On June 3, 2025 Johnson & Johnson reported initial Phase 1 results of JNJ-79635322 (JNJ-5322), a novel investigational trispecific antibody (TsAb) in patients with relapsed or refractory multiple myeloma (Press release, Johnson & Johnson, JUN 3, 2025, View Source;johnsons-trispecific-antibody-show-promising-response-in-heavily-pretreated-multiple-myeloma-patients-302471267.html [SID1234653684]). Among the 36 patients who received the recommended phase 2 dose (RP2D), the overall response rate (ORR) was 86.1 percent. In the 27 patients who were naive to BCMA and GPRC5D directed therapies, the ORR was 100 percent at the RP2D. Findings were featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #7505). The study will also be featured as one of the six best abstracts during the Plenary Abstracts Session at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (Abstract #S100).1

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JNJ-5322 has a novel and distinct structure that builds upon the experience with two approved first-in-class bispecific antibodies: teclistamab and talquetamab. Unlike these bispecific antibodies, JNJ-5322 is a single molecule that simultaneously binds to three distinct targets (BCMA and GPRC5D on multiple myeloma cells, as well as CD3 on T-cells). JNJ-5322 targets two myeloma antigens, with the goal of overcoming tumor heterogeneity and preventing the development of resistance.

In the Phase 1, first-in-human study (NCT05652335), researchers investigated escalating doses of JNJ-5322 in heavily pretreated patients with relapsed or refractory multiple myeloma. In the trial, 126 patients received JNJ-5322 with a median follow-up of 8.2 months. The recommended RP2D of 100 mg Q4W consists of one step-up dose of 5 mg and monthly dosing with 100 mg thereafter.

"The response rate with JNJ-5322 is encouraging as we explore the potential of this trispecific antibody for the treatment of relapsed or refractory multiple myeloma patients," said Niels van de Donk, M.D., Ph. D., VU University Medical Center, Amsterdam, Netherlands. "In addition to its monthly dosing and promising efficacy, the results indicate a promising safety profile and that further study of JNJ-5322 is warranted."

"These promising data are a major step forward as Johnson & Johnson works to transform outcomes in oncology with next-generation immunotherapies, building on our leading portfolio of complementary and combinable therapies. We look forward to seeing the results of planned Phase 2 and Phase 3 studies," said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Johnson & Johnson Innovative Medicine. "We hope to redefine what’s possible in terms of efficacy and safety, creating another strong treatment option clinicians can choose based on the needs of their patients with relapsed or refractory multiple myeloma."

The most common adverse event was cytokine release syndrome (CRS), occurring in 59 percent of patients, but no events were Grade 3 or higher. Twenty-eight percent of patients experienced Grade 3 or higher infections. Five patients had dose-limiting toxicities, and four treatment emergent patient deaths due to adverse events were reported, with one death caused by adenoviral encephalitis related to the drug.

Taste-related AEs were reported in 58 percent of patients, majority Grade 1. The incidence of other GPRC5D-related oral AEs was low, with dry mouth reported in 17 percent of patients (no Grade 2 at RP2D) and dysphagia reported in less than 4 percent of patients (no reported events at the RP2D). In addition, grade 1/2 weight loss occurred in 6% (RP2D) and 12% (all doses) of patients, with no Grade ≥3 weight loss events.

About Multiple Myeloma
Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.3 Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.4 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.5 People with multiple myeloma have a 5-year survival rate of 59.8 percent. While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections.

On June 3, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported it has signed definitive partnership agreements with Zydus Lifesciences Ltd. (NSE: ZYDUSLIFE), including its subsidiaries/affiliates, hereafter referred to as "Zydus," designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL) (Press release, Agenus, JUN 3, 2025, View Source [SID1234653700]).

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The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75M; Agenus to receive up to an additional $50M in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies globally.

Agenus will become Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen’s BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization.

Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus’ established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries.

