On May 13, 2020 DCprime, the front-runner in the field of relapse vaccines, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for DCP-001, an allogeneic cancer relapse vaccine currently being evaluated in a European Phase II trial in Acute Myeloid Leukaemia (AML) patients who are ineligible for hematopoietic stem cell transplantation (Press release, DCPrime, MAY 13, 2020, View Source [SID1234561870]). The IND provides the possibility for DCprime to expand the ongoing ADVANCE-II trial into the Unites States, where DCP-001 had received orphan drug status in Q4 2019.

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"Following encouraging clinical and preclinical data presented at medical conferences in 2019, 2020 should see the first results emerging from the ADVANCE-II study. The possibility to expand our trial activities into the United States is an important step and follows approvals by different European authorities in The Netherlands, Germany, Norway, Sweden, and recently also Finland," said Jeroen Rovers, MD, PhD, Chief Medical Officer of DCprime. "Although we are currently facing challenging times for clinical studies due to the Covid-19 crisis, DCprime remains committed to expanding its clinical network to support the development of relapse vaccines in AML and other cancer types. Securing the regulatory approval now, allows us to move quickly once the current clinical situation around Covid-19 improves."

The currently active international, multi-center, open-label proof-of-concept study ADVANCE-II is recruiting AML patients in complete remission, but with persistent measurable residual disease (MRD), which is associated with a high relapse rate. The effect of DCP-001 on MRD in combination with immunomonitoring will be used to evaluate the efficacy of DCprime’s relapse vaccination strategy.

Clinical data from a previously concluded Phase I clinical study that was presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2019 demonstrated DCP-001’s potential to prolong relapse-free survival and overall survival in the post-remission setting.

On May 13, 2020 Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform therapy called Tumor Treating Fields, reported that the China National Medical Products Administration (NMPA) has approved the Marketing Authorization Application (MAA) for Optune in combination with temozolomide for the treatment of patients with newly diagnosed glioblastoma (GBM), and also as a monotherapy for the treatment of patients with recurrent GBM (Press release, Zai Laboratory, MAY 13, 2020, View Source [SID1234557885]). GBM is the most common form of primary brain cancer, and Optune is the first treatment for glioblastoma approved in China in over 15 years.

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"The NMPA’s approval of Optune is a significant treatment advance for GBM patients in China and another important milestone for Zai," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "Optune was previously granted the Innovative Medical Device Designation, which highlights the differentiation and importance of this novel treatment for GBM patients. We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Optune application, recognizing the high unmet medical need it serves. We look forward to working with Novocure to bring Tumor Treating Fields to GBM and other difficult to treat cancer indications."

"Novocure is working to extend survival in some of the most aggressive cancers through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "Approval of Optune for GBM in Greater China extends the promise of Tumor Treating Fields therapy to patients in the world’s largest market. We thank Zai Lab for their commitment and hard work and congratulate them on their second product approval in six months."

Optune delivers Tumor Treating Fields therapy to the region of the tumor. Globally, more than 15,000 GBM patients have been treated with Optune, to date. Tumor Treating Fields is also approved by the U.S. FDA under the Humanitarian Device Exemption pathway for the treatment of malignant pleural mesothelioma (MPM), which is anticipated to be the next MAA filed with the NMPA. In addition to GBM and MPM, Tumor Treating Fields is under evaluation in global phase 3 pivotal trials for the treatment of brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, and in phase 2 pilot trials for liver cancer and gastric cancer. Approximately 1.5 million patients a year in China are diagnosed with non-small cell lung cancer, pancreatic cancer, ovarian cancer and gastric cancer, collectively.

"In China, there are more than 45,000 patients diagnosed with GBM each year and this approval marks the first new treatment option for these patients in over 15 years," said Jiang Tao, M.D., Ph.D., Head of Beijing Neurosurgical Institute, Founder of Chinese Glioma Genome Atlas, and Professor of Beijing Tiantan Hospital. "Optune was recommended with Level 1 evidence as a treatment for newly diagnosed GBM patients in China’s Glioma Treatment Guideline in 2018, and we are excited to now have Optune available as part of the standard of care for GBM patients in China."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Approved Indications (China)

Optune is intended as a treatment for adult patients (22 years of age or older) with recurrent supratentorial glioblastoma multiforme (GBM) diagnosed by histopathology or imaging, and newly diagnosed supratentorial GBM.

Newly diagnosed GBM

Optune with temozolomide (TMZ) is indicated for the treatment of adult patients with newly diagnosed GBM after surgery and radiotherapy.

Recurrent GBM

Optune is indicated for the treatment of recurrent GBM as a monotherapy.

On May 13, 2020 Viela Bio (Nasdaq:VIE), a clinical-stage biotechnology company pioneering treatments for autoimmune and severe inflammatory disease, reported financial results and provided program highlights for the first quarter ended March 31, 2020 (Press release, Viela Bio, MAY 13, 2020, View Source [SID1234557906]).

