On June 3, 2024 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported the following update on its planned phase 1 safety, feasibility and dose-finding clinical trials of its Hemopurifier in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo (Press release, Aethlon Medical, JUN 3, 2024, View Source [SID1234644045]).

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"We continue to make progress preparing for our planned, safety, feasibility and "dose finding" oncology trials in Australia and India, and want to provide our shareholders and other constituents with an update, stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. In early May, we announced new data showing the in vitro removal of exosomes from cancer patient plasma using a miniature version of our Hemopurifier. This data has been quickly integrated into the required documentation for Ethics Committees at our potential clinical sites. On May 17, 2024, we provided these documents to the Contract Research Organizations for these planned clinical trials. Subsequently, on May 24, 2024, one potential site submitted the documents to its Ethics Board. An additional site in Australia and another in India are currently assembling the packages for submission to their Ethics Committees.

Once we receive the expected Ethics Committee approvals, we will finalize the Clinical Trial Agreements. After this, hospitals can begin recruiting patients for the trials.

As a reminder, the target patient population for these safety, feasibility, and dose finding trials is oncology patients with solid tumors who are failing their anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo.

On June 3, 2024 Sengenics Corporation LLC and Duke Health reported an ambitious collaboration to redefine metastatic colorectal cancer (mCRC) treatment (Press release, Sengenics, JUN 3, 2024, View Source [SID1234644044]). This venture aims to explore the immune system’s response to immunotherapy, leveraging Sengenics’s state-of-the-art KREX technology to discover autoantibody biomarkers related to drug efficacy, resistance, and toxicity, thereby improving survival rates and quality of life for patients.

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mCRC remains a significant challenge in oncology, with a 5-year survival rate of 14% (Rumpold, 2020). Historically, the development of cancer immunotherapies has focused primarily on cellular immunity while neglecting the crucial functions of the humoral immune system. This joint effort will measure the humoral immune response to immunotherapy drugs, atezolizumab and bevacizumab, which have shown promise in clinical trials for mCRC treatment.

The project’s objective is to identify autoantibody biomarkers that can help stratify patients, ensuring they receive personalized and effective treatment regimens. It may also provide further insights into disease progression and mCRC subtypes.

"This research represents a significant step forward in the fight against metastatic colorectal cancer," said Professor Jonathan Blackburn, Chief Scientific Officer at Sengenics. "Autoantibodies not only offer a fresh perspective on treatment outcomes but can also provide biologically relevant and unique insights into disease that are not revealed by other ‘omics’ approaches."

Dr. Andrew Nixon, Professor of Medicine at Duke Health, added, "This collaboration underscores our commitment to enhancing patient care and health worldwide through innovative approaches. Our lab has focused on the development of circulating biomarkers for years, and we’re excited to better understand the roles that autoantibodies play in the development of metastatic colorectal cancer and therapeutic resistance."

The findings from this collaboration could herald a new era in cancer treatment, where precision medicine enables more accurate predictions of treatment outcomes, leading to more successful management of mCRC and potentially other cancers.

On June 3, 2024 Bold Therapeutics, the world leader in the development of novel metallotherapeutics, reported positive Phase 2 safety and efficacy results for the company’s lead asset BOLD-100 in the treatment of advanced metastatic biliary tract cancer (BTC) and gastric cancer (GC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, IL (Press release, Bold Therapeutics, JUN 3, 2024, View Source [SID1234644043]). This follows positive Phase 2 results in the treatment of advanced colorectal cancer presented at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January.

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BTC and GC data from Bold Therapeutics’ ongoing multinational Phase 2 clinical trial (NCT04421820) of BOLD-100 in combination with standard-of-care FOLFOX in the treatment of patients with advanced gastrointestinal cancers at sites in Canada, the United States, Ireland, and South Korea was presented as Abstract #4115 (Poster Board #95) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with pretreated advanced biliary tract cancer: efficacy and safety analysis" and Abstract #4059 (Poster Board #39) "A Phase 2 Study of BOLD-100 in combination with FOLFOX chemotherapy in patients with advanced gastric cancer: efficacy and safety analysis", respectively, in the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary session on June 1, 2024, from 1:30 – 4:30PM CDT.

