On September 5, 2024 Integrated DNA Technologies reported that it is expanding its Archer portfolio of comprehensive genomic profiling (CGP) solutions to include homologous recombination deficiency (HRD) assessment (Press release, INTEGRATED DNA TECHNOLOGIES, SEP 5, 2024, View Source [SID1234646387]). Available as a standalone assay, spiked-in as a supplementary module or integrated in an Archer NGS panel, the new HRD module complements existing Archer microsatellite (MSI) and tumor mutational burden (TMB) assessment capabilities to create a flexible, customizable CGP solution for labs looking to optimize sequencing resources. The HRD assessment is available via the:

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VARIANTPlex HRD Module—available as a spike-in to other Archer panels or ran alone.
VARIANTPlex Complete Solid Tumor v2 panel—expands Archer’s existing Complete Solid Tumor panel, now capable of assessing HRD.
VARIANTPlex Pan Solid Tumor v2 panel—expands Archer’s existing Pan Solid Tumor panel, now capable of assessing HRD.
Powered by Archer’s Anchored Multiplex PCR (AMP) chemistry and Archer Analysis, the new HRD module and updated Archer NGS panels enable downstream applications of precision medicine, provides a differentiated solution that can be customized to fit a lab’s solid tumor research needs, and expands Archer’s existing CGP portfolio.

"With our new HRD module, IDT is enabling labs to unlock the most comprehensive biomarker content from a single, low-input sample," said Steve Wowk, Vice President/General Manager, Gene Reading Business Unit at IDT. "As a trusted cancer research partner, IDT is continuously innovating on its cancer research solutions to equip labs with the timely, accurate and relevant answers they need about cancer, while helping them overcome the challenges they face with technical and resource constraints. With CGP on-market solutions currently a one-size-fits-all, we’re excited to make our HRD module available as a custom CGP solution, building on our commitment to accelerate the pace of genomics by broadly enabling CGP to advance cancer research."

As comprehensive genomic profiling for solid tumors grows in popularity to rapidly identify cancer biomarkers, IDT’s suite of CGP solutions is designed to fit labs unique needs with pre-designed RNA- and DNA-based panels, customizable panels, and supplementary modules to easily target key genomic signatures like MSI, TMB, and HRD. IDT’s CGP solution allows labs to adjust targets quickly without significant changes to established protocols.

To learn more about HRD assessment capabilities and IDT Archer’s CGP solutions, visit View Source

About IDT

For more than 35 years, Integrated DNA Technologies, Inc. (IDT) has empowered genomics laboratories with an oligonucleotide manufacturing process unlike anyone else in the industry, featuring the most advanced synthesis, modification, purification, and quality control capabilities available. Since its founding in 1987, IDT has progressed from a leading oligo manufacturer to a genomics solutions provider supporting key application areas such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. IDT manufactures products used by scientists researching many forms of cancer and most inherited and infectious diseases.

Seeking to fulfill its mission of accelerating the pace of genomics, IDT acquired Archer NGS Research Assays in December 2022. When combined with its existing solutions, the expanded portfolio helps realize the shared vision of enabling researchers to rapidly move from the lab to life-changing advances.

IDT’s infrastructure supports customers around the globe with its manufacturing headquarters situated in Coralville, Iowa, USA, with additional manufacturing sites in San Diego, California, USA; Boulder, Colorado, USA; Research Triangle Park, North Carolina, USA; Ann Arbor, Michigan, USA; Leuven, Belgium; and Singapore.

IDT is proud to be part of Danaher. Danaher’s science and technology leadership puts IDT’s solutions at the forefront of the industry, so they can reach more people. Being part of Danaher means we can offer unparalleled breadth and depth of expertise and solutions to our customers.

Together with Danaher’s other businesses across Biotechnology, Diagnostics and Life Sciences, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day.

For more information about IDT, visit www.idtdna.com and follow the company on LinkedIn, X, Facebook, YouTube, and Instagram.

