On March 27, 2024 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2023, and provided a corporate update (Press release, Cellectar Biosciences, MAR 27, 2024, View Source [SID1234641490]).

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"2023 was a year of significant progress for Cellectar, culminating in the January announcement of the positive data from our pivotal study of iopofosine I 131 in Waldenstrom’s macroglobulinemia," said James Caruso, president, and CEO of Cellectar. "We continue to focus on the preparation of our NDA, which we plan to submit in the second half of 2024 and in parallel request accelerated approval, which if granted, would provide a six-month review period for the NDA. Our data in WM is truly impressive and we look forward to providing this meaningful new therapeutic for patients in a disease with limited treatment options."

Fourth Quarter and Recent Corporate Highlights

· Announced positive topline data achieving its primary endpoint in its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potentially first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (BTKi). CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature. The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]). The overall response rate (ORR) in evaluable patients was 75.6%, and 100% of patients experienced disease control. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months. Notably, iopofosine monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. A study data update is planned for Q2 of 2024.

· Reported a Complete Remission rate of 64% and Overall Response Rate of 73% in highly refractory patients in an Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer. In addition to the High Rate of Complete Remission Durability of clinical activity achieved a 67% Overall Survival and 42% Progression Free Survival at One Year.

· Announced that iopofosine I 131 demonstrated a pathological response with complete clonal clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patient with CNS involvement, also known as Bing-Neel Syndrome (BNS), enrolled in its Phase 2b CLOVER WaM pivotal trial.

· Enrolled the first patient in the company’s Phase 1b clinical study of iopofosine I 131 in pediatric high-grade gliomas (pHGG). The open-label study will evaluate efficacy, safety, and tolerability assessing two dosing regimens to identify the optimal recommended dose and schedule of iopofosine I 131 in pHGG patients for a Phase 2 study. The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data.

· Announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121255 (255Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound expands the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs).

· Announced strategic partnerships with leading physician-led, community-based oncology networks Florida Cancer Specialists and American Oncology Network (AON) to advance the treatment of WM in the community setting.

· Announced a new licensing agreement with the Wisconsin Alumni Research Foundation (WARF) for intellectual property that was the result of collaborative research conducted at the University of Wisconsin-Madison (UW) with iopofosine I 131 in pediatric cancers. Under terms of the agreement, Cellectar has an exclusive license to develop and commercialize iopofosine in various pediatric solid cancers, such as high-grade glioma, neuroblastoma, and sarcoma.

· Expanded the Intellectual Property protection for its PDC Platform to deliver flavaglines as targeted anticancer payloads. The company received the Notice of Allowance for the patent entitled, "Phospholipid-flavagline conjugates and methods of using the same for targeted cancer therapy," from the Japanese, Chinese, Eurasian, Brazilian, and Mexican patent authorities. These patent allowances in key global regions follow prior allowances for the same patent in the U.S., Europe, Australia, and Canada.

· Announced the Tranche A warrants issued as part of the private placement announced in September 2023 were fully exercised. All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.

2023 Financial Highlights

· Cash and Cash Equivalents: As of December 31, 2023, the company had cash and cash equivalents of $9.6 million, compared to $19.9 million as of December 31, 2022. The decrease in cash was primarily a result of research and development expenses, and general and administrative expenses. Net cash used in operating activities during the twelve months ended December 31, 2023, was approximately $32.4 million. Net cash proceeds from the issuance of common stock, preferred stock, and warrants during 2023 was approximately $22.9 million. We believe our cash balance as of December 31, 2023, in combination with the funds generated by the warrants exercised by investors in January 2024 is adequate to fund our basic budgeted operations into the fourth quarter of 2024.

· Research and Development Expense: R&D expense for the year ended December 31, 2023, was approximately $28.2 million, compared to approximately $19.2 million for the year ended December 31, 2022. The overall increase in R&D expense was primarily a result of an increase in manufacturing and related costs related to greater production sourcing necessary to support clinical trials and establish commercial production capabilities.

