is showing great promise in treating TGCT, and we believe it has the potential to treat other related conditions as well."

TGCT is a type of tumour that affects the soft tissue lining of joints and tendons. It is a highly debilitating disease that often impacts large, important joints such as the knee, hip and ankle. It seriously impacts quality of life by causing significant pain and stiffness in affected joints and limiting range of motion. While most patients receive surgical intervention, more than 50% of patients with diffuse disease experience tumour recurrence within three years of surgery [1].

Emactuzumab, a novel next-generation CSF-1R mAb with a potentially best-in-class profile, has demonstrated substantial clinical activity in earlier clinical work in TGCT [2], with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, significant improvements in functional ability, good tolerability and a manageable safety profile. The Phase 3 TANGENT trial will assess its safety and efficacy in patients with localized and diffuse TGCT.

On April 30, 2024 Scenic Biotech, a pioneer in the field of modifier therapies for severe genetic disorders, reported that it has entered into a research collaboration with Bristol Myers Squibb (NYSE: BMY) to accelerate the development of Bristol Myers Squibb’s drug targets by identifying target biology for indication selection and expansion (Press release, Scenic Biotech, APR 30, 2024, View Source [SID1234642469]). Under the terms of the agreement, Scenic Biotech will be entitled to an upfront payment and potential additional payments contingent upon achievement of a range of research, development and commercial milestones. No further financial details have been disclosed.

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"Working with a world leader in drug discovery and development is an important validation of our Cell-Seq platform’s unique capability to link cellular pathways to drug targets," commented Oscar Izeboud, PhD, CEO of Scenic Biotech. "As we continue to advance our own pipeline of first-in-class disease-modifying therapies, we remain committed to harnessing the power of our ground-breaking approach to support our collaborators in crafting innovative medicines for patients with devastating conditions."

The collaboration with Bristol Myers Squibb marks Scenic Biotech’s second strategic collaboration with a major industry partner, following the multi-year genetic modifier collaborative agreement with Genentech announced in 2020. Both collaborations leverage the Cell-Seq platform’s ability to provide genetic insights leading to the discovery and development of novel therapeutics. While Scenic primarily focuses on applying its Cell-Seq technology to identify modifier genes, the technology has demonstrated its ability to map previously unexplored biological pathways and investigate disease biology.