On November 4, 2021Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that updated clinical data from its Phase 1 dose-escalation study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with B-cell malignancies will be presented in a poster session during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia on Sunday, December 12, 2021 (Press release, Xencor, NOV 4, 2021, View Source [SID1234594526]).

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"Plamotamab is generally well tolerated and demonstrates encouraging clinical activity at our recommended intravenous Phase 2 dose, 50 mg flat dosing every two weeks after step-up dosing. We believe the best outcomes for patients require our focus on studying unique combinations of plamotamab with chemotherapy-free partners, and we are initiating the first of these studies in patients with relapsed or refractory diffuse large B cell lymphoma in late 2021 or early 2022," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "Additionally, our recently announced collaboration for advancing plamotamab development will close soon, and this will expand our strategy to develop multiple highly active chemotherapy-free regimens across B-cell cancers, importantly with tumor-selective, co-stimulatory CD28 bispecific antibodies."

Key Highlights from the Abstract

The accepted abstract with data from the study is available through the ASH (Free ASH Whitepaper) website. Updated results will be shared at the ASH (Free ASH Whitepaper) Annual Meeting.

At data cut off on July 1, 2021, 80 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) had received doses of plamotamab. Patients had a median age of 62 years, a median of 4 prior therapies and had been diagnosed a median of 28 months prior to treatment. The study was originally designed in two parts: Part A to establish an initial priming dose with fixed, weight-based dosing regimens and Part B to escalate dosing on administrations subsequent to the priming dose. A third part, Part C, was added to establish a step-up dosing regimen with higher, flat and less frequent, every other week, dosing.

The most common treatment-related adverse event was cytokine release syndrome (CRS), which occurred in 62.5% (50/80) of patients, with 5.0% (4/80) experiencing Grade 3 or 4 events. CRS was generally manageable with premedication. No related neurotoxicity Grade 2 or higher was observed.

The efficacy analysis included 53 evaluable patients who were treated at doses between 80 and 360 mcg/kg (n=45) or at flat doses of 50 mg (n=8). The overall response rate (ORR) was 38.2% (13/34) in patients with diffuse large B-cell lymphoma. The ORR was 80% (8/10) for patients with follicular lymphoma. The median duration of response was 57 days.

After the implementation of higher doses in the flat-dosing regimen, the ORR among all patients with NHL had improved to 50% (4/8) from 42.2% (19/45) in prior weight-based dosing cohorts. At data cut off, the median duration of response was 19.5+ days, with three of four patients continuing to respond to plamotamab monotherapy.

The ORR for patients with prior CAR-T therapy was 25% (4/16).

Presentation Details

Abstract 2494, "Safety and Anti-Tumor Activity of Plamotamab (XmAb13676), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Subjects with Relapsed/Refractory Non-Hodgkin’s Lymphoma"
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Date & Time: Sunday, December 12, 2021. 6:00 – 8:00 p.m. EST
Location: Georgia World Congress Center, Hall B5
About Plamotamab

Plamotamab is an investigational tumor-targeted XmAb bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). CD20 is highly expressed across a range of B-cell tumors, including non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

Plamotamab is currently being evaluated in a Phase 1 clinical study for the treatment of patients with CD20-expressing hematologic malignancies, including NHL and CLL. Preliminary safety and anti-tumor activity from the Phase 1 study indicated that plamotamab was generally well tolerated and demonstrated encouraging clinical activity as a monotherapy.

On November 4, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a company applying innovative diagnostics to inform disease management decisions and improve patient outcomes, reported its agreement with ModMed to establish an interface with ModMed’s electronic health records system, EMA (Press release, Castle Biosciences, NOV 4, 2021, View Source [SID1234594543]). The interface is designed to enable dermatologic clinicians to order Castle’s DecisionDx skin cancer tests from directly within a patient’s medical record in EMA.

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"At Castle, we are excited to facilitate the ordering of our skin cancer portfolio from directly within one of the most widely utilized dermatologic electronic health records systems, EMA," said Toby Juvenal, chief commercial officer of Castle Biosciences. "We are committed to impacting patient care, and our diagnostic tests are designed to provide clinically-actionable information to clinicians and patients to inform disease management decisions. The EMA platform has been ranked #1 by dermatologists for the past eight years by Black Book. Our interface with this system is expected to streamline the ordering process and allow for delivery of Castle’s test results within the system."

