On September 7, 2023 BroadenBio reported the company has received the approval from FDA for the Investigational New Drug (IND) Application of conducting clinical trials on advanced solid tumors for BB3008 (Press release, BroadenBio, SEP 7, 2023, View Source [SID1234640204]). BB3008 is the second clinical-stage product from BroadenBio. The Phase I clinical trial of BroaddnBio’s first product, highly selective FGFR4 small molecule inhibitor BB102, is progressing smoothly and is expected to be completed by the end of this year.

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About BB3008

BB3008 is a highly selective small molecule inhibitor of HPK1 with novel molecular structure developed independently by BroadenBio. BB3008 significantly activates T cell activity in vitro, shows pronounced tumor growth inhibition both as monotherapy and in combination with PD-1 inhibitors, and has excellent pharmacokinetics properties and controllable safety. The preclinical study of BB3008 was been published as "Late-Breaking Research" at the 2023 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). BB3008, as monotherapy or in combination, will be used to overcome the immune suppressive tumor microenvironment and treat malignant solid tumors in clinical trials.

About HPK1

Hematopoietic progenitor kinase 1 (HPK1), also known as MAP4K1, is a serine/threonine kinase mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). HPK1 is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway. As an important intracellular immune checkpoint, HPK1 inhibits the proliferation and functions of T cells and B cells, and also inhibits the antigen presentation by dendritic cells (DCs). Clinical studies have observed upregulation of HPK1 levels in various tumor tissues such as leukemia, bladder cancer, breast cancer, and colon cancer. HPK1 inhibition can restore the immunology functions in tumor microenvironment and enhance T cell-mediated anti-tumor immune effects. Therefore, HPK1 is a potential target for immuno-oncology therapy.

On September 7, 2023 – Daiichi Sankyo (TSE: 4568) reported that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer (Press release, Glycotope, SEP 7, 2023, View Source [SID1234635383]).

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DS-3939 is a specifically engineered potential first-in-class tumor-associated mucin-1 (TA-MUC1) directed antibody drug conjugate (ADC) designed using Daiichi Sankyo’s proprietary DXd ADC technology. TA-MUC1 is a tumor-specific transmembrane glycoprotein and is overexpressed in most human epithelial cancers, making it a promising target for cancer therapy.1,2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer.

"With DS-3939, we are pairing our unique DXd antibody drug conjugate technology with a TA-MUC1 antibody in order to evaluate this novel treatment strategy for patients with several types of advanced cancer," said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. "The initiation of this trial is a significant milestone as DS-3939 is an important new addition to our growing DXd ADC portfolio, which now consists of six ADCs in clinical development, and represents our ongoing commitment to create new standards of care for patients with cancer."

About the Phase 1/2 Trial

The two-part, multicenter, open-label, first-in-human phase 1/2 trial will assess the safety and efficacy of DS-3939 in patients with locally advanced, metastatic or unresectable solid tumors not amenable to standard of care treatment for each tumor type.

The first part of the trial (dose escalation) will assess the safety and tolerability of increasing doses of DS-3939 to determine the maximum tolerated dose and/or the recommended doses for expansion (RDEs) in patients with locally advanced, metastatic, or unresectable solid tumors.

The second part of the trial (dose expansion) will consist of multiple expansion cohorts to continue to assess the safety and efficacy of DS-3939. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, and efficacy endpoints including overall response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetic and biomarker endpoints also will be assessed.

The trial is expected to enroll patients across multiple sites globally, including Asia and North America. For more information, please visit ClinicalTrials.gov.

About TA-MUC1

TA-MUC1 is a tumor-specific transmembrane glycoprotein with aberrant glycosylation due to changes of the expression patterns of some sialyltransferases.1 Based on the overexpression of TA-MUC1 in most human epithelial cancers, it is an attractive target for cancer therapy.2 Currently, there are no TA-MUC1 directed therapies approved for any type of cancer. About DS-3939 DS-3939 is an investigational potential first-in-class TA-MUC1 directed ADC.

