On April 2, 2019 Xynomic Pharma, a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corp. (Nasdaq: BCAC), reported that China, Spain and Poland authorities have approved Xynomic’s application to conduct potentially pivotal Phase 3 trial using Xynomic’s abexinostat, in combination with pazopanib, in patients with renal cell carcinoma (RCC) (Press release, Xynomic Pharmaceuticals, APR 2, 2019, View Source [SID1234534944]). Xynomic plans to initiate this trial in China, Spain, Poland and additional European countries in the first half of 2019. The same trial is currently ongoing in the United States and South Korea. According to a June 2018 research report by Grand View Research, RCC accounts for 1.8% of total adult malignancies globally and 3.4% of all new cancer cases in the United States. The global RCC pharmaceuticals market size is projected to reach US$ 4.6 billion in 2019.

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In addition, the Independent Ethics Committee at the Cancer Hospital Chinese Academy of Medical Sciences in Beijing, China’s number one ranked cancer specialty hospital according to Fudan University’s Hospital Management Institute, has approved Xynomic’s application to conduct two potentially pivotal Phase 2 trials, one to test abexinostat as a third-line mono therapy against diffuse large B-cell lymphoma (DLBCL) and the other as a third-line mono therapy against follicular lymphoma (FL). According to Chinese Medical Association’s Chinese Society of Hematology, DLBCL and FL are the most prevalent and second most prevalent non-Hodgkin’s lymphoma subtype, respectively, in China.

On April 2, 2019 IGEM Therapeutics (IGEM), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported the award of a £0.75 million grant from the UK’s innovation agency, Innovate UK (Press release, IGEM Therapeutics, APR 2, 2019, View Source [SID1234534942]). IGEM will use the Biomedical Catalyst Primer Award to develop novel IgE antibodies targeting HER2, a commercially-validated cancer antigen expressed on a variety of tumour types including breast, ovarian and gastric cancer.

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Currently marketed anti-HER2 IgG antibodies are only able to treat patients with cancers expressing high levels of HER2 antigen. The majority of HER2 positive patients have cancers expressing intermediate or low levels of HER2 and cannot be treated with anti-HER2 IgG antibodies. To address this substantial unmet medical need, IGEM is developing novel, human IgE antibodies that bind to HER2.

The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. Pre-clinical studies in the laboratory of IGEM Founder Dr Sophia Karagiannis at King’s College London have demonstrated superior efficacy with a number of IgE antibodies when compared to their IgG equivalents. IGEM is also developing anti-cancer IgE antibodies targeting folate receptor alpha and CSPG-4.

Dr Tim Wilson, Chief Executive Officer of IGEM, commented: "IGEM is a pioneer in the use of IgE antibodies to treat cancer. We are very pleased to have been awarded our second grant from Innovate UK. Our goal is to harness the potency of the IgE-mediated immune response and thereby provide patients with new safe and effective treatment options for these serious diseases".

On April 2, 2019 Geron Corporation (Nasdaq: GERN) reported that John A. Scarlett, M.D., Chairman and Chief Executive Officer, is scheduled to present a company overview at the 18th Annual Needham Healthcare Conference in New York at 3:30 p.m. ET on Tuesday, April 9, 2019 (Press release, Geron, APR 2, 2019, View Source [SID1234534940]).

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A live audio webcast of the presentation will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company’s website for 30 days.

On April 2, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, reported that Claire Roddie MB, PhD, FRCPath, honorary senior lecturer, Cancer Institute, University College London (UCL), presented today initial data from the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult acute lymphoblastic B cell leukemia (ALL) as a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (Press release, Autolus, APR 2, 2019, View Source [SID1234534937]).

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Relapsed / refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults is an area of significant unmet clinical need. Notably, no CD19 CAR T cell therapeutic has been approved to date for adults with r/r B-ALL. The key challenges identified in clinical studies testing standard CD19 CAR T-cells therapies in this setting are considerable toxicity associated with severe cytokine release syndrome (CRS) and high-grade neurological toxicity.

AUTO1 uses a novel CD19 binder that allows the CAR T cells to disengage rapidly after target cell encounter and kill. Preliminary data from the ongoing Phase 1/2 CARPALL trial of AUTO1 in pediatric ALL presented at the 1st European CAR T Meeting organized by European Hematology Association (EHA) (Free EHA Whitepaper) in February 2019 indicated that AUTO1 has a well-tolerated safety profile and did not induce high grade CRS in pediatric patients.

