1stOncology™: Cancer Intelligence Service – Page 13969 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Celyad to Present Update on allogeneic and autologous NKG2D-based CAR-T Candidates in Refractory mCRC at ESMO 21st World GI Congress

On April 17, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, APR 17, 2019, View Source [SID1234535199]).

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!

"We are delighted for the opportunity to present updated data at the upcoming WCGIC from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of refractory metastatic colorectal cancer" noted Frédéric Lehmann, Head of Global Clinical Development and Medical Affairs at Celyad. "We continue to build upon our clinical experience in the treatment of solid tumors with these novel immunotherapies and the oral presentation at WCGIC represents a special milestone to highlight preliminary data from the industry’s first trial investigating an ‘off-the-shelf ‘ CAR-T candidate for the treatment of solid tumors. In addition, the comparable trial designs between SHRINK and alloSHRINK as well as the similar CAR constructs provide insight into autologous and allogeneic approaches in an advanced solid tumor indication."

Presentation Details:

Abstract #631: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Session: Short Oral Presentation

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.

Affimed Provides Regulatory Update on AFM11 Clinical Program

On April 17, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that it has submitted to the U.S. Food and Drug Administration (FDA) additional information to Affimed’s initial response document submitted in early March relating to the previously-announced clinical hold on AFM11 (Press release, Affimed, APR 17, 2019, View Source [SID1234535196]). The additional information addresses the request from the FDA for the clinical trial protocol for the study of AFM11 for treatment of acute lymphocytic leukemia (ALL). Affimed anticipates receiving a response from the FDA regarding the status of the AFM11 clinical program in the second quarter of 2019.

Moleculin Announces Significant Discovery in Lung Cancer Models

On April 17, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that its ongoing sponsored research at The University of Texas MD Anderson Cancer Center has now demonstrated that Annamycin is able to significantly improve survival in an aggressive form of triple negative breast cancer metastasized to the lungs in animal models (Press release, Moleculin, APR 17, 2019, View Source [SID1234535193]).

"We know that Annamycin was previously shown to be significantly more potent than doxorubicin in both Lewis lung carcinoma in vivo and small cell lung cancer in vitro models," commented Walter Klemp, Moleculin’s Chairman and CEO. "Now we are seeing significant activity against triple negative breast cancer that has metastasized to the lungs. This particular animal model used in our testing is considered to represent a very aggressive form of cancer. We believe our success in increasing the survival rate in mice with this tumor model in combination with the previously observed high uptake of Annamycin by the lungs is a promising indication that supports additional clinical research in lung and metastatic lung cancers."

CASI PHARMACEUTICALS IN-LICENSES EXCLUSIVE WORLDWIDE RIGHTS TO NOVEL ANTI-CD38 MONOCLONAL ANTIBODY PROGRAM FROM BLACK BELT THERAPEUTICS

On April 17, 2019 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. pharmaceutical company with a platform to develop and accelerate the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, reported the signing of a license agreement for exclusive worldwide rights to the investigational anti-CD38 monoclonal antibody (Mab) TSK011010 program from Black Belt Therapeutics Limited (Press release, CASI Pharmaceuticals, APR 17, 2019, View Source [SID1234535187]).

Under the terms of the agreement, CASI has obtained global rights to TSK011010 for an upfront payment of 5 million euros and an equity investment of 2 million euros, as well as certain milestone and royalty payments. The equity investment will be made in a newly established company of Black Belt Therapeutics focusing on novel immuno-oncology targets. CASI will be responsible for all development and commercialization activities of the TSK011010 program.

TSK011010 is at the IND/IMPD submission stage of development, with Phase 1 trials expected to start in late 2019/early 2020. Preclinical data demonstrate TSK011010 to have enhanced activity against a broad array of malignancies which express CD38 and potentially better safety when compared to other CD38 Mabs.

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "This license agreement for TSK011010 is very exciting because based on preclinical data, we believe this molecule has the potential to be best in class and will hopefully translate into meaningful clinical benefits for patients with CD38 malignancies, including multiple myeloma. The addition of TSK011010 to our portfolio provides CASI the opportunity to offer a range of therapeutic options for the treatment of hematologic malignancies."

Alexander Zukiwski, M.D., CASI’s Chief Medical Officer commented, "The preclinical data for TSK011010 targeting multiple myeloma has shown impressive results thus far and seems to outperform other anti-CD38 Mabs. We are enthusiastic and look forward to the clinical development for this novel biological entity as a potential treatment for patients with hematological malignancies, such as multiple myeloma."

About CD-38 Mab TSK011010

Anti-CD38 Mab TSK011010 is a fully human IgG1 monoclonal antibody that recognizes a unique epitope on CD38. It has demonstrated potent CD38+ cell killing, and was designed to directly activate effector T cells and NK cells. In preclinical studies it has demonstrated immune effector mechanisms with strong antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC) activity. GLP IND-enabling studies have been completed and IND/IMPD submissions are planned for 2019.

Intensity Therapeutics Receives Fast Track Designation from U.S. FDA for Development of INT230-6 as Treatment for Relapsed or Metastatic Triple Negative Breast Cancer

On April 17, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company pioneering a novel, immune-based approach to treat solid tumor cancers through direct injection of its proprietary therapeutic agents, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy (Press release, Intensity Therapeutics, APR 17, 2019, View Source [SID1234535185]).

"We are extremely pleased to receive this Fast Track designation, which validates the potential of INT230-6 to treat patients with relapsed or metastatic triple negative breast cancer as a single agent," said Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Finding improved therapies for this disease is a critical unmet medical need, and we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication."

Approximately 15-20% of breast cancers test negative for estrogen receptors, progesterone receptors, and excess HER2 protein, qualifying them as triple negative. TNBC is considered to be more aggressive and have a poorer prognosis than other types of breast cancer, mainly because there are fewer targeted medicines. According to a study published in the Journal of Clinical Oncology, patients who fail two lines of therapy for TNBC typically progress within nine weeks. Those who have failed three lines progress within four weeks.

"This important regulatory designation is based on the promising data observed to date from use of INT230-6 in our breast cancer research," said Ian B. Walters, M.D., Chief Medical Officer of Intensity Therapeutics. "The Fast Track designation will allow us to engage robustly with the Agency to most effectively and efficiently develop our new cancer treatment approach, as well as help us determine other potential indications to pursue for INT230-6. To date, our ongoing Phase 1/2 trial has treated patients with more than 14 different types of advanced solid tumors including TNBC, and we look forward to evaluating use of INT230-6 in other areas for potential registration-enabling studies."

The FDA’s Fast Track program facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantage over available therapy. Fast Track designation allows early and frequent communication between the FDA and a drug company, often leading to earlier drug approval and access by patients. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.