On March 20, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the year ended December 31, 2024 (Press release, MacroGenics, MAR 20, 2025, View Source [SID1234651310]).

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"We concluded 2024 with the achievement of multiple clinical development milestones, including the completion of enrollment in the LORIKEET Phase 2 study evaluating lorigerlimab in combination with docetaxel in patients with mCRPC. We look forward to building upon this momentum in 2025 as we work to advance our novel pipeline of clinical product candidates, including lorigerlimab, MGC026 and MGC028," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Finally, we have determined that the results of the TAMARACK Phase 2 study of vobra duo in mCRPC do not support additional financial investment by MacroGenics. We believe the B7-H3 target continues to have potential and are pleased with the progress being made with our alternate anti-B7-H3 ADC, MGC026."

Updates on Proprietary Investigational Programs

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

Enrollment is now complete in the ongoing LORIKEET Phase 2 trial, a 150 patient randomized study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). The Company expects to provide a clinical update in the second half of 2025.
Based on MacroGenics’ cumulative experience to date from its Phase 1 and Phase 2 studies of lorigerlimab, including in mCRPC – a tumor setting historically insensitive to checkpoint inhibition – the Company plans to conduct the LINNET Phase 2 study. This clinical trial will evaluate lorigerlimab as monotherapy in patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC); both represent areas of unmet need and historically have been relatively insensitive to checkpoint inhibitor therapy. The study’s primary endpoint is ORR, with multiple secondary endpoints to be explored. The Company anticipates enrolling up to 40 patients with PROC and up to 20 patients with CCGC in LINNET, which is expected to commence by mid-2025.
Emerging ADC Pipeline. MacroGenics is developing two clinical and one preclinical antibody-drug conjugate (ADC) molecules that each incorporate a novel, glycan-linked topoisomerase I inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company). These three candidates are described below.

MGC026 is a TOP1i-based ADC that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. MGC026 shares the same variable domain as that of vobra duo. MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in 2025.
MGC028 is a TOP1i-based ADC that targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. The Company previously presented preclinical data showing antitumor activity of MGC028 in in vivo models. Also, in a non-human primate study, MGC028 was well tolerated at high dose levels with mild, reversible side effects and no ocular toxicity, which is often a concern with tubulin-inhibitor-based ADCs. The first patient was recently dosed in a Phase 1 study of MGC028 in patients with advanced solid tumors.
MGC030 is a preclinical TOP1i-based ADC that targets an undisclosed antigen expressed across several solid tumors. There are currently no approved therapeutics to this target. An Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.
Updates on Selected Partnered Programs

MGD024 is a next-generation CD123 × CD3 DART molecule. Under an October 2022 exclusive option and collaboration agreement with Gilead Sciences, Inc. (Gilead), MacroGenics continues to enroll patients in a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Gilead has the option to license MGD024 at predefined decision points during the Phase 1 study.
ZYNYZ (retifanlimab-dlwr) is a monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. In July 2024, Incyte announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal (SCAC) and non-small cell lung cancer (NSCLC) and continues to conduct global studies of retifanlimab across multiple indications. In February 2025, Incyte disclosed that its supplemental Biologics License Application (sBLA) for retifanlimab in advanced/metastatic SCAC was filed with the FDA in December 2024, with approval anticipated in the second half of 2025. To date, MacroGenics has received $365.0 million in upfront and milestone payments from Incyte under the agreement and remains eligible for up to $540.0 million in additional development, regulatory and commercial milestones.
MARGENZA (margetuximab-cmkb) global rights were sold to TerSera Therapeutics LLC (TerSera), a privately-held biopharmaceutical company with a focus on oncology and non-opioid pain management, pursuant to an agreement previously announced. TerSera made a payment of $40.0 million to MacroGenics at closing in November 2024 and MacroGenics may receive additional sales milestone payments of up to an aggregate of $35.0 million. MacroGenics subsequently paid an $8.0 million amendment fee to its former commercialization partner during the fourth quarter of 2024. MacroGenics will manufacture MARGENZA drug substance on behalf of TerSera going forward.
Update on Vobramitamab Duocarmazine

Vobramitamab duocarmazine (vobra duo) is an ADC with a cleavable peptide linker designed to deliver a DNA-alkylating duocarmycin payload to solid tumors that express B7-H3.

