On November 16, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported the presentation of preclinical data on the company’s new anti-CD27 agonist monoclonal antibody program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting, that took place November 10-14, 2021 in Washington D.C (Press release, Kineta, NOV 16, 2021, View Source;utm_medium=rss&utm_campaign=kineta-presented-compelling-preclinical-data-on-its-new-cd27-antibody-program-at-the-2021-sitc-annual-meeting [SID1234595690]). Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster revealing new binding affinity and specificity data on the company’s CD27 monoclonal antibody drug candidates as well as potent agonistic activity on cellular and T cell activation assays.

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"We are highly encouraged with the compelling preclinical data demonstrated with Kineta’s new CD27 monoclonal antibodies" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "CD27 is a promising cancer immunotherapy approach that can mobilize new specific tumor antigen specific T cells to drive a potent anti-tumor response with single agent efficacy as well as synergistic effects with other immune checkpoint inhibitors.

Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q1-Q2 2022.

Key results from the SITC (Free SITC Whitepaper) poster presentation:

147 fully human anti-CD27 monoclonal antibodies with unique sequences were generated
Anti-CD27 agonist assay showed strong agonist activity for 8 pre-selected anti-CD27 antibodies
Human T cell activation assay data for 5 mAbs showed increased proliferation and cytokine secretion
Further in vitro and in vivo developments are on-going to select our lead anti-CD27 agonist antibody
Presentation Details:

Title: A promising cancer immunotherapy target: Novel agonistic human antibodies against the human T-cell costimulatory receptor CD27
Date Presented: November 12-13, 2021
Presenter: Thierry Guillaudeux, PhD
Poster: Click on the link below to view the poster:

CD27 Publications – Poster Presentation at SITC (Free SITC Whitepaper) 2021

On November 16, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno- gene therapy for cancer (Temferon), reported that it will be presenting updated preliminary Phase I/II clinical data on Temferon at two upcoming scientific congresses (Press release, Genenta Science, NOV 16, 2021, View Source [SID1234595706]).

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The Society for Neuro-Oncology (SNO) 2021 Annual Meeting and Education Day, November 18-21, Boston, USA

Title: TEM-GBM: A Phase I-IIa Dose-Escalation Study Delivering IFN-Α within Glioblastoma Multiforme Tumor Microenvironment by Genetically Modified TIE-2 Expressing Monocytes
Type: Poster presentation
Time: Friday November 19, 2021, 7.30 PM – 9.30 PM ET

63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition 2021, December 11-14, Atlanta, USA and virtual

Title: TEM-GBM: An Open-Label, Phase I/IIa Dose-Escalation Study Evaluating the Safety and Efficacy of Genetically Modified Tie-2 Expressing Monocytes to Deliver IFN- α within Glioblastoma Tumor Microenvironment Type: Poster presentation
Day: Sunday December 12, 2021, 6 PM – 8 PM ET

On November 16, 2021 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported the closing of a Series B financing, raising a total of $105 million through a combination of debt and equity (Press release, Geneoscopy, NOV 16, 2021, View Source [SID1234595691]). The round is led by previous investors Lightchain Capital and NT Investments. Other investors in the round include Morningside Ventures, Labcorp, Cultivation Capital, BioGenerator Ventures, and Innovatus Capital Partners.

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"We are extremely pleased to secure this financing with strong support from our previous and new investors. It reflects their confidence in our ability to address the significant unmet need within the colorectal cancer (CRC) screening market for a noninvasive means to not only accurately detect cancer at an early stage, but also advanced adenomas—pre-cancerous polyps that are most likely to become cancerous," said Andrew Barnell, Geneoscopy’s co-founder and CEO. "As positive momentum continues to build for our pivotal and ongoing 10,000-patient trial, the team remains focused on ensuring a successful launch of our noninvasive multifactor RNA colorectal cancer screening test as a meaningful advancement in the fight to prevent colorectal cancer. Moreover, we have already made exciting progress towards broadening our diagnostic portfolio to address additional unmet needs within gastrointestinal health."

Unlike other noninvasive screening options that use DNA or blood-based biomarkers, Geneoscopy’s proprietary method analyzes RNA extracted from patient stool samples to provide the phenotypic and quantitative information necessary to accurately detect precancerous lesions. Early detection is critical as it allows these lesions to be removed and prevents progression to cancer. The U.S. Food and Drug Administration (FDA) granted Geneoscopy’s test its Breakthrough Device Designation in January 2020.

