On October 28, 2024 Parabilis Medicines (formerly FogPharma), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer, reported a corporate name change (Press release, Parabilis Medicines, OCT 28, 2024, View Source [SID1234649752]). The company’s new name, Parabilis (pronounced puh-RAH-buh-liss), draws on Greek and Latin etymologies to mean both ‘beyond what’s possible’ and ‘obtainable,’ reflecting the company’s drive to expand what is therapeutically possible for the treatment of serious diseases, and its commitment to ensuring its medicines reach and benefit patients globally.

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Parabilis also unveiled its expanded Helicon platform, which seamlessly integrates highly innovative AI and experimental technologies to discover, optimize, and deliver Helicon peptide therapeutics for not-yet-drugged targets, in addition to cutting-edge data science techniques the company is employing to optimize trial design and guide future clinical strategies.

"The name Parabilis captures the tremendous aspirations of a group of passionate innovators who are grounded in pragmatism. We are combining breakthrough science, industry-leading artificial intelligence (AI) capabilities, and a relentless drive to create real medicines that change what is possible in treating disease," said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. "That clarity of ambition is reflected in the way we approach our work, integrating data science and new product planning throughout the drug discovery and development lifecycle to ensure we’re single-mindedly pursuing only those medicines that anticipate and address profound unmet needs. Our new company name embodies this spirit: break boundaries, crush dogma, operate with the highest ambitions, and focus relentlessly on the patient at all times."

Parabilis’s investigational lead candidate, FOG-001, is the only clinical-stage inhibitor of the interaction of β-catenin with TCF, a known driver of colorectal cancer (CRC) with a significant role in multiple additional cancers. This target has been a towering challenge in the pharmaceutical industry, known for decades to be a key node, yet intractable. Now 16 months into its development, FOG-001 continues to enroll mostly CRC patients in its Phase 1 precision guided program. The company is also advancing its discovery portfolio with applications in protein degraders and radioligand therapies for the treatment of cancer, with four late discovery programs and integration of AI and advanced data science into every aspect of the discovery and development process.

In early 2024, the company raised a $145 million Series E financing to support the ongoing clinical development of FOG-001 and accelerate its broader Helicon peptide portfolio and platform.

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.