On August 19, 2021 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported financial results for the second quarter ended June 30, 2021 and highlighted recent corporate updates (Press release, Imago BioSciences, AUG 19, 2021, View Source [SID1234586752]).

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"2021 to date has been a transformative year for Imago BioSciences. We have made progress in advancing the clinical development of our lead product candidate bomedemstat for the treatment of blood cancers where the unmet medical need persists. Our growth was anchored by a number of key accomplishments, including our first report on the clinical activity of bomedemstat in essential thrombocythemia at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June, as well as an update from our Phase 2 24-week myelofibrosis trial which is now fully enrolled, expanding our team, and finally, the successful completion of our IPO in July," said Dr. Hugh Y. Rienhoff, Jr., M.D, chief executive officer of Imago BioSciences. "With this momentum, we look forward to continuing enrollment in our Phase 2 trial of bomedemstat in essential thrombocythemia, COVID permitting, and providing updates on both of these ongoing company-sponsored, clinical trials before year-end."

Recent Corporate Developments and Pipeline Updates

Expanded Executive Management Team: In May 2021, Imago appointed Wan-Jen Hong, M.D., as chief medical officer. Dr. Hong joins Imago after 7 years at Genentech, where she served as Group Medical Director in their late-stage clinical development group focused on hematologic oncology.
Completed Enrollment of Phase 2 Myelofibrosis Trial: In May 2021, Imago completed enrollment of 89 patients with advanced myelofibrosis in its Phase 2, 24 week clinical trial of bomedemstat.
Presented Data from Two Phase 2 Studies of Bomedemstat at 2021 European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress: In June 2021, Imago provided updates at the 2021 EHA (Free EHA Whitepaper) Virtual Congress on two Phase 2 clinical trials of bomedemstat, one in patients with essential thrombocythemia (ET) and the second in patients with advanced myelofibrosis (MF). The interim results demonstrate continued encouraging clinical activity and tolerability in these patient groups.
Received Orphan Designation for Bomedemstat in ET from EMA: In June 2021, Imago received orphan designation for bomedemstat for the treatment of essential thrombocythemia (ET) from the European Medicines Agency (EMA). Orphan designation by the EMA is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union.
Successful Completion of Initial Public Offering (IPO): In July 2021, Imago completed an initial public offering and concurrent private placement with Pfizer, resulting in gross proceeds of $174.6 million.
Second Quarter 2021 Financial Results

Cash and Cash Equivalents: As of June 30, 2021, Imago had cash, cash equivalents, restricted cash and short-term investments of $81.1 million. Cash as of June 30, 2021 excludes the net proceeds of approximately $163.7 million from the IPO and private placement, after deducting underwriting discounts and commissions of $10.8 million.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2021 were $7.1 million (including stock-based compensation expense of $0.1 million) as compared to $3.4 million for the same period in 2020. The overall increase in R&D expenses was primarily related to the Phase 2 clinical trial for ET, continued development of commercial material and material to support the ongoing and new clinical trials, and salaries and non-cash stock-based compensation expense for R&D employees as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2021 were $1.7 million (including stock-based compensation expense of $0.3 million) as compared to $0.6 million for the same period in 2020. The overall increase in G&A expenses was primarily driven by increasing costs in connection with our preparation to become a public company.
Net Loss: Net loss for the quarter ended June 30, 2021 was $8.8 million compared to $3.7 million for the same period in 2020.

On August 19, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported that positive interim clinical data from the Company’s FT516 and FT596 programs for patients with relapsed / refractory B-cell lymphoma (Press release, Fate Therapeutics, AUG 19, 2021, View Source [SID1234586751]). FT516 is the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. The Company’s FT596 program incorporates both the hnCD16 Fc receptor and a chimeric antigen receptor (CAR) targeting CD19, which is designed to enable multi-antigen targeting of tumor cells, as well as an IL-15 receptor fusion (IL-15RF) to enhance NK cell activity and survival.

