On November 16, 2022 HIROTSU BIO SCIENCE INC. (Head Office: Chiyoda-ku, Tokyo; Representative: Takaaki Hirotsu; hereafter referred to as "HIROTSU") reported the commercialization of "N-NOSE plus Pancreas," the first next-generation "cancer type specific test" for the "N-NOSE" (Press release, Hirotsu Bio Science, NOV 16, 2022, View Source [SID1234624182]).

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"N-NOSE plus Pancreas" is the world’s first test that can detect early-stage pancreatic cancer. Through the "N-NOSE plus Pancreas", HIROTSU aim to achieve early detection of as many cases of pancreatic cancer as possible and contribute to improving pancreatic cancer treatment results.

Pancreatic cancer, which is particularly difficult to detect in its early stages and is often found in advanced stages up to stage 4, is responsible for about 30,000 deaths annually according to the latest cancer statistics, and the 5-year survival rate by cancer type is significantly lower than that of other cancers. Since there is no effective screening for pancreatic cancer, such as gastric and colorectal cancer screening, the medical society has been saying that it would be revolutionary if a method to test for early-stage pancreatic cancer could be developed.

HIROTSU have been conducting research and development of a "cancer-specific test" as a next-generation test for the "N-NOSE" primary cancer screening test that was launched in January 2020, and we have been putting all our efforts into research and development in order to commercialize a specific test for pancreatic cancer, which is particularly difficult to detect in its early stage. In November 2021, we succeeded in creating a "special nematode" that specifically reacts to the smell of pancreatic cancer by genetically modifying C. elegans nematodes. Subsequent research confirmed that this special nematode is capable of detecting early-stage pancreatic cancer, and after completing verification tests at a testing center, we have now commercialized the "N-NOSE plus Pancreas".

"N-NOSE plus Pancreas" may greatly contribute to early detection and early treatment of pancreatic cancer. We are committed to making use of this technology, which was made possible by the fusion of biotechnology and the idea of using the superior abilities of living organisms, to help save as many lives as possible.

Overview of "N-NOSE plus Pancreas"

Pre-order Period:
From November 17, 2022 to January 3, 2023

Pre-order Website:
View Source

Price:
70,000 yen (tax included)
*35,000 yen (tax included) if applied for during the pre-order period

Shipping of Products:
From January 4, 2023

About N-NOSE nematode cancer screening

N-NOSE is the world’s first primary cancer screening test that utilizes "nematodes," microorganisms that are highly sensitive to the odor of cancer in human urine. Clinical research has shown that nematodes even respond to early-stage cancer (stages 0 and I), which is difficult to detect with conventional screening methods.
The fact that cancer risk can be assessed in one test, regardless of the location in the body,* is another strength that sets N-NOSE apart from other tests.
* Types of cancer that nematodes are known to respond to: stomach, colorectal, lung, breast, pancreatic, liver, prostate, uterine, esophageal, gall bladder, bile duct, kidney, bladder, ovarian, oral/pharyngeal—15 types of cancer (as of September 2019)

On November 16, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported it will present updated efficacy, immunogenicity and safety data from its Phase 1/2 trial of EO2401 in combination with nivolumab +/- bevacizumab, in patients with first progression/recurrence of glioblastoma (ROSALIE trial) in an oral presentation at the 27th Society for Neuro-Oncology (SNO) Annual Meeting which will be held in Tampa Bay, Florida, US on November 16-20, 2022 (Press release, Enterome, NOV 16, 2022, View Source [SID1234624181]).

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The abstract is published in a supplement to Neuro-Oncology, the Official Journal of the Society for Neuro-Oncology, and available via this link.

About EO2401

EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It combines three microbial-derived OncoMimics peptides that closely mimic specific cytotoxic T cell (CD8+ T cell) epitopes on the Tumor-Associated Antigens IL13Ra2, BIRC5 and FOXM1, combined with the helper peptide (CD4+ T cell epitope) Universal Cancer Peptide 2 (UCP2). EO2041 is designed to trigger the immune system into recognizing these epitopes on glioblastoma cells as foreign (non-self) and eliciting a targeted memory T-cell driven cell-killing response against the tumor cells.

Promising data presented during 2022 at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), EANO and SITC (Free SITC Whitepaper)

Data confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab, with the addition of local administration site reactions.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
Addition of bevacizumab, either as a low-dose symptom driven time-limited treatment, or as a continuous treatment at the labelled US dose, to EO2401 in combination with nivolumab supported longer treatment durations and an increase in efficacy.
CD8+ T cells against at least one of the EO2401 peptides was detected in 26 out of 28 patients with some patients exhibiting up to 5% of circulating specific CD8+ T cells. Memory specific CD8+ T cells response were found as early as two weeks after the first vaccination and maintenance of a strong and stable immune response could be detected for more than 10 months.
Additional patients are to be treated with triple combination of EO2401/nivolumab/bevacizumab to support final regimen selection for further studies.
About ROSALIE

ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.