Results for the concluded TAMARACK Phase 2 study included, based on a February 21, 2025 data cut-off, mature median radiographic progression-free survival (rPFS) of 9.5 months for the 2.0 mg/kg cohort (95% CI, 8.5-11.2) and 10.0 months for the 2.7 mg/kg cohort (95% CI, 7.4-11.4) in patients with mCRPC. Safety data from the study remained consistent with prior data disclosures.
Based on its assessment of the vobra duo safety and efficacy profile and an internal resource and portfolio review, MacroGenics has decided not to pursue further internal development of vobra duo and will instead explore potential alternatives for partnering this program.
2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of December 31, 2024, was $201.7 million, compared to $229.8 million as of December 31, 2023.
Revenue: Total revenue was $150.0 million for the year ended December 31, 2024, compared to total revenue of $58.7 million for the year ended December 31, 2023. The increase was primarily due to a net increase of $85.0 million in revenue recognized from milestones achieved under the Incyte License Agreement.
R&D Expenses: Research and development expenses were $177.2 million for the year ended December 31, 2024, compared to $166.6 million for the year ended December 31, 2023. The increase was primarily due to increased research, development, manufacturing and clinical costs related to MGC028, the Company’s preclinical ADC pipeline and lorigerlimab, offset by decreased development and clinical trial costs related to the Company’s discontinued projects and margetuximab.
SG&A Expenses: Selling, general and administrative expenses were $71.0 million for the year ended December 31, 2024, compared to $52.2 million for the year ended December 31, 2023. The increase was due to an amendment fee paid by MacroGenics to its former commercial partner pursuant to the sale of MARGENZA and increased non-cash stock-based compensation and accrued severance expenses related to the separation agreement with the Company’s Chief Executive Officer.
Other Income: Other income for the year ended December 31, 2024, reflected a $36.3 million gain recognized on the sale of MARGENZA.
Net Loss: Net loss was $67.0 million for the year ended December 31, 2024, compared to net loss of $9.1 million for the year ended December 31, 2023.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2024 were 62,819,857.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $201.7 million as of December 31, 2024, in addition to projected and anticipated future payments from partners should extend its cash runway into the second half of 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the ongoing Phase 2 LORIKEET study of lorigerlimab in mCRPC as well as MacroGenics’ other clinical and preclinical studies currently ongoing.
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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

On March 20, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates (Press release, Immuneering, MAR 20, 2025, View Source [SID1234651309]).

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"We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) and an observed ORR of 50% for IMM-1-104 in combination with modified FOLFIRINOX (mFFX). Historic benchmarks for either chemotherapy agent alone are 23% ORR and 32% ORR, respectively. IMM-1-104 in combination with each of mGnP and mFFX was observed to be generally well tolerated. Based on these promising results, we have begun planning for a potential IMM-1-104 global pivotal trial in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer, as we aim to get this exciting potential new treatment option to patients as quickly as possible," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

"Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequently announced a clinical trial supply agreement with Regeneron for Libtayo in combination with IMM-1-104 in patients with non-small cell lung cancer and aim to get these new trials up and running this year. In support of these plans, we were pleased to announce that Dr. Igor Matushansky has joined Immuneering as Chief Medical Officer to oversee clinical activities, including medical and operational leadership for our development programs."

Zeskind concluded: "As we look ahead to the rest of the year – with our cash balance recently fortified – we expect multiple data events, beginning with an update from our IMM-1-104 Phase 2a trial in the second quarter of 2025. We are continuing to build a growing data set that we believe positions our lead asset with the potential to offer an improved profile in comparison to current MEK inhibitors, which currently represents an existing approximately $2.4 billion annual global opportunity in the aggregate."

