On October 28, 2024 Ottimo Pharma, a private biotech company, reported the appointment of world class industry veterans David Epstein as Chair & Chief Executive Officer, Mehdi Shahidi as Head of Development & Chief Medical Officer and James Sabry as Vice-Chair of the Board of Directors (Press release, Ottimo Pharma, OCT 28, 2024, View Source [SID1234647466]).

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Ottimo Pharma, co-founded by Medicxi and Jonny Finlay in 2020, is developing Jankistomig, a PD1-VEGFR2 bi-functional antibody, designed as a dual-pathway, single agent, IgG therapy targeting immune checkpoint inhibition and angiogenesis in the treatment of cancer.

David Epstein, Chair & Chief Executive Officer of Ottimo Pharma, said: "This new medicine is exquisitely designed and offers large potential benefits to patients across a wide range of solid tumors. It will be exciting to scale the team and deliver on the promise to patients."

James Sabry, Vice-Chair of the Board of Ottimo Pharma, said: "I am excited to join the Board of this highly innovative company with a beautifully designed medicine that has the potential to change the face of cancer immunotherapy."

Jankistomig’s unique mode of action blocks the PD1 and VEGF pathways, leveraging its high affinity for PD1 to enhance tumor immune cell biodistribution while minimizing VEGF-related adverse effects, specifically due to its intentionally designed interaction with VEGFR2.

Ottimo Pharma’s goal is to improve cancer treatment outcomes and reduce healthcare burden through this novel combination of mechanisms of action.

Over the last three years, Ottimo Pharma has been running the full pre-clinical characterization of the molecule and anticipates filing an IND in late 2025.

Francesco De Rubertis, Board Member at Ottimo Pharma & Partner at Medicxi, commented: "As we launch Ottimo Pharma, I am confident that the combined expertise of this stellar leadership team will help accelerate the transformation of the original insight by Jonny Finlay in his Scottish lab into a best-in class asset in cancer therapy."

Jonny Finlay, Scientific Founder & Advisor at Ottimo Pharma, added: "I am extremely excited to see Ottimo Pharma come out of stealth. I can’t wait to see the scientific and clinical breakthroughs made by this superb team and this deeply differentiated molecule."

David Epstein, newly appointed Chair of the Board of Directors & Chief Executive Officer, brings over 30 years of experience in drug development, deal making and commercialization, with a strong track record of success. Most recently, David served as CEO of Seagen, and as a member of its Board, until its acquisition by Pfizer in late 2023. From 2010 to 2016, he served as CEO of

Novartis Pharmaceuticals, a division of Novartis AG, and earlier in his career, he founded and led Novartis’ Oncology and Molecular Diagnostics units.

Mehdi Shahidi, MD, joins Ottimo Pharma as Head of Development & CMO, bringing a wealth of expertise in oncology drug development. With over two decades of experience in pharma, including Global Head of Medicine, Oncology and SVP & Chief Medical Officer at Boehringer Ingelheim, he has overseen the clinical development, regulatory filing and registration of multiple drugs. Mehdi completed his clinical oncology training at the Royal Marsden Hospital in London and had a successful clinical and research career in oncology before transitioning to the pharmaceutical industry.

James Sabry, MD, PhD, joins Ottimo Pharma’s Board as non-executive Vice-Chair, with over 30 years of experience in business development and partnering. He currently serves as EVP, Chief Business Officer of BioMarin Pharmaceutical Inc. Prior to this, James was previously Global Head and EVP of Roche Pharma Partnering where he was instrumental in securing key deals that have significantly advanced the company’s R&D pipeline and led to the launch of numerous new medicines. From 2010, he was Senior Vice President of Genentech Partnering.

On October 28, 2024 Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates to deliver best-in-class therapeutics, reported the close of a $92 million Series A financing round led by Novo Holdings, with participation from Gimv, Red Tree Venture Capital, HealthCap as well as existing investors BioGeneration Ventures, M Ventures, and Brabantse Ontwikkelings Maatschappij (BOM) (Press release, Kivu Bioscience, OCT 28, 2024, View Source [SID1234647465]). The funding will be used to advance multiple oncology programs into the clinic.

