On January 21, 2021 NexImmune reported that hiring of Gilead Sciences and Kite Pharma alum Robert Knight, M.D., the T-cell biotech is now gunning for an $86 million IPO (Press release, NexImmune, JAN 21, 2021, View Source [SID1234574228]).

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The startup wants the cash to boost its work on immunotherapy, with its platform designed to employ the body’s own T cells to generate a potent and durable immune response that mimics natural biology.

"Our mission is to create therapies with curative potential for patients with cancer and other life-threatening immune-mediated diseases," the Maryland biotech said in its Securities and Exchange Commission filing.

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It’s early-stage but in the clinic, unusually for a lot of biotech IPO attempts these days, with two candidates in human trials: NEXI-001 in acute myeloid leukemia (AML) and NEXI-002 in multiple myeloma (MM). Early data for these should be out by year-end.

NEXI-001 is a donor-derived, or allogeneic, ACT in a phase 1/2 test for treatment of patients with relapsed AML after allogeneic stem cell transplantation. NEXI-002, meanwhile, is a patient-derived, or autologous, ACT in a phase 1/2 for MM patients that have failed at least three prior lines of therapy.

"The backbone of our approach is our proprietary Artificial Immune Modulation, or AIM, nanoparticle technology platform. The AIM technology enables us to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. Like natural dendritic cells, the AIM nanoparticles employ natural signaling proteins to deliver specific instructions to specific T cells directing a desired immune response," the company said in the filing.

It said what sets it apart is, unlike other cell therapy approaches, it’s is accomplished "without any genetic manipulation of the T cell," thereby creating T-cell products designed to maintain natural target identification, engagement and killing mechanisms.

It now has Knight on board to help with the approach and can tap his vast experience in immunotherapy, which includes work on cell therapy Yescarta with Gilead-Kite as well as stints at Celgene and Sorrento.

The decade-old company, which licensed its core AIM tech from Johns Hopkins University, plans to list on the Nasdaq under the symbol "NEXI."

On January 21, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that its partner BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy today announces that it will host a Key Opinion Leader call on BI-1206 for relapsed or refractory Non-Hodgkin’s Lymphoma on Thursday, January 28, 2021 at 11:30 a.m. Eastern Time (5:30 p.m. CET) (Press release, CASI Pharmaceuticals, JAN 21, 2021, View Source [SID1234574188]).

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The event will feature a presentation by renowned lymphoma expert Mats Jerkeman, MD, Lund University, who will discuss the current treatment landscape, and unmet medical need for patients with relapsed or refractory Non-Hodgkin’s Lymphoma for whom current treatment options are very limited. Dr Jerkeman will also discuss his experience in treating these patients with BioInvent’s anti-FcγRIIB antibody, BI-1206, a novel monoclonal antibody that specifically targets the antibody "brakes" to help overcome resistance to rituximab.

BioInvent’s management team will also provide an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and CASI Pharmaceuticals Chairman and CEO, Dr. Wei-Wu He, will provide an update on the development plan and potential for BI-1206 in China. Dr. Jerkeman and senior members of the BioInvent and CASI management teams will be available to answer questions following the formal presentations.

To register for the call, please click here.

Dr. Mats Jerkeman is Professor in Clinical Oncology at Lund University, Sweden. His research focus is all possible aspects of malignant lymphomas, aiming for the improvement of the quality of life and survival of these patients.

Dr. Jerkeman is the coordinator of several ongoing clinical trials in diffuse large B-cell lymphoma and mantle cell lymphoma. He also serves as Chairman of the Nordic Lymphoma Group, Editor of ESMO (Free ESMO Whitepaper) Guidelines/Lymphoma and as coordinator of the Swedish Lymphoma Register for many years.