· General and Administrative Expense: G&A expense for the year ended December 31, 2023, was $10.7 million, compared to $9.6 million for the year ended December 31, 2022. The increase in G&A costs was primarily a result of an increase in personnel costs partially offset by a reduction in professional fees.

· Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2023, was ($38.0) million, or $(3.11) per share, compared to $(28.6) million, or ($4.05) per share in the year ended December 31, 2022.

Conference call & Webcast Details

Cellectar management will host a conference call for investors today, March 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (in the U.S.) or 1-416-764-8658 (outside the U.S.). The call will be available via webcast by clicking HERE or on the Events page of the company’s website.

On March 27, 2024 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the fourth quarter and full year ended December 31, 2023 and other recent business developments (Press release, Celcuity, MAR 27, 2024, View Source [SID1234641489]).

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"In 2023, we made significant progress advancing development of gedatolisib while strengthening our balance sheet and adding to our leadership team," said Brian Sullivan, CEO and Co-Founder of Celcuity. "Our Phase 3 VIKTORIA-1 trial remains on track to report topline data from the PI3KCA wild type patient sub-group in the second half of this year. We were also excited to begin development of gedatolisib for patients with metastatic castration resistant prostate cancer this past year. Enrollment has begun in our Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide, and we look forward to sharing preliminary data from this trial in the first half of 2025."

Fourth Quarter 2023 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial remains on track to provide topline data for the PIK3CA wild type patient sub-group in the second half of 2024 and for the PIK3CA mutant patient sub-group in the first half of 2025.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor.
○ The Phase 3 VIKTORIA-1 clinical trial is enrolling patients at approximately 220 sites in 23 countries in North and South America, Europe, and Asia.

● The Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration resistant prostate cancer (mCRPC) was initiated in the fourth quarter of 2023. In February 2024, the first patient was dosed.

○ The trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.

● In December 2023, Celcuity presented data from nonclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS). In a panel of breast cancer cell lines, gedatolisib was found to be more cytotoxic and at least 300-fold more potent, on average, compared to the single node PAM inhibitors.

● In February 2024, Eldon Mayer was appointed Chief Commercial Officer. His 30 years of biopharmaceutical commercial experience includes senior leadership roles at several companies where he led the launch of their first drug.

Fourth Quarter and Full Year 2023 Financial Results

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2023, compared to the fourth quarter and full year ended December 31, 2022.

Total operating expenses were $19.7 million for the fourth quarter of 2023, compared to $11.6 million for the fourth quarter of 2022. Operating expenses for the full year 2023 were $66.2 million, compared to $39.4 million for the full year 2022.

Research and development (R&D) expenses were $18.1 million for the fourth quarter of 2023, compared to $10.6 million for the prior-year period. Of the approximately $7.5 million increase in R&D expenses, $6.8 million primarily related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial, and $0.7 million was related to increased employee and consulting expenses.

R&D expenses for the full year 2023 were $60.6 million, compared to $35.3 million for the prior year. Of the approximately $25.3 million increase in R&D expenses, $22.9 million was related to activities supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial. The remaining $2.4 million increase in R&D expenses was related to increased employee and consulting expenses.

General and administrative (G&A) expenses were $1.6 million for the fourth quarter of 2023, compared to $1.0 million for the prior-year period. Employee-related expenses accounted for $0.5 million of the increase. The remaining increase resulted from professional fees and other expenses associated with compliance related activities that support financing and clinical operations.

G&A expenses for the full year 2023 were $5.6 million, compared to $4.1 million for the prior year. Of the approximately $1.5 million increase in G&A expenses, $1.1 million was related to increased employee-related expenses, and $0.4 million was related to professional fees and other expenses associated with compliance related activities that support financing and clinical operations.