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"We are very pleased with the interim safety, response rates, and durability of responses observed in our ongoing clinical studies of FT516 and FT596 for the treatment of patients with relapsed / refractory B-cell lymphomas. These data continue to demonstrate that our off-the-shelf, iPSC-derived NK cell product candidates can uniquely deliver substantial therapeutic benefit and expand patient access to cell-based cancer immunotherapies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "At this time, we are initiating multiple indication-specific, dose-expansion cohorts to broadly assess FT516 in combination with CD20-targeted monoclonal antibody regimens, including in patients that have experienced disease progression following autologous CD19-targeted CAR T-cell therapy. In addition, early clinical data with the single-dose FT596 treatment schedule have shown robust 30-day response rates and we look forward to further assessing both single-dose and multi-dose treatment regimens to validate its potential best-in-class therapeutic profile."

FT596 Program
The ongoing clinical trial in relapsed / refractory B-cell lymphoma is assessing a single dose of FT596 as monotherapy (Monotherapy Arm) and in combination with a single dose of rituximab (375 mg/m2) (Combination Arm) following three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine). As of the data cutoff date of June 25, 2021, 10 patients in the Monotherapy Arm and 10 patients in the Combination Arm were evaluable for assessment of safety and efficacy in the first, second, and third dose cohorts of 30 million cells (n=3 each), 90 million cells (n=4 each), and 300 million cells (n=3 each), respectively (see Table 1). Patients had received a median of four prior lines of therapy and a median of 2.5 prior lines containing CD20-targeted therapy. Of the 20 patients, 12 patients (60%) had aggressive B-cell lymphoma, 10 patients (50%) were refractory to most recent prior therapy, and seven patients (35%) were previously treated with autologous CD19-targeted CAR T-cell therapy.

In the second and third single-dose cohorts of the Monotherapy and Combination Arms comprising a total of 14 patients, 10 of 14 patients (71%) achieved an objective response, including seven patients (50%) that achieved a complete response (CR), as assessed by PET-CT scan per Lugano 2014 criteria on Day 29 following FT596 dosing. Eight of 10 patients (80%) that had not previously received CD19-targeted CAR T-cell therapy achieved an objective response, including five patients (50%) that achieved CR. Two of four patients (50%) that had previously received CD19-targeted CAR T-cell therapy, both of whom were treated in the Combination Arm, achieved a CR. In the first single-dose cohorts of the Monotherapy and Combination Arms comprising a total of six patients, only one patient achieved an objective response, suggesting dose-response treatment effects for FT596. The ongoing dose-escalation study of FT596 is currently enrolling patients in the fourth single-dose cohort of 900 million cells in each arm.

Table 1. FT596 Interim Phase 1 Data – 1 Dose x 1 Cycle
Dose Escalation Cohort Monotherapy
(n=10) Combination
(n=10) Total
(n=20)
Single Dose, Single Cycle OR CR OR CR OR CR
DC1 = 30M 1/3 (33%) 0 0/3 (0%) 0 1/6 (17%) 0
DC2 = 90M 3/4 (75%) 2 2/4 (50%) 2 5/8 (63%) 4
DC3 = 300M 3/3 (100%) 1 2/3 (67%) 2 5/6 (83%) 3
≥ 90M FT596 cells (n=7) (n=7) (n=14)
aCD19 CAR T Naïve 6/6 (100%) 3 2/4 (50%) 2 8/10 (80%) 5
Prior aCD19 CAR T 0/1 (0%) 0 2/3 (67%) 2 2/4 (50%) 2
Total 6/7 (86%) 3 4/7 (57%) 4 10/14 (71%) 7
aCD19 = autologous CD19-targeted CAR T-cell therapy; CR = complete response; DC = dose cohort; M = million; OR = objective response
a Interim FT596 Phase 1 results are as of June 25, 2021 data cutoff date. Data subject to source document verification.
b Response assessment for three patients was entered into database subsequent to data cutoff.
c Objective response (OR) and complete response (CR) are based on Cycle 1 Day 29 protocol-defined response assessment per Lugano 2014 criteria
The FT596 treatment regimens were well tolerated. No dose-limiting toxicities, and no treatment-emergent adverse events (TEAEs) of any grade of immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GVHD) were observed. Two low-grade adverse events (one Grade 1, one Grade 2) of cytokine release syndrome (CRS) were reported, both of which occurred concurrently with other confounding clinical events and resolved on the same day of onset.

