On June 6, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported Company highlights and key achievements year-to-date, including recent clinical progress for lead candidate THIO, a potential first-in-class cancer telomere targeting agent in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC) (Press release, MAIA Biotechnology, JUN 6, 2024, View Source [SID1234644187]).

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"MAIA’s new science for cancer therapy is driving a powerful value proposition for our portfolio of novel anticancer compounds," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Our most recent clinical data points to THIO’s promising disease control, response rates, and post-therapy patient benefits. Third-line treatment with THIO has significantly outperformed reported standard-of-care data in NSCLC.

"Our confidence in the science and clinical pathways for our immuno-oncology therapies continues to grow," Dr. Vitoc added. "This week at ASCO (Free ASCO Whitepaper) 2024, our poster presentation and prospects for conducting studies in various geographies has generated a wealth of positive response and excitement from U.S. and foreign oncologists and investigators about our growing cancer treatment business."

THIO’s dual mechanism of action is designed to induce telomeric DNA damage and boost cancer-specific immune responses. The Phase 2 THIO-101 clinical trial evaluates THIO sequenced with an immune checkpoint inhibitor (CPI), cemiplimab, in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens prior to THIO dosing. MAIA successfully secured a high value clinical supply agreement for the cemiplimab used throughout the THIO-101 trial.

As of April 30, 2024, THIO-101 data from THIO 180mg + CPI in third-line treatment showed, in part:

– overall response rate (ORR) of 38%
– disease control rate (DCR) of 85%
– median progression-free survival (PFS) of 5.5 months
– median survival follow-up time of 9.1 months

"THIO works well in all doses and has an excellent safety profile, but 180mg has shown the greatest efficacy and is well tolerated compared to existing therapies. Hence, we selected 180mg per cycle as the dose going forward," noted Dr. Vitoc. "For this heavily pre-treated population, comparative third-line data is limited. Checkpoint inhibitor resistant and platinum resistant patients are by far the largest populations with unmet medical needs in NSCLC and are also a substantial part of NSCLC cancer therapy market. We believe that our trial is providing the first real dataset in CPI-resistant patients like this. We are confident about THIO’s prospects for substantially extending patient survival and establishing a new standard of care for cancer.

"We remain steadfast in our goals for responsible access to capital. We have increased our access to cash while keeping dilution to a minimum. We plan to continue this strategy, which has shown desired outcomes so far this year while our share price has more than tripled," added Dr. Vitoc.

MAIA reported cash and current assets of $8.7 million as of March 31, 2024. The Company’s cash position has significantly improved due to approximately $12.4 million in funds raised since February 2024 pursuant to a combination of private placements of our equity securities and sales under our at-the-market offering facility, of which approximately $7.4 million has been raised since April 1, 2024 with $6.4 million of this amount due to sales under the ATM facility to fund continuing clinical development. Our independent directors have shown continued support by investing almost $900,000 in our March and April 2024 private placements with other accredited investors.

MAIA’s Phase 2 THIO-101 clinical trial is expected to near completion in 2024. The Company is also engaged in research and development for a portfolio of second-generation THIO-like compounds.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On June 6, 2024 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that its management team will participate in a fireside chat at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, FL (Press release, Arcus Biosciences, JUN 6, 2024, View Source [SID1234644186]). The fireside chat will take place on Wednesday, June 12th, 2024 at 10:00am ET.

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A live webcast of the fireside chat will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

On June 6, 2024 AbbVie (NYSE: ABBV) reported positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC) (Press release, AbbVie, JUN 6, 2024, View Source [SID1234644185]). The study met its primary endpoint with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%).

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In addition, the median duration of response (DOR), a key secondary endpoint, was 8.25 months.

The safety profile of mirvetuximab soravtansine was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting.

"Significant unmet needs remain for patients with platinum sensitive disease, as each subsequent line of therapy in this setting is associated with decreased efficacy and tolerability, which reinforces the need for treatment alternatives for these patients," said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. "The PICCOLO data further support the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients."

About PICCOLO

PICCOLO is a single arm Phase 2 trial evaluating the efficacy and safety of mirvetuximab soravtansine monotherapy in patients with FR-alpha high platinum-sensitive ovarian cancer who have received at least two prior lines of platinum containing therapy or have a documented platinum allergy. The primary end point is objective response rate (ORR), and the key secondary endpoint is duration of response (DOR).

The PICCOLO study was designed to statistically rule out an objective response rate of 28% or lower, as excluded by the lower bound of the confidence interval, a response rate which has been observed with non-platinum, single-agent chemotherapy in platinum-sensitive disease. Patients with PSOC with multiple prior lines of platinum-based therapy or who are ineligible for platinum-based therapy, as in the population in PICCOLO, have no established benchmark standard of care, particularly after disease progression on a PARP inhibitor.

Mirvetuximab soravtansine is also being studied in PSOC in the Phase 3 GLORIOSA trial, in combination with bevacizumab versus bevacizumab alone in maintenance after second-line platinum-doublet therapy.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients will experience recurrence of their disease and require multiple subsequent lines of therapy, with decreasing efficacy and tolerability. Patients who initially respond to platinum-based chemotherapy and relapse 6 months or longer after the initial treatment were classified as platinum sensitive, while patients who relapse within under 6 months after platinum-based chemotherapy were considered platinum resistant.

Platinum-based chemotherapy remains the most active treatment for earlier lines of ovarian cancer. The benefit of retreatment with platinum is generally less with each subsequent line of therapy. While platinum-based doublets predominate treatment for front- and second-line patients based on results from randomized trials, there is no generally accepted standard of care with a clear efficacy benchmark based on prospective trials in third-line or later patients, particularly those whose cancers have progressed on PARP inhibitors.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Mirvetuximab soravtansine approved under the brand name ELAHERE in the United States has received regulatory approval in adults with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries. The safety and efficacy of mirvetuximab soravtansine has not been established for platinum-sensitive ovarian cancer.