Castle’s full suite of skin cancer tests will be available to order within EMA: DecisionDx-Melanoma for cutaneous melanoma, DecisionDx-SCC for cutaneous squamous cell carcinoma and the Company’s Comprehensive Diagnostic Offering for difficult-to-diagnose melanocytic lesions (comprised of myPath Melanoma and DecisionDx DiffDx-Melanoma). Castle’s interface with EMA is expected to be complete by year-end 2021.

On November 4, 2021 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics and monitoring company with the mission to improve patient outcomes by providing clear insights that inform critical decisions in the diagnosis, treatment, and monitoring of cancer, reported the clinical launch of its DetermaIOTM test (Press release, Oncocyte, NOV 4, 2021, View Source [SID1234594571]). DetermaIO is a proprietary gene expression test that assesses the tumor immune microenvironment (TIME) to predict response to immunotherapy. In multiple clinical studies evaluating hundreds of patients across multiple tumor types, including lung, breast, bladder and renal cancers, the test has demonstrated the ability to predict response to immune checkpoint inhibitors (ICI) which has the potential to help inform the optimal use of immunotherapy treatment for more than one million eligible patients annually in the United States alone.

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"For my patients with lung cancer, there are myriad treatment options including mono immunotherapy, combination immunotherapy with chemotherapy, and even a combination of two immunotherapies, each with their benefits and risks in terms of toxicity and side effects," said Dr. Nagdala Abdel-Karim, Director of the Thoracic Oncology Multidisciplinary Clinic and Medical Director of the Georgia Cancer Centers Clinical Trials Program. "Therefore, selecting the right immunotherapy regimen for the patient is a very complex decision. We use PD-L1 and occasionally tumor mutational burden (TMB), but neither biomarker is completely accurate or takes into account both the tumor and its microenvironment, which is important as both determine response to immunotherapy. I am impressed with the DetermaIO data, especially the superior progression free survival relative to legacy biomarkers and feel confident it will enable us to better navigate the immunotherapy decision."

In studies in multiple solid tumors presented at oncology congresses around the world, including at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper), American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and American Association of Cancer Research (AACR) (Free AACR Whitepaper), and in a peer-reviewed publication with authors from MD Anderson and Yale, DetermaIO has demonstrated superior utility in identifying patients who may respond to immunotherapy compared to alternative biomarkers in development. DetermaIO has also demonstrated superior utility in identifying patients who are unlikely to benefit from these immune therapies which can cause serious, long-lasting side effects. In a study presented at the recent ESMO (Free ESMO Whitepaper) congress, triple negative breast cancer patients randomized to receive either neoadjuvant chemotherapy alone or chemotherapy combined with an immune checkpoint inhibitor, DetermaIO positive patients had a 20% higher pathologic complete response only when an ICI was added to standard of care chemotherapy (71% response compared to 51%), while those patients who were DetermaIO negative showed no additional benefit from the addition of immunotherapy to a standard of care regimen. This study confirmed findings in a previously published study where ICI given in combination with standard neoadjuvant chemotherapy showed far superior benefit in DetermaIO positive patients compared to DetermaIO negative.

Padma Sundar, Chief Commercial Officer of Oncocyte, said, "Given the data presented to date, there is strong interest among physicians to access this test and incorporate it into their practice to aid in the complex decision making for immunotherapy treatment. We are launching the test initially as part of an early access program to optimize sample processing and logistics, targeting sites that have successfully partnered with Oncocyte on prior tests. Recruitment for the early access program is ahead of schedule and clinical samples are expected to begin coming in before the end of the year. Demonstrating test adoption is an important step towards pursuing Medicare reimbursement, along with peer reviewed publications which are in progress, and we remain committed to deliver our reimbursement dossier in the first half of 2022."

Ms. Sundar continued, "The next step in our menu roll out is to combine DetermaIO with DetermaTx, a DNA/RNA based comprehensive genomic profiling test, which already has established Medicare reimbursement rates. With both tests performed on a single sample, we will deliver the most complete and differentiated biomarker information needed to make both immunotherapy and targeted therapy decisions to treating physicians, while conserving precious sample and minimizing turnaround time. This, combined with DetermaCNI, our blood-only test for treatment resistance monitoring currently in clinical trials, builds on our ‘one-lab’ offering, and will differentiate us with oncologists. Our one lab and sample sparing approach strengthens our position as an emerging leader in precision oncology testing."

