On November 16, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported new clinical data from its Phase 1/2 expansion study evaluating the single-agent activity of VT1021 in subjects with recurrent glioblastoma (rGBM) (Press release, Vigeo Therapeutics, NOV 16, 2021, View Source [SID1234595721]). The data is being presented in a poster session at the Society for NeuroOncology’s (SNO) 2021 Annual Meeting, taking place from November 18-21, 2021 in Boston.

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VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME. Tsp-1 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated in subjects enrolled in both dose escalation and dose expansion cohorts.

In the rGBM expansion cohort, VT1021 demonstrated significant single agent activity. Among 22 evaluable GBM subjects, 3 had complete response (CR), 1 had partial response (PR), and 7 had stable disease (SD). The overall disease control rate (DCR) was 50%. In the responder group, the average time on study was over 300 days with 2 subjects still on study for over 480 days as of October 31, 2021. These two subjects will continue receiving VT1021 through an extension study.

"Glioblastoma is the most common and aggressive form of brain cancer in adults, recurring after treatment in more than 90% of all patients," said Vigeo COO Dr. Jing Watnick. "In the expansion study, VT1021 demonstrated noteworthy single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47. Vigeo is committed to studying the potential of VT1021 in both newly diagnosed and recurrent GBM subjects in future clinical trials."

Vigeo plans to initiate Phase 2/3 studies in GBM as well as pancreatic cancer during the first half of 2022.

Details for the SNO 2021 presentation are as follows:

Title: Clinical efficacy and biomarker assessment of VT1021, a CD36/CD47 dual-targeting agent, in recurrent glioblastoma
Presenter: Manmeet Ahluwalia, MD
Session: Poster Session
Poster #: CTIM-06
Date and time: November 19, 2021, 7:30 pm – 9:30 pm

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment (TME) from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

On November 16, 2021 Maryland-based biotech company Deka Biosciences ("Deka") reported that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures (Press release, Deka Biosciences, NOV 16, 2021, View Source [SID1234595719]). Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

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Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine to patients that will benefit the most.

In Deka’s Diakines, the scaffold platform is derived from a human antibody fragment, called a single-chain variable fragment, that uniquely functions both as a stabilizing, half-life extension technology and a targeting vector to deliver the cytokine(s) function to specific cell types or the microenvironment of affected tissues. Through stabilization and improved manufacturing techniques, the Diakine scaffold increases production yields and reduces manufacturing costs, and the unique structure enhances the specific functions of each cytokine, unlike most other half-life extending technologies. The company has demonstrated positive responses in preclinical studies, in both cancer and inflammatory disease models. Through extensive investigation, Deka has found that not all people respond to the same cytokine in the same way. Deka has therefore developed assays that evaluate each patients’ response to each cytokine pair and found genetic signatures that are uniquely associated with response to each Diakine. Deka will evaluate this genetic signature in future clinical trials to ensure that each patient is matched with their best Diakine. The team at Deka is committed to developing Diakines that can treat every patient.

"This investment by our multi-national, top-tier syndicate enables our first step in developing the Diakine platform," said John Mumm, CEO and founder of Deka Biosciences. "We are proud to join forces with our board of directors to bring these life-changing medicines to patients as quickly and effectively as possible. We share the vision to fundamentally change the nature of drug development and change the standard of healthcare through coupling our platform technology with predictive precision medicine. We are honored to have Leaps by Bayer as our lead investor as we share the goals to develop cures for patients through innovative science and precision medicine. We dare to leap as they do."

"Leaps by Bayer aims to achieve life transforming breakthroughs for patients, this is why we invest in technologies of tomorrow already today," said Juergen Eckhardt, MD, Head of Leaps by Bayer. "One of humankind’s biggest challenges and one of the big goals Leaps by Bayer is trying to solve is to prevent and cure cancer. We believe next-generation immunotherapies will play a pivotal role in addressing this challenge and Deka Biosciences’ cytokine therapy approach has the potential to change treatment-paradigms for cancer patients and for those suffering from auto-immune diseases."

"Deka Biosciences has developed a unique and strongly differentiated platform to produce cytokines with therapeutically complementary functions that circumvent several challenges associated with naturally occurring and modified cytokines," said Benjamin (Beni) Rovinski, PhD, Managing Director of Lumira Ventures. "At Lumira, our mission is to invest in companies at the forefront of biomedical innovation whose products have the potential to transform patient outcomes. It is gratifying to support Deka in pursuit of such a goal."

"Deka has made impressive progress since its inception. We are excited to partner with Deka, and its Diakine platform, to provide best-in-class therapies to patients," said Yi-Yen Chen, managing director at Echo Investment Capital’s O-Bio fund, a life science focused fund headquartered in Oklahoma City.

The investment will enable Deka to advance its research and talent acquisition and further expand development of its platform, in particular to file the Investigation New Drug (IND) application for the lead oncology program and advance the lead compound into Phase I clinical trials.

On November 16, 2021 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the pricing of an underwritten public offering of 12,500,000 shares of common stock at a price to the public of $5.60 per share, for gross proceeds of $70 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, NOV 16, 2021, View Source [SID1234595717]). All of the shares to be sold in the offering will be offered by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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ViewRay intends to use the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, continued research and development and commercial expenses.

Piper Sandler and Stifel are acting as the joint book-running managers for the offering. Guggenheim Securities is also acting as a book-running manager for the offering. B. Riley Securities and BTIG are acting as co-managers for the offering.

The offering is expected to close on or about November 19, 2021, subject to satisfaction of customary closing conditions.

