On June 16, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported remarkable clinical observations for a patient in Lantern’s Phase 2 HARMONIC clinical trial (Press release, Lantern Pharma, JUN 16, 2025, View Source [SID1234653937]). A 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) has achieved a durable complete response in their target cancer lesions following treatment with LP-300 in combination with standard-of-care chemotherapy. Importantly, the patient continues to show sustained survival benefits after nearly two years.

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The patient, who had previously failed three lines of prior therapy including Keytruda (pembrolizumab) with chemotherapy, radiation therapy, and the EGFR inhibitor Tagrisso (osimertinib), initially demonstrated a partial response with a 57% reduction in tumor volume after completion of the HARMONIC lead-in cohort enrollment in Q3 of 2024. The patient subsequently demonstrated a complete response in the target cancer lesions, specifically the lung and adrenal gland lesions by Q1 of 2025. This type of complete response in the target cancer lesions is atypical for this advanced and recurrent NSCLC after multiple rounds of therapy.

"This remarkable case exemplifies several of the things we have hoped to observe with LP-300 in the HARMONIC trial," said Panna Sharma, President and CEO of Lantern Pharma. "To see a heavily pre-treated patient not only achieve a complete response in their target cancer lesions but maintain that response with excellent quality of life is truly extraordinary. This outcome provides important confirmation of our data and AI-driven approach to drug development and gives us growing confidence as we advance toward potential future registration-enabling studies for this underserved patient population that has no approved treatment options after failing targeted kinase therapies."

Notably, the patient has shown no clinically significant adverse drug reactions or dose-limiting toxicities (DLTs) over 21 cycles of treatment. By February 2025, imaging showed continued complete response in the primary target lesions with only scar tissue remaining at the site of the lung cancer lesions, and the disappearance of the adrenal gland cancer lesion, demonstrating the profound and durable nature of the therapeutic response.

Growing Global Cancer Type with No Approved Options After Kinase Therapy Failure
The proportion of never-smoking patients with non-small cell lung cancer (NSCLC) has been significantly increasing globally over the past 30 years, from 15% in the 1970s to 33% in the 2000s. Lung cancer in never smokers is the fifth leading cause of cancer-related deaths globally, according to the International Agency for Research on Cancer (IARC). Never-smokers represent a distinct subset of lung cancer patients1 with unique genetic profiles and limited treatment options, estimated to represent a $4+ billion annual market opportunity globally. The HARMONIC trial is evaluating LP-300, advanced with Lantern’s proprietary RADR AI platform, in combination with pemetrexed and carboplatin in never-smokers with advanced NSCLC who have progressed after treatment with tyrosine kinase inhibitors (TKIs).

Exceptional Clinical Observations in a Challenging Patient Population With Significant Unmet Needs
This case represents a particularly significant observation given the patient’s extensive treatment history, including with both immuno-oncology agents and targeted kinase therapies, and the challenging nature of advanced NSCLC in non-responsive never-smokers. The sustained response over nearly two years, combined with excellent tolerability, underscore LP-300’s potential to be a transformative treatment option for this underserved patient population and is demonstrative of the mechanistic rationale for this drug-candidate.

"The sustained response we’re observing in this patient, particularly after three lines of prior standard of care treatments, is remarkable and provides strong support for LP-300’s therapeutic potential," said Dr. Reggie Ewesuedo, Vice President of Clinical Development at Lantern Pharma. "The fact that this patient has tolerated 21 cycles of treatment without clinically significant adverse drug reactions and has achieved meaningful durable response reinforces our confidence in the promise of this drug-candidate in this patient population."

About Lantern Pharma’s HARMONIC Trial
The HARMONIC clinical trial is a Phase 2 study (NCT05456256) evaluating LP-300 in combination with standard chemotherapy (pemetrexed/carboplatin) for never-smokers with advanced lung adenocarcinoma who have experienced progression or intolerance to prior tyrosine kinase inhibitor (TKI) therapy. The trial is designed to assess whether LP-300, when added to chemotherapy, improves progression-free survival (PFS) and overall survival (OS) compared to the current standard-of-care chemotherapy doublet alone.

The multicenter, open-label, randomized study has planned enrollment of approximately 90 patients across sites in the United States, Japan, and Taiwan. The trial compares LP-300 in combination with standard-of-care chemotherapy versus chemotherapy alone in a 2:1 randomization, with co-primary endpoints of progression-free survival (PFS) and overall survival (OS).

Upcoming Milestones and Clinical Development
Lantern expects to continue reporting clinical updates from the HARMONIC trial throughout 2025 as enrollment progresses across multiple sites. The company anticipates providing an additional data update from the randomized expansion phase in the second half of 2025.