The launch of DetermaIO is built on the growing body of evidence on the clinical applications of the test, suggesting a potential pan-cancer and pan-immunotherapy utility in both primary and metastatic settings. In combination with the Company’s robust pipeline of diagnostic and monitoring tools, as well as its recently-launched real world cancer registry in early stage NSCLC for DetermaRx, this launch underscores Oncocyte’s commitment to driving rigorous science in order to empower surgeons, physicians, and their patients to better manage the oncology patient journey.

About DetermaIO

DetermaIO is a 27-target multivariate gene expression test performed on FFPE biopsy specimens that measures the presence of subtypes of infiltrating inflammatory cells, and the presence or absence of a differentiated stromal microenvironment. DetermaIO’s proprietary algorithm combines mRNA gene expression data to interpret the physiology of both the tumor and its surrounding micro-environment in order to predict the response to immuno-oncology therapies. For more information, visit www.oncocyte.com/products/determa-io.

On November 4, 2021 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its third quarter 2021 financial results after market close on Thursday, November 11, 2021 (Press release, IntelGenx, NOV 4, 2021, View Source [SID1234594602]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Third Quarter 2021 Results Conference Call Details:

Date: Thursday, November 11, 2021

Time: 4:30 p.m. ET

Live Call: 1-888-506-0058 (Canada and the United States)
1-973-528-0135 (International)

Access Code: 995615
The call will also be broadcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On November 4, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the third quarter ended September 30, 2021 (Press release, ViewRay, NOV 4, 2021, View Source [SID1234594618]).

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Third Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $39.4 million, compared to four new orders totaling $23.4 million in the third quarter of 2020. Total orders for the nine months ended September 30, 2021 represent a 24% growth over total orders for the twelve months ended December 31, 2020.
Total backlog increased to $295.1 million as of September 30, 2021, compared to $238.9 million as of September 30, 2020.
Total revenue of $19.2 million primarily from three revenue units, compared to $10.1 million primarily from one revenue unit in the third quarter of 2020.
Cash usage in the third quarter of 2021 was approximately $17.0 million compared to approximately $16.0 million in the third quarter of 2020.
Cash and cash equivalents were $149.9 million as of September 30, 2021.
"Performance continues to be strong and momentum in our clinical and innovation pipelines are evident." said Scott Drake, President and CEO. "We had a great showing at ASTRO. Data presented by Dr. Michael Chuong on 148 inoperable pancreatic cancer patients with MRIdian SMART displayed 26 month median survival compared to 12-15 months typically seen in patients receiving chemotherapy and standard radiation therapy. Our technical lead should be extended with multiple enhancements pending with the FDA. The future is bright for patients treated on MRIdian."

Three Months Ended September 30, 2021 Financial Results

Total revenue for the three months ended September 30, 2021 was $19.2 million compared to $10.1 million for the same period last year.

Total gross profit (loss) for the three months ended September 30, 2021 was $1.9 million, compared to $(1.1) million for the same period last year.

Total operating expenses for the three months ended September 30, 2021 were $25.2 million, compared to $23.9 million for the same period last year.

Net loss for the three months ended September 30, 2021 was $25.3 million, or $0.15 per share, compared to $28.1 million, or $0.19 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $149.9 million at September 30, 2021.

Nine Months Ended September 30, 2021 Financial Results:

Total revenue for the nine months ended September 30, 2021 was $49.7 million compared to $38.6 million for the same period last year.

Total gross profit (loss) for the nine months ended September 30, 2021 was $0.5 million, compared to $(4.2) million for the same period last year.

Total operating expenses for the nine months ended September 30, 2021 were $75.0 million, compared to $76.4 million for the same period last year.

Net loss for the nine months ended September 30, 2021 was $83.0 million, or $0.51 per share, compared to $81.8 million, or $0.55 per share, for the same period last year.

Financial Guidance

The Company reiterated its 2021 guidance of total revenue in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, November 4, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 5970168. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 5970168.