On May 12, 2020 Pfizer Inc. (NYSE: PFE) reported that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, from May 29-May 31 (Press release, Pfizer, MAY 12, 2020, View Source [SID1234557591]). The data that will be presented build on Pfizer’s strong track record in oncology by providing new insights in areas like breast, colorectal and genitourinary cancers, which include bladder, prostate, and kidney cancer. Data from Pfizer’s early stage pipeline, including a novel anti-HER2 antibody-drug conjugate, will also be presented as Pfizer aims to transform the cancer treatment landscape well into the future.

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"Our data presentations will highlight the depth and breadth of our cancer portfolio, including our current medicines and new generation of potential therapies," said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. "We are particularly excited to share the first presentation of detailed overall survival results from the JAVELIN Bladder 100 trial of BAVENCIO and the final overall survival data from the PROSPER trial of XTANDI. These data will support our rapidly expanding efforts in bladder cancer and add to the growing body of clinical evidence generated with XTANDI in prostate cancer."

New data will be featured in nine oral presentations, including a Plenary Session presentation of data from the JAVELIN Bladder 100 trial evaluating BAVENCIO (avelumab) as a first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC). Additional data provide insights on Pfizer’s medicines, including IBRANCE (palbociclib), BRAFTOVI (encorafenib), XTANDI (enzalutamide) and lorlatinib, as well as its cutting-edge, investigational compounds, including a HER2-targeted antibody-drug conjugate in patients with solid tumors. BAVENCIO is being developed and commercialized in collaboration with Merck KGaA, Darmstadt, Germany. As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI.

To help interested non-scientists better understand the latest research, Pfizer has also developed summaries in non-technical language for results of company-sponsored studies being presented in the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program called "abstract plain language summaries (APLS)." Those interested in learning more can visit www.Pfizer.com/apls to access the summaries directly starting May 29.

Key presentations featuring Pfizer medicines in the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program include:

Pfizer-Sponsored Studies

Plenary Session Oral Presentation (Abstract LBA1)

Sunday, May 31, 1 pm ET

Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase 3 interim analysis.

Powles T

Oral Presentation (Abstract 4001)

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E metastatic colorectal cancer: updated survival results from a randomized, three-arm, phase 3 study versus choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC)

Kopetz S

Poster Discussion (Abstract 5515)

Final overall survival (OS) from PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (nmCRPC)

Sternberg CN

Poster Presentation (Abstract 1039)

A phase 1 dose escalation study evaluating the safety and tolerability of a novel anti-HER2 antibody-drug conjugate (PF-06804103) in patients with HER2-positive solid tumors

Meric-Bernstam F

Poster Presentation (Abstract 5080)

Axitinib plus pembrolizumab in patients with advanced renal cell carcinoma: Long term efficacy and safety from a phase 1b study

Atkins MB

Investigator Sponsored Studies and Clinical Research Collaborations

Oral Presentation (Abstract 1010)

Prognostic impact of ESR1 mutations in ER+ HER2- MBC patients prior treated with first line AI and palbociclib: An exploratory analysis of the PADA-1 trial

Bidard FC

Oral Presentation (Abstract 10504)

Phase 1 trial of lorlatinib in patients with ALK-driven refractory or relapsed neuroblastoma: A New Approaches to Neuroblastoma Consortium study

Goldsmith KC

Oral, poster discussion, and poster sessions, as well as track-based clinical science symposia, will be available on demand for registered participants beginning Friday, May 29 at 8:00 AM ET. A complete list of Pfizer-sponsored abstracts is available at View Source

Merck KGaA, Darmstadt, Germany, and Pfizer have a global strategic alliance to jointly develop and commercialize BAVENCIO.

As part of a global agreement, Pfizer and Astellas jointly develop and commercialize XTANDI. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

On May 12, 2020 Pfizer Inc. (NYSE: PFE) reported that investors and the general public to listen to a webcast of a discussion with Charles Triano, Senior Vice President, Investor Relations, at the RBC Capital Markets 2020 Global Healthcare Conference on Tuesday, May 19, 2020 at 11:30 a.m. EDT (Press release, Pfizer, MAY 12, 2020, View Source [SID1234557590]).

