TD2 Highlights Two Novel HDAC Inhibitors at AACR Annual Meeting

On April 5, 2022 Translational Drug Development (TD2), a precision oncology contract research organization (CRO), reported the presentation of the preclinical results of two novel, targeted epigenetic inhibitors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, LA., to be held April 8-13, 2022 (Press release, Research Corporation Tech, APR 5, 2022, View Source [SID1234611500]).

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Two posters will be presented at AACR (Free AACR Whitepaper) that discuss the exciting preclinical results from the development of isoform-selective HDAC inhibitors, GB-1101 and GB-3103. The posters will highlight the potential synergies of these HDAC inhibitors with PARP and immune checkpoint inhibitors and the impact on tumor immune microenvironment and tumor progression in models of murine breast, human neuroendocrine prostate, and small cell lung cancers.

"The highly selective HDAC6 inhibitor GB-1101 reprogrammed the tumor immune microenvironment and elicited tumor regressions when combined with checkpoint inhibitors. These data suggest that GB-1101 could be an important new targeted epigenetic immunomodulator able to revoke immune privilege to enhance the clinical activity of immune checkpoint therapies," said Paul Gonzales, Vice President of Nonclinical Operations at TD2. "The potent HDAC3 selective GB-3103 showed broad inhibition of genes in DNA repair pathways and could have utility in enhancing PARP inhibitor activity in homologous repair proficient cancers, or in overcoming PARP inhibitor resistance in homologous repair-deficient tumors."

TD2 will be onsite at AACR (Free AACR Whitepaper) to discuss these important results as well as host an exhibitor booth, #1861.

Abstract 1359: Selective HDAC6 Inhibition By GB-1101 Revokes Tumor Immune Privilege and Synergizes with Immune Checkpoint Therapies to Induce Tumor Regressions (Monday, April 11, 9:00 AM – 12:30 PM CST) Molecular Signaling and Metabolic and Epigenetic Regulation in Adaptive Tumor Immunity Poster Session, Section 37, Poster Board Number 18

Abstract 2607: Inhibition of HDAC3 Induces BRCAness and Potent Synergy with PARP Inhibition in Neuroendocrine Prostate and Small Cell Lung Cancers (Tuesday, April 12, 9:00 AM – 12:30 PM CST) DNA Damage Response and Repair Poster Session, Section 22, Poster Board Number 20

Regeneron to Report First Quarter 2022 Financial and Operating Results and Host Conference Call and Webcast on May 4, 2022

On April 5, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2022 financial and operating results on Wednesday, May 4, 2022, before the U.S. financial markets open (Press release, Regeneron, APR 5, 2022, View Source [SID1234611493]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Twist Bioscience and Ginkgo Bioworks Sign New Collaboration

On April 5, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a new supply agreement expanding the depth and breadth of the collaboration between two of the leading organizations in the synthetic biology ecosystem (Press release, Twist Bioscience, APR 5, 2022, View Source [SID1234611491]). The four-year agreement includes an increased commitment by Ginkgo to purchase products from Twist, with the option to access significantly more synthesis capacity to meet Ginkgo’s anticipated growth. The partnership builds on a previous supply agreement signed in 2017.

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"We love to make investments alongside incredible partners like Twist. Over the past four years, we ordered approximately one billion base pairs of synthetic DNA from Twist, allowing us to test hundreds of thousands of proteins across dozens of programs for our customers, resulting in many completed programs spanning vaccine manufacturing, food, flavor, fragrance and even cannabigerol (CBG)," said Jason Kelly, CEO of Ginkgo. "As we grow our capabilities to meet an increasing number and variety of customer needs, we are excited to continue partnering with leading companies in our ecosystem, which includes making sure we secure the high volumes of DNA that Twist is well positioned to supply."

"At Twist, we work in service of our customers, like Ginkgo, who are changing the world for the better," commented Emily M. Leproust, Ph.D., CEO and co-founder of Twist. "Together, Twist and Ginkgo facilitate new product development across multiple industries, with Twist supplying the DNA and Ginkgo programming cells. As the bioeconomy expands with new solutions to the grand challenges facing all of us, we stand ready to deliver day by day, with a vision as to how as an industry, we can truly drive positive outcomes through diverse product solutions."

Entry into a Material Definitive Agreement

On April 5, 2022 The Company reported that entered into a master development services agreement, effective March 31, 2022 (the "Samsung Agreement") with Samsung Biologics Co., Ltd. Pursuant to the Samsung Agreement and certain ancillary agreements, Samsung has agreed to manufacture the antibody AK006 for the Company, among other related services, as directed by the Company from time to time pursuant to ancillary agreements (Filing, 8-K, Allakos, APR 5, 2022, View Source [SID1234611487]). The Samsung Agreement has an initial term of five years, renewing automatically for successive terms of two years unless either party gives the other party six months’ written notice. Either party may terminate the Samsung Agreement under certain other specified conditions, including a material breach by or insolvency of the other party. The Samsung Agreement includes customary indemnification, intellectual property protection, remedies and confidentiality terms, as well as certain quality requirements.

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The foregoing summary of the Samsung Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Samsung Agreement, a copy of which the Company anticipates filing as an exhibit to the Companyʼs Quarterly Report on Form 10-Q for the quarter ending March 31, 2022, after redacting certain portions of the Samsung Agreement for confidentiality purposes.

Nouscom Announces AACR 2022 Late-Breaking Presentation of Translational Phase 1 Data of NOUS-209, an ‘off-the-shelf’ Neoantigen Cancer Immunotherapy for the Treatment of MSI-H Solid Tumors

On April 5, 2022 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vectored immunotherapies, reported that new translational data obtained from the ongoing Phase 1 trial evaluating NOUS-209 has been accepted for presentation in a Late Breaking session at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, NousCom, APR 5, 2022, View Source [SID1234611482]). AACR (Free AACR Whitepaper) will be held in person in New Orleans from 8 to 14th April.

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NOUS-209, Nouscom’s lead product, is an off-the-shelf cancer immunotherapy targeting shared neoantigens, administered in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, for the treatment of Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction solid tumors.

Poster Presentation Details:

Title: Characterization of immune correlates of clinical activity for NOUS-209, an Off-the-Shelf immunotherapy, with Pembrolizumab for treatment of tumors characterized by Microsatellite Instability (MSI).
Session Title: Late-Breaking Research: Clinical Research 1
Date & Time: 10th April 2022, 1:30 PM – 5:00 PM CDT
Location: Ernest N. Morial Convention Center, New Orleans, Louisiana, US
Poster number #8054
Presenter: Dr. Anna Morena D’Alise, Head of Immunology at Nouscom
The full abstract will be available on 8th April at 1pm ET here: View Source!/10517/presentation/19995

About NOUS-209

NOUS-209 is an off-the-shelf immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic frame shift peptides (frameshift mutations, FSPs) that are not found on healthy tissue.

NOUS-209 is designed to comprise 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm, on the basis that an average of 50 neoantigens on any patient’s tumor will be shared with those in NOUS-209. Nouscom’s heterologous prime/boost platform clones these FSPs into Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) vectors, combined with other immunomodulators to harness the full power of the immune response, to generate the viral-vectored vaccine.

NOUS-209 is in Phase 1 clinical trial (NCT04041310), a multicenter, open label, multiple cohorts, first-in-human clinical study of NOUS-209 in combination with pembrolizumab, designed to evaluate safety, tolerability and immunogenicity and to detect preliminary evidence of anti-tumor activity.