Advaxis Reports Second Quarter Fiscal 2019 Financial Results and Provides Pipeline Update

On June 10, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported an update on its clinical pipeline and financial results for the fiscal second quarter ended April 30, 2019 (Press release, Advaxis, JUN 10, 2019, View Source [SID1234536968]).

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Key updates on the progress of the company’s clinical pipeline include the following:

ADXS-NEO: Personalized, Neoantigen-Directed Therapy – The company is currently enrolling patients in its Phase 1 dose-escalation study to evaluate ADXS-NEO, a personalized neoantigen-directed immunotherapy designed to activate a patient’s immune system in a range of cancers. The company presented safety, tolerability and immune correlative data from this study at the American Association of Cancer Research ("AACR") Annual Meeting in March, and updated findings were presented at the Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) at the New York Academy of Sciences ("NYAS") in May. The study’s preliminary data demonstrated anti-tumor immune activation, including T-cell responses to neoantigens and antigen spreading, within one week after the first dose. In addition, data from two microsatellite-stable ("MSS") colorectal cancer patients dosed with ADXS-NEO at 1×108 CFU demonstrated increased CD8+ T-cell infiltration in the tumor microenvironment after three doses of ADXS-NEO. Metastatic MSS colorectal cancer is considered to be a "cold" tumor type and typically exhibits little CD8+ T-cell infiltration and resistance to immunotherapy, yet both MSS patients had their "cold" tumors successfully transition into "hot" tumors with ADXS-NEO therapy. Further, two patients (one treated at 1×109 and one at 1×108 CFU) achieved stable disease in the study per RECIST 1.1 criteria.
ADXS-HOT: Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen-Directed Therapies – ADXS-HOT is a program consisting of over 10 different cancer-type specific immunotherapy constructs, which target hotspot mutations, cancer testis antigens and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to treat most types of non-small cell lung cancer and is in a Phase 1/2 clinical trial. One site is currently activated and enrolling patients with a second site anticipated to be activated by the end of June. The study will determine the recommended dose, safety, tolerability and immune and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor. Preliminary data from this Phase 1/2 study are anticipated in the second half of 2019. The company plans to file INDs on two additional HOT constructs within the next nine months.
ADXS-PSA: Prostate Cancer – The company presented updated clinical and biomarker data at the AACR (Free AACR Whitepaper) Annual Meeting in April on its Phase 1/2 KEYNOTE-046 study of ADXS-PSA, alone and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, for patients with metastatic castration-resistant prostate cancer ("mCRPC"). In addition, updated findings presented at the Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) at the NYAS in May demonstrated clinical activity and prolonged overall survival in MSS mCRPC patients, who typically are not expected to respond to treatment of a checkpoint inhibitor.
ADXS-HPV: Cervical Cancer – In May, the U.S. Food and Drug Administration ("FDA") lifted its partial clinical hold on the Phase 3 AIM2CERV study evaluating ADXS-HPV ("AXAL") for the treatment of patients with high-risk, locally advanced cervical cancer. The company is in discussions with the FDA to allow for an earlier interim analysis for efficacy under proposed revisions to the AIM2CERV protocol.
Management Commentary

"We are very encouraged by the early and promising data from our first neoantigen-directed immunotherapy, ADXS-NEO," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Based on these results, we continue to believe neoantigen-directed immunotherapies can become an important addition to the cancer treatment paradigm due to the unique presentation of neoantigens in cancer cells. The results from our ADXS-NEO program have shown the ability to have an impact within the tumor microenvironment in metastatic colorectal cancer, which historically has been a tumor type that is refractory to immunotherapy. We look forward to starting Part B of the study with ADXS-NEO in combination with a checkpoint inhibitor in the third quarter of this year."