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To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today.

Visitors will be able to listen to an archived copy of the webcast at www.pfizer.com/investors.

On May 12, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will present at the 2020 RBC Capital Markets Global Healthcare Conference on Tuesday, May 19 at 4:15 p.m. ET (Press release, IGM Biosciences, MAY 12, 2020, View Source [SID1234557589]). The conference will be held in a virtual meeting format.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On May 12, 2020 BioXcel Therapeutics, Inc. ("BTI" or "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, reported its quarterly results for the first quarter ended March 31, 2020 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, MAY 12, 2020, View Source [SID1234557588]).

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"BioXcel continued to advance on its key milestones for 2020," stated Vimal Mehta, Chief Executive Officer of BTAI. "Beginning with our neuroscience program, we have made significant progress advancing BXCL501, as evidenced by our three ongoing clinical trials, SERENITY I & II and TRANQUILITY, and our Phase 1b/2 RELEASE trial initiating shortly. In parallel, we are investigating biomarkers associated with agitation in hopes of expanding the potential market for BXCL501 to additional indications. These significant achievements showcase the versatility of this candidate and we believe provides the foundation for creating a highly valuable neuroscience franchise. In addition, we have made great strides with our immuno-oncology program, identifying the recommended dose of BXCL701 when used in combination with KEYTRUDA for our Phase 2 efficacy trial for treatment emergent Neuroendocrine Prostate Cancer. We believe this candidate has the potential to provide a treatment for this advanced prostate cancer that currently does not have an effective standard of care."

Dr. Mehta added, "In light of the COVID-19 pandemic, we are continuously monitoring the safety of our team, as well as its potential impact on our clinical and corporate plans. To date, we have not experienced any significant delays with our ongoing clinical trials and have developed a risk mitigation strategy to manage business operations."

First Quarter 2020 and Recent Highlights

BXCL501-Neuroscience Program

BXCL501 is an investigational sublingual thin film of dexmedetomidine, a selective alpha-2A adrenergic receptor agonist, designed for the treatment of acute agitation. The Company believes BXCL501 may directly target a causal agitation mechanism.

·The SERENITY program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder, is ongoing, with more than one-third of the patients enrolled and treated as of March 19, 2020. Enrollment is progressing as planned, and the Company is on track to report topline data from both Phase 3 trials in mid-2020.
In January 2020, the first patient was enrolled in the TRANQUILITY study, a Phase 1b/2 trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia. BTI is currently assessing safety and tolerability data in order to choose the next tested dose, and the Company expects to report topline results in mid-2020.

·Our Investigational New Drug application for the treatment of opioid withdrawal symptoms, a fourth indication for BXCL501, received clearance from the U.S. Food and Drug Administration in February 2020. The Company is planning to initiate the Phase 1b/2 RELEASE trial for the treatment of opioid withdrawal symptoms shortly.
·In February 2020, researchers at Yale University initiated a Phase 2 study designed to measure biomarkers associated with agitation in patients with schizophrenia and their response to treatment with BXCL501.
·The Company is currently completing the clinical planning stage for its fifth indication, agitation associated with hyperactive delirium, and is preparing to initiate a Phase 1b/2 trial of BXCL501 in the second half of 2020.

BXCL701-Immuno-Oncology Program

BXCL701 is an orally-delivered small molecule, innate immunity activator designed to inhibit dipeptidyl peptidase (DPP) 8/9 and block immune evasion by targeting Fibroblast Activation Protein (FAP). It has shown single agent activity in melanoma and safety has been evaluated in more than 700 healthy subjects and cancer patients.

·After completing the Phase 1b safety lead-in, the Company has initiated the Phase 2 portion of the Phase 1b/2 trial of BXCL701 in combination with pembrolizumab (KEYTRUDA) for treatment emergent Neuroendocrine Prostate Cancer (tNEPC). 0.3 mg of BXCL701 twice daily (BID) was found to be the recommended dose when used in combination with KEYTRUDA and this dose regime will be used for the efficacy assessment of the clinical program. The Company expects to report initial data from this trial in the fourth quarter of 2020.
·The open label Phase 2 basket trial evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid cancers has been initiated. This study, which is being conducted at the MD Anderson Cancer Center, is following the dosing schedule used in the Phase 1b/2 study for tNEPC.
·The BXCL701 phase of the triple combination study of BXCL701, bempegaldesleukin (NKTR-214, Nektar Therapeutics, Inc.) and BAVENCIO (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer is expected to begin following Nektar and Pfizer’s Phase 1b safety trial of a double combination of bempegaldesleukin and avelumab and the outcome of that trial.

