On May 21, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported its collaboration with the American Skin Association to provide a 2021 research grant in the area of melanoma (Press release, Castle Biosciences, MAY 21, 2021, View Source [SID1234580452]).

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The ASA Castle Biosciences Research Grant Melanoma was awarded to Joel Sunshine, M.D., Ph.D., assistant professor at The Johns Hopkins University School of Medicine. The grant will support Dr. Sunshine’s research study entitled "mRNA Nanoparticle Vaccination for Melanoma Immunotherapy."

"These crucial grants in support of cutting-edge dermatological research will improve the chances of finding long sought-after cures and bring hope to those suffering from these devastating illnesses," said ASA Chairman, Howard P. Milstein.

"At Castle, our main focus is to improve the lives of patients with dermatologic diseases," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are proud to recognize and support research in new technology that stands to make meaningful advances in the area of skin cancer. Melanoma remains largely unexplored with respect to the disease’s behavior in response to targeted immunotherapies. With that in mind, we are thrilled to support Dr. Sunshine and his group in pursuing an immunotherapy approach to melanoma."

ASA’s grant program is steered by leading scientists and physicians to support talented researchers, ranging from talented investigators in the early phases of their careers to recognized leaders in the field of dermatology. In particular, ASA-funded researchers have had a broad impact on melanoma research, improving our understanding of its diagnosis, treatment and prognosis. For over thirty years, ASA and its affiliates have funded over $50 million in grants to enhance treatments and continue working toward cures for melanoma, vitiligo, psoriasis, atopic dermatitis and other skin diseases.

On May 21, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy (Press release, Johnson & Johnson, MAY 21, 2021, View Source [SID1234580437]).[1] RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.1,[2] Today’s approval follows the FDA’s decision to grant Breakthrough Therapy Designation (BTD) in March 2020 and to initiate a Priority Review of the Biologics License Application (BLA) in December 2020. This indication is approved under accelerated approval based on overall response rate and duration of response.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1

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"Today’s FDA approval is an important development for people living with non-small cell lung cancer with exon 20 insertion mutations who, until now, have had no approved treatment options to target their disease," said Jill Feldman, co-founder of the EGFR Resisters, an advocacy organization patient group, and a lung cancer patient advocate. "We are excited by the promise this new treatment option brings to people with this particular type of lung cancer and their families."

Lung cancer is the leading cause of cancer death among both men and women, accounting for almost 25 percent of all cancer deaths.[3] Currently available targeted treatments, like EGFR tyrosine kinase inhibitors (TKI) are generally insensitive in treating NSCLC driven by EGFR exon 20 insertion mutations and are not FDA-approved for these patients.[4],[5],[6] In addition, NSCLC driven by this mutation carries a worse prognosis and shorter survival rates compared with lung cancer driven by more common EGFR mutations, such as exon 19 deletions and L858R substitutions.[7],[8] Patients newly diagnosed with metastatic NSCLC with EGFR exon 20 insertion mutations have a real-world median overall survival (OS) of 16.2 months (95 percent confidence interval [CI], 11.0 – 19.4), which is lower than patients with EGFR exon 19 deletions/L858R mutations, who have a real-world median OS of 25.5 months (95 percent CI, 24.5 – 27.0).[9]

"Lung cancer is a complex disease, and through the study and deeper understanding of genetic alterations like EGFR exon 20 insertion mutations, we are able to target the disease in new ways and improve treatment outcomes for patients," said Joshua K. Sabari, M.D., New York University Langone’s Perlmutter Cancer Center and study investigator, who presented the latest clinical trial results at the International Association for the Study of Lung Cancer’s (IASLC WCLC) 2020 World Conference on Lung Cancer Singapore. "Amivantamab-vmjw is an innovative bispecific antibody that brings an important new therapeutic approach to physicians caring for patients with this serious and rare type of lung cancer."