Designed using Daiichi Sankyo’s proprietary DXd ADC technology, DS-3939 is comprised of a humanized anti-TA-MUC1 antibody licensed from Glycotope GmbH, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

On September 7, 2023 – Myricx Bio (‘Myricx’), a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs), reported an antibody license agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd (‘Biocytogen’, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics (Press release, MyricxBio, SEP 7, 2023, View Source [SID1234635233]).

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The agreement will enable Myricx to develop and commercialize ADCs based on an antibody developed using Biocytogen’s proprietary RenMice platform and will expand Myricx’s ADC pipeline of proprietary monoclonal antibodies (mAbs) against important cancer targets to which it conjugates its first-in-class selective cytotoxic payloads based on potent inhibitors of N-MyristoylTransferase (NMT), a completely novel concept in the ADC space.

NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is developing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types.

Under the terms of the agreement, Myricx will provide its proprietary linker and NMTi payload and Biocytogen will conjugate them with its RenMice-derived fully human antibody to make ADCs. Biocytogen will carry out feasibility tests for these ADCs as CRO services, and upon option exercise, Myricx will be responsible for further development and commercialization. Biocytogen will receive an upfront payment and subject to exercise, Biocytogen will be eligible to receive development and commercialisation milestone payments, as well as single-digit royalties on net sales.

Myricx CEO Dr Robin Carr said: "We are delighted to have reached this agreement with Biocytogen with ground-breaking technology to develop novel antibodies for use in drug development. We believe that the combination of its antibody with our novel NMTi-based selective cytotoxic payloads will enable us to develop best-in-class ADCs to meet significant clinical needs in oncology. NMT inhibitors represent a novel class of ADC payloads that can be exploited as targeted therapies in cancer. Based on our positive proof of concept data we believe that ADC-NMTi offer huge potential for selective cancer cell killing via its unique mechanism of action."

"Thanks to Myricx’ recognition of our antibody assets, preclinical discovery expertise and CMC capabilities," said by Dr. Yuelei Shen, President and CEO of Biocytogen. "Myricx is a leading expert in NMTi payloads, and we believe that the combination of both company’s strengths will result in ADC drugs with first-in-class and best-in-class potentials."

On September 7, 2023 Mariana Oncology Inc., a biotechnology company pioneering a new era of radiopharmaceutical innovation to treat cancers with high unmet need, reported the closing of an oversubscribed $175 million Series B financing co-led by Deep Track Capital and Forbion (Press release, Mariana Oncology, SEP 7, 2023, View Source [SID1234635016]). Founding investors Atlas Venture, Access Biotechnology and RA Capital Management are joined by additional new investors Nextech Invest, Surveyor Capital (a Citadel company) and Eli Lilly and Company. Proceeds from the financing will support the advancement of Mariana Oncology’s novel portfolio of precision, next-generation radiopharmaceuticals including its lead candidate, MC-339, as the company transitions into a clinical-stage organization.

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"The support of such a strong syndicate of new and existing investors is a testament to Mariana Oncology’s potential," said Simon Read, Ph.D., Founder and Chief Executive Officer of Mariana Oncology. "In just 18 months since our Series A, we’ve leveraged our deep expertise in peptide discovery and radiochemistry to advance a diversified portfolio of novel molecules. The proceeds from this financing support the advancement of our pipeline and the initial development of our lead candidate, MC-339, which we anticipate will enter the clinic in 2024 in small cell lung cancer, supported by our own GMP radiopharmaceutical manufacturing."

"Radiopharmaceuticals are now being recognized as a logistically viable treatment modality that have demonstrated safety and a high degree of efficacy. These therapies are transforming care for select cancers and are primed to do so across a broader set of indications," said Rebecca Luse of Deep Track Capital. "Mariana Oncology’s pipeline is innovative and differentiated from most existing radiopharmaceutical companies. We are compelled by the broader opportunity for radiopharmaceuticals beyond prostate cancer and look forward to supporting Mariana Oncology’s success along with their seasoned leadership team and strong syndicate."

