Celyad's Positive Data And Other News: The Good, Bad And Ugly Of Biopharma (OTCMKTS:CYADY)

Summary

Celyad reports positive data for allogenic CAR-T.
Sanofi is approved in the EU for Sarclisa in Multiple Myeloma.
Agenus gets IND for its Covid-19 iNKT therapy.
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Celyad Reports Positive Update on Non Gene Edited Allogeneic CAR-T Therapy

Celyad (CYAD) announced update for its Phase 1 clinical trial alloSHRINK. The trial aims to assess the potential of its lead drug candidate CYAD-101 for patients suffering from metastatic colorectal cancer. It enrolled 15 patients with relapsed/refractory mCRC who progressed after chemo. Each patient was administered three consecutive doses of CYAD-101 concurrently with FOLFOX chemo.

The trial evaluated three consecutive dose levels of the drug candidate. The mean number of prior therapies received by patients enrolled in the trial were three and absolute number ranged between one and six. The patients were administrated the drug from a single cell bank which was generated in advance using two manufacturing runs. Each run was undertaken using fraction of an apheresis from a single healthy donor. The trial observed encouraging anti-tumor activity in two patients who achieved a confirmed partial response as per RECIST 1.1 criteria. One of the patients had KRAS-mutation, which is the most common oncogenic alteration found in all human cancers.

The trial did not find any correlation between clinical responses and the degree of human leukocyte antigen matching between patients and CYAD-101 donor cells. This finding implied that the drug candidate may be used in broad range of patient population irrespective of their HLA haplotype. Dr. David Gilham, CSO of Celyad said, “Preclinical data reported during ASCO over the past few days confirm the ability of a single shRNA hairpin to provide prolonged TCR knockdown, which our first shRNA-based allogeneic candidate, CYAD-211. In addition, the data demonstrated the breadth and depth of the shRNA platform, including the concurrent knockdown of up to four genes.” The company believes that its CYAD-200 series of CAR-T candidates has strong potential ahead.

The trial did not observe any clinical evidence of Graft Vs. Host Disease after 44 injections of CYAD-101. The company stated that the data confirms the ability of TIM to diminish signaling of the TCR complex using a non-gene edited approach. The treatment was also found to be well tolerated. Seven patients at least one treatment related adverse event including one patients suffering from grade 1 cytokine release syndrome. However, the events were of grade 1 or 2. No patient had to discontinue the treatment due to AEs.

Celyad now plans to have an expansion cohort to assess the drug candidate following FOLFIRI preconditioning chemotherapy in refractory mCRC patients. The dosage has been recommended at one billion cells per infusion. The company expects to start the enrollment in the expansion cohort of the trial during the fourth quarter of 2020.

Celyad had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology. Horizon’s SMARTvector technology was used for knocking down the TCR complex in allogeneic CAR-T therapies. It was also used for targeting a wide range of proteins. The technology is helpful in expressing shRNA. The continued preclinical evaluation of the shRNA platform has demonstrated the feasibility of the concurrent knockdown of four genes using an optimized framework.

Sanofi Receives EU Approval of Sarclisa for Multiple Myeloma

Sanofi (SNY) reported that its Sarclisa has received the European Commission approval to be used in conjunction with existing standard of care treatment in adults with relapsed/refractory multiple myeloma. The company had used positive data collected from the Phase 3 ICARIA-MM trial for backing its application. In March, 2020, the company had received a positive opinion from the Committee for Medicinal Products for Human Use.

ICARIA-MM trial assessed the potential of the drug candidate in conjunction with pomalidomide and low-dose dexamethasone. The data showed that the combination demonstrated significant reduction in the risk of disease progression or death in adults by 40%. The median PFS for patients treated with the combination stood at 11.5 months, in comparison to median PFS of 6.5 months for patients on pom-dex alone.

The trial showed that the most frequent adverse reactions observed included neutropenia, infusion reactions and upper respiratory tract infection among others. The most frequent serious adverse reactions were pneumonia and febrile neutropenia. John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi said, “The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment.”

Sarclisa is a mAb which works by binding to a specific epitope on the CD38 receptor, found to be highly and uniformly expressed on MM cells. The drug candidate is already approved in the United States, Canada, Australia and Switzerland for use in combination with pom-dex for treating certain adults suffering from relapsed refractory MM. Sarclisa is currently being evaluated in multiple Phase 3 clinical trials for different condition on the MM treatment continuum. It also being assessed for treating other solid tumors and hematologic malignancies.

Agenus Receives FDA Clearance for iNKT Cells IND Application

Agenus (AGEN) reported that the FDA has given its clearance to the Investigational New Drug application for iNKT therapy for treating COVID 19 patients. The company plans to initiate a clinical trial in the near future. The drug candidate AgenT-797 is being tested as a potential therapy for patients suffering from moderate to severe respiratory distress caused by COVID-19.

The application for AgenT-797 has been filed by AgenTus Therapeutics, a subsidiary of Agenus. The company mainly focuses on developing unique allogeneic cell therapies. Its allogeneic iNKTs do not require any type of genetic manipulation. These are produced following GMP conditions and are capable of being manufactured in large quantities. Due to this property and other features, these iNKTs may prove to be more cost efficient than existing cell therapies. Further, these iNKTs may be used in conjunction with lipid ligand or with immune checkpoint antibodies.

Source: Company Website

Allogeneic iNKT cells when combined unmodified and modified with engineered receptors, such as Chimeric Antigen Receptors (CARS) and T cell receptors (TCRs), may help supercharge the human immune system cells to find and wipe out cancer. Koen van Besien, M.D., Ph.D., Professor of Medicine and Director of the Stem Cell Transplant program at Weill Cornell Medical Center and New York Presbyterian Hospital said, "The preclinical data reveal the potential of iNKTs to eliminate virus, dampen harmful inflammation, and promote protection from reinfection. These are all particularly important features as we attempt to overcome COVID-19." The drug candidate has already received the FDA clearance of the IND for treating patients with cancer.

Agenus is currently mulling different options for its subsidiary company AgenTus Therapeutics. Among various options are the possibility of spinning out the subsidiary and issue a portion of the holding to the shareholders as stock dividend. The company is expected to take a decision in this regard by the end of this year.

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