On January 21, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the dosing of the first patient in the dose-expansion cohort of the Phase 1 STRO-002 study. STRO-002 is an internally developed, folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC) for the potential treatment of ovarian cancer (Press release, Sutro Biopharma, JAN 21, 2021, View Source [SID1234574187]). The dose-expansion cohort will assess the efficacy, safety and tolerability of STRO-002 at 4.3 and 5.2 mg/kg, given every 3 weeks in patients with ovarian cancer. The dose-expansion cohort for FolRα-selected endometrial cancer is planned for later this year.

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"We are pleased to advance the clinical development of STRO-002 into dose-expansion studies. Results from our STRO-002 dose escalation in a heavily pre-treated ovarian cancer patient population demonstrated improved outcomes in RECIST response and duration of response," said Dr. Arturo Molina, Chief Medical Officer of Sutro Biopharma. "Sutro plans to expand the study to approximately 35 clinical sites in the U.S. and Europe. We are hopeful that the dose-expansion study will validate the preliminary signs of efficacy we have seen in dose-escalation and provide valuable data on the treatment paradigm and patient population that will benefit from treatment, bringing us one step closer to offering an important new potential treatment option to ovarian cancer patients."

Dr. Lainie Martin, Leader of Gynecology/Oncology Program at Hospital of the University of Pennsylvania and an investigator on the STRO-002-GM1 study, said, "STRO-002 continues to be well-tolerated and we have observed encouraging preliminary activity in patients with advanced platinum-resistant and refractory ovarian cancer. We are excited to be part of the STRO-002-GM1 dose-expansion study and to provide additional clinical data to show the potential of this therapeutic for ovarian patients with limited treatment options."

The dose-expansion study includes two patient cohorts, advanced epithelial ovarian cancer and endometrial cancer. The ovarian cancer cohort currently enrolling includes patients with platinum resistant disease and have received 1-3 prior regimens or platinum sensitive patients that have received 2-3 prior treatment regimens. Patients in the dose-expansion cohort of the STRO-002-GM1 Phase 1 study will be randomized 1:1 and treated with either 4.3 or 5.2 mg/kg STRO-002 intravenously once every three-weeks. Patients will not be pre-selected for FolRα expression and fresh or archival tumor tissue sample is required for immunohistochemistry (IHC) analysis of FolRα expression.

Additional information on the study can be found at: View Source

About the Phase 1 Trial of STRO-002 in Ovarian Cancer
STRO-002-GM1, the Phase 1 open-label, multicenter, dose escalation trial with dose expansion of STRO–002, has completed enrollment. Follow-up is ongoing and will continue to evaluate the safety, tolerability, and preliminary anti-tumor activity of STRO-002 in adults with advanced epithelial ovarian cancer, including fallopian and primary peritoneal cancer. The trial is registered with clinicaltrials.gov identifier NCT03748186. Sutro discovered, developed and manufactures STRO-002 using its proprietary XpressCF cell-free protein synthesis and XpressCF+ site-specific conjugation technologies.

On January 21, 2021 Bio-Thera Solutions, Ltd. (SHA: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT1308, a monoclonal antibody targeting PD-1 in cancer patient volunteers (Press release, BioThera Solutions, JAN 21, 2021, View Source [SID1234574185]).

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"PD-1 is a validated drug target. BAT1308 has demonstrated a very attractive preclinical profile." said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "We have multiple immune-oncology (IO) assets in our pipeline targeting tumor infiltrating regulatory T cells (Tregs). We plan to explore combinations of BAT1308 with those IO assets targeting tumor infiltrating Tregs and other IO assets in our innovative pipeline to treat a broad range of cancers."

The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT1308 is designed to assess the safety and tolerability of BAT1308 as a single agent. The study is expected to enroll subjects with advanced solid tumor. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics and preliminary anti-tumor activity. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.

Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including TIGIT, CTLA4, OX40, CD47 and TGFβ and IO bispecifics targeting synergistic targets like PD-L1/CD47.