Net loss for the fourth quarter of 2023 was $18.8 million, or $0.65 loss per share, compared to a net loss of $11.6 million, or $0.69 loss per share, for the fourth quarter of 2022. Net loss for the full year 2023 was $63.8 million, or $2.69 loss per share, compared to a net loss of $40.4 million, or $2.64 loss per share, in 2022. Non-GAAP adjusted net loss for the fourth quarter of 2023 was $17.6 million, or $0.61 loss per share, compared to non-GAAP adjusted net loss of $10.3 million, or $0.61 loss per share, for the fourth quarter of 2022. Non-GAAP adjusted net loss for the full year 2023 was $57.8 million, or $2.44 loss per share, compared to non-GAAP adjusted net loss of $35.0 million, or $2.27 loss per share, for 2022. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the fourth quarter of 2023 was $18.5 million, compared to $9.5 million for the fourth quarter of 2022. Net cash used in operating activities for the full year 2023 was $53.8 million, compared to $36.0 million for the full year 2022.

In October of 2023, Celcuity closed a private placement of equity that resulted in gross proceeds of approximately $50 million. In December 2023, Celcuity closed on an additional $15 million of gross proceeds through its at-the-market offering. The Company expects to use the net proceeds to advance the clinical development of gedatolisib and for general corporate purposes.

At December 31, 2023, Celcuity reported cash, cash equivalents and short-term investments of $180.6 million. We expect cash, cash equivalents, investments and available funds under our debt facility to provide adequate capital to fund current operational activities into the first half of 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the fourth quarter and full year 2023 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-888-886-7786 or 1-416-764-8658. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=04c7a07803. A replay of the webcast will be available on the Celcuity website following the live event.

On March 27, 2024 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights (Press release, Aura Biosciences, MAR 27, 2024, View Source [SID1234641485]).

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"We’re excited to expand bel-sar into bladder cancer, as we leverage our therapy‘s unique mechanism of action in additional solid cancer indications with major unmet medical need," said Elisabet de los Pinos, Ph.D., CEO of Aura Biosciences. "Bel-sar is a potential vision-and-organ sparing therapy that we believe will change the standard of care in ocular oncology, in particular choroidal melanoma, where there are no treatment options except radiotherapy which leads to vision loss, or surgical removal of the eye. There is an urgent need to develop vision-sparing therapies, as all eye cancers represent an estimated 60,000 patients annually in the US and EU. This is a multi-billion dollar market, which includes choroidal melanoma, choroidal metastases, and ocular surface cancers. Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to expand bel-sar into additional indications, starting with bladder cancer."

Recent Pipeline Developments

Global Phase 3 CoMpass trial actively enrolling patients for the treatment of small choroidal melanoma (CM) and indeterminate lesions (ILs).

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The trial is a superiority trial comparing treatment with bel-sar versus a sham control arm. The trial is a global Phase 3, randomized, multi-center, masked study, and is intended to enroll approximately 100 patients randomized 2:1:2 to receive three cycles of treatment with either high or low doses of bel-sar, or a sham control.

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The Company received written agreement from the U.S. Food and Drug Administration (FDA) under an SPA for the overall design, statistical analysis plan and clinical endpoints. The primary endpoint is time to tumor progression when the last patient completes 15 months of follow up.

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The trial is actively enrolling in the U.S. with a strong endorsement from the ocular oncology community. The Company is on track to activate sites and enroll patients globally throughout 2024.

Positive Phase 2 data evaluating SC administration of bel-sar for patients with small CM and ILs was presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting.

Results:

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Patients who received the therapeutic regimen with three cycles of therapy showed a tumor control rate of 80% (8/10) and a visual acuity preservation rate of 90% (9/10), with most of the patients (>90%) being at 12 months of follow up. Final study results with all patients at 12 months will be presented by year end 2024.

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The overall tolerability profile of bel-sar was favorable, with no dose-limiting toxicities, treatment-related serious adverse events (SAEs) or significant adverse events (AEs) reported as of August 3, 2023. There was no posterior segment inflammation and only mild anterior inflammation (Grade 1) in approximately 18% of the patients which was self-limited or resolved with a short course of topical steroids. Treatment-related AEs were predominantly mild and resolved without sequelae.

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These patients match the criteria for enrollment in the ongoing Phase 3 trial which is highly powered based on the Phase 2 results.

