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Geron to Present at Needham Healthcare Conference

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.

Initial Results from Autolus Therapeutics’ ALLCAR19 Phase 1/2 Trial in Adult Acute Lymphoblastic Leukemia Presented at the AACR Annual Meeting

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]).

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.

FDA Clears the IND for UCARTCS1, the First Allogeneic CAR-T to Treat Multiple Myeloma Patients

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.

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).

Synlogic to Webcast Presentation at the 18th Annual Needham Healthcare Conference

On April 2, 2019 Synlogic (Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will provide a corporate update at the 18th Annual Needham Healthcare Conference at 3:30 pm ET on Tuesday, April 9, 2019, in New York City (Press release, Synlogic, APR 2, 2019, View Source [SID1234534932]).

A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archive copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

Advaxis, Inc. Announces Proposed Public Offering of Common Stock

On April 2, 2019 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that it intends to offer and sell in an underwritten public offering shares of its common stock (Press release, Advaxis, APR 2, 2019, View Source [SID1234534931]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

The Company intends to use the net proceeds from this offering to fund its continued research and development initiatives in connection with its product pipeline including, but not limited to, (i) investment in its ADXS-HOT program in both monotherapy and combination therapy and new cancer types; (ii) investment in ongoing clinical research in ADXS-PSA and ADXS-NEO, in combination therapy; and (iii) general corporate purposes.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 30, 2018. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or via email at [email protected]. The offering may be made only by means of a prospectus supplement and the accompanying prospectus. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.