In a demonstration of mutual commitment, Zydus will also make a strategic equity investment in Agenus by purchasing approximately 2.1 million shares of common stock at $7.50 per share, totaling approximately $16 million in gross proceeds. Agenus intends to apply the net proceeds from the sale of the purchased shares for working capital and general corporate purposes, and will accelerate ongoing clinical development, registration and potential commercialization of BOT/BAL.

By uniting Agenus’ pioneering research and development capabilities with Zydus’ worldwide manufacturing, commercialization and operational strength, this partnership sets the stage for a new era in cancer immunotherapy in India and beyond.

"With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations," said Dr. Garo Armen, CEO of Agenus. "There is also a growing recognition by both countries of the need for the United States to ensure that biopharma supply chains are secure. We are working with Zydus to accelerate future clinical trials for BOT/BAL and eventually its global footprint in oncology therapeutics. This agreement is an expression of confidence in the future of Agenus and in the regulatory environment of the United States. The administration has created an environment that has brought these two trading partners together. The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now."

"We are thrilled to be partnering with Agenus to advance BOT/BAL, which has the potential to benefit thousands of patients in our core markets of India and Sri Lanka annually and millions of solid tumor patients globally. We plan to run clinical trials testing BOT/BAL in both early-stage and late-stage disease, along with expansion beyond colorectal cancer to other major disease settings like triple negative breast cancer," said Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Ltd.

The transaction is subject to customary closing conditions and satisfactory due diligence. The parties aim to complete closing agreements within 60 days.

Conference Call and Webcast

Date/Time: Tuesday, June 3rd; 4:30 p.m. ET
To access dial-in numbers, please register at: View Source
Conference ID: 12788

Advisors

As part of this effort, Agenus was advised by Biotech Value Advisors (BVA), a strategic advisory firm, which provided guidance on transaction structure, partner selection and negotiations.

On June 2, 2025 Eli Lilly and Company (NYSE: LLY) reported new Phase 1 data showing that its folate receptor alpha (FRα) antibody-drug conjugate (ADC) (LY4170156) demonstrated an encouraging safety profile and anti-tumor activity across dose and FRα expression levels in women with heavily pre-treated platinum-resistant ovarian cancer, including patients previously treated with mirvetuximab soravtansine (Press release, Eli Lilly, JUN 2, 2025, View Source [SID1234653604]). A preliminary overall objective response rate (ORR) of 55% was observed at the potential recommended Phase 2 dose of 4 mg/kg. Lilly’s FRα targeting ADC is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. These data will be presented today in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"ADCs have begun to change the treatment paradigm for some women with ovarian cancer, but a large proportion of patients still have a significant need for new therapies that improve outcomes regardless of FRα expression level," said Isabelle Ray-Coquard, M.D., Ph.D., president of the ENGOT (European Network of Gynecological Oncology Trial) group, medical oncologist at the Centre Léon Bérard Lyon France and principal investigator for the trial. "These initial data show activity across all doses and levels of FRα expression, including in patients previously treated with a FRα targeting treatment. Taken together with the emerging safety and tolerability profile, these data demonstrate early potential to meaningfully improve outcomes for women living with advanced ovarian cancer."

As of the March 9, 2025 data cutoff, the study enrolled 95 participants with high-grade serous ovarian cancer across four dose levels (2 – 6 mg/kg). Patients received a median of five prior systemic regimens (range 1-10), and 15% were previously treated with mirvetuximab soravtansine. Among the 95 patients, 51% had tumors with FRα expression less than 75%, 34% had FRα expression of 75% or higher, and 16% had expression results pending. Key endpoints were safety, pharmacokinetics, and anti-tumor activity per RECIST v1.1.