Corporate Highlights

Phase 1 Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: Today, Immuneering provided a case study update for a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for over 13 months so far. The patient – who previously progressed on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily. As of the most recent available scan, the patient has maintained stable disease with a RECIST SLD change of -24.2%. In addition to a 91% reduction in peak CA 19-9 levels, IMM-1-104 has been well tolerated by the patient, who has reported improved quality of life and approximately 12% weight gain.
Named Dr. Igor Matushansky as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, joined the company as Chief Medical Officer. In this role, Dr. Matushansky will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer.
Announced Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the intended evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC).
Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include additional combination arms.
Launched Pancreatic Cancer Advisory Board: In December, Immuneering announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance.
FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma: In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.
FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the FDA granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer.
Near-Term Milestone Expectations
IMM-1-104

Further IMM-1-104 Phase 2a data expected in the second quarter of 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025.
Fourth Quarter and Full Year 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were $36.1 million, compared with $85.7 million as of December 31, 2023. These amounts exclude net proceeds of $13.7 million from the Company’s ATM facility raised in January 2025.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $14.9 million compared with $11.9 million for the fourth quarter of 2023. Full year 2023 R&D expenses were $48.0 million compared to $41.6 million for full year 2023. The increase in fourth quarter and full year 2024 R&D expenses as compared to the same respective periods of 2023 was primarily attributable to higher clinical costs related to the Company’s lead IMM-1-104 program and increased personnel to support ongoing research and development activities.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were $3.7 million compared with $4.4 million for the fourth quarter of 2023. Full year 2024 G&A expenses were $16.1 million compared to $16.8 million for full year 2023. The decrease in fourth quarter and full year 2024 G&A expenses as compared to the same respective periods of 2023 was primarily due to lower external professional fees and a reduction in employee-related costs, partially offset by higher stock-based compensation related to the general and administrative functions supporting the business.
Net Loss: Net loss attributable to common stockholders was $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024, compared to $15.1 million, or $0.52 per share, for the quarter ended December 31, 2023. Net loss attributable to common stockholders for full year 2024 was $61.0 million, or $2.04 per share, compared to $53.5 million, or $1.88 per share, for full year 2023.
2025 Financial Guidance

Based on cash and cash equivalents as of December 31, 2024, plus proceeds from the Company’s subsequent utilization of its ATM facility, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.

On March 20, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that it has elected to discontinue development of EO-3021 (Press release, Elevation Oncology, MAR 20, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-discontinue-development-of-eo-3021-advancing-eo-1022-while-evaluating-strategic-options [SID1234651308]). EO-3021 is a Claudin 18.2 antibody-drug conjugate (ADC), which Elevation Oncology was developing for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers. Elevation Oncology will continue to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors, and, in parallel, is initiating a process to evaluate strategic options to maximize shareholder value.

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The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology’s Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of 22.2% (95% CI: 10, 39; 1 confirmed complete response and 7 confirmed partial responses) and a disease control rate (DCR) of 72.2% (95% CI: 55, 86) among 36 evaluable patients with gastric or GEJ cancer and Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+. In the safety analysis of all enrolled patients (n=85), treatment with EO-3021 was observed to be generally well-tolerated, with an adverse event profile consistent with previously reported data, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia.

"We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to other Claudin 18.2 ADCs in development," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on these data, we have decided to discontinue further development of EO-3021. I want to express my tremendous gratitude to the patients, physicians and site coordinators who participated in the EO-3021 clinical trial."

Mr. Ferra continued, "We are turning our focus to our potentially differentiated HER3 ADC, EO-1022, which incorporates glycan site-specific conjugation and is designed to address significant and emerging unmet needs in many HER3-expressing cancers. We look forward to presenting preclinical data supporting its potential at the AACR (Free AACR Whitepaper) Annual Meeting next month. In parallel, we are initiating efforts to evaluate strategic options for the company. With cash into the second half of 2026 and a disciplined operating strategy, we are well-positioned to advance EO-1022 while working to identify and capitalize on the best opportunities to maximize value for our stakeholders."