FT596 Patient Case Studies
The multi-antigen targeting functionality of FT596 is designed to uniquely address tumor heterogeneity and overcome antigen escape, and has the potential to drive responses in patients that might not effectively be treated with single-antigen targeted modalities, such as monoclonal antibodies, bispecific engagers and CAR T-cell therapies. The following are two case studies from the clinical trial:

Patient 2014. In the Monotherapy Arm, a 78-year-old woman with splenic diffuse red pulp small B cell lymphoma, who had received four prior therapies including three CD20-targeted regimens, presented with CD19High and CD20Null tumor cells indicative of CD20 antigen escape. The patient achieved a CR after single-dose, single-cycle treatment at 90 million FT596 cells as monotherapy with resolution of all metabolically active disease including clearance of baseline bone marrow involvement, demonstrating the activity of the product candidate’s CAR receptor.
Patient 2016. The Combination Arm included a 68-year-old male with transformed indolent lymphoma who had received six prior therapies, including three anti-CD20-containing regimens and autologous CD19-targeted CAR T-cell therapy. The patient achieved a CR after single-dose, single-cycle treatment at 300 million FT596 cells in combination with rituximab with resolution of all metabolically active disease, suggesting that the product candidate’s hnCD16 receptor can synergize with rituximab to drive complete responses in patients that have progressed following CD19-targeted CAR T-cell therapy.
Re-treatment with Second FT596 Cycle
The FT596 protocol currently allows for the re-treatment of eligible patients with a second, single-dose cycle subject to consent of the U.S. Food and Drug Administration (FDA). All requests by the Company for re-treatment were approved by the FDA. Of note, based on review of data submitted to date to the FDA, the Company is amending its FT596 clinical protocol at the FDA’s recommendation to allow for re-treatment with a second FT596 cycle without requiring the agency’s consent.

In second and third single-dose cohorts of the Monotherapy and Combination Arms as of the data cutoff date, four patients with CR at the end of the first single-dose cycle were re-treated, all of whom remained in CR following disease assessment at the end of the second cycle, and an additional four patients were re-treated and had not yet been assessed for response. The second, single-dose FT596 cycle was well tolerated, and no events of any grade of CRS, ICANS, or GVHD were observed.

FT516 Program
The clinical trial in relapsed / refractory B-cell lymphoma is assessing FT516 in an off-the-shelf treatment regimen of up to two cycles, with each cycle consisting of three days of conditioning chemotherapy (500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine), a single dose of rituximab (375 mg/m2), and three weekly doses of FT516 each with IL-2 cytokine support. The FT516 treatment regimen is designed to be administered in the outpatient setting. Dose escalation is currently ongoing in the fourth multi-dose cohort of 900 million cells per dose.

At the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in June, the Company highlighted positive interim clinical data for 11 patients treated in the second and third multi-dose cohorts of 90 million cells per dose (n=4) and 300 million cells per dose (n=7). Patients had received a median of three prior lines of therapy and a median of two prior lines containing CD20-targeted therapy. Of the eleven patients, eight patients had aggressive B-cell lymphoma, five patients were refractory to their most recent prior therapy, and four patients were previously treated with autologous CD19 CAR-T cell therapy. No dose-limiting toxicities, and no FT516-related serious adverse events or FT516-related Grade 3 or greater adverse events, were observed. The FT516 treatment regimen was well tolerated, and no TEAEs of any grade of CRS, ICANS, or GVHD were reported.

