On April 6, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S. dollar-denominated senior unsecured notes due 2031 (collectively, the "notes"), in connection with the previously announced spinoff of Organon & Co. ("Organon") from Merck (Press release, Merck & Co, APR 6, 2021, View Source [SID1234577617]). As part of the spinoff, the notes will be assumed by Organon and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

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Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation").

In member states of the European Economic Area, this announcement is directed only at persons who are "qualified investors" within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); (ii) falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc.") of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On April 6, 2021 Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that it has entered into a global distribution agreement with ABCAM plc (AIM: ABC; NASDAQ: ABCM) to sell the Group’s recently developed SARS-CoV-2 research ELISA Affimer reagents (Press release, Avacta, APR 6, 2021, View Source [SID1234577632]).

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Avacta has developed Affimer reagents which can be used in a high performance ELISA laboratory test to detect the SARS-CoV-2 spike protein with high sensitivity and excellent specificity for the spike protein of the original strain of the virus and other dominant variants such as B117 ("Kent" strain) and D614G.

ABCAM is one of the world’s leading suppliers of high-quality biological reagents and kits which are used in a wide range of fields including drug discovery, diagnostics and basic research. Under the worldwide, non-exclusive distribution agreement, ABCAM will enable the global research community to access Avacta’s SARS-CoV-2 spike protein Affimer research reagents through its on-line catalogue. This will allow scientists around the world to perform the ELISA test in their own laboratories and support the global fight against the pandemic.

Dr Alastair Smith, Chief Executive of Avacta Group commented: "We are delighted that we have established a global route to market for the SARS-CoV-2 spike protein Affimer reagents through ABCAM’s dedicated global commercialisation infrastructure.

As far as we are aware, our spike protein ELISA test is the most sensitive test of its kind and, in ABCAM, we have a world-leading partner capable of maximising the commercial potential of the Affimer reagents by making them globally available to scientists who are researching into the SARS-CoV-2 coronavirus.

I look forward to further updating the market on progress across the Group in due course."

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

On April 6, 2021 Umoja Biopharma, a biotechnology company pioneering an integrated, in vivo immunotherapy platform, reported the appointment of Nushmia Khokhar, M.D., as Chief Medical Officer (Press release, Umoja Biopharma, APR 6, 2021, View Source [SID1234577649]).

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"We are excited to welcome Dr. Khokhar to the Umoja team. Nushmia is an accomplished oncologist who has spent a significant portion of her career overseeing the transition of novel cancer therapeutics from discovery to clinical development," said Andy Scharenberg, M.D., co-founder and CEO of Umoja. "Her expertise across early and late-stage clinical development will be invaluable to the company during a milestone year."

Prior to joining Umoja, Dr. Khokhar was the Senior Vice President, Head of Clinical Development at Autolus where she played a critical role in advancing the company’s autologous T-cell products and clinical programs. She also held numerous roles at Janssen Oncology, leading several successful clinical trials, directing the Phase 3 registration trial of Yondelis in soft tissue sarcomas, and serving as the Global Clinical Leader for the breakthrough therapy daratumumab (Darzalex) for hematologic cancers. Dr. Khokhar received her medical training from the Aga Khan University in Pakistan before completing a post-doctoral fellowship at Memorial Sloan-Kettering Cancer Center with a focus on pharmacology and molecular therapeutics. She completed a residency in internal medicine at Washington Hospital Center in Washington, D.C. prior to completing a Hematology/Oncology Fellowship at the Northwestern University Feinberg School of Medicine.

"Umoja’s innovative and integrated in vivo approach, along with its TumorTag technology platform has the potential to overcome serious barriers that have held back the CAR-T cell therapeutic space," said Dr. Khokhar, CMO of Umoja Biopharma. "Now is our time to make CAR-T cell treatments better, more efficient, and applicable for maximum patient impact, not only in heme malignancies but also in solid tumors. I’m looking forward to joining the Umoja team in the hopes of making this promise a reality."

On April 6, 2021 Volastra Therapeutics, a biotechnology company developing novel therapies for the prevention and treatment of metastatic cancer, reported the extension of its original $12 million seed round to a total of $44 million (Press release, Volastra Therapeutics, APR 6, 2021, View Source [SID1234577601]). New investors Vida Ventures and Catalio Capital Management joined a syndicate that includes Polaris Partners, Droia Ventures, ARCH Venture Partners and Quark Venture.

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The funding supports the further build-out of Volastra’s technology platform, which exploits unique insights into chromosomal instability (CIN) to rapidly identify and validate novel targets to block metastasis. In the U.S. alone, more than 350,000 people a year are diagnosed with metastatic cancer. Less than a third respond to targeted or immuno-therapies, making metastasis one of the most pressing unsolved challenges in cancer.

"The support of our new and existing investors reflects the increasing interest around CIN as a core driver in cancer biology," said Charles Hugh-Jones, M.D., Volastra’s Chief Executive Officer. "This latest financing places us in a position of strength to advance our bold vision to change the treatment paradigm for patients with metastatic cancers."

"Our initial investment in Volastra reflected our excitement about the potential of this novel approach to address an unmet need in oncology," said Amy Schulman, Volastra Director and Managing Partner, Polaris. "With this seed extension, we are delighted to expand our syndicate with Vida Ventures and Catalio Capital Management, who share our commitment to identifying and funding innovation that has the potential to have a meaningful impact for patients."

Volastra’s scientific founders were the first to identify CIN as a key driver of metastatic cancer. The company is developing proprietary computational and experimental approaches to understand CIN biology and drive drug discovery. Among Volastra’s tools is a proprietary technology suite to bulk-measure and exploit vulnerabilities in chromosomally unstable cancer cells.