Efficacy results demonstrate responses at all dose levels, across all FRα expression levels, including in patients who progressed on prior mirvetuximab soravtansine. In the 58 efficacy-evaluable patients (37 patients remain ongoing prior to first response assessment and were therefore not yet efficacy-evaluable at the time of the data cutoff), the ORR was 45% (26/58 patients), and the disease control rate was 74% (43/58). At the potential recommended Phase 2 dose of 4 mg/kg, the ORR was 55% (11/20 patients). The most common treatment-emergent adverse events across all dose levels included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%). Treatment-emergent neuropathy and ocular toxicity has not been observed to date. No maximum tolerated dose has been established.

"We are excited to share these first clinical data for our FRα targeting ADC, demonstrating a promising tolerability and efficacy profile across all FRα expression levels," said David Hyman, M.D., Chief Medical Officer, Lilly. "Based on these results, we believe there is the potential to significantly expand the number of ovarian cancer patients who could benefit from a FRα ADC. We are now focused on rapidly advancing this potential new medicine into registrational Phase 3 clinical trials."

For more information on Lilly’s oncology pipeline click here.

About LY4170156
LY4170156 is an investigational, next-generation antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα). FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth.1,2 FRα is overexpressed in many solid tumors such as ovarian, non-small cell lung, and colorectal cancers.1,3,4

LY4170156 was designed to target FRα across expression levels with an improved therapeutic index. LY4170156 is composed of an Fc-silent, FRα specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). PSARlink’s unique structure "masks" the cytotoxic molecules enabling them to stay in the body longer, providing the potential to broaden the therapeutic index of ADCs. LY4170156 is currently being studied in patients with ovarian cancer as well as other FRα-expressing solid tumors, NCT06400472.

On June 2, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, reported updated clinical data of IBI354 (HER2 monoclonal antibody-camptothecin derivative conjugate) in advanced solid tumors at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2025, View Source [SID1234653636]).

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IBI354 has demonstrated promising anti-tumor efficacy and favorable safety profiles across multiple solid tumors. It not only holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity" for tumor types such as ovarian cancer and breast cancer, but also validates the advantages of Innovent’s ADC technology platform. The results of IBI354 lays the foundation for the subsequent development of Innovent’s next-generation of bispecific ADCs and dual-payload ADCs, marking a milestone in Innovent’s next-generation "IO+ADC" oncology development strategy.

The data presented is from a Phase 1/2 clinical study (NCT05636215) aimed at evaluating the safety, tolerability, and preliminary efficacy of IBI354 in participants with advanced solid tumors. As of March 24, 2025, a total of 368 participants with advanced solid tumors were enrolled and received different doses of IBI354 monotherapy, the median follow-up duration was 11.5 months (range: 0.7-19.6), the median treatment duration was 27.0 weeks (range: 3.1-81.3) and 74 (20.1%) pts were still on treatment. The tumor types including 178 with breast cancer, 92 with ovarian cancer, 38 with colorectal cancer, and 60 with other tumors.

IBI354 monotherapy demonstrated excellent safety profile

The dosage was escalated to 18mg/kg, with no DLT events observed.
The most common treatment-related adverse events (TRAEs) were anemia, nausea, and white blood cell count decreased. The incidence of interstitial lung disease (ILD) was only 1.9%, all were grade 1-2.
Overall, 27.4% of patients experienced TRAEs ≥ grade 3, 17.7% experienced TRAEs leading to dose interruption, 2.7% experienced TRAEs leading to dose reduction and 1.6% experienced TRAEs leading to discontinuation, with no TRAEs leading to death.
IBI354 monotherapy showed promising efficacy signals in multiple tumor types