ELAHERE (mirvetuximab soravtansine-gynx) U.S. USE and IMPORTANT SAFETY INFORMATION

What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who:
• have not responded to or are no longer responding to treatment with platinum-based chemotherapy
and
• have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE is right for you.

It is not known if ELAHERE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:
Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
• Your healthcare provider will send you to see an eye care professional to check your eyes before you start treatment with ELAHERE, during treatment with ELAHERE, and as needed for any worsening signs and symptoms of eye problems.
• Your healthcare provider will prescribe steroid eye drops and lubricating eye drops before you start and during your treatment with ELAHERE. You should use eye drops as directed by your healthcare provider.
• Do not wear contact lenses throughout your treatment with ELAHERE unless you are told to use them by your healthcare provider.

What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions, including if you:
• have vision or eye problems.
• have numbness or tingling in your hands or feet.
• have liver problems.
• are pregnant or plan to become pregnant. ELAHERE can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ELAHERE.

Patients who are able to become pregnant:
• Your healthcare provider should do a pregnancy test before you start treatment with ELAHERE.
• You should use an effective birth control (contraception) during treatment and for 7 months after your last dose of ELAHERE.
• are breastfeeding or plan to breastfeed. It is not known if ELAHERE passes into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of ELAHERE.

Tell your healthcare provider about all the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements. Taking certain other medicines during treatment with ELAHERE may cause side effects.

What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:
• Eye problems. Eye problems are common with ELAHERE and can also be severe. Tell your healthcare provider right away if you develop any eye problems during treatment with ELAHERE, including blurred vision, dry eyes, sensitivity to light, eye pain, eye redness, or new or worsening vision changes.
• Lung problems (pneumonitis). ELAHERE can cause severe or life-threatening inflammation of the lungs that may lead to death. Tell your healthcare provider right away if you get new or worsening symptoms, including trouble breathing, shortness of breath, cough, or chest pain.
• Peripheral neuropathy. Nerve problems called peripheral neuropathy are common during treatment with ELAHERE and can also be severe. Your healthcare provider will monitor you for signs and symptoms of nerve problems. Tell your healthcare provider if you get new or worsening numbness, tingling, burning sensation or pain in your hands or feet or muscle weakness.

The most common side effects and abnormal labs of ELAHERE include:
• increased liver enzymes in the blood
• feeling tired
• blurred vision
• nausea
• diarrhea
• stomach-area (abdominal) pain
• changes in the cornea (part of the eye)
• peripheral neuropathy
• muscle, bone, or joint pain
• decreased red or white blood cell counts
• decreased platelets
• decreased magnesium level in the blood
• dry eye
• constipation
• vomiting
• decreased albumin level in the blood
• decreased appetite

Your healthcare provider may change your dose of ELAHERE, delay treatment, or completely stop treatment if you have certain side effects.

These are not all of the possible side effects of ELAHERE. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
Please see Full Prescribing Information, including Boxed WARNING and Medication Guide

On June 6, 2024 Exicure, Inc. (Nasdaq: XCUR) has historically been an early-stage biotechnology company focused on developing nucleic acid therapies targeting ribonucleic acid against validated targets. In September 2022, the Company reported a significant reduction in force, suspension of preclinical activities and halting of all research and development, and that the Company was exploring strategic alternatives to maximize stockholder value (Press release, Exicure, JUN 6, 2024, View Source [SID1234644182]).

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2023 Financial Results

Cash Position: Cash and cash equivalents were $0.8 million as of December 31, 2023, as compared to $8.6 million as of December 31, 2022. Subsequent to December 31, 2023, our cash and cash equivalents have decreased to approximately $0.2 million as of May 31, 2024. Subsequent to May 31, 2024, the Company received a $0.7 million loan from DGP Co., Ltd., a significant stockholder. The loan has a maturity of ten months from issuance and interest at a rate of 6.0% per annum is payable at maturity. The Company believes that its cash and cash equivalents are insufficient to continue to fund operations and additional funding is needed in the very near term.

Research and Development (R&D) Expense: Research and development expenses were $1.4 million for the year ended December 31, 2023, as compared to $19.8 million for the year ended December 31, 2022. The decrease in R&D expense for the year ended December 31, 2023 of $18.3 million reflects the stoppage of clinical, preclinical, and discovery program activities and a reduction in employee headcount with lower employee-related expenses and fewer discovery, preclinical, and clinical program activities resulting from the restructuring activities that the Company announced in December 2021 and September 2022.

General and Administrative (G&A) Expense: General and administrative expenses were $12.7 million for the year ended December 31, 2023, as compared to $10.9 million for the year ended December 31, 2022. The increase in G&A expense of $1.8 million for the year ended December 31, 2023 was mostly due to certain expenses that previously had been recorded as research and development expenses, such as office facilities, legal, and payroll related costs, that no longer met the criteria to be classified as research and development expenses due to the shift in our historical business operations discontinuing all research and development activities.

Net Loss: The Company had a net loss of $16.9 million for the year ended December 31, 2023, as compared to a net loss of $2.6 million for the year ended December 31, 2022. Although operating expenses were reduced by more than 50%, there were no revenues to offset these expenses resulting in an increase in net loss of $14.3 million.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, so our ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in very near term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

On June 6, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, Interim President & CEO of Aclaris, will participate in a fireside chat during the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 11:20 AM ET in Miami, Florida (Press release, Aclaris Therapeutics, JUN 6, 2024, View Source [SID1234644181]).

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.