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.

On June 16, 2025 Pierre Fabre Laboratories reported the acquisition from Antares Therapeutics, Inc. ("Antares"), a spin-out of Scorpion Therapeutics, Inc., of the worldwide rights for PFL-721 and PFL-241 (formerly known as STX-721 and STX-241, respectively) (Press release, Pfizer, JUN 16, 2025, View Source [SID1234653932]). Under the terms of the agreement, Pierre Fabre Laboratories will expand its previous agreement with Scorpion Therapeutics to hold the global rights for both assets and will be leading the clinical development of both programs.

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PFL-721 is a mutant-specific EGFR exon 20 and HER2 exon 20 inhibitor, soon to transition to dose optimization within a first-in-human trial in NSCLC. PFL-241 is a mutant-specific, brain penetrant, 4th generation EGFR inhibitor, currently in dose escalation in a first-in-human trial, to address C797S resistance mutations in NSCLC patients.

NSCLC is the most common sub-type of lung cancer and various EGFR mutations are the most frequent drivers of NSCLC, occurring in approximately 14-38 percent of tumors, depending on geography.[1], [2], [3]

"With this agreement with Antares, Pierre Fabre Laboratories now own the global rights for all the assets within our R&D portfolio: exarafenib, PFL-002 (formerly VERT-002), PFL-721 and PFL-241. The R&D team is fully engaged and committed to progress the clinical development of these programs, aiming at providing novel and differentiated precision medicines to patient populations with significant unmet needs." said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

On June 16, 2025 AbbVie (NYSE: ABBV) reported the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed (Press release, AbbVie, JUN 16, 2025, View Source [SID1234653931]). Results from the VERONA trial will be available in a future medical congress and/or publication. Any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician.

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These data do not impact any current approved indications for venetoclax.

About the Phase 3 VERONA Trial
VERONA is a global Phase 3 randomized, controlled trial comparing the efficacy and safety of venetoclax in combination with azacitidine compared to azacitidine and placebo, in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (higher-risk MDS). The primary outcome measure is overall survival (OS). Key secondary outcome measures include modified overall response (mOR) and complete remission (CR).

More information can be found View Source

About VENCLEXTA/VENCLYXTO (venetoclax)
VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

VENCLEXTA (venetoclax) U.S. Uses and Important Safety Information 2

Uses

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ have other medical conditions that prevent the use of standard chemotherapy.

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

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.