"We have used the valuable insight we have gained from our ADXS-NEO platform to further advance our ADXS-HOT drug constructs. We are in discussions with a leading academic institution to finalize an investigator-sponsored trial evaluating ADXS-HOT in patients with prostate cancer, and anticipate the IND for this construct will be filed later this year." He added, "In order to ensure we have the appropriate resources to fund our programs, we have taken cost-control measures over the past year. These efforts have resulted in a reduction to our cash burn of more than 50% for the first six months of fiscal year 2019 versus the comparable period last year." He concluded, "We are actively reviewing our plans to finance the areas of the business where we feel there is a strong likelihood of us achieving our mission of improving the lives of people with cancer and their loved ones."

Fiscal Second Quarter Financial Results

Research and development expenses for the second quarter of fiscal year 2019 were $6.0 million, compared with $10.4 million for the second quarter of fiscal year 2018. The $4.4 million decrease was primarily attributable to cost controls initiated in the second half of fiscal year 2018. In addition, there was a decrease in clinical trial expenses resulting from the partial clinical hold on AIM2CERV and the winding down of several older studies, partially offset by an increase in expenses related to the startup costs associated with the commencement of the Phase 1/2 ADXS-HOT clinical trial.

General and administrative expenses for the second quarter of fiscal year 2019 decreased 37% to $3.1 million from $4.9 million for the second quarter of fiscal year 2018. The $1.8 million decrease was primarily attributable to a reduction in headcount and in professional and consulting fees related to external strategy and program assessment work performed in fiscal 2018.

Revenue decreased approximately $0.5 million to $1.2 million for the second quarter of fiscal 2019 from $1.7 million for the second quarter of 2018 due to the termination of the collaboration agreement with Amgen effective February 2019. Net loss for the second quarter of fiscal year 2019 was $9.4 million or $1.59 per share, compared with a net loss for the second quarter of fiscal year 2018 of $13.4 million or $4.03 per share.

Net cash used during the six months ended April 30, 2019 was $11.4 million. As of April 30, 2019, Advaxis had cash and cash equivalents of $33.7 million, which includes $9.0 million in net proceeds from a public offering completed in April.

Conference Call

The company will host a business update call on Tuesday, June 11, 2019 at 11:00 a.m. ET. During the call, Advaxis’ senior management will review the company’s clinical development programs and fiscal second quarter financial results, and provide a general business update.

The conference call and live audio webcast information is as follows:

WHEN: Tuesday, June 11, 2019 at 11:00 a.m. ET
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 6199489
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning June 11, 2019 two hours after the completion of the call. To access the recording, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the operator with the conference ID: 6199489. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.

Agios to Present at the Goldman Sachs Global Healthcare Conference on Tuesday, June 11, 2019

On June 10, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company is scheduled to present at the Goldman Sachs Global Healthcare Conference in Rancho Palos Verdes, California on Tuesday, June 11, 2019 at 2:40 p.m. PT (Press release, Agios Pharmaceuticals, JUN 10, 2019, View Source [SID1234536967]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

On June 10, 2019 The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies (Press release, US FDA, JUN 10, 2019, View Source [SID1234536966]). Polivy is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.

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"Antibody-drug conjugates are an emerging class of targeted immunotherapies for cancer. This type of therapy, unlike traditional chemotherapy, is intended to target specific cells," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Today’s approval of Polivy provides an alternative option for patients in whom multiple treatments have not worked."

More than 18,000 people are diagnosed with DLBCL each year in the U.S. Although it can be cured, about 30 to 40% of patients suffer relapse. This type of cancer grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs. Signs and symptoms of DLBCL may include swollen lymph nodes, fever, recurring night sweats and weight loss.

Polivy is an antibody that is attached to a chemotherapy drug. Polivy binds to a specific protein (called CD79b) found only on B cells (a type of white blood cell), then releases the chemotherapy drug into those cells. Efficacy was evaluated in a study of 80 patients with relapsed or refractory DLBCL who were randomized to receive Polivy with BR or BR alone. Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.

The most common side effects of Polivy plus BR include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.

