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

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"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]).

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— 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."

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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.

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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."

On June 17, 2021 The Children’s Oncology Group (COG), the world’s largest organization devoted exclusively to childhood and adolescent cancer research, and Signify Health, Inc. (NYSE:SGFY), a leading platform that leverages advanced analytics, technology and nationwide healthcare provider networks, reported a partnership to facilitate clinical trial participation for pediatric patients through in-home clinical services (Press release, Children’s Oncology Group, JUN 17, 2021, View Source [SID1234584158]).

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Through this new collaboration, pediatric patients participating in COG Study AALL1731, a clinical trial for a therapy to treat B-cell acute lymphoblastic leukemia (B-ALL), now have expanded options to facilitate receipt of experimental treatment at home. Participating in clinical trials that involve infusion therapies can be challenging for families because infusions require a credentialed provider to administer them, and because home health agencies are unable to bill insurance for investigational therapies.

AALL1731 (NCT03914625) is sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement (CRADA) with Amgen, and is currently open at 195 U.S. COG sites. This in-home infusion service is for the patients assigned to receive blinatumomab on AALL1731 who are unable to access outpatient pumps and homecare. Amgen has provided funding to NCI under the CRADA to support more pediatric patients to receive blinatumomab at home.

B-ALL is the most prevalent childhood cancer, representing 20% of diagnoses in children younger than 15 years old and is the leading disease-related cause of death for children ages one to 19. Although improved treatments have led to higher survival rates for children with B-ALL, approximately 15% of children will have their leukemia return after remission is achieved. More effective treatment is needed for these children. Promising new therapies have the potential to alter the course of disease progression and removing barriers to participating in clinical trial programs is a primary focus for researchers and drug sponsors.

"This collaboration to provide in-home clinical services will allow more children to spend time at home receiving the investigational therapy while enabling much-needed research to deliver safer, and hopefully more effective therapies," said Mignon Loh, M.D., Chair of the COG ALL Committee. "A decentralized clinical trial approach will relieve unnecessary stress on families who are struggling financially and emotionally from their child’s cancer diagnosis. We hope that home access to investigational agents will increase participation in these important clinical trials."

Signify Health’s home-based clinical support services can help patients initiate investigational and approved therapies faster, improve their adherence, and provide a better overall experience for patients and families. Signify Health’s national network of credentialed clinicians will provide in-home infusion pumps and infusion bag changes to pediatric patients who have requested the in-home alternative. Signify clinicians will document patient metrics in real-time and be on call for the first 24 hours after a bag change to address any potential pump malfunctions.

"There is no better use of our network than to help children with cancer access potentially life-changing therapies," said Kyle Armbrester, CEO of Signify Health. "By activating the home as an alternate site of care, we hope to alleviate some of the burden and stress for families so that they can spend more time and energy focusing on what matters most."

On June 17, 2021 Mevion Medical Systems reported the upgrade of the MEVION S250 Proton Therapy System at the S. Lee Kling Proton Therapy Center at Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, MO, to a MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning and FLASH capabilities (Press release, Mevion Medical Systems, JUN 17, 2021, View Source [SID1234584157]). Originally installed and treating patients since 2013, the MEVION S250 was the first compact proton therapy system in the world.

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"This upgrade strengthens our commitment to provide the most up to date proton technology to cancer centers and their patients," said Tina Yu, CEO of Mevion. "We are delighted to continue a collaboration with our longest clinically operational collaborator for many years to come."

The S. Lee Kling Proton Therapy Center features two independent Mevion proton therapy systems, each with its own dedicated compact accelerator. The system upgrade will enable the center to offer Mevion’s industry leading HYPERSCAN Pencil Beam Scanning on both systems. HYPERSCAN enables faster and sharper delivery of therapeutic radiation to tumors while sparing healthy tissue. FLASH*, a non-invasive, ultra-high dose rate technique delivering treatments in less than one second, may dramatically improve the cancer-fighting benefits of therapeutic radiation by shortening treatment courses and lessening side effects.

The purchase agreement with Barnes-Jewish Hospital was signed in December 2020 and received Certificate of Need Approval in March 2021. The upgraded room is scheduled to be put into service in 2022.

As the leading supplier of compact proton therapy systems in the United States, Mevion has been selected by more leading cancer centers, including NCI-Designated Cancer Centers, and has treated over 6,000 patients worldwide. Mevion’s leading-edge clinical capabilities, combined with its compact, affordable design, and industry-leading ramp-up time, have changed the landscape of proton therapy.

*FLASH Therapy is currently under preclinical research and is not yet available for commercial sale or clinical use.