Ongoing Response Assessment
Of the 11 patients treated in the second and third multi-dose cohorts, eight patients (73%) achieved an objective response, including six patients (55%) who achieved CR, as assessed by PET-CT scan per Lugano 2014 criteria on Day 29 following the second FT516 treatment cycle. Notably, two of four patients (50%) previously treated with autologous CD19 CAR-T cell therapy achieved CR. At three months following first infusion, all eight responders maintained their response without further therapeutic intervention (3-Month Rate of 73% OR and 55% CR). As of the data cutoff date of July 7, 2021:

Five patients (45%) maintained their response without further therapeutic intervention, including four patients that remained in CR (4.6-9.5 months) and one patient that remained in partial response (6.1 months);
Two patients that had achieved CR experienced disease progression (4.2 and 5.1 months); and
One patient that had achieved partial response was treated with additional anti-cancer therapy (4.1 months).
FT516 Patient Case Study
The ASCO (Free ASCO Whitepaper) presentation featured a case study of a 36-year old male with triple-hit, high-grade B-cell lymphoma with rearrangements of MYC, BCL2, and BCL6 genes. The patient was refractory to all prior lines of therapy with the exception of autologous CD19 CAR T-cell therapy, for which a complete response of two months’ duration was achieved. The patient was most recently refractory to an investigational CD20-targeted T-cell engager and presented with bulky lymphadenopathy with the largest lesion measuring approximately 10 centimeters. The first FT516 treatment cycle resulted in a complete response with resolution of all metabolically active disease and 85% reduction in the size of target lesions. The patient received a second FT516 treatment cycle, after which the response assessment continued to show complete response. As of the data cutoff date of July 7, 2021, the patient’s most recent assessment at 4.9 months showed MRD negativity, confirming a profound CR.

Today’s Webcast
The Company will host a live audio webcast today, Thursday, August 19, 2021 at 4:30 p.m. ET to review interim clinical data for the Company’s FT516 and FT596 off-the-shelf, iPSC-derived NK cell programs. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in a multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

On August 19, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that data from a preclinical study evaluating its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), in the treatment of leptomeningeal metastases (LM), and presented plans for a Phase 1 clinical trial of 186RNL also in LM (Press release, Cytori Therapeutics, AUG 19, 2021, View Source [SID1234586750]). The data and upcoming trial plans were presented in two electronic posters (ePosters) at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually August 19-20, 2021.

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"Leptomeningeal metastases are a fatal complication of advanced cancer and despite affecting more than 110,000 people per year in the United States alone, there remains a significant lack of effective therapies to treat this devastating disease," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, and presenter of both ePosters. "Given our promising clinical experience thus far using 186RNL in recurrent glioblastoma, we are optimistic about the potential safety and efficacy for 186RNL as a novel treatment option for other central nervous system diseases like leptomeningeal metastases and certain pediatric brain cancers."

Data from the ePoster entitled "Preclinical safety and activity of intraventricular Rhenium-186 Nanoliposome (186RNL) for leptomeningeal metastases" demonstrated that, following five different doses of 186RNL tested in non-tumor bearing rats administered with the highest doses (1.340mCi and 1.15mCi) presented minimal weight loss the first week after surgery, but gained it back in subsequent weeks and showed no overt neurological symptoms through the evaluation.

These results suggest that the maximum tolerable dose of 186RNL was not reached, and given the encouraging efficacy shown in pre-clinical LM models, 186RNL has the potential to provide high therapeutic doses for LM with low rates of toxicity.

Additional key findings include:

The mean absorbed radioactivity for the 186RNL-treated cohort was 1,094 Gy (+/- 218.59) and was retained at two days after injection.
186RNL-treated rats had significantly lower luciferase relative to controls (p=0.0286) based on the bioluminescent imaging that was used to track tumor growth.
Kaplan-Meier plot showed a statistically significant difference in overall survival with the 186RNL-treated animals outliving the controls (p=0.0377).
"The novel design of 186RNL prolongs CNS exposure when delivered to the brain by convection enhanced delivery and we believe it will perform similarly in the leptomeningeal spaces where cancerous cells circulate and along the membrane linings where metastases are found," stated Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "This encouraging preclinical data from Dr. Brenner and his team supports RNL’s potential in this significant unmet medical need and Plus’ proposed clinical development program."