Bel-sar is being evaluated in additional ocular oncology indications with a collective incidence of approximately 60,000 patients/year in the US/EU per year. The Company’s plan is to initiate clinical development in choroidal metastasis (Cmets), an indication with a high unmet medical need where bel-sar has the potential to be the first approved therapy that is vision and organ sparing. Cmets is the second potential ocular oncology indication for bel-sar affecting over 20,000 patients in the US/EU annually. The Company is on track to initiate a Phase 2 trial in 2024.

The Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) is currently ongoing, and the Company expects to report data in mid-2024. This represents an area of high unmet need with approximately 80,000 patients diagnosed in the U.S. every year where we have the possibility to selectively treat and induce a tissue and tumor specific immune response to prevent progression and recurrence of the disease. The Company received Fast Track Designation from the Oncology Division of the FDA for NMIBC in June 2022.

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The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 21 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The trial will provide histopathological evaluation after the local treatment to assess bel-sar’s biological activity which will include the evaluation of focal necrosis and immune activation.

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The trial has completed enrollment of the cohort that received bel-sar injection without light activation. Protocol mandated safety review found no safety issues and the study has proceeded to the bel-sar injection plus light activation cohorts.

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Preliminary data from the first patient in the light activated cohort of the trial, demonstrated a clinical complete response demonstrated by absence of cancer cells on histopathology with evidence of extensive necrosis and immune activation after a single administration of bel-sar followed by light activation.

Recent Corporate Events

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Raised Gross Proceeds of $99.0 million in an underwritten public offering. In November 2023, the Company announced the pricing of an underwritten public offering of 11,000,000 shares of its common stock at a price to the public of $9.00 per share. The offering closed on November 9, 2023.

Full Year and Fourth Quarter 2023 Financial Results

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As of December 31, 2023, Aura had cash and cash equivalents and marketable securities totaling $226.2 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2026.

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Research and development expenses increased to $20.3 million and $65.2 million for the three months and full year ended December 31, 2023, respectively, from $13.2 million and $42.2 million for the three months and full year ended December 31, 2022, respectively, primarily due to ongoing clinical costs associated with the progression of the Phase 2 study and contract research organization costs associated with the start of the Phase 3 global trial, and manufacturing and development costs for bel-sar.

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General and administrative expenses increased to $4.5 million and $19.8 million for the three months and full year ended December 31, 2023, respectively, from $4.5 million and $18.1 million for the three months and full year ended December 31, 2022, respectively. General and administrative expenses include $1.2 million and $1.1 million of stock-based compensation for the three months ended December 31, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in travel expenses related to growth of the Company.

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Net loss for the three months and full year ended December 31, 2023, was $22.1 million and $76.4 million, respectively, compared to $16.6 million and $58.8 million for the three months and full year ended December 31, 2022, respectively.

On March 26, 2024 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been dosed in Australia in the clinical study (JSKN033-101) of JSKN033, a subcutaneous formulation with HER2 bispecific antibody-conjugated drug and PD-L1 monoclonal antibody, for the treatment of HER2-expressing, advanced or metastatic solid tumors.

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Previous clinical studies have shown that combining antibody-drug conjugates (ADCs) with immunotherapy can enhance treatment efficacy and substantially prolong overall survival. However, this combination approach often leads to prolonged infusion and hospitalization durations, along with increased adverse events. The safety concern will be further exacerbated when chemotherapy regimens are included in the combo regimen. These factors can significantly impact patient medication compliance.

JSKN033, developed on top of the superior solubility and stability of Envaforlimab, is anticipated to offer a novel and effective treatment option for patients and healthcare providers by combining immune-oncology (IO) and ADC therapies. Notably, the nature of subcutaneous injectable will lead to improved safety and convenience. This innovative approach aims to mitigate the challenges associated with IV infusion, thereby enhancing patient adherence and treatment outcomes.

JSKN033-101 is an open-label, muti-center, phase I/II clinical study. The study consists of dose escalation and dose expansion phases: the Phase I dose escalation stage aims to assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JSKN033 in patients with advanced or metastatic HER2-expressing solid tumors, determining the maximum tolerated dose (MTD) and/or Phase II recommended dose (RP2D); the Phase II dose expansion stage will evaluate the efficacy and safety of JSKN033 in HER2-expressing gastrointestinal tumors at the RP2D dose.