RYBREVANTTM is a fully-human bispecific antibody directed against EGFR and MET receptors.1 RYBREVANTTM binds extracellularly (outside of the cell) inhibiting tumor growth and leading to tumor cell death.1 Today’s accelerated FDA approval is based on positive results from the Phase 1 CHRYSALIS study, a multicenter, open-label, clinical study evaluating RYBREVANTTM as a monotherapy in patients enrolled in the prior platinum containing chemotherapy cohort.1,[10] Initial results from the CHRYSALIS EGFR exon 20 insertion mutation population, which supported the BTD, were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, and updated results were presented at the IASLC WCLC 2020.

"The approval of RYBREVANT, along with the companion diagnostic test, addresses high unmet need in the treatment of people with genetically defined non-small cell lung cancer," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "At Janssen, we are committed to the development of innovative therapies like RYBREVANT and believe that advancing medicines targeting specific pathways can bring the greatest benefits and improve outcomes for patients with tumor alterations such as EGFR and MET."

The FDA simultaneously approved Guardant Health’s Guardant360 CDx liquid biopsy blood test as a companion diagnostic for use with RYBREVANTTM.

Next-generation sequencing tests offer an alternative to polymerase chain reaction (PCR)-based tests which fail to identify 50 percent or more of exon 20 insertion mutations.[11] Information on FDA-approved tests for the detection of EGFR genetic alterations in NSCLC is available at: View Source

"Today’s milestone reflects progress and determination in our mission to develop and deliver transformational therapies to improve the lives of people diagnosed with some of the most devastating and complex diseases of our time," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "The approval of RYBREVANT, the first lung cancer treatment for Johnson & Johnson, strengthens our commitment to harness science, expertise and scale to dramatically alter the trajectory of lung cancer, and reduce the impact of the world’s leading cause of cancer mortality."

About RYBREVANTTM
RYBREVANTTM is being studied in a comprehensive clinical development program for people with untreated advanced EGFR-mutated NSCLC, including the Phase 3 MARIPOSA (NCT04487080) trial studying RYBREVANTTM in combination with lazertinib**.[12] Another Phase 3 trial, PAPILLON (NCT04538664), is studying RYBREVANTTM in combination with carboplatin-pemetrexed for people with advanced or metastatic EGFR-mutated NSCLC with exon 20 insertion mutations.[13] RYBREVANTTM received U.S. FDA BTD in March 2020 and Priority Review Designation following the BLA announcement in December 2020.[14],[15] Janssen has filed regulatory submissions for RYBREVANTTM with health authorities in Europe and other markets.

**In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

About the CHRYSALIS Study
CHRYSALIS (NCT02609776) is a Phase 1 open-label, multicenter, first-in-human study to evaluate the safety, pharmacokinetics and preliminary efficacy of RYBREVANTTM as a monotherapy and in combinations including with lazertinib, a novel third-generation EGFR TKI[16], in adults with advanced NSCLC.10 The study consists of two parts: RYBREVANTTM monotherapy and combination-dose escalations and RYBREVANTTM monotherapy and combination-dose expansions.10

In the ongoing Phase 1 CHRYSALIS study, patients with locally advanced or metastatic NSCLC with EGFR Exon 20 insertion mutations weighing less than 80 kg received RYBREVANTTM 1050 mg and patients weighing at least 80 kg or more received RYBREVANTTM 1400 mg weekly for four weeks, with the initial dose as a split infusion in week 1 on day 1 and day 2, then administered every two weeks thereafter until disease progression or unacceptable toxicity.1 Disease response using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) as evaluated by Blinded Independent Central Review (BICR), was the primary endpoint.1 In the prior-platinum chemotherapy treated cohort (n=81), the confirmed ORR, as assessed by blinded independent central review, was 40 percent (95 percent CI, 29 – 51), with 3.7 percent having complete responses (CR) and 36 percent achieving partial responses (PR).1

