On April 2, 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 the pricing of an underwritten offering of 14,478,764 shares of its common stock at a price of $5.18 per share (Press release, Sutro Biopharma, APR 2, 2024, View Source [SID1234641705]). The gross proceeds from this offering are expected to be approximately $75.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. All of the shares of common stock are being offered by Sutro. The offering is expected to close on or about April 4, 2024, subject to the satisfaction of customary closing conditions.

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The offering was led by a high quality group of new and existing healthcare focused institutional investors.

Sutro intends to use the net proceeds of this offering, together with its existing cash, cash equivalents and marketable securities, primarily for general corporate purposes, which may include funding research, clinical and process development and manufacturing of its product candidates, increasing its working capital, developing itscommercialization infrastructure, expanding its manufacturing capabilities, acquisitions or investments in businesses, products or technologies that are complementary to its own, capital expenditures and other general corporate purposes.

BofA Securities is acting as sole book-running manager in the offering.

The shares are being offered by Sutro pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus may also be obtained, when available, from: BofA Securities, NC1-0220-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, North Carolina, 28255-0001, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 2, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported its financial results for the year ended December 31, 2023 and provided a business update (Press release, Phio Pharmaceuticals, APR 2, 2024, View Source [SID1234641704]).

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Recent Corporate Updates

PH-762

In 2023, we made substantial progress as a focused drug development organization. In April, we submitted our first IND to the U.S. Food and Drug Administration (FDA), addressing an immuno-oncology disorder and seeking clearance to commence a Phase 1B dose escalation trial in various forms of skin cancer with our lead INTASYL compound PH-762. One month later we received clearance from the FDA to begin our trial in stage IV melanoma, Merkel cell and cutaneous squamous cell carcinoma (cSCC), including the early stages I and II in cSCC. The latter clearance was significant since there are no drugs specifically approved to treat early stages I and II of cSCC. The current standard of care for these diseases is surgical intervention, which may not always be an ideal medical option when tumor size or placement occur on certain areas of the face and scalp. Our INTASYL compound PH-762 may offer an alternative which could shrink tumor size, if not eliminate the lesion, as well as reducing the extent of surgical intervention to allow for tissue sparing and facilitating a faster patient recovery.

As of February, the first two patients in our first cohort have completed treatment with PH-762 with no reported adverse events.

We now have four investigation sites under contract to participate in the trial. The sites consist of George Washington University, Banner MD Anderson, Centricity and Integrity Research.

AgonOx Study Development

In February 2021, we entered into a clinical co-development collaboration agreement (the "Clinical Co-Development Agreement") with AgonOx, a private company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer. Under the Clinical Co-Development Agreement, we and AgonOx are working to develop a T cell-based therapy using PH-762, and AgonOx’s "double positive" tumor infiltrating lymphocytes ("DP TIL") technology. AgonOx is conducting a Phase 1 clinical trial of PH-762 treated DP TIL in patients with advanced melanoma and other advanced solid tumors. In August and September, AgonOx infused the first two patients with their DP TIL. In November, a third patient was infused with a combination of TIL and our PH-762 product candidate. Further patient infusions have been delayed due to a facility renovation at the Providence Cancer Research Center, which is expected to reopen in May 2024.

Cost Rationalization

In 2023 we implemented a cost rationalization program driven by our transition from discovery research to product development. This resulted in a decision not to renew our building lease in Marlborough, MA., which lease expires on March 31, 2024. A smaller research footprint has been established in the Massachusetts Biomedical Initiatives in Worcester, MA, where we occupy 321 sq. ft of laboratory space. Additionally, we rationalized discovery research personnel resulting in a headcount reduction of 36%. Expense reductions have been redirected to funding the Phase 1B clinical trial of PH-762.

Patent Portfolio Enhancement

Two new patent applications were filed covering the intratumoral administration of PH-762 for the treatment of various skin cancers, and the synergistic combination of an INTASYL compound and a systemic antibody. In addition, five new patents covering multiple INTASYL compounds were granted in the US (2), Japan (1), South Korea (1) and Hong Kong (1).

