Ribon Therapeutics Announces Publication in Cancer Cell of Pre-Clinical and Mechanism of Action Data for RBN-2397

On July 22, 2021 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported the first publication in the peer-reviewed journal, Cancer Cell, of preclinical data from its lead asset, RBN-2397, a small molecule inhibitor of PARP7 (Press release, Ribon Therapeutics, JUL 22, 2021, View Source [SID1234585077]). The published data demonstrate that inhibition of PARP7 can activate antitumor immune responses in cancer cells through restoration of Type I interferon (IFN) signaling and cause complete regressions in preclinical models. These preclinical findings support Ribon’s development program for RBN-2397 and validate targeting of PARP7, a key vulnerability in cancer stress support pathways, as a therapeutic strategy.

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PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung (SCCL), which represents approximately 30% of all non-small cell lung cancers. PARP7 is the first monoPARP to be targeted therapeutically and RBN-2397 is the first potent and selective PARP7 inhibitor to enter clinical development.

"This publication in Cancer Cell demonstrates RBN-2397’s mechanism of action of inhibiting a key stress response pathway in cancer cells, illustrating how inhibition of PARP7 can elicit complete tumor regression in preclinical models, as well as tumor-specific adaptive immune response, through restoration of Type I IFN signaling in tumor cells," said Heike Keilhack, Ph.D., Senior Vice President of Biological Sciences, Ribon Therapeutics. "We are pleased that these data provide further evidence of the critical role PARP7 plays in cancer and antitumor immunity, independent of other PARPs, as well as a strong rationale for clinical development of RBN-2397."

Key findings of the publication are summarized below:

PARP7 is a monoPARP that acts as a brake in cytosolic nucleic acid sensing in a TBK1-dependent manner blocking Type I IFN signaling and antitumor immunity
RBN-2397 is a potent and selective inhibitor of PARP7, and drug effects in tumor models are dependent on PARP7, but not PARP1
Inhibition of PARP7 by RBN-2397 induces complete tumor regression in a lung cancer xenograft and tumor-specific adaptive immune memory in an immunocompetent mouse cancer model by restoration of Type I IFN signaling
"These findings illustrate the foundational science behind RBN-2397 and our preclinical programs, which we have identified by combining our deep understanding of the critical roles of NAD+-utilizing enzymes in cancer and inflammatory diseases, with our team’s drug development expertise, to bring novel treatments to patients with limited options," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "We look forward to providing updates on our clinical studies with RBN-2397 and the rest of our pipeline leveraging our BEACON+ platform."

Ribon recently completed the dose-escalation portion of its Phase 1 trial evaluating RBN-2397 as a monotherapy in patients with advanced solid tumors. In June 2021, data from this portion of the study, presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, showed RBN-2397 was well tolerated with evidence of PARP7 inhibition and preliminary signs of antitumor activity.

The expansion portion of the Phase 1 trial is currently enrolling patients in a number of defined cohorts, including SCCL. Ribon plans to initiate a Phase 1b/2 study with checkpoint inhibitors in SCCL in the second half of 2021.

A link to the publication can be found here: View Source

About RBN-2397

RBN-2397 is an orally available small molecule inhibitor of PARP7 that Ribon Therapeutics is 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 (NCT04053673). 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.

Brian McNamara appointed CEO Designate of new independent Consumer Healthcare company

On July 22, 2021 The Board of GSK (GSK) reported that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022 (Press release, GlaxoSmithKline, JUL 22, 2021, https://www.gsk.com/en-gb/media/press-releases/brian-mcnamara-appointed-ceo-designate-of-new-independent-consumer-healthcare-company/ [SID1234585076]).

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As set out at GSK’s Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK’s holding to shareholders. The new resulting Consumer Healthcare company is expected to attain a premium listing on the London Stock Exchange.

The company will be a new world-leader in Consumer Health with a portfolio which generated annual sales of more than £10 billion in 2020. The company will have a strong portfolio of brands including Sensodyne, Voltaren, Panadol and Centrum and will hold category leadership positions and major sales presences in the US and China.

Sir Jonathan Symonds, GSK Chairman, said: "We are delighted to announce Brian’s appointment to lead the proposed new Consumer Healthcare company, following a thorough process conducted by the Board. Brian is an exceptional leader, and through two global integrations, has successfully transformed GSK Consumer Healthcare into a category-leading business. His strong track record of success and deep experience of fast moving consumer goods and consumer health, proven at P&G, Novartis and GSK, means he is the right choice to unlock the potential of Consumer Healthcare as an independent company and deliver its strong prospects for sustainable sales and profit growth, high cash generation and attractive returns for shareholders."