Permanent discontinuation of RYBREVANTTM due to an adverse reaction (AE) occurred in 11 percent of patients who received RYBREVANTTM.1 AEs resulting in permanent discontinuation of RYBREVANTTM in greater than or equal to one percent of patients were pneumonia, infusion-related reactions (IRR), pneumonitis/interstitial lung disease (ILD) dyspnea, pleural effusion and rash.1 Dose interruptions of RYBREVANTTM due to AEs occurred in 78 percent of patients.1 IRR requiring infusions interruptions occurred in 59 percent of patients.1 Adverse reactions requiring dose interruption in greater than or equal to five percent of patients included dyspnea, nausea, rash, vomiting, fatigue and diarrhea.1 The most common AEs (greater than or equal to 20 percent) in patients who received RYBREVANTTM were rash (84 percent), IRR (64 percent), paronychia (50 percent), musculoskeletal pain (47 percent), dyspnea (37 percent), nausea (36 percent), fatigue (33 percent), edema (27 percent), stomatitis (26 percent), cough (25 percent), constipation (23 percent) and vomiting (22 percent).1

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.[17]

Access to RYBREVANTTM (amivantamab-vmjw)
Janssen offers comprehensive access and support information and resources to assist patients in gaining access to RYBREVANTTM. Janssen will work closely with payers and providers to ensure RYBREVANTTM is broadly accessible and affordable for people with NSCLC with EGFR exon 20 insertion mutations. Our comprehensive patient support program, Janssen CarePath, helps patients get started on RYBREVANTTM and stay on track. Janssen CarePath helps verify insurance coverage for patients, provides reimbursement information, helps find financial assistance options for eligible patients and provides ongoing support to help patients start and stay on RYBREVANTTM. If patients have commercial or private health insurance and need help paying for RYBREVANT, the Janssen CarePath Savings Program may be able to help. For more information, visit Rybrevant.JanssenCarePathSavings.com. If patients don’t have commercial or private health insurance, Janssen CarePath can provide information about other resources that may help with out-of-pocket medication costs. Learn more at JanssenCarePath.com/Rybrevant or call a Janssen CarePath Care Coordinator at 833-RYBREVANT (833-792-7382).

About Non-Small Cell Lung Cancer (NSCLC)
Worldwide, lung cancer is one of the most common cancers, and NSCLC makes up 80 to 85 percent of all lung cancers.[18],[19] The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.19 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.8 EGFR mutations are present in 10 to 15 percent8,11,[20],[21],[22] of people with NSCLC adenocarcinoma and occur in 40 to 50 percent of Asians.[23],[24] The five-year survival rate for all people with metastatic NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.[25],[26] EGFR exon 20 insertion mutations are the third most prevalent activating EGFR mutation.2 Patients with EGFR exon 20 insertion mutations have a real-world five-year OS of 8 percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world five-year OS of 19 percent.9

RYBREVANT IMPORTANT SAFETY INFORMATION1

WARNINGS AND PRECAUTIONS
Infusion Related Reactions1
RYBREVANT can cause infusion related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting.

Based on the safety population, IRR occurred in 66% of patients treated with RYBREVANT. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62% and 1.3% of patients permanently discontinued RYBREVANT due to IRR.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2. Monitor patients for any signs and symptoms of infusion reactions during RYBREVANT infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity.

Interstitial Lung Disease/Pneumonitis1
RYBREVANT can cause interstitial lung disease (ILD)/pneumonitis. Based on the safety population, ILD/pneumonitis occurred in 3.3% of patients treated with RYBREVANT, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Dermatologic Adverse Reactions1
RYBREVANT can cause rash (including dermatitis acneiform), pruritus and dry skin. Based on the safety population, rash occurred in 74% of patients treated with RYBREVANT, including Grade 3 rash in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% of patients, and RYBREVANT was permanently discontinued due to rash in 0.7% of patients.

Toxic epidermal necrolysis occurred in one patient (0.3%) treated with RYBREVANT.

Instruct patients to limit sun exposure during and for 2 months after treatment with RYBREVANT. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen. Alcohol free emollient cream is recommended for dry skin.

If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. Withhold, dose reduce or permanently discontinue RYBREVANT based on severity.

Ocular Toxicity1
RYBREVANT can cause ocular toxicity including keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, and uveitis. Based on the safety population, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients treated with RYBREVANT. All events were Grade 1-2. Promptly refer patients presenting with eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT based on severity.