The never-smoker NSCLC population represents a significant and growing unmet medical need, with no therapies specifically approved for this patient subset. Approximately 15-20% of all lung cancer patients in the U.S. are never-smokers, with significantly higher rates in Asian populations, where up to 50% of new lung cancer diagnoses occur in never-smokers.

About LP-300
LP-300 was advanced with Lantern’s proprietary RADR AI platform to aid in the confirmation of combination synergies and the proposed mechanism of action. The lead-in cohort of the Phase 2 HARMONIC trial demonstrated an initial 86% clinical benefit rate and 43% objective response rate, leading to the current randomized expansion phase.

On June 16, 2025 Imbrium Therapeutics L.P. ("Imbrium"), a clinical-stage biopharmaceutical company, reported pipeline developments at the BIO International Convention on Wednesday, June 18, at 9:15 a.m. in Room 153B (Press release, Imbrium Therapeutics, JUN 16, 2025, View Source [SID1234653936]). Imbrium is actively seeking partnerships to advance the development of investigational therapeutics for multiple indications across several disease areas including genitourinary disorders, substance use disorders, and cancerous malignancies.

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Imbrium is discussing two investigational agents, sunobinop and tinostamustine, both of which could present substantial revenue opportunities*.

Sunobinop is a novel, first-in-class, nociceptin receptor partial agonist. The orally active investigational drug is in Phase 1b/2a clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop’s pharmacological properties offer a unique approach under investigation for alcohol craving, consumption and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop has been shown in early studies to target the sensory nerves in the bladder to affect urination, pain, and nocturia. Global or regional rights are available for partnership.

Tinostamustine is a novel, first-in-class, investigational drug combining DNA alkylating activity and histone deacetylase inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine was shown to improve survival in difficult-to-treat newly diagnosed patients and is on track for accelerated development. It has the potential to be the first new chemotherapeutic to treat GBM in more than 20 years. Tinostamustine has also shown promise in early clinical studies in other solid and hematological tumors. U.S. rights are available for partnership.

"We are committed to securing partnerships that further advance promising novel therapies," said David Saussy, Head of Licensing & Business Development. "We look forward to presenting these pipeline highlights at BIO and moving our research programs forward to help address unmet patient needs."

Tinostamustine and all proposed indications for sunobinop are open to partnering. For more information, e-mail [email protected]. For more information about our pipeline, click here.

*This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that sunobinop or tinostamustine will successfully complete development or gain FDA approval.

On June 16, 2025 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported the appointment of Enda Moran, PhD, MBA as Chief Operating Officer (COO) (Press release, Solu Therapeutics, JUN 16, 2025, View Source [SID1234653935]).

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"As we advance our Phase 1 clinical trial of STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies, Enda brings outstanding experience in large-scale biomanufacturing and company operations to our leadership team," said Philip J. Vickers, President and CEO of Solu Therapeutics. "His expertise in scaling biologic therapeutics and guiding early-stage programs through development will be instrumental as we grow and work to deliver transformative therapies for patients living with cancer, immunological diseases and other serious illnesses."

As COO, Dr. Moran will lead core operational functions at Solu including chemistry manufacturing and controls (CMC), quality, program management, IT, and facilities management. He will also play a key role in building the infrastructure needed to support Solu’s CyTAC (Cytotoxicity Targeting Chimera) and TicTAC (Therapeutic Index Control Targeting Chimera) platforms as the company progresses toward multiple clinical and regulatory milestones.

"I am very excited to join the Solu Therapeutics team at this pivotal moment as the company moves into a new phase of growth," said Dr. Moran. "The CyTAC and TicTAC platforms are rooted in strong science and have the potential to change the landscape for patients who are desperately in need of new treatment options. I look forward to applying my experience to maximize the potential of these platforms and bring a new generation of innovative therapies to the patients who need them most."

Dr. Moran has over three decades of experience leading biomanufacturing and technical development across pharma and biotech. He previously held senior scientific roles at GSK and Wyeth before joining Pfizer as Senior Director of Biomanufacturing, where he led global teams supporting the development and production of successful commercial therapies including Enbrel, Trumenba, Xyntha, and the Prevnar13 vaccine. He later joined Northern Biologics as Vice President and Head of CMC and Manufacturing, where he was instrumental in advancing multiple development programs and enabling the strategic acquisition of assets by AstraZeneca and Boehringer Ingelheim. Most recently, he served as CEO of Matrivax, leading a successful corporate restructuring and completion of a Phase 1 clinical trial.

On June 16, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of ZYNLONTA to treat relapsed/refractory marginal zone lymphoma (r/r MZL) will be presented during a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20 (Press release, ADC Therapeutics, JUN 16, 2025, View Source [SID1234653934]). These data will be made available online beginning on Wednesday, June 18, at 8:30 a.m. CEST. The single-arm, open-label, study is led by Izidore S. Lossos, MD, Chief, Division of Hematology Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine.

