On June 15, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for early-stage cancer detection and broad-spectrum cancer therapeutics, reported the poster "Vitamin B12 deprivation does not phenocopy selective cytotoxicity of CD320 and LRP2 silencing" at the University of Massachusetts (UMass) T.H. Chan Medical School’s fifth annual RNA Therapeutics Symposium June 21-23, 2023, in Worcester, MA (Press release, BioAffinity Technologies, JUN 15, 2023, View Source [SID1234632766]).

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The RNA Therapeutics Institute at UMass leverages RNA biology and clinical research to develop new therapeutics for multiple diseases based on the fundamental mechanisms of cellular RNAs.

David Elzi, Ph.D., Vice President of Research, and William Bauta, Ph.D., Senior Vice President of Therapeutics, will discuss the Company’s recent work that demonstrated that deprivation of vitamin B12 does not play a role in the selective cytotoxicity of cancer cells observed after silencing the expression of two specific genes, CD320 and LRP2. The vitamin B12 research follows the Company’s discovery that using small interfering RNA (siRNA) to knock down CD320 and LRP2 killed cancer cells in vitro without harming healthy cells.

One of the functions of CD320 and LRP2 is to bind to and transport vitamin B12 into cells. Since they have that in common, Drs. Elzi and Bauta tested the hypothesis that eliminating vitamin B12 could be the mechanism behind the death of cancer cells when CD320 and LRP2 are silenced. Experiments proved otherwise.

"Our research on targeted gene silencing began in order to better understand the mechanism behind our proprietary porphyrin TCPP’s ability to selectively stain cancer cells. In the process, we learned that treatment with siRNAs targeting specific cell surface receptors, CD320 and LRP2, both of which transport vitamin B12, adversely affects cancer cell survival but not normal cells," Dr. Elzi said. "However, when the cell culture medium did not contain measurable amounts of vitamin B12, we found no difference in cell growth compared to the culture medium supplemented with vitamin B12."

"We are continuing our investigation into how and why the simultaneous knockdown of CD320 and LRP2 inhibits cancer cell growth with no apparent effect on healthy cells. Our ultimate objective is to use this discovery to develop targeted therapeutics for multiple cancers," Dr. Bauta added.

bioAffinity Technologies’ noninvasive test for early-stage lung cancer, CyPath Lung, incorporates TCPP to identify cell populations in sputum that indicate cancer is present in the lung. CyPath Lung uses flow cytometry and AI-driven automated analysis to detect signals indicative of lung cancer.

On June 15, 2023 The Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) and US Medical Innovations, LLC (USMI) reported significant positive results from the first FDA Phase I IDE (#G190165) clinical trial for cancer using Canady Helios TM Cold Plasma (CHCP) combined with standard surgical resections at the 2023 American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (May 31-June 4, 2023) (Press release, JCRI-ABTS, JUN 15, 2023, View Source [SID1234632765]). Safety was the primary endpoint; secondary endpoints were the effect on local regional recurrence (LRR), cancer cell death, preservation of surrounding healthy tissue, and patient survival. (ClinicalTrials.gov identifier: NCT04267575)

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Cancer remains a significant global health challenge, with over 1.9 million new cases and 608,570 cancer-related fatalities in the United States in 2021. Advances in chemotherapy, radiation, surgery, immunotherapy, and molecular targeted therapy regimes have improved survival, but solid tumor resections still have a risk of LRR and a poor five-year survival rate. Surgery is the primary treatment for most solid tumors, but complete removal of cancerous tissue (R0), microscopic tumor cells (R1) or visible tumor (R2) is challenging which can lead to LRR in 5% to 65% of cases.

USMI’s Canady Helios Cold Plasma (CHCP) system, a non-thermal (26-30°C) and non-contact Cold Atmospheric Plasma (CAP) jet, offers a promising solution. The three-dimensional bioelectric Plasma Treated Electromagnetic Field (PTEF) created by CHCP causes a biophysical phenomenon known as Irreversible Electroporation (IRE), that increases cancer cell membrane permeability to CAP species such as Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS). This process results in cancer cell death while sparing the noncancerous tissue. The JCRI-ABTS research laboratory discovered and patented the process by which CHCP-treated cancer cells undergo histone mRNA oxidation and degradation, leading to the activation of DNA damage response genes and cell death (link)1. Standard CHCP treatment dosages for 32 cancer cell lines including breast, sarcoma, glioblastoma, melanoma, ovarian, prostate, colorectal, and lung cancers. have been developed in the JCRI-ABTS laboratory.