BTC Efficacy and Safety:

18 out of 22 patients treated were eligible for efficacy evaluation;
Patients had received a median of 2 prior therapies;
Median progression-free survival (PFS) of 6.0 months [95% CI: 3.8 – 10.0] and median OS of 7.3 months [95% CI: 4.5 – 13.0], which compares extremely favorably with standard-of-care outcomes;
One patient (n=1) achieving a partial response (PR) for an objective response rate (ORR) of 6% [95% CI: 1.0, 23.0], fourteen (n=14) patients with stable disease (SD), and disease control rate (DCR) of 83% [95% CI: 62.0, 95.0];
Patients received a median of 4 cycles (range: 1 – 41) of therapy; and
For all treated patients (n=21), 21 had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=10, 46%), nausea (n=8, 36%), fatigue (n=7, 32%), peripheral-sensory neuropathy (n=6, 27%), and pyrexia (n=6, 27%).
GC Efficacy and Safety:

18 out of 21 patients treated were eligible for efficacy evaluation;
Patients had received a median of 4 prior therapies;
Median progression-free survival (PFS) of 4.2 months [95% CI: 2.8 – 7.1] and median OS of 7.9 months [95% CI: 4.8 – 15.0], which compares extremely favorably with standard-of-care outcomes;
Two patients (n=2) achieved a partial response (PR) for an objective response rate (ORR) of 11% [95% CI: 2.0, 31.0], eleven (n=11) patients with stable disease (SD), and disease control rate (DCR) of 72% [95% CI: 49.0, 89.0];
Patients received a median of 6 cycles (range: 1 – 27) of therapy; and
For all treated patients (n=21), 19 patients had ≥ 1 TRAEs, most commonly neutrophil count decrease (n=7, 33%), nausea (n=6, 29%), and peripheral-sensory neuropathy (n=4, 19%), with most AEs being grade 1-2.
"Driven by our dedicated and talented employees and supported by generous grants and subsidies from the government of Canada, BOLD-100 continues to exceed expectations," added E. Russell McAllister, CEO. "On top of the robustly positive Phase 2 clinical data presented at both ASCO (Free ASCO Whitepaper) and ASCO (Free ASCO Whitepaper) GI, Bold Therapeutics expects to announce intriguing nonclinical data later this year, specifically biomarker data that we think will generate significant excitement amongst both clinicians and scientists as we disrupt commonly held perceptions about how to safely and effectively treat some of the most difficult-to-treat solid tumor indications where existing therapies are largely ineffective."

Later this month, Bold Therapeutics expects to begin enrolling patients into a multinational Phase 2 randomized clinical trial comparing two different doses of BOLD-100 in combination with standard-of-care FOLFOX against standard-of-care FOLFOX in patients with second-line FOLFOX-naïve colorectal cancer. Based on prior results, we expect to see significant improvements in both safety and efficacy outcomes. In addition, Bold Therapeutics is currently manufacturing drug product to support a pivotal Phase 3 trial in advanced colorectal cancer.

On June 3, 2024 Minghui Pharmaceutical, Inc., a late-stage clinical biopharmaceutical company, reported that the preliminary Phase 1/2 clinical data of MHB088C (B7-H3 ADC) was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in an oral presentation (Press release, Minghui Pharmaceutical, JUN 3, 2024, View Source [SID1234644042]).

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Abstract #: 3012

Results of a Phase 1/2 Study of MHB088C: a Novel B7-H3 Antibody-Drug Conjugate (ADC) Incorporating a Potent DNA Topoisomerase I Inhibitor in Recurrent or Metastatic Solid Tumors

In this Phase 1/2 study, the safety/tolerability, pharmacokinetics, and efficacy of MHB088C in patients (pts) with recurrent or metastatic solid tumors were evaluated. The study results were as follows:

