IMDELLTRA is the first and only therapy that targets DLL3 using a Bispecific T-cell Engager, which activates the patient’s own T cells to attack tumor cells expressing DLL3. The FDA granted accelerated approval to IMDELLTRA based on findings from the Phase II DeLLphi-301 clinical trial. This trial assessed IMDELLTRA in patients with small cell lung cancer (SCLC) who had not responded to at least two prior treatments and were given a 10 mg dose every two weeks. The study reported that IMDELLTRA at this dosage (N=99) achieved a notable objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and a median duration of response (DoR) of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with complete survival data still pending.
J&J Acquisition of Proteologix, Inc. Marks Strategic Move in Atopic Dermatitis Market
Johnson & Johnson revealed that it has finalized a deal to purchase Proteologix, Inc., a privately-owned biotech firm specializing in bispecific antibodies for immune-mediated conditions, for $850 million in cash, along with possible additional milestone payments.
Proteologix’s portfolio features PX128, a bispecific antibody that targets both IL-13 and TSLP, which is about to commence phase 1 trials for moderate to severe atopic dermatitis and moderate to severe asthma. Additionally, PX130, another bispecific antibody targeting IL-13 and IL-22, is in preclinical development for moderate to severe AD. Given that AD and asthma are heterogeneous diseases with varying disease-driving pathways in different patient subpopulations, addressing multiple pathways holds the potential for achieving high efficacy and remission.
PX128 blocks IL-13-induced Th2 skin inflammation, a key process in conditions like atopic dermatitis and asthma, along with TSLP, which triggers tissue inflammation in these diseases. Similarly, PX130, like PX128, hampers IL-13-driven Th2 skin inflammation. Additionally, PX130 targets IL-22 to enhance the skin barrier, guarding against inflammation caused by environmental factors such as allergens. Both drugs are formulated for less frequent dosing, catering to patient convenience. These new additions to the pipeline exemplify a strategic approach aimed at creating a diverse and complementary range of bispecific drugs.
Besides PX128 and PX130, the purchase will supply J&J with additional bispecific antibody programs applicable to various diseases, enhancing the company’s ability to develop innovative bispecific programs.
FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy BREYANZI for Relapsed or Refractory Follicular Lymphoma
Bristol Myers Squibb has revealed that the FDA granted accelerated approval for BREYANZI® (lisocabtagene maraleucel; liso-cel), a therapy using CD19-directed chimeric antigen receptor (CAR) T cells, to treat adults with relapsed or refractory follicular lymphoma who have undergone two or more prior systemic therapies. This approval is based on response rate and response duration, with continued approval hinging on further confirmation of clinical benefits in subsequent trials. Additionally, BREYANZI has been incorporated into the National Comprehensive Cancer Network (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory follicular lymphoma.
In cases of relapsed or refractory follicular lymphoma, BREYANZI is administered as a one-time infusion, with a single dose consisting of 90 to 110 million CAR-positive viable T cells. Refer to the Important Safety Information section below for details, including Boxed WARNINGS about Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
“BREYANZI is a key part of our cell therapy offerings, delivering a unique profile for various B-cell cancers,” stated Bryan Campbell, Senior Vice President and Head of Commercial Cell Therapy at Bristol Myers Squibb. “The recent approval of BREYANZI for relapsed or refractory follicular lymphoma offers a single-infusion treatment option with the potential for long-term remission. Its safety profile supports administration and monitoring in both inpatient and outpatient settings at a growing number of certified treatment centers across the U.S.”
AbbVie and Gilgamesh Pharmaceuticals Enter Agreement to Innovate Future Psychiatric Treatments
AbbVie and Gilgamesh Pharmaceuticals have announced a partnership and an option-to-license agreement aimed at creating advanced treatments for psychiatric conditions. This collaboration will utilize AbbVie’s psychiatric expertise and Gilgamesh’s cutting-edge research platform to uncover new neuroplastogens.
Classic psychedelic compounds offer new ways to address mental health disorders, showing promising results where other treatments have failed. However, these first-generation compounds can cause intense psychoactive effects, such as hallucinations, requiring administration under medical supervision and additional supportive care.
Next-generation compounds, called neuroplastogens, aim to harness the beneficial mechanisms of these psychedelics while reducing their challenging psychoactive effects. These new compounds show great potential for treating various psychiatric conditions, including mood and anxiety disorders. Gilgamesh has used an innovative research platform to successfully identify leading compounds in this new class of therapeutics.
“There’s still a significant gap in meeting the needs of those with psychiatric disorders, and advancing this field requires exploring new technologies and methods,” stated Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research at AbbVie. “We are excited to collaborate with Gilgamesh’s outstanding team to develop innovative neuroplastogens and open up new treatment possibilities in psychiatry.”
“We are excited to join forces with AbbVie, a leading global pharmaceutical company dedicated to innovative psychiatric care, to tackle the significant challenges in mental health treatment,” stated Jonathan Sporn, M.D., CEO of Gilgamesh Pharmaceuticals. “Together, our collaboration will lead groundbreaking research into a new generation of therapies with promising potential to enhance patient outcomes.”
According to the agreement, AbbVie and Gilgamesh will collaborate on researching and developing a range of advanced treatments for psychiatric disorders. Once the option is exercised, AbbVie will take charge of development and commercialization efforts. Gilgamesh will get an upfront payment of $65 million from AbbVie and could receive up to $1.95 billion in total from option fees and milestones, along with tiered royalties ranging from mid-single to low-double digits on net sales.
Eisai Initiates FDA Rolling Review for LEQEMBI Subcutaneous Maintenance Dosing in Early Alzheimer’s, Fast Track Status Secured
Eisai Co., Ltd. and Biogen Inc. have announced that Eisai has begun the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (marketed in the U.S. as LEQEMBI®) as a subcutaneous autoinjector for weekly maintenance dosing. This follows the FDA granting the drug Fast Track designation. LEQEMBI is intended for the treatment of Alzheimer’s disease in patients who have Mild Cognitive Impairment (MCI) or are in the mild dementia stage, collectively known as early Alzheimer’s disease.
The BLA relies on data from the Clarity AD (Study 301) open-label extension (OLE) and modeled observations. If the FDA approves it, the LEQEMBI autoinjector could be used for home or medical facility administration. The injection process is quicker than the IV formulation. For the subcutaneous autoinjector’s 360 mg weekly maintenance regimen under review, patients who have completed the biweekly IV initiation phase would receive weekly doses to maintain effective drug levels, sustaining the clearance of highly toxic protofibrils that can continue to harm neurons even after amyloid-beta (Aβ) plaque removal from the brain.
LEQEMBI has received approval in the United States, Japan, and China, and its applications are currently under review in several other regions, including the European Union, Australia, Brazil, Canada, Hong Kong, the United Kingdom, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore, and Switzerland. In March 2024, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for monthly LEQEMBI intravenous (IV) maintenance dosing. Eisai leads the development and regulatory processes for lecanemab worldwide, with both companies collaborating on commercialization and promotion, and Eisai retaining final decision-making authority.