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"We’re excited to have the backing of this top-tier syndicate, who share our vision for developing kinder, gentler ADC therapies that are more effective and safer for cancer patients," said Mohit Trikha, Ph.D., President and Chief Operating Officer of Kivu Bioscience. "Our next-generation ADCs address key limitations of current treatments, particularly by engineering stable ADCs we have the potential to reduce off-target side effects which in turn widens the therapeutic window. This funding allows us to accelerate the development of our Topo1i-based ADC pipeline to the clinic, where we plan to quickly differentiate Kivu’s products from past endeavors. We are inspired by patients and driven by data to accelerate transformative medicines."

Kivu is utilizing the proprietary Synaffix site-specific linker-payload technology to deliver next-generation ADC therapeutics. The GlycoConnect technology, which couples the linker specifically to asparagine-297, delivers a clean, highly homogenous product. This technology not only offers a clear manufacturing advantage over other conjugation techniques, but also produces an ADC that is more stable, significantly reducing off-target side effects. This approach widens the therapeutic window, improving the safety profile for patients. Addressing the discontinuation and dose-reduction rates seen with ADCs will establish Kivu’s place in treating solid tumors.

"ADCs are an established modality for treating cancer, but tolerability issues limit the pace of advancement in the space. The early data from Kivu suggested superior stability of the constructs, clearly pointing toward targets that have been pursued by earlier generations of ADCs, but which failed due to high rates of drug discontinuation. That data in the hands of this outstanding management team tells an incredibly compelling story – one we are excited to support. We see tremendous opportunity for the Kivu pipeline to produce a new generation of targeted therapies as best-in-class novel ADCs across a broad range of cancers," said Daniel O’Connell, M.D., Ph.D., Partner, Novo Holdings.

Kivu’s assets are in late-stage preclinical studies and target areas of high unmet medical need. The company’s platform is differentiated by its superior ability to avoid the issues seen with currently marketed ADCs and addresses key limitations related to stability and therapeutic precision and delivery. The company is set to begin Phase 1 trials for its lead candidate in 2025.

On October 28, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported its participation in the inaugural Google Cancer AI Symposium, in Boston. BPGbio President and CEO Niven R. Narain, Ph.D., will deliver a presentation on "Making AI for Discovery Real – Prioritizing Biology before Tech," on October 30 at 2:45 pm (Press release, BPGbio, OCT 28, 2024, View Source [SID1234647464]).

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Dr. Narain’s session will delve into the evolving landscape of AI-driven drug discovery, highlighting both the opportunities and challenges. Drawing from BPGbio’s pioneering history in the intersection of AI and Biology and his lens of experience, Narain will share best practices that have fueled the company’s robust clinical pipeline, which includes its BPM31510, currently in a phase 2b for glioblastoma multiforme (GBM) and a phase 2a for pancreatic cancer, as well as a potential pivotal trial targeting multiple primary CoQ10 deficiency mutations.

"It is a privilege to be invited to speak at Google’s inaugural Cancer AI Summit, especially on a topic BPGbio has pioneered for the past decade," said Dr. Narain. "I look forward to sharing our journey, use cases, and wins with industry leaders and esteemed researchers. By combining the strengths of biology and AI technology, we can address the immense challenges of cancer research and accelerate the development of more effective therapeutics. I also plan to highlight the community of global partners who helped galvanize our road to success."

During the presentation, Dr. Narain will also provide updates on BPGbio’s robust portfolio of therapeutic candidates, many of which are in late-stage clinical trials. These candidates have been identified/guided using the company’s proprietary AI-powered NAi Interrogative Biology Platform, which facilitates target discovery, biomarker identification, and drug development through all stages—from preclinical to late-stage development. The NAi Platform is currently advancing key partnerships with pharmaceutical companies, academic institutions, and government organizations on various disease indications.