The Clinical Trial was a multi-center, open-label, prospective, and controlled study conducted between March 2020 – April 2021 at Rush University Medical Center (RUMC) in Chicago, IL, USA, and Sheba Medical Center (SMC) in Tel HaShomer, Israel. Molecular biological studies were performed at JCRI-ABTS. Twenty patients ranging from 26-85 years of age undergoing surgery for advanced stage 4 or recurrent solid tumors were enrolled. Patients with preoperative treatments such as neoadjuvant chemotherapy, immunotherapy, radiation, and previous surgery were eligible.

Characteristics of Patients

Characteristic

No.

%

No. of Patients

20

Sheba Medical Center

5

25

Rush Medical Center

15

75

Age

Median

59.5

Range

26-85

Female

10

50

Male

10

50

Ethnicity

White

18

90

African American

1

5

Other

1

5

ECOG1 Performance Status

<2

20

100

Cancer types (all metastatic)

Adenoid Cystic Carcinoma

1

5

Anal

1

5

Angiosarcoma

1

5

Breast

1

5

Cholangiocarcinoma

1

5

Chordoma

1

5

Colon

2

10

Melanoma

1

5

Mesothelioma

1

5

Non-Small Cell Lung*

3

15

Ovarian

1

5

Renal

1

5

Sarcoma**

4

20

Squamous Cell Carcinoma

1

5

1 ECOG – Eastern Cooperative Oncology Group
* Two Carcinomas and 1 Adenocarcinoma
** Desmoplastic small round cell sarcoma, myxofibrosarcoma, pleomorphic sarcoma, and pleomorphic spindle cell sarcoma

Overall response rates (ORR) at 26 months for R0 and R0 with Microscopic Positive Margins (R0-MPM) patients were 69% (95% CI, 19-40%) and 100% (95% CI, 100 – 100.0%), respectively. ORR was defined as no recurrence from the time of CHCP treatment to LRR in R0 resected patients. ORR was evaluated by postoperative T2 weighted MRI, PET or CT scans.

Overall Survival (OS) for R0 (n=7), R0-MPM (n=5), R1 (n=6), and R2 (n=2) patients at 28 months were 86%, 40%, 67%, and 0%, respectively. The cumulative OS rate was 24% at 31 months (n=20, 95% CI, 5.3 – 100.0). OS was defined as the duration from the intraoperative CHCP treatment to death.

CHCP treatment did not affect intraoperative physiological vital signs (blood pressure, pulse, O2 saturation, end tidal CO2, and temperature, p > 0.05). No systemic toxicities or device-related adverse events were observed. Overall, CHCP treatment combined with surgery is safe, selective towards microscopic tumor cells at the margin, and demonstrates exceptionally low LRR in R0 and R0-MPM patients.

Time
(Months)

Number at
Risk

Deaths

Survival Rate

Standard
Error

Lower 95% CI

Upper 95% CI

0

20

0

100%

0.00

1.00

1.00

5

18

2

90%

0.07

0.78

1.00

10

16

3

75%

0.10

0.58

0.97

15

15

0

75%

0.10

0.58

0.97

20

15

1

70%

0.10

0.53

0.93

25

8

0

70%

0.10

0.53

0.93

30

3

2

48%

0.15

0.26

0.88

31

2

1

24%

0.19

0.05

1.00

OS analysis for CAP-treated patients (n=20). P=0.0058.

Jerome Canady, MD., FACS., Surgical Oncologist, and CEO stated, "One inherent problem of excising any solid tumor tissue is ensuring complete surgical removal of the tumor and the microscopic tumor cells at the margins, which reduces the chance of local regional recurrence. To date, there are no treatments on the market that ensure the complete eradication of microscopic tumor cells at the surgical margin without damaging the surrounding healthy tissue. CHCP treatment with surgery shows immense promise in controlling local recurrence and improving survival in patients with advanced solid tumors. The treatment selectively kills microscopic tumor cells at the surgical margin. CHCP treatment is non-invasive, administered for 5 – 7 minutes intraoperatively, and has no side effects. It seamlessly integrates into existing treatment protocols without disruption."

Professor of Surgery Giacomo Basadonna MD., Ph.D., FACS Department of Surgery University of Massachusetts School of Medicine Worcester and co-author of the study stated, "The results of this clinical investigation are truly remarkable and offer renewed hope to cancer patients with advanced disease. The data from the trial combined with the amount of mechanistic information collected over many years, clearly show that Canady Helios Cold Plasma treatment causes cancer cells to die within a brief period leaving normal tissue untouched. The current trial shows that treating the surrounding tissue following tumorectomy prevents local recurrence and increases overall survival. Although this trial was conducted in patients with severe disease for regulatory reasons, the results open the door to treating the tumor bed and the adjacent tissue following removal of primary malignancies and truly guarantee cancer-free surgical margins."

