On April 14, 2025 Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, reported that Intas Pharmaceuticals has completed its acquisition of the UDENYCA (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc (Press release, Coherus Biosciences, APR 14, 2025, View Source [SID1234651917]). UDENYCA, a biosimilar to Neulasta (pegfilgrastim), expands the company’s portfolio of FDA-approved products and accelerates Accord BioPharma’s growth in the biosimilar industry.

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By acquiring UDENYCA, Accord BioPharma will continue to make this treatment available to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. UDENYCA’s three administration options — autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS) — offer flexibility for patients to receive their treatment at home, on-the-go, or in the office. Since the brand’s commercial launch, more than 300,000 patients are estimated to have been treated with UDENYCA and over 1.4 million units have been sold.

The acquisition not only expands Accord BioPharma’s product offerings, but also brings a wealth of talent from Coherus BioSciences. Key Coherus employees across multiple functions, including Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing, will join Accord BioPharma, playing a crucial role in supply and services continuity/transition and expanding the company’s work around UDENYCA.

"The completion of the UDENYCA acquisition marks a pivotal moment for Accord BioPharma, as it not only strengthens our market presence but broadens our capabilities as we endeavor to innovate and expand in the biosimilar space," said Chrys Kokino, U.S. President of Accord. "We are delighted to welcome talented employees from Coherus, whose historical knowledge and expertise will complement that of our existing team, making us stronger and better equipped to achieve our goals with UDENYCA."

"We are energized by this addition to Accord BioPharma’s portfolio because it exemplifies our commitment to improving patient access to high-quality treatments that effectively meet the needs of both patients and healthcare providers," said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. "We are pleased with the successful completion of this agreement and are excited about the future opportunities it brings for Accord BioPharma in the U.S. market."

INDICATION
UDENYCA (pegfilgrastim-cbqv) is a leukocyte growth factor indicated to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Allergies to Acrylics (UDENYCA ONBODY only): The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The granulocyte colony stimulating factor (G-CSF) receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Potential Device failures (UDENYCA ONBODY only): Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

UDENYCA Prefilled Syringe: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
UDENYCA Autoinjector: 6 mg/0.6 mL in a single-dose prefilled autoinjector.
UDENYCA ONBODY: 6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the on-body injector for UDENYCA.

Full Prescribing Information, including Patient Information and Instructions For Use, is available at www.UDENYCA.com.

Advisors
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. acted as legal counsel to Accord and Intas with respect to the Transaction.

On April 14, 2025 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that it will have an oral presentation in collaboration with medical centers at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting entitled "Safety and efficacy of BAT8006, a Folate Receptor α (FRα) antibody drug conjugate (ADC), in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial" (Press release, BioThera Solutions, APR 14, 2025, View Source [SID1234651918]). Three posters will be also presented in the poster session, covering TROP2-ADC BAT8008, HER2-ADC BAT8010, BAT1006 (an ADCC-enhanced anti-HER2 mAb with a different epitope from BAT8010) , and a novel PD-1 mAb BAT1308 in various solid tumors.

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Presentation details are as follows:

Oral presentation:

Abstract Title: Safety and efficacy of BAT8006, a folate receptor α (FRα) antibody drug conjugate, in patients with platinum-resistant ovarian cancer: Update on the dose optimization/expansion cohort of BAT-8006-001-CR trial.
Abstract ID: 5517
Type: Rapid Oral Abstract-Gynecologic Cancer
Time: 6/3/2025, 8:00 AM-9:30 AM CDT
Poster 1:

Abstract Title: BAT8008, a TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1 study.
Abstract ID: 3024
Type: Poster Session
Time: 06/02/2025 1:30 PM-4:30 PM CDT
Poster 2:

Abstract Title: A phase Ⅰb/Ⅱa study of BAT8010+BAT1006, an anti-HER2 monoclonal antibody-exatecan conjugate combined with an ADCC-enhanced HER2 mAb in patients with advanced solid tumors.
Abstract ID: 1027
Type: Poster Session
Time: 6/2/2025 9:00 AM-12:00 PM CDT
Poster 3:

Abstract Title: Primary efficacy and safety results of BAT1308, a PD-1 inhibitor, + chemotherapy ± bevacizumab in phase 2 trial for persistent, recurrent, or metastatic cervical cancer.
Abstract ID: 2611
Type: Poster Session
Time: 6/2/2025 1:30 PM-4:30 PM CDT

On April 14, 2025 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a successful FDA Type D meeting on the Phase 3 registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma (UM) (Press release, Ideaya Biosciences, APR 14, 2025, View Source [SID1234651919]).