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") and automatically became effective upon filing. This offering is being made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, 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 November 16, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported that it will incorporate data from both the Memorial Sloan Kettering Cancer Center (MSK) OncoKB database and National Comprehensive Cancer Network (NCCN)’s Clinical Practice Guidelines in Oncology (NCCN Guidelines) into its clinical reports (Press release, Tempus, NOV 16, 2021, View Source [SID1234595716]). Tempus is collaborating with two of the world’s largest clinical decision-support resources to support the genomic foundational science and clinical applications of its xT assay.

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Tempus reports will reflect therapy choices based on molecular profile and corresponding NCCN Guidelines recommendations and information from the OncoKB database, therefore making it easier for physicians to optimize treatment plans for their patients. Tempus is also the largest genomic sequencing company to incorporate the OncoKB database, which recently received partial recognition by the Food & Drug Administration (FDA) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.

"We are combining and curating two of the most robust oncology resources in the world and delivering them to physicians through the lens of their patients’ specific molecular and clinical profiles," said Kimberly Blackwell, MD, Chief Medical Officer at Tempus. "This initiative is a step towards making our diagnostics even smarter and making personalized care achievable for every patient facing cancer."

The OncoKB database features detailed information regarding specific alterations in 682 cancer genes, curated from various sources, including FDA drug labels, medical professional group guidelines, medical and scientific literature, and clinical trial eligibility criteria. The FDA recognized a portion of the OncoKB database as a source of valid scientific evidence and mapped the selection of cancer mutations to FDA Level 2 (clinical significance) and FDA Level 3 (potential clinical significance).

"OncoKB channels the clinical and scientific expertise of MSK physician-scientists into a structured database that provides information about the biologic and therapeutic implications of cancer-specific alterations," said Debyani Chakravarty, PhD, Lead Scientist, OncoKB and Assistant Attending, Department of Pathology at MSK.

The NCCN Guidelines are a comprehensive, continuously-updated set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States. Specific NCCN Guidelines have also been developed for cancer screening and prevention, therapeutic management, supportive care issues, and specific populations. The NCCN Guidelines are intended to assist all individuals who impact decision-making in cancer care including physicians, nurses, pharmacists, payers, patients and their families, and many others.

"This collaboration with Tempus will help us share the frequently-updated, evidence and expert consensus-based recommendations in the NCCN Guidelines more seamlessly with healthcare providers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "We are happy to be working with this precision medicine technology company to place important cancer decision support tools at the point-of-care, ultimately benefiting patients."

On November 16, 2021 Individualized cancer diagnosis and treatment regimens are the future of oncology care and require harnessing the advances of scientific research (Press release, Indivumed, NOV 16, 2021, View Source [SID1234595715]). In a milestone moment, Northwell Health and its partner Indivumed GmbH, a Hamburg, Germany-based oncology research company, reported that they have successfully consented 1,000 patients, enabling the standardized collection and analysis of cancer biospecimens to be made available for researchers worldwide and to provide a unique basis for the multi-omics database of Indivumed to define novel targets and subsequently therapies.

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Northwell Health’s Cancer Institute diagnoses and cares for more than 19,000 new cancer patients annually. During the consented patient’s normal treatment, the Northwell Health Biospecimen Repository (NHBR) research team applies the Indivumed Standard Operating Procedure for collecting excess cancer tissue from various organ sites, including lung, breast, colorectal, and uterine. They send the carefully procured cancer tissue – frozen within 10 minutes to assure biological tissue composition – to Indivumed GmbH’s U.S. headquarters in Frederick, MD. These de-identified patient samples are then made available to scientists to further study at The Feinstein Institutes for Medical Research, Northwell Health’s science arm, and others across the globe in an effort to advance cancer research, develop anti-tumor drugs and enhance personalized medicine approaches.

"We strive to provide outstanding patient care, cutting-edge clinical trials and new scientific discoveries to treat cancer," said Jeff Boyd, PhD, vice president, chief scientific officer and director of the Center for Genomic Medicine at Northwell Health Cancer Institute. "We will continue to expand our ability to collect these critical biospecimens and gain a better understanding between cell biology and the development of targeted, effective cancer therapies," added Dr. Boyd, who is also the director of the Institute of Cancer Research at the Feinstein Institutes.

"Individualized cancer diagnosis and treatment that is based on specialized, comparable, high-quality clinical data and biospecimens are essential," said Hartmut Juhl, MD, PhD, Founder and CEO of Indivumed. "This milestone achievement and continued partnership with Northwell Health revives our hope that we make a dramatic difference in precision medicine by deciphering multi-omics data for the benefit of cancer patients."

Samples have been collected since 2017 at the start of a three-year agreement, and in 2020 Northwell Health and Indivumed GmbH initiated a new five-year partnership to expand the cancer biobanking activities. Northwell Health, the largest health care provider in New York State, serves a diverse regional patient population. This is critical for cancer research, as the collected samples represent a broad spectrum of patient demographics and genetics. The close relationship between Indivumed GmbH and Northwell Health also strengthens Northwell Health’s ability to support its affiliation with Cold Spring Harbor Laboratory, further bolstering basic and translational cancer research to develop new oncology therapies.

Indivumed is a world leader in tissue collection, preservation, and data analytics based on the largest comprehensive multi-omics database available. With Northwell Health’s help, it will add thousands of biological samples to be used in research and clinical trials for communities worldwide. Indivumed is on track to collect and store an additional 100 samples by year’s end with Northwell Health.