Strengthened Balance Sheet

·In February 2020, the Company raised net proceeds of approximately $60 million in connection with its common stock offering. BTI believes that proceeds from this offering, together with current reserves, provide cash runway to fund key clinical, regulatory and operational milestones into 2021.

COVID-19

During the first quarter of 2020, the Company took steps in line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the State of Connecticut to protect the health and safety of its employees and the community. In particular, the Company implemented a work-from-home policy for all employees and has restricted on-site activities to certain chemical, manufacturing and control ("CMC") and clinical trial activities. To date, the Company has not experienced any significant delays to its ongoing or planned clinical trials; however, this could rapidly change.

First Quarter 2020 Financial Results

BTI reported a net loss of $14.9 million for the first quarter of 2020, compared to a net loss of $7.2 million for the same period in 2019. The first quarter 2020 results include approximately $0.8 million in non-cash stock-based compensation.

Research and development expenses were $12.4 million for the first quarter of 2020, as compared to $5.7 million for the same period in 2019. The increase was primarily due to an increase in clinical trial expenses, salaries, bonus and related costs, professional research and project-related costs and chemical, manufacturing and controls costs related to our BXCL501 and BXCL701 product candidates.

General and administrative expenses were $2.6 million for the first quarter of 2020, as compared to $1.7 million for the same period in 2019. The increase was primarily due to professional fees for additional legal and patent services.

Total operating expenses for the first quarter of 2020 were approximately $15.0 million, as compared to total operating expenses of approximately $7.4 million for the same period in 2019.

As of March 31, 2020, cash and cash equivalents totaled approximately $80.1 million.

Conference Call:

BTI will host a conference call and webcast today at 8:30 a.m. ET. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors sections of the BTI website at www.bioxceltherapeutics.com. The replay will be available through May 26, 2020.

On May 12, 2020 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, reported that advances from its "off-the-shelf" or allogeneic platform at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual meeting which kicked off in virtual format today (Press release, Adaptimmune, MAY 12, 2020, View Source [SID1234557587]).

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Data from a poster summarized recent advances in Adaptimmune’s allogeneic platform demonstrating the production of engineered T-cells, differentiated from human induced pluripotent stem cells (hiPSC) (iT cells). The poster was presented by Garth Hamilton, PhD, a Principal Scientist at Adaptimmune, and Joanna Brewer, PhD, Adaptimmune’s SVP Allogeneic Research. There is a video webcast of this presentation available on the Adaptimmune website: https://bit.ly/2L6jtx5.

"We have clearly demonstrated that we can make T-cells from stem cells. These cells express our engineered SPEAR TCR targeting MAGE-A4 and can kill tumor cells in vitro as effectively as control cells," said Jo Brewer, Adaptimmune’s SVP of Allogeneic Research. "We have also reached a milestone in editing our engineered TCRs into the hiPSC genome to enable successful differentiation. This is one critical element as we plan to build large banks of pluripotent cells for our proprietary differentiation process, to generate functional T-cells expressing our engineered receptors. These are great advances as we prepare for clinical use."

Summary

·Poster Title: Driving ADP-A2M4 SPEAR Expression from an Endogenous Hematopoietic Lineage Promotor for "Off-the-Shelf" T-Cell Therapy for MAGE-A4+ Solid Tumors
·Edited hiPSCs (iT-cells) expressing the ADP-A2M4 TCR can kill cancer targets in vitro
·Data suggests that, like autologous SPEAR T-cells currently in clinical trials, ADP-A2M4 iT-cells have potential to be an efficacious cell therapy
·Ability to promote T-cell receptor expression in iT-cells via genetic knock-in at a defined locus offers an opportunity to produce multiple clonal iPSC banks encoding specific SPEAR TCRs against a range of tumor antigens