These groundbreaking results highlight the safety, selectivity, and significant reduction of local regional recurrence achieved through the combination of CHCP treatment and surgery. USMI’s Canady Helios Cold Plasma system opens a new and promising avenue for addressing the challenges of eradicating microscopic residual cancer cells following surgical tumor resection without damaging surrounding healthy tissue.

JCRI-ABTS and USMI thank the participating patients and their families, prior compassionate use patients, surgical teams performing these advanced surgical procedures, and allowance by SMC and RUMC.

USMI’s FDA Phase 2 Multi-Center Clinical Trial is expected to take place in Q/4 2023.

The accompanying report for this Phase 1 Clinical Trial has been submitted to a peer review journal. The Abstract can be viewed on the ASCO (Free ASCO Whitepaper) website at View Source

Reference data1 JCRI Discovers the Mechanism using Canady Helios Cold Plasma to Induce Cell Death in Breast Cancer

For more information about the CHCP clinical trial and USMI’s innovative medical technologies, please visit ClinicalTrials.gov identifier: NCT04267575.

On June 15, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, reported the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML) (Press release, InnoCare Pharma, JUN 15, 2023, View Source [SID1234632764]).

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"Orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in Chinese patients with r/r MZL."

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Oral Presentation

Orelabrutinib, a New-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma (MZL) (Abstract Number: Nr.283)

Professor Jun Zhu of Beijing Cancer Hospital said, "Orelabrutinib demonstrated high response rates with durable disease remission and was well tolerated in Chinese patients with r/r MZL."

The primary endpoint was overall response rate (ORR) assessed by an Independent Review Committee (IRC) based on the Lugano 2014 classification.

Among the enrolled Chinese patients, the majority had late-stage diseases, with the stage IV accounting for 75.9%. After a median follow-up of 22.3 months, the IRC-assessed ORR was 57.8%, and median duration of response (DoR) and median progression-free survival (PFS) was 34.3 months and 36.0 months respectively. The 12-month PFS rate was 84.3% and the rate of overall survival (OS) was 91.5% at 12 months.

Treatment was well tolerated with most treatment-related adverse events (TRAE) being grade 1 or 2.

Online Publication

Orelabrutinib-lenalidomide-rituximab in patients with untreated mantle cell lymphoma (MCL): a prospective, multicenter, single-arm phase 2 POLARIS study in China (Abstract Number: Nr.600)

This study aimed to explore the efficacy and safety of orelabrutinib plus lenalidomide and rituximab in untreated MCL. The preliminary data indicated that the orelabrutinib plus lenalidomide and rituximab exerted synergistic antitumor activity, with a good safety profile in the treatment of MCL.

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25, 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of Phase II registrational trial for R/R MCL was completed in the U.S.

In addition, orelabrutinib’s global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) achieved proof of concept (PoC), and orelabrutinib’s phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) is ongoing in China.

On June 15, 2023 REVEAL GENOMICS, S.L., a Barcelona-based biotech start-up seeking to revolutionize precision oncology through diagnostic innovation, reported another validation of HER2DX, the world’s first specialized genomic test for HER2+ breast cancer (Press release, REVEAL GENOMICS, JUN 15, 2023, View Source [SID1234632762]). The results were obtained from analysis of HER2DX in tumor samples from the PHERGAIN phase II clinical trial, led by MEDSIR (Spain). Last year, REVEAL GENOMICS and MEDSIR announced a strategic partnership.

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MEDSIR´s PHERGAIN trial, the first results of which were published in the Lancet Oncology in 2021 and recently announced at ASCO (Free ASCO Whitepaper) Congress, randomized 356 patients with newly diagnosed HER2+ breast cancer to neoadjuvant systemic therapy with 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab (i.e., arm A) or 2 cycles of chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab (i.e., arm B). After 2 cycles of treatment in arm B, patients underwent a 18F-FDG-PET. If a metabolic response was observed, patients continued treatment with 6 additional cycles of chemotherapy-free dual HER2 blockade (i.e., a total of 8 cycles). If no metabolic response was observed by 18F-FDG-PET, patients received 6 cycles of multi-agent chemotherapy, trastuzumab, and pertuzumab. The co-primary endpoints were pathological complete response (pCR) rate after surgery following 8 cycles of chemotherapy-free dual HER2 blockade, and 3-year invasive disease-free survival (iDFS) of patients in arm B.

HER2DX genomic test was applied in 292 (82.0%) baseline pre-treatment tumor biopsies. The HER2DX pCR-score was found to be significantly associated with pCR, regardless of the treatment regime, 18F-FDG-PET metabolic response, and hormone receptor status. Despite a short median follow-up of 3.6 years, 85.0% and 100.0% of events were identified as high-risk according to the 2 pre-specified cutoffs of the HER2DX risk-score. In contrast, 98% and 100% of patients with HER2DX low-risk were disease-free at last follow-up, according to the 2 pre-specified cutoffs of the HER2DX risk-score.

