On January 26, 2021 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage, oncology-focused biopharmaceutical company with a vision of transforming lives with safer, more effective therapies, reported the completion of its previously announced underwritten public offering of 14,285,714 shares of its common stock at a price to the public of $7.00 per share, with net proceeds to CytomX of approximately $93.6 million, after deducting underwriting discounts and commissions and estimated offering expenses (Press release, CytomX Therapeutics, JAN 26, 2021, View Source [SID1234574286]). All shares in the offering were sold by CytomX. In addition, CytomX has granted the underwriters of the offering a 30-day option to purchase up to an additional 2,142,857 shares of its common stock at the public offering price, on the same terms and conditions.

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J.P. Morgan Securities LLC, Cowen and Company, LLC and Piper Sandler are acting as joint bookrunning managers for the offering.

The securities described above were offered pursuant to a registration statement that was filed with the Securities and Exchange Commission ("SEC") on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019. The final prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 21, 2021 and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone: +1 (833) 297-2926, or via email: [email protected]; and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On January 26, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that three abstracts from multiple clinical studies will be featured at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC), scheduled for January 28-31, 2021 (Press release, Biodesix, JAN 26, 2021, View Source [SID1234574307]). Findings from these recent studies demonstrate that an individual patient’s immune profile can provide information to support treatment decisions for patients diagnosed with advanced non-small cell lung cancer (NSCLC).

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"These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC"

MA08.03: Immunotherapy alone or with chemotherapy in advanced NSCLC? Utility of clinical factors and blood-based host immune profiling.
An abstract authored by Wallace Akerley, MD, of the University of Utah Huntsman Cancer Institute demonstrates that host immune classifier (HIC) testing can equip physicians with key information to help guide treatment decisions for patients with newly diagnosed advanced NSCLC.

The prospectively designed INSIGHT observational study (NCT03289780) found that a clinically validated, blood-based HIC successfully helped to predict Immune Checkpoint Inhibition (ICI) therapy outcomes. The HIC test accurately stratified survival for patients receiving ICI but not ICI in addition to platinum-doublet chemotherapy. This suggests that HIC testing can be used to determine the appropriate treatment course for advanced NSCLC patients by identifying patients who may benefit from more aggressive treatment strategies, including ICI plus platinum-based chemotherapy combinations. The highly anticipated abstract for this presentation is part of the conference press program, and therefore under embargo until the presentation at 3:45 a.m. EST on January 30, 2021.

P33.06: Utilizing serum proteome to understand response and resistance to immune checkpoint inhibitors in advanced non-small cell lung cancer
An abstract presented by Won Kyung Hur, MD, of Olive View-UCLA Medical Center, reports data from a study on the Primary Immune Response (PIR) test, a proteomic classifier that identifies an aggressive disease state associated with resistance to ICI therapy. While treatment options for patients with advanced NSCLC have evolved significantly with the introduction of ICI, many patients develop either primary or secondary resistance to ICI, making them unable to benefit from this therapy. Response and resistance to ICI treatment for NSCLC are poorly understood.

This presentation will report findings from an independent validation of the PIR test, led by Young Kwang Chae, MD, which identifies an aggressive NSCLC disease state associated with resistance to ICI therapy. Findings from the study suggest that the PIR test can help predict patient survival with ICI therapy and guide treatment decisions for patients with advanced NSCLC. The data will be available for viewing at 11:00 a.m. EST on January 27, and Dr. Hur will present the data on January 28, 2021.

FP07.17: The Impact of Blood Based Host Immune Profile to Identify Aggressive Early Stage NSCLC
The abstract, authored by Eric Schaefer, MD, of Highlands Oncology Group, reports findings from the INSIGHT study, which is evaluating the utility of the Biodesix Lung Reflex testing strategy. The data suggest that using blood-based immune profiling with proteomic testing can help to identify patients with aggressive lung disease at an early stage. This early identification can benefit patients significantly by prompting either enhanced surveillance or additional treatment and may lead to more accurate determination of patient prognosis and classification of disease stages. Dr. Schaefer will present the data on January 28, 2021.