Corporate Update:

Elevation Oncology is implementing a workforce reduction of approximately 70%. The total cash payments and costs related to this reduction in force are estimated to be approximately $3 million, with a significant majority of these amounts expected to be paid though the end of June 2025. As part of this reduction, Elevation Oncology’s Chief Medical Officer, Valerie Malyvanh Jansen, M.D., Ph.D., will step down, effective March 31, 2025. Dr. Jansen will continue to support the company in a consulting capacity.

"I want to thank the employees who will be departing as part of this restructuring. Over the past five years, my colleagues have worked tirelessly to advance a novel pipeline of selective medicines, demonstrating a tremendous commitment to making a difference for people living with cancer. I am deeply appreciative of their dedication, support and contributions," added Mr. Ferra.

Based on its current operating plans, Elevation Oncology now expects that its cash, cash equivalents, and marketable securities of $93.2 million as of December 31, 2024, will be sufficient to fund its operations into the second half of 2026.

On March 20, 2025 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported a Q4 and Full Year 2024 business update (Press release, Adaptimmune, MAR 20, 2025, View Source [SID1234651305]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "2025 is the year of commercial execution for Tecelra, as we begin to generate value from our promising sarcoma franchise. The launch is going very well and each step in delivering this important medicine: activating our treatment network; identifying biomarker eligible patients; exceptional manufacturing quality and turn-around times, strengthens our sarcoma platform capabilities for both Tecelra and for lete-cel. These results give us confidence in our strategy to build value from our sarcoma franchise and our path to profitability in 2027. In the context of the current capital markets, we are assessing all strategic options to enable us to achieve these goals."

Tecelra launch momentum increasing – the first commercial product in Adaptimmune’s sarcoma franchise

● 20 Authorized Treatment Centers (ATCs) now accepting referrals
● On track to have the full network of approximately 30 ATCs open by end of 2025
● Apheresed 3 patients in 2024 and invoiced 2 with Q4 product revenue of $1.2m
● Apheresed 10 patients in 2025 to date
● Successful reimbursement with no denials to date
● 100% success rate in manufacturing to date with no capacity constraints

Lete-cel – the next product in Adaptimmune’s sarcoma franchise

● Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024)
● On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026
● Lete-cel will expand the addressable patient population for sarcoma franchise

On March 19, 2025 Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") reported updated data confirming efficacy of its Targeted Hyperthermia Therapy ("THT") cancer treatment in an immunotherapy resistant cancer (Press release, Sona Nanotech, MAR 19, 2025, View Source [SID1234652834]). In this follow-up data to the previously released preliminary study (see press release dated December 11, 2024), again using an industry-standard, immunotherapy resistant, CT-26 colon cancer model, Sona’s THT cancer treatment was 100% effective in activating a strong, effective immune system response. In these experiments, animals treated with a PD-1 checkpoint inhibitor, a standard of care immunotherapy, experienced no benefit with tumors growing similarly to tumors in the control group of untreated animals. However, in a new, second cohort of eight animals first treated with Sona’s THT and then treated with a PD-1 inhibitor, 100% of animals responded demonstrating near complete arrest in tumor growth in the majority of animals as highlighted by the dashed green line in Figure 1, below.

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Sona Nanotech CMO, Dr. Carman Giacomantonio, commented, "In this study, Sona’s THT cancer treatment is clearly the difference maker in inhibiting the growth of this notoriously difficult-to-treat cancer. THT’s ability to cause the expression of new antigens causes the immune system to engage, which we show permits immunotherapies to work better, making THT a powerful potential immunotherapy in its own right."

Sona Nanotech CEO, David Regan, commented, "While still an early preclinical study, we are nonetheless very excited to see the repeatability of our earlier successful preclinical colorectal study results. This data gives us additional confidence as to THT’s ability to enhance the response rates of immunotherapies used in humans, which we expect to be able to assess shortly in our first-in-human early feasibility study."

Further data from this experiment can be found in the Company’s updated corporate presentation, which can be accessed in the Investor Section of its website.

Sona’s THT cancer treatment uses the Company’s patented, biocompatible gold nanorods ("GNRs") to treat certain solid cancer tumors, shrinking them and stimulating the immune system, which has been shown in preclinical studies to enhance the response rates of two different immunotherapy drugs, IL-2 and PD-1.