On June 10, 2019 Sosei Group Corporation ("the Company"); (TSE: 4565) and its strategic alliance partner Pfizer reported that a new clinical candidate from their multi-target drug discovery collaboration was nominated to advance into clinical development (Press release, Sosei Heptares, JUN 10, 2019, View Source [SID1234552773]). Sosei Heptares will receive a $3 million milestone payment from Pfizer for this achievement. The first clinical candidate under this collaboration was nominated by Pfizer in May 2019.

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Dr. Malcolm Weir, Executive VP and Chief R&D Officer of Sosei Heptares, said: "We are very pleased to reach this development milestone for another candidate in our partnership with Pfizer so soon after nominating the first clinical candidate last month. The teams at Sosei Heptares and Pfizer have worked well together to generate and advance a novel molecule against a difficult GPCR target, highlighting again the power and potential of this approach and the combined capabilities being deployed."

The multi-target drug discovery collaboration between Sosei Heptares and Pfizer was signed in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

In an effort to address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering milestone payments from Pfizer, including the US$3 million announced today, as well as $3 million in May 2019, both resulting from the nomination of new clinical candidates. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a US$33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.

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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On June 10, 2019 Oncologie, an innovative biopharmaceutical company using proprietary biomarkers to drive clinical development of next-generation oncology therapeutics, reported that it has closed an $80M Series B financing (Press release, Oncologie, JUN 10, 2019, View Source [SID1234536984]). Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined by a syndicate of new investors including Panacea Venture Healthcare and Korea Investment Partners.

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The funding will be used to advance Oncologie’s three clinical stage programs, as well as its proprietary biomarker platform and in-licensing activities. Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. Oncologie’s other programs include a TLR9 activator, lefitolimod, and a unique VEGF-targeting antibody, varisacumab. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic "driver" mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Company will also continue to leverage its platform to identify best-in-class assets for licensing and development.

"Expectations for precision medicine are increasing worldwide. By matching the right drug to the right patient, Oncologie’s innovative biomarker platform is designed to build value by narrowing patient populations, accelerating development timelines and reducing failure," said Laura E. Benjamin, PhD, Founder, President, and CEO. "This funding allows us to accelerate the development of our pipeline and platform, and grow our portfolio through partnering or acquisition."

"Over the past year, Oncologie has assembled an outstanding team of experienced professionals and a robust pipeline around a truly innovative biomarker platform," said Peter Bisgaard, Managing Director for NanFung Life Sciences and Managing Partner of Pivotal BioVenture Partners. "I am particularly excited by Oncologie’s biomarker strategy and approach, which leverages cutting-edge science to optimize patient selection in the challenging arena of the tumor microenvironment. This team has ambitious and strategic growth plan for building a leading oncology therapeutics company around this platform and around a pipeline of next-generation immunotherapies. "

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.

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.