As of the data cutoff date of March 18, 2019 in the ongoing Phase 1/2 ALLCAR19 trial of AUTO1 in adult ALL patients, 13 patients were leukapheresed, and products for 12 patients were manufactured, including 7 with Autolus’ semi-automated, fully enclosed manufacturing process. Two patients are pending infusion. Among the 10 infused patients to date, the median age is 41 and 70% were male, with median lines of treatment of 4 (the range is 2-7). Five of the ten treated patients had ³ 50% BM blasts and were considered to be high-risk for severe CRS. Patients received a split dose based on disease burden for a total dose of up to 410 million cells.

Safety results

Using the Lee criteria, there were no patients with severe CRS (³ Grade 3), and 2 of 10 patients (20%) with Grade 2 CRS. Tocilizumab was used in 2 of 10 patients (20%). None of the patients were admitted to intensive care due to CRS. One patient developed delayed Grade 3 neurotoxicity following high levels of CAR T expansion, which was quickly reversed with steroids. Four patients died while enrolled in the trial, two due to progression of leukemia and two due to sepsis, a common complication of advanced ALL.

Efficacy results

Nine patients were evaluable for response at 1 month and 8 (88%) had a molecular complete response. One patient died of sepsis before the one-month evaluation point. At a median follow up of 5 months (range 0.62-10.6 months), 6/10 patients are alive and continue to be in molecular remission. There continues to be evidence of ongoing B cell aplasia and CAR T persistence.

"AUTO1 delivered promising early remission rates, CAR T cell expansion and persistence in this adult ALL trial cohort," said Dr. Roddie. "Despite enrolling patients with high tumor burden, we believe the safety profile in the trial appears to compare very favorably to other CD19 CARs and is consistent with the safety profile of AUTO1 observed in pediatric patients in the CARPALL trial."

"These data from the ALLCAR19 study of AUTO1 in relapsed refractory ALL, while early, are encouraging, with a high response rate we now associate with CAR T cell therapies, but with a potentially improved safety profile. If AUTO1 continues to be associated with a lower incidence of adverse events with additional patients treated, this could represent an important advance for more vulnerable adult patients, as side effects of these therapies, including serious cytokine release syndrome and neurotoxicity, limit our ability to treat these individuals." said Krishna Komanduri, M.D., Kalish Family Chair in Stem Cell Transplantation and Director, Adult Stem Cell Transplant Program at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine.

"The strong persistence of the CAR T cells over time, coupled with the low frequency of severe CRS events seen in these patients, represent encouraging initial data for AUTO1 in relapsed/refractory adult ALL," said Dr. Christian Itin, chairman and chief executive officer of Autolus Therapeutics. "We expect AUTO1 in adult ALL to move into a registration trial towards the end of this year."

For information about the ALLCAR19 trial, visit View Source;rank=1

Conference Call Information

Autolus management will host a conference call featuring Dr. Roddie on Tuesday, April 2, 2019 at 8:00 am ET/ 1:00 pm BST to discuss the ALLCAR19 data presented at AACR (Free AACR Whitepaper). To listen to the webcast and view the accompanying slide presentation, please go to View Source

The call may also be accessed by dialing 866-679-5407 (U.S.) or 409-217-8320 (international) and referencing conference ID 7679666. After the conference call, a replay will be available for one week. To access the replay, please dial 855-859-2056 (U.S.) or 404-537-3406 (international) and enter conference ID 7679666.

About AUTO1

AUTO1 is a CD19 CAR T cell investigational therapy designed to overcome the limitations in safety—while maintaining similar levels of efficacy—compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, Autolus believes AUTO1 may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the T cells’ abilities to engage in serial killing of target cancer cells. In 2018, Autolus signed a license agreement under which Autolus acquired global rights from UCL Business plc (UCLB), the technology-transfer company of UCL, to develop and commercialize AUTO1 for the treatment of B cell malignancies. AUTO1 is currently being evaluated in two Phase 1/2 trials, one in pediatric ALL and one in adult ALL.

About Adult Acute Lymphoblastic Leukemia

According to the American Cancer Society, acute lymphoblastic leukemia (ALL) is predicted to affect approximately 5,960 adults in the United States in 2018. Combination chemotherapy enables 90% of adult patients to experience CR (complete response). Despite this, the prognosis of adult ALL is still poor and has not changed significantly during the last two to three decades, with long-term remission rates limited to 30–40%. Approximately 50% of all adult ALL patients will relapse.