In addition, the Company presented trial design plans for its upcoming Phase 1 clinical trial as part of an ePoster entitled, "ReSPECT-LM: Maximum tolerated dose, safety, and efficacy of intraventricular Rhenium-186 Nanoliposome (186RNL) for leptomeningeal metastases." The multi-center, sequential cohort, open-label, dose escalation study, which will begin patient accrual in the fourth quarter of 2021, pending FDA IND approval, will evaluate the safety, tolerability, and distribution of 186RNL via intrathecal infusion to the ventricle of breast and non-small cell lung cancer patients with LM after standard surgical, radiation, and/or chemotherapy treatment. The starting dose of 186RNL will be 6.6 mCi in a volume of 5 mL followed by an expansion at the maximum tolerated dose to determine efficacy. The primary endpoint of the study is the incidence and severity of adverse events and dose limiting toxicities, and the secondary endpoints are the overall response rate, duration or response, progression free survival, and overall survival.

This ReSPECT-LM Phase 1 clinical trial follows preclinical studies, in which tolerance to doses of 186RNL as high as 1075 Gy was shown in rat models with LM with no observed significant toxicity and treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.

186RNL contains the rhenium-186 isotope which is a beta energy emitter with a short 2 mm average path length in tissue and favorable radiation properties, which allow high specific activity radiotherapy with limited exposure to surrounding tissues. In treating LM, whole body radiation is used as part of a palliative regimen for poor-risk patients while tumor control using focal radiation therapy to treat bulky or symptomatic areas is used for good-risk patients. These approaches carry the risk of significant side effects and have no significant effect on survival, respectively.

Copies of each poster will be made available under the Presentations tab of the Investors section of the Company’s website when presentations go live at www.plustherapeutics.com.

About Leptomeningeal Metastases

Leptomeningeal Metastases (LM) are a rare but typically fatal complication of advanced cancer that affects the fluid-lined structures of the central nervous system and are diagnosed in approximately five percent of patients with metastatic cancer. With survival measured in weeks to months, novel approaches are needed that can both improve quality and quantity of life.

On August 19, 2021 Coeptis Therapeutics, Inc. (OTC PINK: COEP), a pharmaceutical company focused on the development of innovative technologies designed to disrupt conventional treatment paradigms and improve patient outcomes, reported it has exercised its option to acquire ownership in two technology assets that target CD38 cancers from VyGen-Bio, Inc., a majority-owned subsidiary of Vycellix, Inc (Press release, Coeptis Pharmaceuticals, AUG 19, 2021, View Source [SID1234586749]). These two technology assets will now be co-developed by Coeptis and VyGen-Bio. The technologies, CD38-GEAR-NK, a cell therapy product being developed to protect CD38+ natural killer (NK) cells from destruction by anti-CD38 monoclonal antibodies (mAbs), and CD38-Diagnostic, an in vitro diagnostic tool being developed to help identify cancer patients who may be appropriate candidates for anti-CD38 mAb therapy were both discovered by scientists at the Karolinska Institutet in Stockholm, Sweden.

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This transaction follows Coeptis’ initial entry into two separate exclusive option agreements with VyGen-Bio, Inc. as announced on May 18, 2021. Per the option agreements and subsequent amendments, Coeptis paid VyGen-Bio a combination of cash and promissory notes to acquire the rights to the co-development assets.

"Securing the ownership in the co-development assets for CD38-GEAR-NK and CD38 Diagnostic from VyGen-Bio is a critical step in the growth of Coeptis Therapeutics and in the development of these potentially groundbreaking technologies targeting CD38-related cancers," said Dave Mehalick, President and CEO, Coeptis Therapeutics. "Our vision is to co-develop CD38-GEAR-NK and CD38 Diagnostic to provide safer and more targeted administration of anti-CD38 mAbs in the treatment of cancers that are known to be associated with CD38, including multiple myeloma, chronic lymphocytic leukemia and acute myeloid leukemia. We view this agreement as a significant value driver for the company and plan to soon initiate development programs that leverage these technologies, with the first indication expected to be multiple myeloma."