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"With the PDUFA date for our lead product candidate, inebilizumab, approaching in about one month, we are nearing another major company milestone—our first potential U.S. regulatory approval," said Bing Yao, Ph.D., Chief Executive Officer at Viela Bio. "In anticipation, our field teams have been hard at work continuing to prepare for the potential product launch. Based on positive efficacy and safety data in the pivotal N-MOmentum trial—which studied a broad, real-world spectrum of adults with neuromyelitis optica spectrum disorder, or NMOSD—we believe inebilizumab has the potential to be a first-line monotherapy option that could change the treatment paradigm for thousands of patients affected by this rare and devastating neuroinflammatory disease."

Continued Dr. Yao: "While it is still too early to gauge the full potential impact of the COVID-19 pandemic, at present, we have been fortunate to experience minimal effects on our business and we continue to make solid progress advancing our entire pipeline. Today, we announced positive interim results from cohorts of patients with cutaneous lupus erythematosus in our ongoing Phase 1b trial of VIB7734 and we recently initiated a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome."

PROGRAM HIGHLIGHTS

Inebilizumab

Company Advances Field Planning Activities

The U.S. Food and Drug Administration (FDA) is continuing its review of the Biologics License Application (BLA) for inebilizumab, with a Prescription Drug User Fee Act (PDUFA) action date of June 11, 2020. In preparation for the potential U.S. regulatory approval of inebilizumab, Viela has hired and trained market access and sales teams, and deployed MSLs. Should Viela secure product approval, the Company anticipates being able to initiate commercial launch activities shortly thereafter.

Viela Preparing for Additional Clinical Trials with Inebilizumab

Viela Bio recently submitted two Investigational New Drug (IND) applications to the FDA to begin human studies of inebilizumab in myasthenia gravis and IgG4-related disease, and plans to initiate Phase 3 pivotal and Phase 2b trials, respectively, in mid-year 2020. Viela Bio initiated a Phase 2 trial in 2019 for kidney transplant desensitization. Due to the COVID-19 pandemic, the Company has voluntarily paused enrollment of new patients in the kidney transplant desensitization trial.

VIB4920

Viela Advancing Multiple Mid-Stage Studies with VIB4920

Viela dosed the first patient at the end of 2019 in a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome—a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain. Due to the COVID-19 pandemic, the Company has voluntarily paused enrollment of new patients, while those currently enrolled continue in the trial. VIB4920 is an investigational fusion protein designed to bind to CD40L, blocking the T cells’ interaction with CD40-expressing cells. In earlier clinical studies, VIB4920 demonstrated the ability to address immune overactivation in T and B cell-driven diseases such as Sjögren’s syndrome. In response to COVID-19, the Company has voluntarily paused enrollment in its Phase 2 trial in patients with kidney transplant rejection. The Company is exploring other potential indications associated with the CD40/CD40L co-stimulatory pathway in which to pursue additional clinical studies with VIB4920.

VIB7734

Company Reports Promising Interim Results from Phase 1b Trial

Viela today reported positive interim Phase 1b data from a study with VIB7734, its novel anti-ILT7 therapy, in patients with cutaneous lupus erythematosus (CLE). The data provide preliminary evidence that VIB7734 can safely deplete plasmacytoid dendritic cells (pDCs) in these patients. In addition, the skin biopsy results, interferon signature and the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores—an important indicator that quantifies disease activity and damage in CLE patients—indicated clinically meaningful change from baseline. The drug candidate is designed to deplete pDCs by binding to ILT7, a cell surface molecule specific to pDCs. Viela looks forward to the final data from this trial and plans to provide additional information at a future medical conference.

CORPORATE UPDATE

Viela Strengthens its Board of Directors

Viela announced the election of Rachelle Jacques to its Board of Directors in April 2020. As a veteran of the biotechnology and pharmaceutical industries, she has held various leadership roles of increasing responsibility throughout her career and currently serves as the Chief Executive Officer at Enzyvant Therapeutics, Inc., a biopharmaceutical company focused on developing therapies for patients with rare diseases.

FINANCIAL RESULTS

For the first quarter of 2020, Viela reported a net loss of $40.8 million, compared to a net loss of $21.0 million for the first quarter of 2019.

As of March 31, 2020, Viela had $335.2 million in cash, cash equivalents, and investments and no outstanding debt. Viela received $30.0 million in cash for the upfront licensing fee from Mitsubishi Tanabe Pharma Corporation in the first quarter of 2020.

Research and development expenses were $26.8 million for the first quarter of 2020, which include $1.6 million of non-cash stock-based compensation expenses.

General and administrative expenses were $15.3 million for the first quarter of 2020, which include $1.1 million of non-cash stock-based compensation expenses.

Total operating expenses for the first quarter of 2020 totaled $42.1 million, compared to $21.7 million for the first quarter of 2019. Non-cash share-based compensation expenses totaled $2.7 million for the first quarter of 2020, compared to $0.6 million for the
2020 Financial Guidance

Viela Bio expects that its cash, cash equivalents and investments will fund its operating plans into mid-year 2022.

Conference Call and Webcast

The Company will host a live webcast and conference call to discuss financial results and program highlights for the first quarter of 2020 today at 5:00 p.m. ET.