Embryo Fetal Toxicity1
Based on its mechanism of action and findings from animal models, RYBREVANT can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during treatment and for 3 months after the final dose of RYBREVANT.

Adverse Reactions1
The most common adverse reactions (≥20%) were rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.

On May 21, 2021 Kiromic Biopharma, Inc. (Nasdaq: KRBP) is an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) reported that is used to develop novel oncology therapeutics (Press release, Kiromic, MAY 21, 2021, View Source [SID1234580453]).

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Kiromic is pleased to announce the identification of new targets for the treatment of solid tumors, identified through the application of its bioinformatics platform (CancerDiff and Diamond AI). These new targets include novel epitopes of NY-ESO-1 and a Cancer Selective Isoform Splice Variant of Mesothelin (Isomesothelin). Strikingly, in vitro, and in vivo experiments have demonstrated that the identified IsoMesothelin variant is an excellent target for specific and potent allogeneic CAR Gamma Delta T-cell therapy for solid tumors.

These preclinical results represent a key milestone in the development process of Kiromic and were showcased in 3 posters presented during the annual April 2021 American Association of Cancer Research meeting:

AACR Posters:
247

Identification of an Ovarian Cancer Selective Splice Variant of Mesothelin Utilizing the Kiromic Proprietary Search Engine CancerDiff

1534

Mesothelin Isoform 2 is a Novel Target for Allogeneic CAR Gamma Delta T-cell Therapy in Solid Tumors

243

Identification of Novel Epitopes of NY-ESO-1 for Solid Malignancies by Kiromic Proprietary Search Engine Diamond

Poster 247: Showcases how CancerDiff was validated and then used to predict the upregulation of IsoMSLN in ovarian cancer.

Technical
Capabilities

CancerDiff was able to:

— identify and validate a unique peptide isoform of mesothelin post transcription within 71% of ovarian cancer (OV) specimens, and

— confirmed the upregulation of IsoMSLN in Ovarian cancer.

What makes CancerDiff Special vs. nearest competition

These data sets derived from publicly available proteomic repositories were searched for their unique signature peptide variants that were expressed on the surface of cancer cells.

These datasets, from the clinical study "S038 Confirmatory Study performed at Johns Hopkins University", were downloaded from CPTAC (View Source).

Data originated from TMT10plex quantification for global proteomic profiling acquired with Orbitrap Fusion Lumos mass spectrometer.

13 datasets were analyzed, comprising 94 ovarian tumor and 23 ovarian normal tissue samples from the same group of ovarian cancer patients.

For data parsing and data quality control, data was processed by MS Biowork through the MaxQuant software v1.6.2.3 (www.maxquant.org) for recalibration of MS data, filtering of database search results at the 1% protein and peptide false discovery rate (FDR), calculation of reporter ion intensities (TMT), and isotopic correction of reporter ion intensities (TMT).

The identification of unique peptides such as the isoform of mesothelin is allowing us to specifically improve on these unique biomarkers.

Human labor required to yield equivalent results

Normally, this requires several scientists working for months to reach the same research conclusion.

Poster 1534: In collaboration with premier Institutions such as MD Anderson Cancer Center (MDACC) and Baylor Medical College we have validated our first target IsoMSLN and its monoclonal antibody specific binder expressed in indication-specific solid malignancies.

Technical
Capabilities

Using a bioinformatics platform (CancerDiff), we searched and analyzed for public gene expression databases

What makes CancerDiff Special vs. nearest competition

In our data mining, we were able to identify cancer-associated antigens caused by alternative splicing. One particular alternative splicing of interest is the isoform of mesothelin.

Isoform 1 is the predominant transcript detected in normal and tumor tissues and has been a promising target for cancer immunotherapy in the past. However, Isoform 2 is a minor transcript using alternatively spliced exons producing 8 additional amino acids compared to isoform 1.

For example, our data shows that isoform 2 of Mesothelin is selectively expressed in ovarian cancers but not in normal tissues.