About JSKN033

JSKN033 is the global first subcutaneous fixed-dose combination (FDC) independently developed by Alphamab Oncology, consisting of JSKN003 and envafolimab. JSKN003 is a HER2 dual-epitope-targeting glycan-specific antibody-drug conjugate (ADC), comprising of three components: a bispecific antibody targeting two non-overlapping epitopes of HER2 extracellular domains, a cleavable linker, and a topoisomerase I inhibitor. Envafolimab is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment, which has been approved by the National Medical Products Administration of China (the "NMPA") as the global-first subcutaneous injection PD-(L)1 inhibitor in November 2021.

(Press release, Alphamab, MAR 26, 2024, View Source [SID1234657014])

On March 26, 2024 BioDuro-Sundia’s partner, DigmBio, a South Korean biotechnology company, reported its selective PARP1 inhibitor for the treatment of triple-negative breast cancer has been approved by Korea Food and Drug Administration (MFDS) for Investigational New Drug (IND) application (Press release, DigmBio, MAR 26, 2024, View Source [SID1234654545]).

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Founded in April 2020, DigmBio is a pioneering biotech company discovering and developing novel therapies to treat oncology, neurodegeneration, and fibrosis. The lead program DM5167 is the 2nd generation PARP1 selective inhibitor. According to preclinical study results, DM5167, a novel selective PARP1 inhibitor, exhibits superior in vivo safety, particularly in terms of hematotoxicity and demonstrates enhanced selectivity in enzyme assays, and possesses a more efficient DNA trapping capability. Notably, DM5167 showcases excellent brain permeability, rendering it suitable for treating brain metastasis and brain cancer. DigmBio CEO Kim Jung-min stated, "We are pleased to receive official approval from the Food and Drug Safety Department without the need for any special supplements to the clinical drug. Due to its demonstrated excellent anti-tumor efficacy in various animal models, we anticipate positive safety and effectiveness outcomes in phase 1 clinical trials compared to existing drugs."

As a global trusted Contract Research, Development and Manufacturing Organization (CRDMO) BioDuro-Sundia’s integrated Chemistry, Manufacturing, and Controls (CMC) departments facilitated one-stop IND-Enabling services for DigmBio, encompassing process development, formulation, analysis, GMP production, and IND application document preparation. Its effective communication among departments facilitated rapid approval by the Korean MFDS. Dr. Jung-Ho Kim, Chief Strategy Officer of DigmBio said, "We are grateful to the BioDuro-Sundia team for their responsive and timely work on the DM5176 project, which accelerated our project’s approval process."

"As a global partner of DigmBio, we sincerely congratulate the approval of the DM5167 project for the Korean IND," said Dr. Jim Li, Global CMC President of Asia Pacific at BioDuro-Sundia. "BioDuro-Sundia is committed to offering comprehensive new drug R&D solutions with high quality and efficiency. We are honored to collaborate with DigmBio and anticipate their differentiated drugs with unique advantages to benefit the patient at earliest."

BioDuro-Sundia is committed to providing a comprehensive, one-stop new drug R&D service platform and professional technical support to global biopharmaceutical companies. The integrated CMC department delivers integrated services from the IND to the New Drug Application (NDA) stage, encompassing Active Pharmaceutical Ingredient (API) development, formulation development, analysis support, Drug Metabolism and Pharmacokinetics (DMPK), pharmacology, toxicology, project management, and IND application support. Additionally, a robust Environmental, Health, and Safety (EHS) policy and Intellectual Property protection system establish a reliable foundation for collaboration. With team members boasting extensive experience in new drug R&D and registration applications, coupled with proficiency in regulations and policies across multiple regions, including China, US, EU, Japan, South Korea, and Australia, BioDuro-Sundia is equipped with a professional project management system and a rigorous quality management system. Looking forward, BioDuro-Sundia will continue to invest in our CMC capabilities to support partners’ new drug development programs with leading technical services.