Brian joined GSK from Novartis in 2015, where he was head of the Over the Counter (OTC) division. He has been a driving force behind two successful Joint Ventures, first between GSK and Novartis and more recently with Pfizer to create a new world-leading Consumer Healthcare business.

Brian McNamara, CEO Designate, Consumer Healthcare, said: "I am honoured to have this opportunity. Together with the many talented people we have in our business, I am looking forward to our exciting future as an independent company. I am confident we are well positioned for growth, building on our brands and innovation, with leading-edge science and human understanding, to deliver better everyday health."

Appointment and selection process

As previously communicated, the Board of GSK conducted an extensive search and selection process to appoint a CEO Designate for the new Consumer Healthcare company. The process, conducted over six months and supported by two leading global search firms, was overseen by the Nominations & Corporate Governance Committee and resulted in direct evaluation and interview of several external and internal candidates for the position.

Consumer Healthcare Board

With the separation of Consumer Healthcare, the Board of GSK has been preparing for two separate, appropriately qualified, independent boards at the point of separation. A formal process to appoint a Chair and to form a Board of Directors for the new Consumer Health company is well underway. The appointment of a Chair is expected in the second half of 2021 who will then, in accordance with best practice, lead the process of appointments to establish the new Board. This new Board will include the appropriate mix of skills, experience, diversity and continuity, relevant to Consumer Health, to represent and maximise the value of this new business for shareholders.

Notes to Editors

Brian McNamara – additional information

Brian began his career at P&G and, over a 16-year tenure, gained extensive experience in product supply, brand marketing, and customer leadership before moving to Novartis in 2004.

Brian is a Board member of the Consumer Goods Forum (CGF). He previously served as a Board Member of the Global Self Care Federation (GSCF) for seven years, acting as Chairman from February 2017 to March 2019 and, for three years was an active member of the Board of Trustees for Treloar’s – a trust providing support and independence education for young people with physical disabilities.

Brian has an undergraduate degree in Electrical Engineering from Union College in Schenectady, New York and an MBA in Finance from University of Cincinnati.

Synaffix Signs $246m Deal with ProfoundBio

On July 22, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the signature of a license and option agreement with ProfoundBio, an emerging oncology biotherapeutics company (Press release, Synaffix, JUL 22, 2021, View Source [SID1234585075]).

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The deal provides access to multiple novel linker-payload technologies developed by Synaffix and includes access to the GlycoConnect glycan conjugation and HydraSpace polar spacer technologies, both of which are known to optimize the therapeutic properties (efficacy and safety) of ADCs. Upon signature, ProfoundBio was granted non-exclusive license rights to deploy the above technologies for one therapeutic program that targets an undisclosed specific tumor associated antigen (TAA). Additionally, ProfoundBio retains license option rights to a second TAA that can be nominated later.

Under the terms of the agreement, Synaffix is eligible to receive upfront and potential milestone payments worth up to $246 million, plus tiered royalties­­ on net sales. No further financial details are disclosed.

ProfoundBio will be responsible for the research, development, manufacturing and commercialization of the ADC products. Synaffix will closely support ProfoundBio’s research activities and be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect, and HydraSpace technologies.

Baiteng Zhao, CEO of ProfoundBio said:

"Selecting the right linker-payload for each ADC is critical for success. Through our collaboration with Synaffix, we can access multiple potent ADC linker-payloads and efficiently optimize the competitive position of our therapeutic pipeline."

"With the solid experience and track record of our founding management team and a strong venture capital syndicate behind us, we are well positioned to rapidly progress multiple best-in-class and first-in-class ADC candidates to the clinic. We look forward to working closely with Synaffix to achieve this."

Peter van de Sande, CEO of Synaffix said:

"This collaboration is another example of Synaffix’ proprietary technologies helping biotech and pharma companies optimize the competitive positions of their ADC pipelines."

"The ProfoundBio team brings multiple decades of valuable ADC development experience from Seattle Genetics (now Seagen) and MSD. into our collaboration. We are looking forward to continuing our close collaboration with ProfoundBio on their emerging ADC portfolio and supporting the development of multiple ADCs into the clinic and beyond."

Lilly Confirms Date and Conference Call for Second-Quarter 2021 Financial Results Announcement

On July 22, 2021 Eli Lilly and Company (NYSE: LLY) reported its second-quarter 2021 financial results on Tuesday, August 3, 2021 (Press release, Eli Lilly, JUL 22, 2021, View Source [SID1234585074]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Operational Highlights

On July 22, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021 (Press release, Oncolytics Biotech, JUL 22, 2021, View Source [SID1234585073]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using reference code: 148-191#.