On July 29, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, reported its engagement with ICON Clinical Research Limited ("ICON") to expand it’s Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) (Press release, Hoth Therapeutics, JUL 29, 2025, View Source [SID1234654617]).

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Additional regulatory approval for the Phase II clinical trial is expected from potentially three EU countries in the upcoming months. The EU approval is part of the Company’s international clinical development strategy for HT-001. The trial is currently enrolling patients in multiple sites in the United States. This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at www.hoththerapeutics.com.

"We are delighted with the addition of clinical sites in the EU and for a strong partnership with ICON. ICON was selected based on their previous clinical trial management experience and their interest in novel therapies," said Robb Knie, CEO of Hoth Therapeutics. "Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial."

On July 29, 2025 ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of alpha radioligand therapies (ARTs) to treat a range of cancers, reported the closing of a $132 million Series B financing co-led by new investors Sofinnova Investments and B Capital along with a life sciences dedicated investment fund that invested previously (Press release, ARTBIO, JUL 29, 2025, View Source [SID1234654616]). Further support came from existing investors F-Prime, Omega Funds, and Third Rock Ventures, and new investors Qatar Investment Authority and Alexandria Venture Investments. These proceeds will be used to advance the company’s development of ARTs.

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"This sizable investment from both existing and new investors will enable ARTBIO to continue innovating therapies that treat a range of deadly cancers with power and precision," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "Our team is grateful for the investment and recognition of the need to build a supply chain that matches the properties of the therapies and the unique payload that we use."

This latest round of funding will support the advancement of ARTBIO’s pipeline, including its lead program, AB001, for metastatic castration-resistant prostate cancer, through Phase II clinical trials, and enable continued expansion of the company’s supply chain. The company plans to rapidly advance its manufacturing network infrastructure to supply global clinical trials, and ultimately, commercialization.

"ARTBIO’s approach to ART has the potential to positively change standards of care in cancer," said Robert Mittendorff, M.D., General Partner at B Capital. "ARTBIO’s lead asset, AB001, is designed to fully harness the unique power of lead-212. My team and I are excited for what’s to come."

A critical enabler of ARTBIO’s success is its patented AlphaDirect isotope isolation technology, which enables flexible production of clinical-grade lead-212 (212Pb) and therapeutic doses daily. This is achieved by a strategically distributed manufacturing network, improving access and de-risking common supply chain issues.

"With a differentiated ART portfolio and integrated manufacturing approach, ARTBIO represents the ideal company that we look to partner with," said Maha Katabi, Ph.D., General Partner at Sofinnova Investments. "Equally impressive is their proprietary generator technology which is a game-changer for navigating around supply and production challenges for radioisotopes in today’s complex environment."

On July 29, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO) and CellVax Therapeutics Inc., a privately held clinical-stage biotechnology company focused on individualized cell-based immunotherapies, reported a partnership expansion upon prior work on FK-PC101 – currently in a Phase II clinical trial for high-risk prostate cancer patients – and will include cGMP manufacturing, drug substance and drug product technology transfer, and GMP facility preparation in support of FK-GI101, an autologous cell-based immunotherapy targeting gastric, pancreatic, and colon cancer and the current FK-PC101 trial (Press release, CellVax Therapeutics, JUL 29, 2025, View Source [SID1234654615]).

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FK-GI101 is based on CellVax’s proprietary platform that utilizes a patient’s own tumor cells harvested during surgery. These cells are modified in the lab to express MHC Class II molecules, enhancing visibility to the immune system. The cells are then irradiated to render replication-incompetent before being administered back to the patient to activate a personalized immune response against residual or recurring tumor cells.

"We’re proud to deepen our collaboration with CellVax as they bring their pioneering platform into new and challenging indications," said Darren Head, CEO of Cellipont Bioservices. "FK-GI101 represents a bold, patient-specific approach to immunotherapy in gastrointestinal cancers—areas with urgent unmet medical needs. At Cellipont, we are committed to providing the robust manufacturing infrastructure and expertise required to move such transformative therapies closer to patients."

"Expanding our partnership with Cellipont is a critical step in scaling our personalized immunotherapy platform. Their operational excellence and shared commitment to innovation make them the ideal partner as we advance FK-GI101 into the clinic. With their support, we are accelerating our efforts to deliver targeted, patient-derived treatments to those facing some of the most difficult-to-treat cancers," said Fernando Kreutz, Chief Executive Officer at CellVax Therapeutics.

On July 29, 2025 Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, reported positive written feedback from the U.S. Food and Drug Administration (FDA) regarding the company’s proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (Press release, Atossa Therapeutics, JUL 29, 2025, View Source;metastatic-breast-cancer-302516013.html [SID1234654614]).