"Geneoscopy’s multifactor RNA screening test shows great potential to provide increased sensitivity over current noninvasive screening methods to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are a precursor in up to 70% of CRC cases," said Jason Dinges of Morningside. "We are pleased to join the other investors in this round and believe Geneoscopy’s novel diagnostic approach is poised to shift the standard of care for CRC screening, lower cancer incidence in average-risk patients, and holds great promise to improve the management of additional gastrointestinal diseases."

Responsible for over 50,000 deaths annually, colorectal cancer is the second leading cause of cancer-related death in the United States.1 Disease progression begins with polyps that may develop into cancer over time. Early detection and treatment are crucial to improve survival. Unfortunately, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. However, this screening method is challenged with low patient compliance. This has only been exacerbated by the COVID-19 pandemic, which led to a more than 37% decline in CRC screenings. Noninvasive, at-home collection testing options, such as Geneoscopy’s future test, have become increasingly important options to ensure patients receive the CRC screening they need.

On November 16, 2021 ORPHELIA Pharma and K.S. KIM INTERNATIONAL (SK-PHARMA) LTD reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) in the territory of the Russian Federation (Press release, ORPHELIA Pharma, NOV 16, 2021, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-and-k-s-kim-sk-pharma-sign-an-agreement-to-supply-kigabeq [SID1234595693]).

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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in the European Union, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).

"We are delighted to sign this agreement with K.S. KIM, which is based on the value of Kigabeq in paediatrics", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their strong footstep in the distribution of orphan medicines in the Russian territory, K.S. KIM is an excellent partner for Kigabeq."

"With Kigabeq, the only pediatric presentation of vigabatrin, K.S. KIM is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Dr. Shlomo Sadoun, CEO of K.S. KIM, "Kigabeq is a drug which address unmet medical needs for young patients affected by severe and resistant epilepsies. Our ultimate objective is to register Kigabeq as an orphan drug in Russia, nevertheless we will start distributing it immediately as an unlicenced medicine augmenting unmet needs ".

"Our objective is to make Kigabeq available as widely as possible, so that all children affected by infantile spasms can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with K.S. KIM, we are very confident that Russian children suffering from infantile spasms will have access to Kigabeq as quickly as possible."

On November 16, 2021 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc., a biotechnology company focused on developing its clinical-stage platform technology enabling antibody-drug conjugates (ADCs) with an excellent therapeutic index (Press release, SOTIO, NOV 16, 2021, View Source [SID1234628156]). SOTIO will obtain rights to deploy LCB’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens.

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The deal enables SOTIO to combine its proprietary antibodies with LCB’s ADC technology platform in order to deliver novel therapeutics for the treatment of solid tumors and includes LCB’s proprietary conjugation technology ConjuAll and potent linker-payload platform including multiple different payloads.

Under the terms of the multi-target agreement, LCB is eligible to receive upfront and potential milestone payments worth up to $1027.5 million, payable based on certain developments and regulatory achievements, plus royalties on net sales. The deal includes upfront and near-term milestones worth up to $29.5 million, subject to exercise of the options and achievement of success-based milestones. No further financial details are disclosed.

"At SOTIO we are building an innovative pipeline of ADC programs and plan IND filing for our lead program SOT102 by the end of 2021. The licensing agreement with our new, experienced partner LegoChem allows us to broaden our oncology pipeline with additional programs and solid tumor targets. We are looking forward to using the potential of LegoChem’s ADC technology platform and to develop innovative ADCs for patients in need," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO.

SOTIO will be responsible for research, development, manufacturing and commercialization of the ADC products, while LCB will support and work closely with SOTIO for the research activities and the manufacturing of components that are specifically related to its proprietary ConjuAll and the linker-payload technologies.

Dr. Yong-Zu Kim, CEO and President of LCB added: "This collaboration is yet another example that illustrates how the value proposition of the LCB platform can increase the competitive position of our partners within the ADC space. SOTIO is an ideal partner for LCB due to its expertise and strategic focus on innovative antibody drug conjugates, and we look forward to working closely together on multiple innovative programs."