Health care professionals are advised to monitor patients closely for infusion-related reactions, low blood counts and fatal and/or serious infections. Health care professionals should also monitor patients for tumor lysis syndrome (a complication from many tumor cells being killed off at the same time), liver damage (hepatotoxicity) and progressive multifocal leukoencephalopathy (PML), a fatal or life-threatening infection of the brain. FDA advises health care professionals to tell females of reproductive age to use effective contraception during treatment with Polivy and for three months after the last dose. Women who are pregnant or breastfeeding should not take Polivy because it may cause harm to a developing fetus or newborn baby.

Polivy in combination with BR was granted accelerated approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on an endpoint that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Polivy’s clinical benefit.

The FDA granted this application Breakthrough Therapy and Priority Review designations. Polivy also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Polivy to Genentech.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Sesen Bio Announces Successful Pre-BLA Meeting with FDA for Vicinium®

On June 10, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for patients with cancer, reported that it has completed a successful Type B Pre-Biologics License Application (BLA) meeting regarding the approval path for Vicinium for the treatment of patients with high-risk, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, JUN 10, 2019, View Source [SID1234536965]). The Company has reached alignment with the U.S. Food and Drug Administration (FDA) on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the Company expects to initiate submission of the BLA in the fourth quarter of 2019. The FDA also indicated that the nonclinical data, the clinical pharmacology data, and the safety database are sufficient to support a BLA submission, and that no additional clinical trials are necessary for a BLA submission.

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Rolling Review of the BLA enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. The final module submission for the BLA will be CMC, and Sesen Bio plans to meet with the FDA in the second half of 2019 to discuss the content and timing of that module.

"We have now had two successful meetings with the FDA over the last three weeks, which build on our long-term relationship with the Agency and make our regulatory path forward for Vicinium even more clear," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Gaining alignment with the FDA on an Accelerated Approval Pathway, in addition to a rolling review of the BLA, significantly increases our confidence in our regulatory pathway and our ability to bring a product to market that has the potential to save and improve the lives of patients."

On May 21, 2019 Sesen Bio announced a positive outcome from its previous meeting with the FDA, a Type C CMC meeting, where Sesen Bio reached agreement with the FDA on the Analytical Comparability Plan, and confirmed, subject to final comparability data to be provided in the BLA submission, that no additional clinical trials were deemed necessary for comparability.

Sesen Bio plans to schedule two additional meetings with the FDA in the second half of 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, and a Type B CMC meeting to discuss the submission strategy of the CMC module.

Conference Call Information
To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2958515. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

PharmaCyte Biotech CEO in Thailand to Oversee Production of Final Clinical Trial Material for IND Submission

On June 10, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Chief Executive Officer, Kenneth L. Waggoner, and his team are now in Bangkok, Thailand (Press release, PharmaCyte Biotech, JUN 10, 2019, View Source [SID1234536964]). They have been attending meetings on site at Austrianova’s GMP manufacturing facility. Production of PharmaCyte’s clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is already underway.

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On Tuesday, June 11, Mr. Waggoner and PharmaCyte’s consultant cellular biologist, David A. Judd, will observe and assist the team from Austrianova, if needed, as they continue their work to produce the necessary clinical trial material for PharmaCyte’s planned clinical trial for LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the necessity to be on the ground at the GMP production facility, "We are at a very crucial point on our path to a clinical trial. The production of our clinical trial material is vital to our success in the clinic, and it is vital to advancing our clinical development timeline. We need the testing of the finished cancer product to get underway. The data from those tests should enable us to complete our Investigational New Drug application (IND). After the changes Austrianova made to the manufacturing process, about which we have already reported, we are back on track. We’ll be here in Thailand overseeing the production runs that will produce the clinical trial material PharmaCyte needs to continue its journey to the clinic."

Also, a film crew will be on hand to document the company’s manufacturing process for the production of a video that will tell PharmaCyte’s pancreatic cancer therapy story in its entirety.

As a reminder, Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies for over 35 years, 30 of which have been with a major biotechnology company in the United States.