"Volastra’s approach is focused on defining and treating the biology of metastasis," said Lewis Cantley, Ph.D., Professor of Cancer Biology in Medicine and Meyer Director of the Sandra and Edward Meyer Cancer Center, Weill Cornell Medical College. "In just over a year, the Volastra team has shepherded this science into the next stage of development, building technologies to identify CIN at scale and developing novel compounds to block metastasis. By leveraging these unique insights into CIN, we are one step closer to unlocking new therapeutic options for some of the toughest-to-treat solid tumors."

Volastra recently announced a partnership with Dewpoint Therapeutics to discover novel molecules capable of blocking immuno-suppressive signaling in CIN-high tumors. In addition, Volastra announced a collaboration with Microsoft to develop proprietary artificial intelligence algorithms to detect and predict metastatic potential in human tissue samples

On April 6, 2021 Ribon Therapeutics, a clinical stage oncology company developing therapeutics targeting stress support pathways, reported that it will present one oral and four poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting (Week 1), taking place from April 10 to 15, 2021 (Press release, Ribon Therapeutics, APR 6, 2021, View Source [SID1234577618]). Abstracts are available at: www.aacr.org.

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"The breadth of new pre-clinical data that we are presenting this year at AACR (Free AACR Whitepaper) further validates our BEACON+ platform targeting novel cellular stress pathways," said Heike Keilhack, Ph.D., Senior Vice President of Biological Sciences, Ribon Therapeutics. "We are particularly encouraged by our research further elucidating the mechanism of action of our PARP7 inhibitor and lead asset, RBN-2397, and its potential for efficacy in numerous types of cancer."

Ribon Therapeutics will present the following from its development program and platform:

Abstract Title: RBN-2397: A potent and selective small molecule inhibitor of PARP7 that induces tumor-derived antitumor immunity dependent on CD8 T cells
Presenter: Joseph M. Gozgit, Ph.D., Director, Biological Sciences, Ribon Therapeutics
Date & Time: Sunday, April 11, 2021 at 2:00 PM ET
Session Type: Minisymposium
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer
Abstract ID: 48
Summary:

RBN-2397 restores Type I interferon (IFN) signaling in cancer cells and researchers demonstrate that this is an on-target effect of inhibiting the catalytic activity of PARP7 and not PARP1. Researchers further show that the adaptive immune response was required for the antitumor effects of RBN-2397.
Abstract Title: Elevated PARP7 expression in select cancers identifies a target population for RBN-2397 therapy
Presenter: Jodie Wong, Research Associate, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Biomarkers Predictive of Therapeutic Benefit
Abstract ID: 381
Summary:

RBN-2397 is a PARP7 inhibitor that induces cancer cell autonomous and immune stimulatory effects in preclinical models through enhanced Type I IFN signaling in cancer cells. Elevated PARP7 expression or amplification may identify cancer patients who could derive benefit from treatment with RBN-2397. Researchers showed the presence of PARP7 amplifications as well as high expression levels in several tumor types including non-small cell lung carcinoma, breast, and pancreatic ductal adenocarcinoma, providing evidence for the therapeutic relevance of PARP7 inhibition and highlighting potential patient selection strategies to identify those patients more likely to benefit from RBN-2397 treatment.
Abstract Title: Investigating the mechanism of PARP7 inhibition in Type I interferon signaling by arrayed CRISPR screening
Presenter: Bin Gui, Ph.D., Senior Scientist, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Cellular Responses to Anticancer Drugs
Abstract ID: 1021
Summary:

To investigate the underlying mechanism of PARP7 inhibition and to determine the drivers of the differential sensitivity across cell lines, researchers performed arrayed CRISPR knockout screens, targeting approximately 240 genes in the nucleic acid sensing and IFN signaling pathways, in the presence and absence of PARP7 inhibition. The arrayed screens confirmed multiple hits from a previous genome-wide pooled synthetic/lethal CRISPR dropout screen, shedding light on the mechanism by which PARP7 acts as a critical suppressor of the innate immune response in tumor cells and demonstrating both redundancy and crosstalk between different nucleic acid-sensing pathways.
Abstract Title: Targeted Degradation of PARP14 Using a Heterobifunctional Small Molecule
Presenter: Tim J. Wigle, Ph.D., Senior Director, Biochemical & Cellular Pharmacology, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Novel Targets and Pathways
Abstract ID: 1348
Summary:

RBN012811 is a heterobifunctional small molecule based on a catalytic inhibitor of PARP14 that binds in the enzyme’s NAD+-binding site and recruits the E3 ligase cereblon to ubiquitinate PARP14 and selectively target it for degradation. Researchers found that in PARP14 expressing cells, RBN012811 has a half-maximal degradation concentration (DC50) of 0.005 μM and it does not cause degradation of other PARP enzymes. In human primary macrophages, PARP14 degradation by RBN012811 led to a dose-dependent decrease of IL-10 release induced by IL-4 stimulation.
Abstract Title: Small molecule inhibitor of CD38 modulates its intra- and extracellular functions leading to antitumor activity
Presenter: Prashant B. Shambharkar, Ph.D., Senior Scientist, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Novel Targets and Pathways
Abstract ID: 1344
Summary:

Inhibition of CD38 with a small molecule affects both intra- and extra-cellular CD38 activity and modulates key metabolites playing an important role in immunomodulation. Further, data indicate that CD38 is expressed at baseline in cancer and further increased by immune checkpoint inhibitor treatment. Finally, catalytic inhibition of CD38 can lead to antitumor activity in mouse cancer models.
Following its AACR (Free AACR Whitepaper) presentations, Ribon Therapeutics expects to make the poster presentations available on its corporate website via the following link: View Source

About RBN-2397

RBN-2397, is an orally available small molecule inhibitor of PARP7 that we are developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.