"The promising nature of Mariana Oncology’s pipeline is particularly exciting when we look at the possible positive impact on patients," said Geert-Jan Mulder, M.D., Managing Partner of Forbion. "MC-339 has the potential to transform the treatment of small cell lung cancer with the targeted delivery of an actinium payload leveraging the advantages of peptides for enhanced tumoral distribution. We look forward to Mariana Oncology’s evolution into a clinical-stage company with the potential to efficiently deliver an effective new standard of care to patients in the future."

In conjunction with this financing, Rebecca Luse from Deep Track Capital and Geert-Jan Mulder, M.D., from Forbion will join the Board of Directors.

On September 7, 2023 Noetik, an AI drug discovery company leveraging machine learning and proprietary human data to develop precision therapeutics in immuno-oncology, reported that it closed an oversubscribed $14M seed financing round led by DCVC, with participation from Zetta Venture Partners, 11.2 Capital, Catalio Capital Management, Epic Ventures, Intermountain Ventures, North South Ventures, Chau Khuong and CJNV BioVentures, Enveda Founder and CEO, Viswa Colluru and Hummingbird Nomads Fund, and Recursion CEO & CFO, Chris Gibson and Michael Secora (Press release, Noetik AI, SEP 7, 2023, View Source [SID1234635015]).

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Noetik has built an industry-defining multimodal tissue profiling platform that combines self-supervised learning with spatial biology to tackle fundamental problems in cancer immunology. In less than 12 months of operations Noetik has generated hundreds of terabytes of human data across a data stack that includes genomics, transcriptomics, and proteomics to enable the development of foundation models for cell and tissue biology.

The funding will support Noetik’s significant internal data generation efforts and the continued development of transformer-based machine learning methods. From these data, the company aims to rapidly initiate target and therapeutics discovery. The funding will also be used to expand Noetik’s team in machine learning, computational biology, and cancer immunology.

"The microscope enabled a view of nature at the cellular level, now advanced AI methods provide us with a view of nature at the systems level. We can integrate molecular, cellular, and tissue information to discover novel therapeutic targets and study patients’ response to immunotherapies. Science has tended to remove complexity and simplify problems for human understanding, but now using modern machine learning we embrace natural complexity to discover more relevant representations of biology," said Ron Alfa, M.D., Ph.D., CEO & Co-Founder, Noetik. "We are here to make cancer drugs. Our commitment to patients is to discover better cancer therapeutics that have a higher probability of clinical success, using the most advanced computational tools."

"Technology will have the greatest impact on therapeutics by enabling better prediction of clinical success of new oncology therapies. The biggest bottleneck is clinical failure, with an ever-growing discovery funnel. Using machine learning, Noetik can discover the circuit diagram of tumor biology to unlock the next generation of precision oncology for end-to-end therapeutics discovery," said James Hardiman, General Partner, DCVC.

"The first generation of AI drug discovery was built on supervised learning which relies on human labels that are difficult to scale and limited by existing knowledge. Recent advances in self-supervision allow AI to learn directly from data and build internal representations of biology untethered to existing models of disease. This creates an opportunity to rethink the role of AI in drug development and build new platforms that use foundation models to encode and extract insights from machine-learned biology. We are excited to work with Noetik to apply these ideas to oncology and develop the next-generation of precision therapies," said Dylan Reid, Partner, Zetta Venture Partners.

Noetik’s founding leadership team includes Lacey Padron, Ph.D., Chief Technical Officer, who was previously VP Informatics at the Parker Institute for Cancer Immunotherapy. At the Parker Institute, Padron focused on using integrated multiomic data analysis to uncover biomarkers, mechanisms of action, and novel therapies from cancer immunotherapy patient data. She also led the development of a best-in-class data platform to store, integrate, and analyze data from 20+ molecular data types with detailed clinical outcomes and annotation.

"We founded Noetik not only to conduct impactful science, but to bring together some of the most talented people in the industry to build the ML-enabled therapeutics company of the future. One of the most challenging aspects of bringing together biology and machine learning is building exceptional interdisciplinary teams," said Jacob Rinaldi, Ph.D., CSO & Co-Founder, Noetik. "We’re recruiting a world-class, deeply technical team that have built in this space and are passionate to work on solving hard problems to make an impact for patients."

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