On January 21, 2021 Kuur Therapeutics, the leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies, reported clinical updates for both the phase 1 GINAKIT2 study of KUR-501 (autologous GD2 CAR-NKT cells) being tested in patients with relapsed/refractory (R/R) neuroblastoma, and the phase 1 ANCHOR study of KUR-502 (off-the-shelf CD19 CAR-NKT cells) being evaluated in patients with R/R CD19 positive malignancies (Press release, Kuur Therapeutics, JAN 21, 2021, View Source [SID1234574184]). Complete responses and evidence of tumor homing have been observed in both trials, and the CAR-NKT cell therapy has been safe and well-tolerated.

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"We are very excited by these results, which help validate the biology and clinical activity of CAR-NKT cells. Although these are phase 1 studies and continue to recruit patients, we are pleased we have been able to demonstrate tumor homing, an important property of CAR-NKT cells, along with an excellent safety profile," said Kurt Gunter MD, Kuur Chief Medical Officer. "We are grateful to the patients and families for their participation in these studies and to the scientists and physicians at Baylor College of Medicine for their scientific leadership."

"We are encouraged by the evidence of clinical activity with an allogeneic approach, especially at such a low dose," said Dr. Carlos Ramos, Principal Investigator of the ANCHOR study, Professor of Medicine at the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine, and member of the Dan L Duncan Comprehensive Cancer Center. "We look forward to advancing the program and treating additional patients."

In the GINAKIT2 study, out of ten evaluable patients and with escalation to a dose level (DL) of 1×108 cells/m2, one complete response (CR) and one partial response (PR) have been observed to date, with stable disease (SD) in three additional patients. The patient with the CR is notable in that a PR was observed after the initial 1×108 cells/m2 dose, and a subsequent single dose at the same level deepened the response to a CR. Tumor biopsies show CAR-NKT cells homing to the neuroblastoma tumor site at all dose levels. KUR-501 has so far demonstrated a promising safety profile, with only one case of grade two cytokine release syndrome (CRS) and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).

In the ANCHOR study, of the two evaluable lymphoma patients treated to date at the starting DL of 1×107 cells/m2, one patient has experienced a CR and the other a PR. The patient with a CR was initially observed to be in PR four weeks after infusion but subsequently converted to a CR without additional therapy. Biopsy of the patient’s lymph node prior to conversion to CR status revealed viable, allogeneic CD19 CAR-NKT cells. The patient with a PR had previously failed autologous CAR-T cell therapy. KUR-502 has so far demonstrated a promising safety profile with no CRS, no ICANS, and no evidence of graft versus host disease (GvHD).

"We are very pleased to be able to report the first complete response in a patient treated with an allogeneic engineered CAR-NKT cell therapy," said Kevin S. Boyle, Sr., Chief Executive Officer of Kuur. "The clinical activity and safety data from both clinical trials are encouraging for the potential of our innovative CAR-NKT cell platform to create effective therapies for cancer patients."

The trials are being conducted at Baylor College of Medicine (Kuur’s CAR-NKT cell platform partner), Houston Methodist Hospital and Texas Children’s Hospital.

About KUR-501

KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in a phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high-risk neuroblastoma. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target and has extensive potential applications in the treatment of hematological and solid tumors.

About KUR-502

KUR-502 is built on Kuur’s next-generation CAR-NKT platform with novel engineering capabilities that harness and enhance the unique tumor-homing properties of NKT cells. The NKT cells used in Kuur’s CAR-NKT platform have an invariant T cell receptor that does not distinguish between self- and non-self tissues, making the cells unlikely to induce GvHD when given to another person. Preclinical data generated by Baylor College of Medicine indicate that while human CAR-T cells cause severe GvHD, CAR-NKT cells from the same donor do not.

The ANCHOR (NCT03774654) study is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The single-arm study will evaluate three dose levels with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19 positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by delays to get treatment, a requirement for patient leukapheresis, and issues with inferior quality leukapheresis starting material due to prior treatment. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, Baylor College of Medicine and is currently recruiting participants.