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"These updated results further support the potential of ZYNLONTA as an effective single-agent treatment for patients with r/r MZL, including high-risk POD24 patients," said Lossos, the study’s principal investigator. "Importantly, the treatment was generally well tolerated, with manageable safety consistent with the known profile."

As of February 10, 2025, a total of 27 adult patients with r/r MZL and previously treated with ≥1 line of systemic therapy were enrolled with 26 patients evaluable for response. Highlights of the data include:

Overall response rate (ORR) of 84.6% (22/26); complete response (CR) rate of 69.2% (18/26)
Among POD24 patients assessed for response, a CR rate of 61.5% (8/13) was observed
CR was maintained in 17 of 18 CR patients who achieved CR, with longest duration of CR of 27 months from start of treatment
Progression-free survival (PFS) was 92.9% at 12 months
27 enrolled patients experienced adverse events (AE), consistent with the known safety profile of ZYNLONTA and most commonly grade 1 or 2. Grade 3 and 4 AEs were observed in 16 and 2 patients, respectively and included neutropenia, RSV lung infection and hyponatremia (with 2 AEs occurring in the same patient). Three patients needed dose reduction and one patient discontinued treatment after cycle 4 due to cholestatic hepatitis that fully recovered.
The study is being conducted at Sylvester Comprehensive Cancer Center and at City of Hope, and recently expanded to Emory Winship Cancer Institute and Vanderbilt-Ingram Cancer Center to accelerate enrollment to 50 patients with r/r MZL. More details on this ongoing Phase 2 clinical trial can be found at View Source (identifier: NCT05296070).

"Based on the updated Phase 2 IIT data to be shared at ICML, we are encouraged by the potential opportunity in r/r MZL and look forward to seeing additional data, as the trial expands to other sites." said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "As this trial progresses, assuming the results continue to be positive, we plan to potentially pursue a regulatory pathway and compendia in parallel as soon as sufficient data are available."

In addition to the MZL poster presentation at ICML, an oral encore presentation of the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) will also be presented at ICML Friday, June 20 at 3:00 p.m. CEST.

About ZYNLONTA

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On June 16, 2025 BioDlink reported that its self-developed Bevacizumab Injection (Pusintin) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria (Press release, Tot Biopharm, JUN 16, 2025, View Source [SID1234653933]). This significant milestone accelerates BioDlink’s global expansion efforts, and reaffirms its R&D and commercialization strength in biosimilar—offering a high-value, accessible treatment option for cancer patients worldwide.

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Leveraging synergies with Kexing BioPharm, the global licensee for Pusintin in emerging markets, Pusintin has initiated regulatory filings in 35 countries. The approval in Nigeria not only marks the implementation of its global strategy but also signifies officially opening the door to the African market, bringing more affordable treatment alternatives to Nigerian patients.

ADDRESSING AFRICA’S GROWING HEALTHCARE NEEDS

Africa, with a population exceeding 1.5 billion (World Bank, 2024), faces increasing medical demand. Nigeria, as the "most populous country in Africa" (~220 million people), possesses both massive healthcare challenge and a major growth opportunity. According to the World Health Organization (WHO), Nigeria reports over 120,000 new cancer cases annually, growing at a rate of 5% per year—amid limited access to high-quality therapies. Pusintin’s approval meets this urgent medical need while serves as a model for expansion into other emerging-market.

INTERNATIONALLY RECOGNIZED MANUFACTURING & QUALITY EXCELLENCE

The approval has validated Pusintin’s compliance complies with international standards for R&D, manufacturing, and quality system. BioDlink’s production facilities have already passed GMP inspections in China, Japan, Brazil, Colombia, Egypt, Indonesia, and Argentina and also passed antibody drug and ADC EU QP inspection 4 times in past two years. BioDlink’s global-quality system ensures robust commercial supply, delivering more than 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including European and the U.S. in the past 3 years.

This millstone marks the beginning of BioDlink’s international commercial rollout, injecting new momentum into its revenue diversification strategy and reinforcing its capabilities in global biosimilar commercialization.

BioDlink operates a large-scale, GMP-compliant biologics manufacturing facility, featuring four commercial lines with five drug substance production centers (including non-toxic conjugated drug substance units) and four drug production centers. Its world-class facilities and stringent quality system deliver reliable global supply for monoclonal antibodies (mAbs), bispecific antibodies, XDCs, and other biologics at global standards.

SUSTAINING GLOBAL MOMENTUM

BioDlink will continue collaborating with Kexing BioPharm to accelerate Pusintin’s approval in Southeast Asia and Latin America. Driven by a committed to innovation, quality, and global compliance, BioDlink will continue accelerating its expansion in overseas and emerging markets—bringing life-changing therapies to more patients worldwide.