On April 2, 2019 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCARTCS1, in patients with multiple myeloma (MM) (Press release, Cellectis, APR 2, 2019, View Source [SID1234534933]). The IND for UCARTCS1 was filed on December 28, 2018 and approved by the FDA within a month, on January 25, 2019. Cellectis is the sponsor of the UCARTCS1 clinical study (MUNDI-01) and successfully ensured the manufacturing and release of UCARTCS1 GMP batches, as well as an IRB approval.

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UCARTCS1 is based on a tailored manufacturing process developed by Cellectis, which removes both the CS1 antigen and TCR from the T-cell surface using TALEN gene editing technology, before adding the CS1 CAR construct. This approach has both clinical and operational benefits: the UCART is designed to have a lymphodepleting effect, and the CAR T-cell cross reaction is suppressed, allowing for successful manufacturing.

UCARTCS1 is the first allogeneic CAR-T therapy for MM to enter clinical development. This milestone reinforces Cellectis’ leadership in the space, as it represents the fourth TALEN gene-edited allogeneic CAR-T product candidate developed by Cellectis to be approved for clinical trials following UCART191 for ALL patients, UCART123 for AML patients and UCART22 for B-ALL patients. The Phase 1 of the MUNDI-01 study is designed to assess the safety and tolerability at increasing dose levels of UCARTCS1 in patients living with MM.

"The last quarters have been very productive for Cellectis’ UCARTCS1 product candidate. We successfully manufactured and released GMP batches of UCARTCS1, filed an IND and secured approval from the FDA to start the MUNDI-01 Phase 1 clinical study," said Dr. André Choulika, Chairman and CEO of Cellectis. "This is the 4th time in 4 years that Cellectis demonstrates excellence with an allogeneic product candidate. It further demonstrates the strength of our innovation, our manufacturing process and our execution, as we are eager to bring the first allogeneic multiple myeloma CAR T-cell treatment to patients."

We anticipate the clinical research to be led by Dr. Krina Patel, Principal Investigator, Assistant Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine at the MD Anderson Cancer Center in Houston, Texas. We plan to have two additional sites enrolling patients for this clinical study: Weill Cornell Medicine under the leadership of Dr. Ruben Niesvizky, Director of the Multiple Myeloma Center at New York Presbyterian Hospital-Cornell Medical Center and Hackensack Meridian under the supervision of Dr. Andre Goy, Chairman and Director of John Theurer Cancer Center (JTCC) at Hackensack University Medical Center.

About UCARTCS1

UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of multiple myeloma (MM). CS1 (SLAMF7) is highly expressed on MM tumor cells and is an attractive target because there is strong evidence of tumor response to monoclonal antibody treatment targeting it. The limitation so far has been the presence of the CS1 target on the surface of T-cells, which has hindered the access to CAR-Ts and bispecific antibodies. As an example, the introduction of a CAR construct in T-cells induces cross T-cell reaction and leads to their self-destruction during manufacturing. Cellectis solved this issue by using TALEN gene editing to knock-out the CS1 gene from T-cells before introducing the CS1 CAR construct.

The UCARTCS1 MUNDI-01 clinical trial is a Phase 1 dose-escalation and dose-expansion study to evaluate the safety, expansion, persistence and clinical activity of UCARTCS1 (allogeneic engineered T-cells) in patients with MM. Dose level 1 will be administered at 1×106 UCARTCS1 cells per kilogram, and dose levels 2 and 3 will be administered at 3×106 and 9×106, respectively. The Dose Limiting Toxicity (DLT) period is 28 days in concordance with a 28-day staggering for the first 2 patients at each dose level.

MM is a cancer that forms in a type of white blood cell called a plasma cell, which helps the body to fight infections by making antibodies that recognize and attack germs. MM causes cancer cells to accumulate in bone marrow, where they crowd out healthy blood cells. The American Cancer Society estimates that 32,110 new cases of MM will be diagnosed and 12,960 deaths are expected to occur in the U.S. in 2019.

The manufacturing process of Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, non-alloreactive engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production is industrialized with defined pharmaceutical release criteria.

Information about ongoing clinical trials is publicly available on dedicated websites, such as: www.clinicaltrials.gov (U.S.) and www.clinicaltrialsregister.eu (Europe).