BPGbio’s therapeutic pipeline includes candidates for glioblastoma (orphan drug), pancreatic cancer (orphan drug), primary CoQ10 deficiency (rare pediatric disease designation), epidermolysis bullosa (orphan drug), squamous cell carcinoma (orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease, and Parkinson’s disease.

For more information on BPGbio’s participation in the Google Cancer AI Symposium, visit www.bpgbio.com.

About the NAi Interrogative Biology Platform

The NAi Interrogative Biology Platform combines BPGbio’s industry-leading, clinically annotated proprietary biobank, purpose-built Bayesian artificial intelligence, and the compute power of the world’s fastest supercomputer, Frontier, housed at Oak Ridge National Laboratory.

Collectively, these tools enable the company to bring artificial intelligence to biology, inspiring AI-driven target nomination, discovery, molecule design, and more. The platform has been used to identify more than 100 drug targets and diagnostic biomarkers and supported research collaborations with a range of government, industry and academic partners including the U.S. Department of Defense (DoD), Sanofi, and Harvard Medical School.

On October 28, 2024 Delta-Fly Pharma reported following to the previous information on September 10th. 2024, we are excited to share our latest development status (Press release, Delta-Fly Pharma, OCT 28, 2024, View Source [SID1234647463]).

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Enrollment of patients is progressing smoothly into the Phase I portion of the Phase I/II study of DFP-10917 combined with Venetoclax in AML patients previously treated with Venetoclax, one regimen. The first three patients are showing encouraging safety and efficacy results suggested further promising development.

The existing standard combination chemotherapy for AML patients is Azacitidine and Venetoclax, but it is not comfortable for AML patients. We’re trying to do a combination of DFP-10917 with Venetoclax, as an alternative safer AML therapy, objective NDA approval from the FDA in the US under possible collaboration with a global mega-pharma.

The Phase III study of DFP-10917 in relapsed/refractory AML patients is planned data cut-off as decreasing in the number of long-term survivors since then.

On October 28, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data supporting the critical role of blood-based testing in increasing overall colorectal cancer (CRC) screening adherence at the American College of Gastroenterology (ACG) 2024 Annual Meeting in Philadelphia, Oct. 25-30, 2024 (Press release, Guardant Health, OCT 28, 2024, View Source [SID1234647462]).

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Guardant and its research partners will share real-world data demonstrating poor patient compliance with repeat stool-based screening. A study of more than 350,000 patients shows that less than half of patients who underwent stool-based CRC screening completed the retesting recommended in clinical guidelines over the following four-year period, highlighting the need for alternative options to improve overall compliance to repeat testing.

A second presentation will report on the one-year outcomes of individuals tested with Guardant’s Shield blood test for CRC screening in the ECLIPSE study to understand the implications of "false positive" results. Study results demonstrate that the rate of non-colorectal malignancies does not differ in those who tested positive with Shield compared to those who tested negative.

"Research has clearly demonstrated the value of colorectal cancer screening in detecting cancer early, when it is most treatable, but screening is only effective if an individual completes the test," said Craig Eagle, MD, chief medical officer at Guardant Health. "We look forward to sharing findings at the ACG meeting that support the potential of a blood-based screening option like the Shield test to improve overall screening rates among the millions of eligible individuals who may prefer a more pleasant screening option."

Guardant Health and collaborator presentations at ACG 2024

Presentation

Title

Time / Location

Tuesday, October 29

28

Evaluating the Risk of Non-Colorectal Cancers in Individuals With a False Positive Blood-Based Colorectal Cancer Screening Test

8:30am ET /

Terrace Ballroom 2-3

P3672

Real-World Adherence to Repeat Testing for Stool-Based Non-Invasive Colorectal Cancer Screening Tests Among Individuals With Average Risk – ACG Presidential Poster Award winner

10:30am-4:00pm ET / Exhibit Hall E

The full abstracts for Guardant Health and a list of all abstracts being presented at the ACG Annual Meeting can be found on the ACG meeting website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook.