On June 17, 2021 KIYATEC, Inc. reported the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients (Press release, KIYATEC, JUN 17, 2021, View Source [SID1234584163]). The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances1, an open access clinical journal.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict Glioma assay.

The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

"Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment," said Matthew Gevaert, PhD, CEO of KIYATEC.

Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

On June 17, 2021 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Bevacizumab, pursuant to Section 351(k) pathway of the Public Health Service Act, and with a standard review goal date in the second quarter of 2022 according to the BsUFA (Biosimilar User Fee Act) (Press release, Amneal Pharmaceuticals, JUN 17, 2021, View Source [SID1234584162]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The biosimilar was developed in collaboration with mAbxience, a Spain-based biotechnology company. Bevacizumab is the biosimilar version of Avastin and when approved will be marketed under the proprietary name AlymsysTM. Alymsys was approved by the European Medicines Agency (EMA) in February 2021. Amneal and mAbxience believe that the data supports the biosimilarity of its AlymsysTM product to Avastin.

"The FDA’s acceptance of our BLA for Bevacizumab is a significant milestone in our journey to become an important player in biosimilars," stated Chirag and Chintu Patel, Co-Chief Executive Officers. As previously announced, the Company expects its initial biosimilar portfolio will include Filgrastim (biosimilar for Neupogen), Pegfilgrastim (biosimilar for Neulasta) and Bevacizumab (biosimilar for Avastin).

Bevacizumab is a vascular endothelial growth factor inhibitor. Amneal is seeking approval for Bevacizumab for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment and metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first line Alymsys-containing regimen. Amneal also intends to seek approval for the remainder of the indications from the reference product label as soon as possible, subject to patent and regulatory exclusivities, by the biosimilarity pathway pursuant to Section 351(k).

According to IQVIA, a leading healthcare data and analytics provider, U.S. annual sales for Bevacizumab for the 12 months ended April 2021 were approximately $2.8 billion.

On June 17, 2021 Cullgen Inc., a leading biotechnology company developing small molecule therapeutics based on its proprietary uSMITE platform of targeted protein degradation technology, reported that Drs. Jian Jin and Yue Xiong, co-founders of Cullgen, have published a review of targeted protein degradation technology as well as a comprehensive summary of degraders in development for the treatment of cancer in the prestigious journal, Nature Reviews Cancer (Press release, Cullgen, JUN 17, 2021, View Source [SID1234584161]). The article reviews the history and mechanism of targeted protein degradation, the ubiquitin-proteasome system, and the key principles required for design of heterobifunctional small-molecule degraders. The publication also contains an in-depth review of the current state and challenges associated with the use of common E3 ligands. The article is entitled "Advancing targeted protein degradation for cancer therapy". The complete publication can be found on-line here: View Source

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The use of targeted protein degradation principles by pharmaceutical companies has now become ubiquitous in drug development strategies", said Dr. Jin. "We are thrilled to see that forty years of research on the ubiquitin-proteasome system has made such a significant contribution to drug discovery", added Dr. Xiong, Cullgen’s Chief Scientific Officer. "We look forward to witnessing more targeted protein degraders entering human clinical trials in the near future".

"As pioneers in ubiquitin ligase and protein degradation field, the contributions of Drs. Jin and Xiong have positioned Cullgen as one of the leading companies in this revolution of drug discovery. Since the founding of Cullgen about three years ago, we have built an extensive therapeutic pipeline utilizing conventional and novel E3 ligands developed in house", said Ying Luo, Chairman and President of Cullgen. "Our co-founders’ visionary insights into the complicated ubiquitin-proteasome system provide Cullgen with a clear advantage in the development of the next generation of targeted therapies."

On June 17, 2021 Kiromic reported that it is being recognized as a pioneer of Gamma Delta T (GDT) cell therapy manufacturing and has been invited to present its off-the-shelf allogeneic CAR-T technology at the prestigious Gamma Delta T Cell Summit in July 2021 (Press release, Kiromic, JUN 17, 2021, View Source [SID1234584160]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

— April 2021. KRBP presented its manufacturing of GDT cells at the recent AACR (Free AACR Whitepaper) 2021 annual meeting.

— June 2021. KRBP received an invitation from the GDT cell summit organizers to present Kiromic’s technology.

— July 2021. KRBP will present at the GDT Cell summit.

— 3Q 2021. Projected First In-Human dosing for solid tumors.

Early clinical data is starting to come in. The excitement is building. The race is on.

The Annual Gamma Delta T Therapies Summit is gathering the world leaders in Gamma Delta T therapies who will harness GDT cells and bring to market the first effective, allogeneic GDT cell therapy for solid tumors. Gamma Delta T-cell Summit Link: View Source

Chief Executive Officer of Kiromic, Maurizio Chiriva-Internati, DBSc, PhDs, stated:

"We are developing what we believe is ground-breaking innovative technologies and have demonstrated that our chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicity.

This invitation to present at the July conference is a recognition of our progress and we are grateful for this opportunity.

GDT cell manufacturing has been a challenge for the cell therapy space.

At this conference, we will be reviewing how we have faced the challenges of cell extraction, cell gene edits, manufacturing yields, and product purity."

Chief Operating & Manufacturing Officer of Kiromic, Ignacio Núñez comments:

"Our end-to-end operations organization, including manufacturing, supply chain, QA, QC and compliance continues the preparation and readiness for Phase 1 of the clinical trials targeted for 3Q 2021.

Our operations team is growing, incorporating industry veterans with exceptional cell and gene therapy experience.

We are excited with the launch of this high performing team and a revolutionary process around a continuous improvement mindset."

Chief Strategy and Innovation of Kiromic, Gianluca Rotino, stated:

"The GDT cell industry is taking notice of our progress, and as such our GDT cell technology will be the exclusive domain of Kiromic for years to come."

——————————————————

About Kiromic Scientific Posters Presented at AACR (Free AACR Whitepaper) 2021

Session

PO.IM02.01

Focus

Adoptive Cell Therapy

Poster No.

LB148

Link to AACR (Free AACR Whitepaper) Poster

Gamma delta T cells engineered with a chimeric PD-1 receptor effectively control PD-L1 positive tumors in vitro and in vivo with minimal toxicities.

Take Away

Chimeric PD-1 (chPD1)

Demonstrated that Kiromic’s chPD1 receptor was effective on solid tumors in both in vitro and in vivo models with minimal toxicity.

Previous Press Release:

Kiromic announces 6 posters presented at AACR (Free AACR Whitepaper) 2021 showcasing our Artificial Intelligence (AI) Biomarker engine

About AACR (Free AACR Whitepaper) (American Association of Cancer Research)

On June 17, 2021 PanTher Therapeutics (PanTher), a privately held oncology company revolutionizing the treatment of solid tumors through direct, localized, and sustained delivery of proven and novel therapeutic agents, reported that it has closed an oversubscribed $5.4M Series A round led by Catalyst Health Ventures (CHV), with participation by Angel Physicians Fund (APF) and other notable investors (Press release, PanTher Therapeutics, JUN 17, 2021, View Source [SID1234584159]). The Series A round brings the total amount raised by the company to $7.4M.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Proceeds from the funding will go toward the company’s first-in-human clinical trial. The company also announced today the additions of Darshana Zaveri, Managing Partner at CHV, Manish Bhandari, Managing Partner at APF, and Maria Palasis, President and CEO of Lyra Therapeutics, to its board of directors.

PanTher’s novel approach empowers oncologists to treat patients with life-threatening cancers by unlocking a drug’s full potential through direct, sustained treatment at the tumor site. The company’s proprietary platform is based on technology that was developed at the Massachusetts Institute of Technology (MIT) and was subsequently in-licensed by PanTher.

PanTher’s lead candidate is designed to control tumor progression in pancreatic cancer and improve survival rates, and it is easily integrated into a commonly used, minimally invasive staging procedure. PanTher’s platform technology can be adapted to treat additional solid tumor indications.

"The close of this Series A further establishes PanTher’s growth to a clinical-stage company, and our new board members reinforce our depth of knowledge and experience as we continue to build a collaborative and results-oriented culture," said Laura Indolfi, CEO and Co-Founder of PanTher Therapeutics. "It also allows us to continue investigating the potential of using our highly adaptable platform to treat other indications and exploring optimal localized cancer therapies for each of those indications."

"PanTher represents a truly new therapeutic modality that has the potential to change the way we deliver lifesaving drugs to tumors," noted Zaveri. "There is a clear, identifiable, unmet need in the treatment paradigm for patients with solid tumors, including tumors associated with pancreatic cancer, which is one of the most lethal and hardest-to-treat cancers."

"It is exciting to be part of a company whose technology is designed to produce better outcomes for cancer patients," said Palasis. "I am looking forward to collaborating with such a talented team of experts to advance new ways to effectively target chemotherapeutic drug therapy and reduce the toxicity and debilitating side effects that chemotherapy agents can produce when administered through traditional systemic intravenous or oral routes."