At data cutoff, MHB088C was well tolerated. The most common TRAEs were hematological toxicities. 4 mg/kg Q3W was the DLT dose and 3 mg/kg Q3W was defined as the MTD. 1.6 mg/kg Q2W, 2.0 mg/kg Q3W and 2.4 mg/kg Q3W demonstrated favorable safety profiles with low single-digit Grade ≥3 hematological AEs for the two lower doses. No interstitial lung disease (ILD) was reported as of the data cutoff.
­ Of 98 efficacy evaluable pts with different tumor types at doses ranging from 0.8 mg/kg to 4.0mg/kg, ORR was 33.7% (33/98) and DCR was 83.7% (82/98), with DoR not reached yet. The majority of pts remain on the treatment.
­ Of 31 efficacy evaluable pts with small cell lung cancer (SCLC), ORR was 61.3% (19/31) and DCR was 93.5% (29/31). 24 pts (77.4%) remain on the treatment, and 6 pts (19.4%) achieved 60% or more tumor reduction, with 2 CRs of target lesion at 3.0 mg/kg. Among 10 pts at 1.6 mg/kg Q2W, ORR was 80% and DCR was 90%.
­ Of 7 efficacy evaluable pts with esophageal squamous cell carcinoma (ESCC), ORR was 42.9% and DCR was 85.7%. The median follow-up was over 3.0 months.
Professor Lin Shen from the Beijing Cancer Hospital stated: "MHB088C represents an innovative advancement in cancer treatment as a novel B7-H3 ADC equipped with a potent DNA Topo I inhibitor. The preliminary data are highly encouraging, showcasing clinically meaningful and durable antitumor activities at very safe doses across multiple cancer types. We are optimistic about the ongoing study and anticipate further positive clinical outcomes."

Dr. Guoqing Cao, CEO of Minghui Pharmaceutical, stated: "We are excited to share the results of Phase 1/2 study of MHB088C at the 2024 ASCO (Free ASCO Whitepaper). MHB088C is a well-differentiated B7-H3 ADC, conjugating an optimal anti-human B7-H3 antibody with our Proprietary SuperTopoiTM payload. We are seeing robust efficacy at very safe doses without major hematological toxicity or ILD. Particularly, in SCLC, 9 out of 10 patients experienced tumor shrinkage at 1.6 mg/kg Q2W, with an ORR of 80%. The durability of responses was also notable in ESCC, with an ORR of 43% and median follow-up over 3 months.

The safety profile of MHB088C is consistent with that of our other program MHB036C, a TROP-2 ADC, without major hematological toxicity or ILD either. Between the two clinical programs, with data from more than 250 patients, we are confident that we now have one of the best ADC platforms in the industry. Efficacy in other cancer types has also been observed and will be reported in future conferences. We look forward to initiating registrational trials of the monotherapy for selected tumor types by the end of 2024 and exploring the IO combination in earlier line settings for both ADC assets in the near future."

About MHB088C
MHB088C is a novel B7-H3 ADC generated through Minghui’s SuperTopoiTM ADC platform. Minghui’s proprietary payload is 5 to 10 times more potent than DXd, retaining key advantages such as bystander effect while eliminating the risk of interstitial lung disease. Conjugated with Minghui’s proprietary B7-H3 antibody, which has superior binding and internalization compared to the competitor’s antibodies, MHB088C has demonstrated remarkable anti-tumor efficacy across various cancer types. It was 3 to 10 times more potent in killing tumor cells than the competitor’s compound in xenograft models.

On June 3, 2024 Researchers from NYU Langone Health’s Perlmutter Cancer Center reported their latest findings and research at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Conference, held May 31 to June 4 at Chicago’s McCormick Place (Press release, NYU Langone Health, JUN 3, 2024, View Source;research-at-asco-2024-annual-conference-302162148.html [SID1234644041]).

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Among these presentations:

a three-year update on the long-term efficacy of an mRNA vaccine for use in patients being treated for metastatic melanoma
a retrospective look at treatment patterns and outcomes in patients with advanced endometrial cancer
a look at the safety and efficacy of a noninvasive combination treatment for patients with recurrent glioblastoma
"This year’s crop of presentations is a showcase of the Perlmutter Cancer Center’s commitment to delivering the highest level of research and clinical care," said Alec Kimmelman, MD, PhD, the center’s director.