Scientific News

We presented new data on the immunotherapeutic activity of INTASYL compounds alone and as Adoptive Cell Therapy at conferences, including American Academy of Cancer Research (AACR) (Free AACR Whitepaper), Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), and at the triple meeting of AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). New data was presented on INTASYL PH-894 showing that local treatment with PH-894 presents a strategy to decrease BRD4 expression and upregulate MART-1 expression to increase immune response to cancer cells while reducing toxicities associated with systemic therapies. This further supports development of PH-894 for injectable solid tumor indications such as melanoma.

In addition, data was presented that demonstrates the effectiveness of PH-894 as an antitumor cytotoxic agent (directly killing tumor cells). The addition of PH-894 to cells in vitro elicited concentration-associated apoptosis of all human cancer cell lines tested, including head and neck squamous cell carcinoma (HNSCC), breast cancer, lung cancer, glioblastoma, melanoma, colon cancer, ovarian cancer, and cervical cancer.

As previously disclosed, we have elected to defer further work on our PH-894 product candidate in order to prioritize and advance our PH-762 clinical trials.

Financial Results

Cash Position

At December 31, 2023 we had cash of $8.5 million as compared with $11.8 million at December 31, 2022.

Research and Development Expenses

Research and development expenses were $6.3 million for the year ended December 31, 2023 as compared with $7.0 million for the year ended December 31, 2022, a decrease of 10%. The decrease was primarily due to decreased costs related to the completion of our IND-enabling preclinical studies for PH-894 and reduced lab supplies as a result of a decrease in lab personnel and a shift in focus on clinical development, partially offset by an increase in clinical-related costs for the two U.S. PH-762 Phase 1 clinical trials as compared to the prior year period.

General and Administrative Expenses

General and administrative expenses were $4.4 million for the year ended December 31, 2023 as compared with $4.5 million for the year ended December 31, 2022, a decrease of 2%. The decrease was primarily due to decreases in personnel-related expenses related to organizational department changes, one-time executive search-related fees for our President and CEO and D&O insurance premiums, partially offset by increased professional fees for legal services as compared to the prior year period.

Net Loss

Net loss was $10.8 million, or $5.20 per share, for the year ended December 31, 2023 as compared with $11.5 million, or $10.10 per share, for the year ended December 31, 2022. The decrease in net loss was primarily due to the changes in research and development expenses, as described above.

On April 2, 2024 NeoVirTech reported the company in partnership with Imactiv-3D, the ImPACT team from the Cancer Research Center of Toulouse and the National Veterinary School of Toulouse, obtains funding from AAP France 2030 organized by the French Government and the Occitanie region for the development of an innovative theranostic platform for cancer virotherapy, in strong collaboration with CHU de Toulouse and Oncopole Claudius Régaud (Press release, NeoVirTech, APR 2, 2024, View Source [SID1234641703]).

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This program, called Perseverance, supported by Transgene, aims to accelerate the preclinical development of oncolytic viruses (OV), viruses modified and armed to specifically destroy cancer cells. The program is organized into different work tasks, involving the design of ANCHORTM autofluorescent VO candidates for in vivo monitoring of infection and replication of VOs, their production and validation. ANCHOR VOs are then used to perform a virogram on different cancer cell lines to achieve precise mapping of oncolytic activities. The VOs are then optimized and tested for their interaction with pre-existing treatments. Finally, ANCHORTM VOs are tested on organoids derived from patients tumors, the infection of which is analyzed by deep learning and AI processes, and tested on animal models (mouse/rabbit).

At the end of the program, Perseverance offers a clear vision of the efficiency of a given VO on the most relevant models and close to the patient, in order to accelerate their development and guide clinical and therapeutic decisions.

The program is open to any VO of interest, regardless of their stage of development. For more information: [email protected]

On April 2, 2024 NANOBIOTIX, a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported completion of the dose escalation part of a Phase 1 study evaluating potential first-in-class radioenhancer NBTXR3 for patients with non-small cell lung cancer ("NSCLC") that cannot be treated by surgery ("inoperable"), and has come back ("recurrent") (Press release, Nanobiotix, APR 2, 2024, View Source [SID1234641702]). whom have previously been treated with definitive radiation therapy and are amenable to re-irradiation. The Phase 1 study ("Study 2020-0123") is being conducted by The University of Texas MD Anderson Cancer Center ("MD Anderson") as part of an ongoing strategic collaboration with Nanobiotix.