In HER2-positive breast cancer cohort (n= 88, treated at 6~15mg/kg, the median prior treatment lines was 4), the confirmed objective response rate (ORR) and the disease control rate (DCR) were 59.1% and 90.9%, respectively. In 9 mg/kg Q3W subgroup (n=29), the ORR and the DCR were 72.4% and 89.7%, respectively. The median progression-free survival (PFS) was 14.1 months (95% CI: 8.3-not calculable [NC]) with events of 48.3%. The median overall survival (OS) was immature with events of 3.4%.
In ovarian cancer cohort (n=92, treated at 2~12mg/kg, the median prior treatment lines was 3), the cORR was 41.2% and the DCR was 82.0%. In the 12mg/kg Q3W subgroup (n=40), the cORR reached 55.0% and the DCR was 90.0%. In participants with HER2 1+ (n=27), the ORR reached 55.6% and the DCR was 88.9%. As of the data cutoff date, the median follow-up time was 11.9 months, and the median PFS was 7.1 months (95% CI: 5.2−10.8) in 12mg/kg Q3W dose group. The median OS was not mature with events in 14 (34.1%) pts and a 12-month OS rate of 63.9% (95% CI: 45.0−77.8).
Professor Qi Zhou, Chief Physician at the Gynecologic Oncology Center of Chongqing University Affiliated Cancer Hospital and the Principal Investigator of the gynecologic oncology cohort study, stated, "The treatment of platinum-resistant recurrent ovarian cancer is difficult and the prognosis is poor, threatening the life and health of women. Extending PFS and OS in platinum-resistant recurrent ovarian cancer patients remains a clinical challenge for gynecological oncologists. ADC drugs provide a new direction for overcoming resistance mechanisms by precisely delivering cytotoxic agents. HER2, as a validated solid tumor target, has made breakthroughs in breast and gastric cancer fields, while the novel ADC drug IBI354 shows broad-spectrum antitumor activity through unique design in HER2 low-expression (IHC 1+) platinum-resistant ovarian cancer. In the Phase 1 study with a dose of 12mg/kg Q3W, IBI354 demonstrated an ORR of 55.0% and DCR of 90.0%, with a median PFS reaching 7.1 months. The safety profile was very good without common severe interstitial lung disease or ocular toxicity seen in other ADCs. These results significantly outperform traditional chemotherapy regimens, suggesting its potential breakthrough efficacy in the platinum-resistant population. The Phase 3 study of IBI354 in platinum-resistant ovarian cancer (HeriCare-Ovarian01) has been initiated, and I am looking forward to the results, as well as the further validation of the long-term benefits for patients receiving IBI354."

Doctor Charlotte Rose Lemech from Scientia Clinical Research Ltd, Australia, stated: "Breast cancer is one of the most common malignant tumors among women globally and remains a leading cause of cancer-related deaths. The amplification or overexpression of HER2 (human epidermal growth factor receptor 2) is recognized as a key driver in the development, progression, and metastasis of breast cancer, with approximately 15%-20% of breast cancer patients exhibiting HER2 overexpression. ADCs have become the new standard treatment for later line HER2 positive breast cancer. In this Phase 1 study, IBI354 has demonstrated encouraging efficacy and safety data, achieving high ORR and DCR especially in 9 mg/kg Q3W subgroup. Long term survival was also achieved with the median PFS of 14.1 months. IBI354 also differentiates itself from other HER2 targeted therapies with its safety profile. The incidence of interstitial lung disease was extremely low and most of the hematological toxicity and gastrointestinal adverse events were mild to moderate and can be effectively managed with standard supportive care. This favorable safety profile enhances the clinical application potential of IBI354 and we look forward to IBI354 achieving more breakthroughs in the field of breast cancer treatment."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "With the rapid development of ADC drugs in the field of tumor treatment, Innovent is steadily advancing its strategic layout in the ADC field. At this year’s ASCO (Free ASCO Whitepaper) conference, we update the safety and efficacy data of IBI354 across various advanced solid tumors. These clinical results not only confirm the potential therapeutic value of IBI354 but also demonstrating Innovent’s innovative strength and technological advantages in ADC drug development. The phase 3 study of IBI354 in platinum-resistant ovarian cancer has been initiated, and more clinical studies are also planned. We will continue to invest in next-generation ADC molecules, aiming to address unmet clinical needs and bring patients with more effective and safer treatment options."