On November 16, 2022 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that it expects to receive a milestone payment of $7.5 million from AstraZeneca, after AstraZeneca dosed the first patient in its ARTEMIDE Phase 2 study with AZD2936, a PD-1/TIGIT bispecific antibody derived from COM902, Compugen’s clinical-stage anti-TIGIT antibody (Press release, Compugen, NOV 16, 2022, View Source [SID1234624180]).

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"The advancement of AZD2936 into Phase 2 by AstraZeneca, a global leader in the development of oncology therapeutics, builds our confidence in the therapeutic potential of our anti-TIGIT antibody, COM902," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Like COM902, AZD2936 was engineered to reduce Fc effector functionality, with the potential to enhance anti-tumor activity. We believe that this is the optimal design and look forward to seeing how it plays out in the clinic."

Dr. Cohen-Dayag added, "Our license agreement with AstraZeneca is part of our strategy to broaden opportunities for our pipeline and specifically capitalize on the potentially emerging promise of bispecific products while maintaining our focus on the development of COM902 as part of various combinations either by Compugen or in collaboration with future partners, including in combination with COM701 our potential first-in-class anti-PVRIG antibody."

About the Compugen-AstraZeneca License Agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen’s monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multi-specific antibody products, excluding such bispecific and multi-specific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. To date, Compugen has received a $10 million upfront payment, an additional $8 million in milestone payments and is entitled to an additional $7.5 million payment triggered by Phase 2 initiation, out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi or multi-specific products are developed based on Compugen’s monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

On November 16, 2022 Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), which is building the leading platform for cell programing and biosecurity, reported the sale of shares of its Class A common stock for gross proceeds of approximately $100 million to BTIG, LLC, as the underwriter in the registered public offering of those shares (Press release, Ginkgo Bioworks, NOV 16, 2022, View Source [SID1234624179]). In connection with this offering, Ginkgo has granted the underwriter a 30-day option to purchase up to an additional $15 million of shares of Class A common stock.

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The last reported sale price of Ginkgo’s Class A common stock on November 15, 2022 was $2.67 per share. The underwriter proposes to offer for sale the shares of common stock from time to time in one or more transactions on the New York Stock Exchange, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to the prevailing market prices or at negotiated prices, subject to receipt and acceptance by it and subject to its right to reject any order in whole or in part.

BTIG, LLC is acting as the sole book-running manager for the offering. The offering is expected to close on or about November 18, 2022, subject to the satisfaction of customary closing conditions.

Ginkgo intends to use the net proceeds from the offering to offset the cash used to finance the acquisition of certain assets and liabilities of Bayer CropScience LP and for other general corporate purposes. The shares described above are being offered by Ginkgo pursuant to an effective shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (the "SEC") on October 4, 2022 and declared effective by the SEC on October 14, 2022. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on November 15, 2022. The final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus can be obtained at the SEC’s website View Source or from BTIG, LLC at 65 East 55th Street New York, NY, 10022 or by e-mail at [email protected].

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

On November 16, 2022 Inhibrx, Inc. (Nasdaq: INBX), a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, reported updated efficacy and safety data from the ongoing Phase 1 INBRX-109 expansion cohorts for the treatment of chondrosarcoma. Inhibrx presented this dataset as of May 2022 at the Annual Connective Tissue Oncology Society (CTOS) Conference , which included matured data on the original chondrosarcoma cohort and initial data from an additional cohort of chondrosarcoma patients with the isocitrate dehydrogenase (IDH) mutation (Press release, Inhibrx, NOV 16, 2022, View Source [SID1234624178]). Additionally, Inhibrx announced further updated results from this dataset as of November 2022.

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Among the 33 patients evaluable as of November 8, 2022, the observed disease control rate was 87.9%, or 29 out of 33 patients as measured by RECISTv1.1, with two patients achieving partial responses (6.1%) and 27 patients achieving stable disease (81.8%). Disease control was observed in patients with and without IDH1/IDH2 mutations. Of those achieving stable disease 55.6% had decreases from baseline in tumor size. Clinical benefit was durable, 14 of 33 patients (42.4%) who achieved disease control had a clinical benefit lasting greater than 6 months, and the longest duration of stable disease is 20 months. To date, the median progression-free survival (PFS) is 7.6 months, and five patients remain on study.

Treatment-related adverse events (AEs) were reported in less than 5% of the patients with the most common being increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. There were no grade 4 or 5 events reported among patients with treatment-related AEs.

About Chondrosarcoma
Chondrosarcoma is a rare malignant bone tumor of cartilage-producing cells and usually arises in the pelvis or long bones. Although chondrosarcoma is considered rare with an estimated annual incidence of 1 in 200,000, it is the most common primary bone cancer found in adults. Surgical resection is the only curative treatment and patients with unresectable or metastatic disease have a poor prognosis. There are currently no approved therapies for unresectable or metastatic chondrosarcoma.

About INBRX-109
INBRX-109 is a precision-engineered, tetravalent death receptor 5 (DR5) agonist antibody designed to exploit the tumor-biased cell death induced by DR5 activation.

In 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma and orphan-drug designation to INBRX-109 for chondrosarcoma in the United States.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, potential registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma, which is currently ongoing.