"By partnering with Coeptis, we are accelerating the development of a new class of natural killer cells, which we envision to be capable of enabling optimized combination therapy with monoclonal antibodies to maximize patient response rates, as well as advancing first-in-class companion diagnostic approaches to ensure optimal patient selection," said Arnika Wagner, Ph.D., Assistant Professor, Gene and Cell Therapy Group, Karolinska Institutet (KI), and Chief Scientific Officer for VyGen-Bio. "We are also privileged to be collaborating on these projects with distinguished faculty at KI via partnership with NextGenNK, an international Competence Center for the development of next-generation NK cells coordinated by KI and funded by Sweden’s Innovations Agency, Vinnova." For more information about NextGenNK, please visit: View Source

CD38-GEAR-NK is a NK cell-based investigational therapeutic engineered to enable combination therapy with anti-CD38 mAbs, potentially minimizing the risks and side effects from CD38-positive NK cell fratricide. The first indication is expected to be multiple myeloma, an incurable cancer of plasma cells.

CD38-Diagnostic is an investigational in vitro screening tool to potentially pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK.

On August 19, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the European Commission (EC) has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy (Press release, Bristol-Myers Squibb, AUG 19, 2021, View Source [SID1234586747]).

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Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.1Abecma is delivered via a single infusion with a target dose of 420 x 106 CAR-positive viable T cells within a range of 260 to 500 x 106 CAR-positive viable T cells. Abecma is approved for use in all European Union (EU) member states.*

"The EC approval of Abecma is an important milestone for the treatment of multiple myeloma, and moves us closer to offering a first-in-class, personalized therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care," said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. "With this third regulatory approval for Abecma worldwide, we are proud to be advancing the science of cell therapy and continuing to bring this first anti-BCMA CAR T cell therapy to patients in need."

In Europe, nearly 50,000 people are diagnosed with multiple myeloma each year.2 Despite advances in treatment, multiple myeloma remains an incurable disease, and many patients suffer through periods of remission and relapse. Patients with relapsed and refractory multiple myeloma who have been exposed to all three major drug classes often have poor clinical outcomes and few remaining treatment options.3,4,5,6

"In multiple myeloma, when a patient’s cancer is no longer responding to their current treatment regimen or the patient relapses, the disease becomes increasingly difficult to treat," said Jesus San Miguel, M.D., Ph.D., Medical Director of the Clinica Universidad de Navarra, Navarra, Spain and KarMMa clinical trial investigator. "In the KarMMa trial, treatment with ide-cel proved to elicit deep and durable responses in a significant proportion of patients with triple-class exposed multiple myeloma, including many who were heavily pretreated and had high-risk disease. The approval is important for patients in Europe, as it represents another potential therapeutic option for clinically meaningful outcomes and long-term disease control."

Bristol Myers Squibb is committed to making Abecma commercially available to patients in the EU. The company is currently focused on several required factors, including treatment center qualification and onboarding, completion of reimbursement procedures and scaling up its manufacturing capacity to meet increasing global demand. The company is also actively pursuing options to expand its manufacturing global supply network to make Abecma available to more patients around the world, including the addition of a European-based manufacturing facility in Leiden, Netherlands. Meanwhile, Bristol Myers Squibb will continue to manufacture Abecma for EU and U.S. patientsat the company’s state-of-the-art cellular immunotherapy manufacturing facility in Summit, New Jersey.

"Multiple myeloma patients who have tried and exhausted multiple rounds of treatment options have been hoping for new and transformative options," said Brian G.M. Durie, Chairman, International Myeloma Foundation. "The approval of Abecma, an innovative anti-BCMA CAR T cell therapy, is an exciting milestone for patients in the European Union."

Abecma was granted Conditional Marketing Authorization under the European Medicines Agency PRIME (Priority Medicines) scheme. Conditional Marketing Authorization is granted in the interest of public health where the benefit of immediate availability fulfills a critical unmet need. Conditional Marketing Authorization in the EU is initially valid for one year but can be extended or converted into a full Marketing Authorization after the submission and assessment of additional confirmatory data. For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers and help support access to therapies, including Abecma.