"These results further demonstrate the importance of understanding a patient’s immune profile as a part of determining appropriate treatment for patients with NSCLC," said Scott Hutton, CEO of Biodesix. "By pursuing personalized testing approaches to help guide treatment decisions, we strive to help prevent patients from receiving ineffective and costly care. More than ever, we’re focused on and committed to relentlessly seeking the best treatment plan for every patient with lung cancer. We are tremendously proud to share these new and important study results with the medical community."

On January 26, 2021 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous formulation (sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 4,190 million in 2020 (Press release, Genmab, JAN 26, 2021, View Source [SID1234574287]). Net trade sales were USD 2,232 million in the U.S. and USD 1,958 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX and DARZALEX FASPRO under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX(daratumumab)
DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with newly diagnosed light-chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. It is also approved in the U.S. for the treatment of adult patients with multiple myeloma: in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology. .DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma and the first and only approved treatment for patients with AL amyloidosis in the U.S.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,4,5,6,7

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On January 26, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has commenced additional studies to determine the exact sequence of the DNA encoding of the enzyme in the cells of its CypCaps product for pancreatic cancer and the stability of the sequences, in line with the requests provided by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 26, 2021, View Source [SID1234574308]).

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The cell clone used to produce the CypCaps product has been augmented to produce the cytochrome P450 enzyme. This enzyme converts ifosfamide from its inactive form to its cancer-killing form and is the basis for how CypCaps works. PharmaCyte has already shown that the enzyme is produced, that the expression of the enzyme is stable over time and that the enzyme is functional. The FDA has now asked PharmaCyte to provide the exact DNA sequence and configuration of the genetic augmentation responsible for the production of cytochrome P450 in the cells. This requires additional studies that necessitates a multi-prong approach, including the employment of a new, state of the art, technique.

The information provided by these analyses will also strengthen and extend the already existing data that has been presented to the FDA by PharmaCyte on (i) the site of integration of the DNA encoding of the cytochrome P450 enzyme; and (ii) the data on the stability of the cells, even before they are encapsulated using the Cell-in-a-Box to produce the CypCaps product. Thus, these new studies will add to the data that PharmaCyte already has on the long-term stability and shelf life of the final CypCaps product.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Our team is pleased that we’ve commenced these additional studies and that we’re on a path to address more of the FDA’s comments regarding our treatment for locally advanced, inoperable pancreatic cancer (LAPC). As well as addressing the FDA’s comments, the information that will be created by these studies will bolster and augment our existing data on the stability of the cells used in the CypCaps product. While the data generated will not change the fact that the CypCaps product is functional, biologically active, and effective, it will generate further data on the exact configuration of the DNA that gives rise to the therapeutic effects of CypCaps."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On January 26, 2021 Notable Labs, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, reported that it is hosting a live webinar on February 9th to unveil their integrative data platform (Press release, Notable Labs, JAN 26, 2021, View Source [SID1234574366]). The Notable data scientists will share an in-depth discussion on how data generated from the functional and multi-omic drug sensitivity screen for Acute Myeloid Leukemia (AML) can be harnessed for biomarker discovery, improved drug development and complement patient mutational data for more precise treatment strategies.

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"This webinar will highlight the integration of three technologies: a flow-cytometry drug sensitivity screen, DNA-Seq, and RNA-Seq," said CEO Laurie Heilmann. "By augmenting a stand-alone drug sensitivity screen with multi-omic data, Notable Labs is amassing a continually-growing dataset that ultimately will provide utility for drug development and patient care in AML and other Hematologic oncology indications."

The webinar will cover how this dataset, containing samples with matched drug sensitivity, gene expression, and variant data, enables researchers to look at the relationships between different data types. The data analysis can then be used to discover biomarkers, look at patient population stratification, and gain a deeper understanding of how drug sensitivity is influenced by genetics and gene expression. Advanced registration is required. Please see [link] for complete registration information.