This alternatively spliced isoform thus makes it an ideal target for incorporation into CAR-T cells.

In the past, this process to identify alternatively spliced forms of biomarkers would have taken multiple scientists several months to achieve the same results.

This poster shows for the first time the validation of the first target: An IsoMSLN monoclonal antibody specific binder for indication-specific solid malignancies such as ovarian cancer, pancreatic adenocarcinoma, and primary mesothelioma, validating the Anti-IsoMSLN CAR GDT cells as a specific and potent off-the-shelf tumor therapy.

(GDT: Gamma Delta T-cells)

Human labor required to yield equivalent results

Normally, this requires several scientists working for months to reach the same research conclusion.

Poster 243: As a validation of our Diamond AI algorithms, we used our Diamond AI algorithm to predict a well-known target like NY-ESO-1.

Technical
Capabilities

Using our proprietary software DIAMOND, Kiromic was able to:

— Perform a metanalyses of expression data

— Predict the immunogenicity of NY-ESO-1 peptides

Diamond AI’s findings were compared to published expression and immunogenicity data.

What makes this validation special

This poster validates the predictive value of DIAMOND algorithms, the meta-analyses of expression data of cancer-testis antigen New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) and predicts immunogenic peptides compared to experimental data in the literature.

In agreement with published clinical observations, DIAMOND metanalysis showed NY-ESO-1 genic overexpression in cutaneous melanoma, lung adenocarcinoma, and sarcoma.

Taken together these data support DIAMOND as a reliable platform for the discovery of new immunogenic targets for cancer therapy.

Human labor required to yield equivalent results

In the past, this calculation of peptide binding affinities to HLA molecules would have taken multiple scientists several months to achieve the same results.

CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs, stated:

"I am very proud to present an Artificial intelligence (AI) platform that can empower scientists and investors to directly leverage data and experiments for generating new ideas and formulate hypotheses.

This is the focus of Kiromic BioPharma (NASDAQ: KRBP), a pre-clinical stage biotechnology company that uses ‘Pragmatic creativity.’

Our novel approach consists of backing ideas with data that offer directional clues to react more effectively. Thanks to ten years of experience in developing AI technologies, we have been able to provide our scientists with the ability to democratize idea generation and get specific answers to specific problems.

Diamond’s ‘brain’ is equipped with a deep learning neural network technology, able to classify information from Kiromic’s Digital Library. This neural network technology is an extensive resource integrating clinical studies, genomic, and proteomic datasets. Diamond orchestrates all the raw data and produces new datasets for cancer target screening.

Diamond can also identify new genes (biomarkers, mutations, isoforms, neoepitopes, gene methylation status) highly and specifically expressed in targeted diseases. The software exploits its ‘intelligence’ to highlight these new genes across the entire patient population, mapping out the exact portion of the gene to elicit an immune response.

Additionally, Diamond can perform meta-analysis and convolution studies, integrating big data from experimental platforms, allowing an intuitive visualization of consistent and accurate results in a user-friendly fashion.

CancerDiff is differentiated by its user-friendly interface. The interface is a web-browser integrated suite, and once the user logs into the software, she/he can choose a starting analysis at ‘Tumor level,’ selecting the ‘Tumor Search’ check-box, and a popup menu with 38 cancers is provided.

We believe that Diamond is more accurate than other tools due to the implementation of robust statistics that compare healthy and pathologic gene expression. Other tools that utilize the TCGA database only provide information on healthy tissues. Moreover, Diamond offers a series of algorithms that single out the identified epitopes with a strong affinity for a given HLA haplotype, predicting how much those epitopes have an affinity for B and T cells.

Diamond is a powerful software that can accomplish several requests in the context of neoantigen discovery. The statistics implemented for the antigens identified are based on a weighted t-test conducted to compare the distributions of cancerous and healthy tissue expression data. The method is robust and effective.

We can do all of this through our integrated software: Diamond, and CancerSplice, solutions that are created ‘around’ scientists that require the ability to discover and explore new hypotheses based on supporting evidence in real-time. These powerful algorithms can quickly check an idea’s validity, with deeply applied methodological rigor, in real-time.