The webcast will be accessible on the Events & Presentations page of Viela Bio’s website. Individuals can participate in the conference call by dialing (877) 783-8848 (domestic) or (631) 350-0960 (international) and referring to conference ID #: 3052446.

The archived webcast will be available for replay on the Viela Bio website approximately two hours after the event.

On May 13, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will present new preclinical data on the anti-tumor activity of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, in models of colorectal cancer (Press release, Syros Pharmaceuticals, MAY 13, 2020, View Source [SID1234557922]). These data will be presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO20) taking place May 29-31 . Syros will also present on the design of its ongoing Phase 1 trial of SY-5609 at ASCO (Free ASCO Whitepaper)20.

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The abstracts for these presentation are now available online on the ASCO (Free ASCO Whitepaper)20 website, at View Source

Details of the poster presentations are as follows:

Presentation Title: Activity of SY-5609, an oral, noncovalent, potent, and selective CDK7 inhibitor, in preclinical models of colorectal cancer
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Liv Johannessen, Ph.D., Syros
Abstract Number: 3585
Poster Number: 315

Presentation Title: First-in-human phase I study of SY-5609, an oral, potent, and selective noncovalent CDK7 inhibitor, in adult patients with select advanced solid tumors
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Presenter: Kyriakos P. Papadopoulos, M.D., South Texas Accelerated Research Therapeutics (START)
Abstract Number: TPS3662
Poster Number: 392

Presentations will be available for on-demand viewing on the ASCO (Free ASCO Whitepaper)20 website beginning May 29, 2020, at 8 a.m. EDT.

On May 13, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate (Press release, ImmunoGen, MAY 13, 2020, View Source [SID1234557939]). These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program on May 29, 2020. Three "trial in progress" posters will also be presented during the meeting.

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"With the benefit of the clinical profile demonstrated by mirvetuximab monotherapy, we have pursued a development strategy to establish mirvetuximab as the agent of choice in combination regimens to treat expanded populations of patients with recurrent ovarian cancer. To this end, we are encouraged by the compelling anti-tumor activity and favorable tolerability observed with the combination of mirvetuximab plus bevacizumab in patients for whom a non-platinum based regimen is appropriate," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These findings show greater depth and duration of tumor reduction in women whose tumors express high levels of FRα, regardless of platinum status, reinforcing the potential of this doublet in these patients. As these data mature, we look forward to further evaluating this combination in the recurrent ovarian cancer setting."

INITIAL DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB
This cohort enrolled 60 patients with FRα-positive recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate, with a median age of 60 years and a median number of 2 prior lines of therapy (range 1-4). The combination of mirvetuximab soravtansine with bevacizumab in this cohort demonstrates encouraging anti-tumor activity with a favorable tolerability profile, particularly among the subset of patients with high levels of FRα expression.

Key findings include:

In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate (ORR) was 43% (95% CI, 31, 57).
In patients with high FRα expression (n=33), the confirmed ORR was 61% (95% CI, 42, 77), with an ORR of at least 50% in each of the platinum-resistant and platinum-sensitive subgroups.
With many patients remaining on study, the duration of response and progression free survival data are immature.
The adverse events (AEs) observed with the doublet were as expected based on the side effect profiles of each agent. The most common treatment-related low grade AEs were diarrhea, blurred vision, nausea, and fatigue; grade 3+ AEs were infrequent, with the most common being hypertension and neutropenia.
"With the increasing need for non-platinum regimens in recurrent ovarian cancer, we are excited to further advance mirvetuximab in combination with bevacizumab, building on the prior data for this combination in women with platinum resistant disease," stated Lucy Gilbert, MD, Professor, and Director of the Gynecologic Oncology Division at McGill University Health Center in Montreal, Canada. "These initial data demonstrate meaningful clinical benefit in women with recurrent disease, regardless of platinum status, and I look forward to reporting longer-term follow up and further evaluating the doublet in this expanded patient population."

ORAL PRESENTATION SESSION

Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer"
Day/Time: Friday, May 29 at 8:00 AM ET
Lead Author: Lucy Gilbert, MD, McGill University Health Center, Montreal, Canada
Abstract: 6004
TRIAL IN PROGRESS POSTERS
The following posters will be available on Friday, May 29 at 8:00 AM ET in the ASCO (Free ASCO Whitepaper) Meeting Library:

Title: "MIRASOL (GOG 3045/ENGOT OV-55): A Randomized, Open-label, Phase 3 study of Mirvetuximab Soravtansine versus Investigator’s Choice of Chemotherapy in Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor Alpha (FRα) Expression"
Lead Author: Kathleen Moore, MD, University of Oklahoma Health Sciences Center
Abstract: TPS6103 (Poster 274)
Title: "A Phase 1/2 Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic Malignancies"
Lead Author: Naval Daver, MD, MD Anderson Cancer Center
Abstract: TPS7563 (Poster 336)
Title: "A Phase 1b/2 Study of the CD123-Targeting Antibody-Drug Conjugate IMGN632 as Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia"
Lead Author: Naval Daver, MD, MD Anderson Cancer Center
Abstract: TPS7564 (Poster 337)
Additional information can be found at www.asco.org.

ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.