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

Abecma Clinical Trial Results

The efficacy of Abecma is based on results from the pivotal KarMMa study in which 128 patients with relapsed and refractory multiple myeloma who had received at least three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and were refractory to the last treatment regimen were treated with Abecma.7

In the study, the overall response rate (ORR) was 73% (95% CI: 66-81), and 33% of patients achieved a complete response (CR; 95% CI: 25-41). Onset of response was rapid with a median time to response of one month. In addition, responses were durable, with a median duration of response of 10.6 months (95% CI: 8.0 – 11.4), and 23 months (95% CI: 11.4 – 23.3) for those who achieved a CR.7

In a pooled safety analysis of 184 patients treated with Abecma in the KarMMa and CRB-401 studies, cytokine release syndrome (CRS) occurred in 81% of patients, with Grade >3 CRS, using the Lee grading system, occurring in 5.4% of patients. There was one case of fatal (Grade 5) CRS reported. The median time to onset of CRS was one day (range: 1-17 days) and the median duration of CRS was five days (range: 1-63 days). Any grade neurotoxicity (NT) of the 128 patients receiving Abecma in the KarMMa study occurred in 18% of patients, including Grade 3 events in 3.1% of patients, with no Grade 4 or 5 events occurring. The median time to onset of NT was two days (range: 1-10 days) and the median duration was three days (range: 1-26 days).7

The most common (>20%) adverse reactions in the pooled safety analysis included neutropenia, CRS, anaemia, thrombocytopenia, infections – pathogen unspecified, leucopenia, fatigue, diarrhoea, hypokalaemia, hypophosphataemia, nausea, lymphopenia, pyrexia, cough, hypocalcaemia, infections – viral, headache, hypomagnesaemia, upper respiratory tract infection, arthralgia, and oedema peripheral. The most common Grade 3 or 4 adverse reactions were neutropenia (88.6%), anaemia (58.2%), thrombocytopenia (53.5%), leucopenia (45.1%), lymphopenia (30.4%), infections – pathogen unspecified (17.9%), hypophosphataemia (17.4%), febrile neutropenia (14.7%), hypocalcaemia (7.1%), infections – viral (7.1%), pneumonia (6.0%), CRS (5.4%), hypertension (5.4%) and hyponatraemia (5.4%).7

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, AND PROLONGED CYTOPENIA

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.
Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. CRS occurred in 85% (108/127) of patients receiving ABECMA. Grade 3 or higher CRS (Lee grading system) occurred in 9% (12/127) of patients, with Grade 5 CRS reported in one (0.8%) patient. The median time to onset of CRS, any grade, was 1 day (range: 1 – 23 days) and the median duration of CRS was 7 days (range: 1 – 63 days) in all patients including the patient who died. The most common manifestations of CRS included pyrexia (98%), hypotension (41%), tachycardia (35%), chills (31%), hypoxia (20%), fatigue (12%), and headache (10%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome (ARDS), atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Fifty four percent (68/127) of patients received tocilizumab; 35% (45/127) received a single dose while 18% (23/127) received more than 1 dose of tocilizumab. Overall, across the dose levels, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS. All patients that received corticosteroids for CRS received tocilizumab.