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"The successful FDA Type D meeting provides darovasertib a registrational path as neoadjuvant therapy for UM, using primary clinical endpoints of eye preservation and proportion of patients with vision loss, with no detriment to EFS as a secondary endpoint required for both cohorts. Based on the promising clinical efficacy and safety observed with darovasertib in the neoadjuvant setting in over 90 patients and the recent Breakthrough Therapy Designation by the US FDA, we are excited to advance the darovasertib program into our second registrational trial," said Dr. Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed to broadly address primary and metastatic UM (MUM). Darovasertib has received U.S. FDA Breakthrough Therapy Designation as neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for darovasertib in combination with crizotinib in adult patients with metastatic uveal melanoma (MUM), where a Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative MUM is ongoing. Darovasertib has also been designated as an Orphan Drug by the U.S. FDA in UM, including in MUM.

FDA Guidance from the Type D Meeting on the Phase 3 Neoadjuvant Darovasertib Registrational Trial Design for Potential Regulatory Approval in Primary UM

IDEAYA is targeting to initiate the Phase 3 randomized clinical trial evaluating neoadjuvant darovasertib in primary UM in the first half of 2025. The randomized Phase 3 clinical trial design incorporates guidance and feedback from the U.S. FDA following a recent Type D meeting.

In the Phase 3 clinical trial, we currently project approximately 520 patients will be randomized 2:1 to the darovasertib treatment versus control arm. There will be 2 cohorts enrolled: 1) 120 enucleation eligible UM patients, 2) 400 PB eligible UM patients. For the enucleation cohort, the randomization will be with or without darovasertib as neoadjuvant therapy. For the PB cohort, the randomization will be darovasertib followed by PB versus PB alone.

Key highlights of the Phase 3 registrational trial design in neoadjuvant UM, based on FDA guidance:

Eye preservation rate (exceed lower bound of 10% eye preservation rate with a 95% confidence interval) is the primary endpoint for the enucleation UM cohort
Proportion of patients with vision loss from the time of randomization and time of completion of PB is the primary endpoint for the plaque brachytherapy cohort. Vision detriment will be measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) of >15-letters lost
No detriment to Event-Free-Survival (EFS) is a secondary endpoint for both cohorts and is required for approval. No detriment is defined as overlapping confidence intervals
Additional secondary endpoints: Overall Response Rate (>20% ocular tumor shrinkage by product of diameters), proportion of patients with clinically significant macular edema, proportion of subjects with 20/200 vision loss or worse (legal blindness), proportion of subjects with reduction of radiation dose of >20% delivered to key eye structures
Potential to submit the enucleation cohort data for regulatory review earlier than the PB cohort pending the EFS data maturity in both cohorts
300mg BID darovasertib will be the move-forward dose for the registrational trial

On April 13, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported $18M in Australian Federal Government Funding from the Medical Research Future Fund (MRFF) Frontiers Initiative for ‘Defeating Prostate Cancer with Targeted Alpha Therapy’ (Press release, Advancell, APR 13, 2025, View Source [SID1234651896]).

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One out of eight men develops prostate cancer. With the support from the Medical Research Future Fund (MRFF) Frontiers Initiative, the goal of the multidisciplinary multi-institutional investigator team is to transform the clinical management of prostate cancer by leveraging leading therapeutic radiopharmaceutical technology paired innovative clinical development and a deep understanding of tumour biology to improve the lives of patients with prostate cancer.