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"NBTXR3 is designed as a product candidate with the potential to improve treatment outcomes for patients with cancer in any setting where radiotherapy is a part of the treatment regimen. While these patients experience different cancer types and are each faced with unique challenges, what they share is an urgent need for therapeutic innovation with the chance to make a difference," said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. "We believe the injection feasibility and favorable safety profile we have observed from the completed dose escalation part of this Phase 1 lung cancer study could pave the way for additional clinical development of NBTXR3 for patients with inoperable, recurrent lung cancer and patients amenable to re-irradiation."

The completed dose escalation part of Study 2020-0123 established the recommended Phase 2 dose after determination of injection feasibility and observation of a favorable safety profile. The expansion part of the study, further evaluating safety and early signals of efficacy, is ongoing.

About MD ANDERSON STUDY 2020-0123
MD Anderson Study 2020-0123 (NCT04505267) is a Phase 1 study evaluating the best dose and observing the adverse effects of NBTXR3 activated by radiation therapy ("RT") for the treatment of non-small cell lung cancer ("NSCLC") that cannot be treated with surgery ("inoperable"), and has come back ("recurrent"), in patients who have previously been treated with definitive RT. The primary objectives of the study include a safety assessment of re-irradiation in these patients and determination of the recommended Phase 2 dose of NBTXR3 activated by RT. The re-irradiation safety assessment part and the dose-finding part of the study have completed. An expansion part evaluating additional signals of safety, feasibility, anti-tumor response, and time-to-event outcomes is ongoing.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On April 2, 2024 Labcorp, a global leader of innovative and comprehensive laboratory services, reported the company will present abstracts in the areas of immunology, cellular biology, genomics and liquid biopsy at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in San Diego (April 5-10, 2024) (Press release, LabCorp, APR 2, 2024, View Source [SID1234641701]).

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The depth and breadth of Labcorp’s oncology research solidifies the company’s commitment to delivering guideline-based, biomarker-driven testing solutions, strengthening existing evidence of clinical utility and supporting the pharmaceutical industry from discovery to companion diagnostics development through commercialization to facilitate patient access to novel targeted therapies.

"Labcorp is advancing cancer care through our pioneering research in precision oncology and our global collaborations with pharmaceutical, biotechnology and clinical research partners. Our robust presence at this year’s AACR (Free AACR Whitepaper) Annual Meeting is a testament to our dedication to leading with science, showcasing our commitment to innovation, and highlighting our role in shaping the future of personalized medicine," said Shakti Ramkissoon, M.D., Ph.D., vice president, medical lead for oncology at Labcorp. "Our research initiatives are focused on transforming the diagnostic landscape, enhancing patient care, and fueling a new era of targeted, effective treatments that will improve health and improve lives."

Of the 21 abstracts to be presented at the AACR (Free AACR Whitepaper) Meeting, 13 were internal studies by Labcorp researchers and eight were conducted in collaboration with research partners from premiere academic institutions and medical centers.

Spotlight Theater
Title: Biomarker solutions for all: Innovative solid tumor MRD detection and immune profiling solutions for advanced drug development
Date: Tuesday, April 9
Time: 10:00 a.m. PT
Location: Spotlight Theater A

Oral Presentations
Abstract #6559: Clinical validity of post-surgery circulating tumor DNA testing in stage III colon cancer patients treated with adjuvant chemotherapy: The PROVENC3 study
Date: Tuesday, April 9
Time: 3:10 p.m. – 3:25 p.m. PT
Location: Ballroom 6 CF – Upper Level – Convention Center

Poster Presentations
Track: Immunology
Session: Biomarkers, Immune Monitoring and Immune Assays
Abstract #83: NK cell ADCC assays: Leveraging flow cytometry and reporter cell lines for enhanced biological relevance and throughput
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 3