Late-Breaker Rapid Oral Abstract: Three-year update on the long-term efficacy of an mRNA vaccine for use in patients being treated for metastatic melanoma
Monday, June 3, 10:15AM CT

In a follow-up presentation at ASCO (Free ASCO Whitepaper) to the recently published clinical trial describing the effectiveness of combining the immunotherapy drug pembrolizumab with V940—an investigational individualized neoantigen mRNA vaccine for people with high-risk, surgically removed melanoma—this three-year update looks at the longer-term recurrence rates of treated patients.

The primary analysis of the phase 2 trial, led by Jeffrey S. Weber, MD, PhD, deputy director of Perlmutter Cancer Center, and sponsored by Moderna and Merck, assessed patients who received the vaccine, called mRNA-4157/V940, and the immunotherapy drug pembrolizumab, comparing their risk of recurrence and development of distant metastases to those who had received only pembrolizumab.

This three-year follow-up analysis showed a higher percentage of durable and meaningful long-term recurrence-free survival or survival without distant spread of cancer in patients who received both treatments (74.8 percent) compared to those who received only pembrolizumab (55.6 percent). The patients’ overall survival also improved with combination treatment, at 96.0 percent compared to 90.2 percent with pembrolizumab alone.

"This additional information continues to support the potential of mRNA-4156/V940 in combination with pembrolizumab for patients with metastatic melanoma," said Dr. Weber. "We have followed up this work with a randomized phase 3 trial in more than a thousand patients, which we hope will provide a definitive assessment of the efficacy of the combination of V940 and pembrolizumab compared to pembrolizumab alone."

Poster: A retrospective look at treatment patterns and outcomes in patients with advanced endometrial cancer
Monday, June 3, 9AM

This retrospective study, led by Bhavana Pothuri, MD, director of gynecologic oncology research at Perlmutter Cancer Center and a professor in the Department of Obstetrics and Gynecology, assesses testing for treatment options, treatment patterns, and outcomes among patients with advanced endometrial cancer. In the past decade, newer therapies have been introduced for advanced endometrial cancer. Molecular profiling of mismatch repair/microsatellite instability (MMR/MSI) status has become an important testing tool to determine treatment, but real-world data on the prevalence of its use is limited.

Researchers looked at 1,441 deidentified patients with advanced endometrial cancer who started therapy between January 2018 and June 2023, analyzing patient characteristics, treatment patterns, and testing patterns.

While MMR/MSI testing was common, less than 50 percent of patients were receiving new therapies, and further study with implementation science may aid in increased adoption.

"Advanced endometrial cancer is the fourth most common cancer affecting women in the United States, and it is the only gynecologic malignancy with increasing incidence—and increasing mortality that is soon expected to surpass that of ovarian cancer," said Dr. Pothuri. "Despite increasing trends, there may be outstanding barriers to the adoption of new therapies. We need further studies to assess these changes in outcomes over a longer time frame, along with continued education to increase awareness and access to newer FDA-approved treatments."

Poster: The safety and efficacy of a noninvasive combination treatment for patients with recurrent glioblastoma
Saturday, June 1, 9AM

Dimitris G. Placantonakis, MD, PhD, an associate professor in the Department of Neurosurgery, is presenting an ongoing, multicenter phase1/2 study that explores if sonodynamic therapy is safe and can help patients with recurrent or progressive glioblastoma live longer.

Recurrent glioblastoma is a lethal brain tumor that has an extremely poor prognosis and no effective therapies. Sonodynamic therapy is a noninvasive combination treatment that uses a drug, aminolevulinic acid HCL (SONALA-001), and a device, the Exablate 4000 Type 2.0, to deliver focused ultrasound to target glioblastoma cells. This has been shown in previous studies to lead to tumor cell death and improved survival in animal models.

People enrolled in this trial are receiving different dosage levels in order to determine the maximum tolerable dose for further study. The phase 2 portion will further characterize safety, along with evaluation of the efficacy of this treatment, with other key endpoints, including overall survival and recurrence rate.

"We are very excited about this study because, as a new therapy, it offers hope for people with this disease," said Dr. Placantonakis. "This is also exciting because it offers a noninvasive treatment approach that pulses ultrasound waves from a device that is outside the head, so there is no need to surgically remove the tumor, and it eliminates the risk of side effects that are inherent in conventional brain surgery."