"The results of HER2DX in PHERGAIN are remarkable and support the strong predictive and prognostic value of the test in patients with early-stage HER2+ breast cancer. The test will help to select which patients might be treated with trastuzumab and pertuzumab without chemotherapy, a treatment strategy with better quality of life than multi-agent chemotherapy," commented Dr. Antonio Llombart, Principal Investigator of the PHERGAIN trial, Co-founder of MEDSIR, and Head of the Medical Oncology Department at Hospital Arnau de Vilanova (Valencia, Spain).

Dr. Javier Cortés, Chief of the International Breast Cancer Center (IBCC, Spain) and Co-founder of MEDSIR, added, "Today’s positive results confirm the ability of the HER2DX scores to predict pCR and survival outcome following different anti-HER2-based treatments, including chemotherapy-free regimes. The test has extensive clinical validation across many studies and patients, and, in my opinion, should be recommended and included in clinical guidelines".

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS concluded, "Today’s positive results for HER2DX are a significant step forward for our company. We look forward to continuing to work with healthcare payers and providers to make this test reimbursed and available worldwide."

Detailed results of this study will be presented at a future medical congress and submitted for publication.

About the HER2DX test
HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX️ is a prognostic, predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient to respond to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About HER2+ breast cancer
HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically, and biologically heterogeneous, and standard clinical-pathologic assessment is not sufficient to capture this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

On June 15, 2023 Biostar Pharma, Inc. (hereinafter referred to as "Biostar"), the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that, after having in-depth discussions with the FDA through pre-IND meetings, the FDA has approved the IND of a phase 2/3 clinical trial with seamless protocol design for the company’s core product utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Biostar, JUN 15, 2023, View Source [SID1234632760]).

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Designated as BG01-2202, this trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable (UTD1) versus docetaxel. The study is going to be conducted at about 50 sites in about 10 countries and regions across US, Europe and Asia -Pacific. About 760 patients are planned to be enrolled, 90 for phase 2 with ORR (objective response rate) as the primary endpoint and 670 for phase 3 with OS (overall survival) as the primary endpoint and PFS (progression free survival), ORR, etc. as the secondary endpoints.

Dr. Li Tang, Chairman of Biostar Pharma commented: "This is an important milestone for global development of utidelone injectable — an innovative anti-cancer drug and new generation epothilone analogue. We are fully committed to advancing this pivotal multi-national study and also willing to partner with global pharmaceutical companies to bring this product to market around the world to benefit more patients".

This study was warranted by a previous open-label, multi-center phase 2 trial conducted in China (NCT03693547) of utidelone as single-agent to treat patients with advanced NSCLC who had received at least two prior systemic regimens including platinum-containing chemotherapy or targeted therapy, which demonstrated promising clinical efficacy and manageable safety profile with outcomes of 19.0% ORR, 81.0% DCR (disease control rate), 4.37 months of median PFS and 71% of 12-month OS rate. The median OS was not reached by the cut-off date. The results were selected by 2022 ELCC (European Lung Cancer Congress) as poster presentation. A phase 3 study to evaluate utidelone versus docetaxel in locally advanced or metastatic NSCLC patients that have failed chemotherapy with a platinum-containing regimen has also been initiated and being in progress now in China.

Unmet Medical Need

Lung cancer remains the leading cause of cancer death worldwide [1]. NSCLC accounts for about 85% of lung cancer cases [2,3] and more than 75% of patients with lung cancer are diagnosed with locally advanced or stage IV disease [4]. Although currently targeted therapies and/or immunotherapies are commonly used for advanced NSCLC, limitations are obvious. Many patients either do not have a targetable driver gene alteration or are not suitable for immunotherapy [5,6]. Besides, acquired resistance to targeted- and immune-therapy is a substantial problem. In this case, chemotherapy, such as platinum- and taxane-based regimens, remains the fundamental treatment. However, acquired resistance to standard chemotherapies still presents challenges, which may limit their efficacy [7,8]. There is a huge unmet clinical need for alternative chemotherapeutic agents that can overcome, or are less susceptible to, drug resistance and have clinical efficacy in heavily pretreated patients.

About Utidelone

Being derived from Biostar’s synthetic biology technology platform, utidelone is a genetically engineered best-in-class epothilone analog, which is a class of microtubule-targeting agent that has differential mechanisms of action from taxanes and is developed to overcome drug resistance. Utidelone injectable has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. Relevant study results were twice selected for oral presentations at ASCO (Free ASCO Whitepaper) annual meetings and invited to publish in Lancet Oncology and Annals of Oncology.