Track: Molecular/Cellular Biology and Genetics
Session: Cellular Stress Responses 1
Abstract #379: Landscape of HIF-1α expression across 24,186 solid tumors using comprehensive immune profiling
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 16

Track: Clinical Research
Session: Circulating Nucleic Acids 1
Abstract #970: Liquid biopsy-informed precision oncology clinical trial to evaluate the utility of ctDNA comprehensive genomic profiling
Date: Sunday, April 7
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Clinical Research
Session: Predictive Biomarkers 1
Abstract #2496: Molecular characterization of stage III colon cancer patients with recurrence after adjuvant chemotherapy
Date: Monday, April 8
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 43

Track: Clinical Research
Session: Biomarkers in Clinical Trials
Abstract #3629: Prevalence of claudin18.2 expression in gastric/gastroesophageal junction adenocarcinoma among patients in TranStar101 and TranStar102 clinical trials
Date: Monday, April 8
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Clinical Research
Session: Biomarkers in Clinical Trials
Abstract #3652: Spatial transcriptomic study of the tumor microenvironment in HNSCC
Date: Monday, April 8
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Experimental and Molecular Therapeutics
Session: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Abstract #4628: Validation of an Automated, Scalable Comprehensive Genomic Profiling Assay for Hematologic Malignancies
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 26

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5020: Pre-analytical characterization of cell-free DNA to enable liquid biopsy for solid tumors
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5022: MEDOCC-CrEATE trial: Feasibility of measuring circulating tumor DNA after surgery to guide adjuvant chemotherapy in stage II colon cancer patients
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Clinical Research
Session: Circulating Nucleic Acids 4
Abstract #5017: Analytical performance of contrived samples for validation of liquid biopsy assays
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 40

Track: Tumor Biology
Session: Models to Study Immune Cells in the Tumor Microenvironment
Abstract #4204: Subcutaneous vs. orthotopic tumor models: a comparative assessment
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 10

Track: Tumor Biology
Session: Tumor Evolution Models and Technologies
Abstract #4305: Analysis of tumor heterogeneity in syngeneic models; CT26.WT colon carcinoma and 4T1-Luc2-1A4 breast carcinoma in female BALV/cAnNHsd mice
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 13

Track: Immunology
Session: Adoptive Cell Therapies 3: CAR-T Cells
Abstract #4002: Investigating CAR-T cell efficacy and activation in the disseminated NALM6-luc human B-cell acute lymphoblastic leukemia model
Date: Tuesday, April 9
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 2

Track: Clinical Research
Session: Predictive Biomarkers 6
Abstract #6443: Enhanced detection of ctDNA molecular response for immunotherapy treated non-small cell lung cancer through analyses of cell-free and matched white blood cell DNA
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 44

Track: Clinical Research
Session: Adoptive Cellular Therapy 2
Abstract #6334: Metabolic reprogramming enhances expansion and potency of CAR T cells
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 40

Track: Tumor Biology
Session: Spatial Resolution of the Tumor Microenvironment
Abstract #5493: Digital spatial profiling of MC38 colon carcinoma following checkpoint inhibition
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 10

Track: Experimental and Molecular Therapeutics
Session: Novel Therapeutics and Preclinical Models
Abstract #6005: Generation of new oncology cell models through long-term acclimation under hypoxic and hyperbaric culture conditions
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 28

Track: Clinical Research
Session: Predictive Biomarkers 5
Abstract #6393: The predictive role of TNF-related genes in patients receiving immune checkpoint inhibitors
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 43

Track: Prevention/Early Detection/Interception, Population Sciences
Session: Biomarker-Based Screening
Abstract #6079: Comparison of FIT and ctDNA tests for detection of individuals with colorectal cancer in population-based screening
Date: Tuesday, April 9
Time: 1:30 p.m. – 5:00 p.m. PT
Section: 31

Track: Clinical Research; Molecular/Cellular Biology and Genetics
Session: Immune Checkpoint Inhibitor Therapy
Abstract #7526: Landscape of TIGIT and PD-L1 co-expression in solid tumors
Date: Wednesday, April 10
Time: 9:00 a.m. – 12:30 p.m. PT
Section: 42