About IBI354 (Anti-HER2 Antibody-Camptothecin Derivative Conjugate)

IBI354 is an innovative HER2-targeted antibody–camptocinin derivative conjugate developed by Innovent’s proprietary SoloTx ADC platform. With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors. Innovent Biologics is conducting clinical studies to assess the efficacy and safety of IBI354 for multiple advanced solid tumors.

On June 2, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new clinical results from the PREDICT DNA and SCANDARE studies highlighting the capabilities of its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test for monitoring and predicting neoadjuvant therapy (NAT) response in triple negative breast cancer (TNBC), one of the most aggressive types of breast cancer (Press release, Personalis, JUN 2, 2025, View Source [SID1234653652]).

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"Many triple negative breast cancer patients receive neoadjuvant therapy prior to surgery as standard of care. The data from these two studies independently suggest that an ultrasensitive ctDNA assay like NeXT Personal could help these patients better understand their risk of relapse, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "We believe this data, once published, can form the basis for seeking reimbursement coverage for neoadjuvant therapy monitoring in breast cancer. We are excited to continue to work with leading collaborators to expand the data around the use of NeXT Personal in breast cancer with the goal of helping breast cancer patients optimize their care."

Results from the PREDICT DNA study were presented yesterday by Dr. Natasha Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial)."

"The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence," said Dr. Ben Park, MD PhD, Vanderbilt-Ingram Cancer Center. "We partnered with Personalis because of their technology’s ultrasensitive detection of ctDNA down to 1 to 3 parts per million. Our results demonstrate that patients who ‘clear’ their ctDNA after upfront chemotherapy have excellent outcomes that mirror those with pCR, identifying a group of patients who, despite having residual disease at the time of surgery, will be at extremely low risk for recurrence. Conversely, those with detectable ctDNA after upfront chemotherapy are at a much higher risk of recurrence, and serial ctDNA measurements after surgery can help identify patients who may benefit from either escalation or de-escalation of therapies. We are truly excited by these results as they will allow us to more precisely risk-stratify patients with breast cancer in future trials and clinical practice."

Key findings included:

ctDNA status after completion of NAT (post-NAT) was highly prognostic for relapse-free survival (RFS).
Patients with ctDNA detected post-NAT were ~10 times more likely to relapse than patients who were ctDNA negative.
Detection of ctDNA post-NAT was more predictive of recurrence than pCR.
Patients who did not have detectable post-NAT ctDNA had excellent outcomes regardless of pathologic response.
Preliminary analyses indicate that patients who had post-surgical ctDNA detected were >85 times more likely to experience disease recurrence.
48% of post-NAT ctDNA detections were <100 PPM, highlighting the importance of NeXT Personal’s ultrasensitive performance.
Overall, the results suggest that ultrasensitive ctDNA detection in patients with TNBC after completion of NAT and prior to surgery may be used as a prognostic marker, independent of pCR, to guide clinical decision making for additional adjuvant therapies.
Dr. Luc Cabel, MD, PhD, Institut Curie, Paris, presented results from a second study titled "Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC)." This study included 86 patients with early stage (Stage I-III) TNBC receiving neoadjuvant therapy. Key findings included:

ctDNA was detected in 100% (84/84) of pretreatment baseline plasma samples.
The majority of ctDNA detections during NAT (51%) and post-NAT (55%) were in the ultrasensitive range below 100 PPM of ctDNA.
Post-NAT ctDNA status was highly prognostic. Patients with ctDNA detected post-NAT were ~36 times more likely to have a distant relapse than patients who tested negative.
For patients who were non-pCR, ctDNA negative patients were 93% less likely to relapse than ctDNA positive patients.
ctDNA status can be combined with pCR status to assess patient distant relapse risk following NAT.
Said François-Clément Bidard, MD, PhD, one of the Institut Curie lead investigators on the study, "Our results uncover the clinical need for ultrasensitive MRD testing, and pave the way for ctDNA-based adjuvant therapy decisions in early triple negative breast cancer."