Overall rate of CRS was 79% and rate of Grade 2 CRS was 23% in patients treated in the 300 x 106 CAR+ T cell dose cohort. For patients treated in the 450 x 106 CAR+ T cell dose cohort, the overall rate of CRS was 96% and rate of Grade 2 CRS was 40%. Rate of Grade 3 or higher CRS was similar across the dose range. The median duration of CRS for the 450 x 106 CAR+ T cell dose cohort was 7 days (range: 1-63 days) and for the 300 x 106 CAR+ T cell dose cohort was 6 days (range: 2-28 days). In the 450 x 106 CAR+ T cell dose cohort, 68% (36/53) of patients received tocilizumab and 23% (12/53) received at least 1 dose of corticosteroids for treatment of CRS. In the 300 x 106 CAR+ T cell dose cohort, 44% (31/70) of patients received tocilizumab and 10% (7/70) received corticosteroids. All patients that received corticosteroids for CRS also received tocilizumab. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. CAR T cell-associated neurotoxicity occurred in 28% (36/127) of patients receiving ABECMA, including Grade 3 in 4% (5/127) of patients. One patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. The median time to onset of neurotoxicity was 2 days (range: 1 – 42 days). CAR T cell-associated neurotoxicity resolved in 92% (33/36) of patients with a median duration of neurotoxicity was 5 days (range: 1 – 61 days). The median duration of neurotoxicity was 6 days (range: 1 – 578) in all patients including those with ongoing neurotoxicity at the time of death or data cut off. Thirty-four patients with neurotoxicity had CRS. Neurotoxicity had onset in 3 patients before, 29 patients during, and 2 patients after CRS. The rate of Grade 3 neurotoxicity was 8% in the 450 x 106 CAR+ T cell dose cohort and 1.4% in the 300 x 106 CAR+ T cell dose cohort. The most frequently reported (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (20%), tremor (9%), aphasia (7%), and delirium (6%). Grade 4 neurotoxicity and cerebral edema in 1 patient has been reported with ABECMA in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have been reported after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs and symptoms of neurologic toxicities. Rule out other causes of neurologic symptoms. Monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): HLH/MAS occurred in 4% (5/127) of patients receiving ABECMA. One patient treated in the 300 x 106 CAR+ T cell dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved. The rate of HLH/MAS was 8% in the 450 x 106 CAR+ T cell dose cohort and 1% in the 300 x 106 CAR+ T cell dose cohort. All events of HLH/MAS had onset within 10 days of receiving ABECMA with a median onset of 7 days (range: 4-9 days) and occurred in the setting of ongoing or worsening CRS. Two patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional standards.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or 1-888-423-5436.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. Infections (all grades) occurred in 70% of patients. Grade 3 or 4 infections occurred in 23% of patients. Overall, 4 patients had Grade 5 infections (3%); 2 patients (1.6%) had Grade 5 events of pneumonia, 1 patient (0.8%) had Grade 5 bronchopulmonary aspergillosis, and 1 patient (0.8%) had cytomegalovirus (CMV) pneumonia associated with Pneumocystis jirovecii. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, preemptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 16% (20/127) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit prolonged cytopenias following lymphodepleting chemotherapy and ABECMA infusion. In the KarMMa study, 41% of patients (52/127) experienced prolonged Grade 3 or 4 neutropenia and 49% (62/127) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. Rate of prolonged neutropenia was 49% in the 450 x 106 CAR+ T cell dose cohort and 34% in the 300 x 106 CAR+ T cell dose cohort. In 83% (43/52) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 65% (40/62) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 2.1 months. Median time to cytopenia recovery was similar across the 300 and 450 x 106 dose cohort.

Three patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. Two of the three patients died from complications of prolonged cytopenia. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to institutional guidelines.

Hypogammaglobulinemia: Plasma cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with ABECMA. Hypogammaglobulinemia was reported as an adverse event in 21% (27/127) of patients; laboratory IgG levels fell below 500 mg/dl after infusion in 25% (32/127) of patients treated with ABECMA.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

The safety of immunization with live viral vaccines during or following ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.

Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. Monitor life-long for secondary malignancies. If a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 to obtain instructions on patient samples to collect for testing of secondary malignancy of T cell origin.

Effects on Ability to Drive and Operate Machinery: Due to the potential for neurologic events, including altered mental status or seizures, patients receiving ABECMA are at risk for altered or decreased consciousness or coordination in the 8 weeks following ABECMA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include CRS, infections – pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, and Summary of Product Characteristics for ABECMA.

About Abecma

Abecma is the first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, first approved in the U.S. in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is also approved in Canada for relapsed and refractory multiple myeloma. Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement with Bristol Myers Squibb and bluebird bio. Bristol Myers Squibb will assume sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.