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The FDA has provided highly constructive responses ahead of the scheduled pre-Investigational New Drug (IND) meeting, affirming key elements of Atossa’s clinical development plan, negating the need for a virtual meeting, and paving the way for a potential IND submission targeted for the fourth quarter of 2025.

"These FDA responses mark a significant milestone for the Company and are supportive of our comprehensive approach to developing (Z)-endoxifen for metastatic breast cancer," stated Dr. Steven Quay, Atossa’s Chief Executive Officer and Chairman of the Board. "The detailed feedback received significantly advances our goal of submitting an IND by year-end. Importantly, the FDA’s support of our dose optimization strategy and general agreement with our nonclinical data package leave us confident in our scientific rationale and overall regulatory approach."

Key Highlights:

Dose Optimization Strategy Affirmed: FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the proposed dose optimization study and provided clear guidance on randomization cohort sizes and study design enhancements.

Combination Study Support: The Agency agreed with the scientific rationale for combining (Z)-endoxifen with approved breast cancer standard-of-care therapies, such as some CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine. While not all combinations will be investigated in this study, FDA guidance on the matter is helpful in narrowing the strategic approach for the potential IND.

Nonclinical Data Package Deemed Adequate: FDA indicated the existing nonclinical safety data package is adequate to proceed without additional general toxicity or neurotoxicity studies.

Agreement on Cardiac Safety Assessments for Monotherapy: FDA confirmed Atossa’s cardiac safety assessment plan, including serial electrocardiograms (ECGs) and QT interval monitoring, is sufficient for the monotherapy portion of the trial.

Next steps: In the coming weeks, Atossa will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study. The Agency acknowledged the Company’s plan to file an IND in 2025 and encouraged Atossa to incorporate specific safety and eligibility refinements in the final protocol, which the Company has accepted.
Dr. Quay continued, "With the FDA’s feedback now in hand, Atossa is energized and moving quickly. We believe the company is well positioned to maintain strategic momentum and meet regulatory milestones, bringing us closer to delivering (Z)-endoxifen to patients in need and driving shareholder value. Further updates will be provided as the trial design is finalized, and next steps are implemented."

Atossa’s progress reflects the strong strategic momentum promised in the March 11, 2025 announcement of a metastatic focus; momentum that aligns well with FDA expectations and regulatory standards, including fulfilling Project Optimus requirements, a crucial next step in advancing (Z)-endoxifen toward potential approval.

The FDA’s Project Optimus initiative emphasizes data-driven dose exploration to maximize benefit and minimize toxicity. In line with this guidance, Atossa will explore multiple dose levels in its upcoming clinical study to define the optimal dose for combination therapy, while seeking to maintain a balance between efficacy and patient safety.

About (Z)-Endoxifen

(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. This innovation ensures optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In over 700 subjects (healthy volunteers and breast cancer patients), doses up to 360 mg/day have been administered with no maximum tolerated dose (MTD) identified, supporting continued dose-ranging exploration.

Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.

On July 29, 2025 AbbVie (NYSE: ABBV) reported the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA (venetoclax) and acalabrutinib in previously untreated patients with CLL, offering CLL patients another VENCLEXTA combination regimen with the potential for time-limited treatment (Press release, AbbVie, JUL 29, 2025, View Source [SID1234654613]).

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The submission is based on the positive results from the Phase 3 AMPLIFY trial.1 The combination regimen of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.2

"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.

About the AMPLIFY Study
AMPLIFY is an AstraZeneca-sponsored, global, multi-center Phase 3 trial evaluating VENCLEXTA plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.1

Data presented at the 2024 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed that the fixed-duration combination regimen of VENCLEXTA and acalabrutinib reduced the risk of disease progression or death by 35% vs chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004). The safety profile of the VENCLEXTA and acalabrutinib combination regimen is consistent with the known safety profile of each individual therapy alone. The most common adverse events in any grade were neutropenia, hemorrhage, and COVID-19 in patients administered VENCLEXTA plus acalabrutinib. The most frequent Grade 3 or higher adverse event was neutropenia seen in 26.8% of patients. Among events of clinical interest, low rates of tumor lysis syndrome were observed with events of any grade seen in 0.3% of patients treated with VENCLEXTA plus acalabrutinib compared to 3.1% for patients treated with chemoimmunotherapy. No new safety signals were observed in the AMPLIFY study.2

About VENCLEXTA (venetoclax)
VENCLEXTA (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 targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA 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 Information3

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.