The research program is enabled by AdvanCell’s proprietary (Lead-212) 212Pb alpha isotope production technology along with the delivery of a first-in-field clinical platform trial to accelerate the translation of 212Pb-based targeted alpha therapies, one of the most exciting breakthroughs in cancer treatment.

Dr. Anna Karmann MD PhD, AdvanCell Chief Medical Officer said: "On behalf of all Co-Investigators, I would like to thank the Australian Government and MRFF Frontiers Initiative committee for this prestigious award. Targeted alpha therapies are among the most promising in oncology. We believe this MRFF-funded research can be practice changing and have a lasting positive impact on the lives of patients with prostate cancer. We highly value the support and opportunity this funding provides to fast-track translation and accelerate the development of novel combination therapies in an industry-academic partnership."

AdvanCell is collaborating with world-leading experts in Australia and globally, underpinning the transformative nature of the important clinical research. The clinical PIs include internationally renowned physician scientists Prof. Louise Emmett (St Vincent’s Hospital, Sydney and University of New South Wales) and Prof. Shahneen Sandhu (Peter MacCallum Cancer Centre, Melbourne).

Prof. Louise Emmett: "This collaborative Frontiers grant gives us the tools to deeply evaluate optimal combinations with targeted alpha therapy in prostate cancer – aiming for longer better lives using great technology in a smart way."

Prof. Shahneen Sandhu: "Our MRFF grant will accelerate the development of innovative targeted alpha therapy combinations designed to enhance patient care and clinical outcomes."

Scientific investigators include Prof. Richard Payne (The University of Sydney), Prof. Matt Trau, Dr. Alain Wuethrich, Dr. Kevin Koo (The University of Queensland), Dr. Scott Lovell (University of Bath), A/Prof. Serigne Lo (Melanoma Institute Australia) and Dr. Thomas Kryza and Dr. Simon Puttick (AdvanCell).

Prof. Stephen Rose, Head of Translational Medicine and Clinical Science at AdvanCell, highlighted the importance of the MRFF funding. "The MRFF funding supports Australian innovation to drive the establishment of sovereign manufacturing capabilities to accelerate clinical translation of 212Pb-targeted alpha therapy."

On April 12, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that results from a Phase 3 registrational clinical study evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) for the treatment of adult patients with advanced triple-negative breast cancer (TNBC) and results from an early Phase I/II clinical study of sac-TMT for the treatment of adult patients with advanced non-small-cell lung cancer (NSCLC) were published in the top international medical journal Nature Medicine (Impact Factor (IF)= 58.7) (Press release, Kelun, APR 12, 2025, View Source [SID1234651895]).

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Results

TNBC: Based on the results of the multicenter, randomized, controlled Phase III OptiTROP-Breast01 (NCT05347134) clinical study, the current publication reports on the efficacy and safety of sac-TMT versus investigator’s choice chemotherapy for the treatment of patients with locally advanced, recurrent or metastatic TNBC. The results of the study showed that sac-TMT demonstrated statistically and clinically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to investigator’s choice chemotherapy. Based on this study, sac-TMT was approved for marketing for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting). The data from this study were presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

NSCLC: Based on the results of two early clinical studies of sac-TMT, the article reports on the efficacy and safety of sac-TMT in previously treated advanced NSCLC with or without epidermal growth factor receptor (EGFR) mutations. The article also explored in vitro experiments on the potential mechanisms of sac-TMT treatment for NSCLC, suggesting that EGFR mutations can increase the endocytosis and anti-tumor activity of TROP2 ADCs.

Dr. Michael Ge, CEO of Kelun-Biotech said, "These successful publications in Nature Medicine mark the international academic community’s recognition of the clinical efficacy and application value of sac-TMT in the treatment of advanced TNBC and NSCLC. The Company’s novel product, sac-TMT, has been marketed in China for two indications. Meanwhile, the Company is also actively promoting the registrational clinical studies of sac-TMT in multiple indications, including breast cancer and lung cancer. Kelun-Biotech has always been committed to promoting innovation and leadership, and we look forward to continuing our research in the field of ADCs in partnership with MSD."

About sac-TMT (佳泰莱)

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.