Our integrated software solution is how we have chosen to support critical business decisions concerning a therapeutic product, contributing to opening the possibility of better healthcare in the future."

CSIO of Kiromic, Mr. Gianluca Rotino, stated:

"With the results displayed in these three posters, Kiromic has demonstrated the ability to position itself among the leaders in the development and application of Artificial Intelligence in immunology and immunotherapy in general.

The competitive advantage is multiple and disruptive.

Just think of the identification and development time of a biomarker with or without artificial intelligence.

Identifying specific isoforms of a gene for at least 38 cancers, using a manual strategy, could be equivalent (but not wholly equivalent) to finding two identical telephone numbers, comparing 38 different phone books from 38 different US cities.

We should take into consideration the possibility of a permutation system that encompasses all the combinatorial possibilities to find two similar chunks of genes, with different lengths, found in all of these 38 books.

This type of finding would be equivalent to a human working for 7.6690286748 × 1026195 weeks. And just for a single biomarker.

Thanks to the application of our AI, these times and related costs are reduced to a few weeks of computing with a reduced need for full time employees.

However, we believe that our AI platform will not just give us a significant advantage in the discovery process, but we believe it will also power our clinical trials."

CFO of Kiromic, Mr. Tony Tontat, stated:

"Our drug discovery process has always had AI at its core.

Our investment and then our deployment of AI has allowed us to shorten the time required to reach our IND filing and, soon, our expected first-in-human clinical trial.

According to Reports.com market investments in AI in the Healthcare Market is expected to reach $8 Billion by 2022 with a CAGR of 52.68% (2017-2022).

We look forward to extending the lead in the market by continuing to invest in our AI technologies."

———————————-

About Kiromic Artificial Intelligence

Kiromic Artificial Intelligence System, is a modular multilayer system composed of two main modules:

CancerDiff and Diamond AI.

CancerDiff is a computational tool designed to identify the upregulation of splice variants of specific target genes at the RNA level. The software can identify new effective and specific tumor targets for immunotherapies which exist as tumor selective isoforms that have null or very low presence in healthy tissues. The identification of these isoforms allows the researcher to specifically address unique biomarker variants expressed on the surface of cancer cells. Thus, CancerDiff can improve biomarkers screening selection and gene-target therapies.

Diamond is a robust suite of algorithms platform which is able to mine public and proprietary genomic and proteomic databases and to use machine learning to identify targets for immunotherapy. Diamond can map the most immunogenic fragments of a protein and can predict the immunogenicity of peptides and to calculate their affinities to different HLA types. Specifically, Diamond can predict the processing of peptides, their HLA binding, and their ability to activate T and B cell response. Other available prediction platforms can rarely perform all of these with accuracy. For example, not all peptides that are presented by target cells can efficiently trigger immune response. Our system can identify peptides that can do both.

On May 21, 2021 Fresenius Kabi reported that Temsirolimus Injection, a drug used to treat advanced renal cell carcinoma, is now available in the United States (Press release, Fresenius, MAY 21, 2021, View Source [SID1234580438]). This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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On May 21, 2021 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, reported a poster presentation featuring data from the Company’s Phase 3 CONDOR study at the upcoming 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Meeting, which will be held from June 4-8, 2021 (Press release, Lantheus Medical Imaging, MAY 21, 2021, View Source [SID1234580454]).

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The presentation will be made available for the duration of conference.

Details for the ASCO (Free ASCO Whitepaper) presentation are as follows:

Session Title: Poster Session: Genitourinary Cancer – Prostate, Testicular and Penile
Title: PSMA-targeted imaging with 18F-DCFPyL-PET/CT in patients (pts) with biochemically recurrent prostate cancer (PCa): A phase 3 study (CONDOR)—A subanalysis of correct localization rate (CLR) and positive predictive value (PPV) by standard of truth.
Presenter: Frederic Pouliot, M.D., Ph.D., F.R.C.S.C., Centre Hospitalier Universitaire (CHU) de Québec-Université Laval
Abstract No: 5023