Disclaimer: RUO — For research use only. Not for use in diagnostic procedures. Unless otherwise agreed to in writing, IDT does not intend these products to be used in clinical applications and does not warrant their fitness or suitability for any clinical diagnostic use.

On September 5, 2024 HDAX Therapeutics ("HDAX"), a biotechnology company pioneering a novel approach to targeting HDAC6 for the discovery and development of breakthrough therapeutics for high unmet medical needs, reported the first closing of an oversubscribed US$3.2 (CA$4.3) million seed round (Press release, HDAX Therapeutics, SEP 5, 2024, View Source [SID1234646388]). The financing was led by SeedFolio, FACIT, and Toronto Innovation Acceleration Partners ("TIAP"), with participation from Eos Bioinnovation ("Eos"), Ontario Centre of Innovation ("OCI"), and other investors. Proceeds from this financing will support the company’s progress towards preclinical development candidate nomination and further advancement of its pipeline programs.

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In conjunction with the financing, Brock Reeve, CEO of Eos, and Prakash Gowd, Vice President at TIAP, have joined the HDAX Board of Directors. David Koehler, FACIT and Joe Gatto, SeedFolio will join as Board Observers.

Recent advances in HDAC biology have highlighted the critical role of HDAC6 in microtubule dysfunction, validating the therapeutic potential of this target in inflammatory disease, metabolic dysfunction, and neurological disorders. The involvement of HDAC6 in multiple disease states has led to the pursuit of HDAC6-selective drugs by several companies. However, drug development efforts targeting HDAC6 have faced significant challenges, such as poor efficacy, off-target toxicities, and inadequate drug exposure. Drawing on over 7 years of research originating from the lab of renowned serial entrepreneur Professor Patrick Gunning at the University of Toronto, HDAX was purpose-built to address the challenges of developing effective drugs targeting HDAC6. Harnessing its unique molecular recognition technology, HDAX has devised a next-generation binding mechanism that has the potential to discover best-in-class HDAC6 inhibitors. HDAX’s novel mechanism addresses key drug-design challenges of weak binding, poor pharmacokinetics, and off-target toxicities, paving the way for potentially transformative therapeutic benefits for patients.

"HDAX Therapeutics is at the forefront of developing next-generation HDAC6-targeting therapeutics to improve patient outcomes. Our novel binding mechanism allows us to effectively and safely target the underlying drivers of disease, positioning us to be potentially best-in-class in the HDAC6 space," said Nabanita Nawar, co-founder and CEO of HDAX. "Securing this financing highlights our truly differentiated innovation and the broad applicability of our technology. With this capital, we are well-positioned to advance our pipeline toward development candidate nomination and ultimately deliver meaningful and safe disease-modifying therapies to patients."

"HDAX has made tremendous progress in discovering potent and selective HDAC6 inhibitors, leapfrogging other companies pursuing the target. HDAX’s molecules will not only advance our understanding of HDAC6 biology but also unlock the target’s potential in addressing a number of diseases with high unmet needs," said Roman Fleck, Executive Chairman of HDAX.

Prakash Gowd, TIAP Vice President, commented, "We are incredibly proud to have been able to support HDAX since its inception – first through our University of Toronto Early-Stage (UTEST) program, and now through this pivotal financing. It is a tremendous example of the type of highly innovative and highly promising life sciences ventures we are building in collaboration with our ecosystem partners."

"FACIT commercializes Ontario’s leading oncology ventures, and HDAX’s compelling preclinical profile and strong scientific foundation align with our goals to impact patients," said David O’Neill, FACIT President. "We look forward to working with the management team and alongside other ecosystem partners to realize the full clinical potential of HDAX’s pipeline."

On September 05, 2024 FACIT reported the company congratulates HDAX Therapeutics ("HDAX") on the closing of a seed financing round to develop their best-in-class HDAC therapeutics for the treatment of a serious cancer conditions (Press release, FACIT, SEP 5, 2024, View Source [SID1234646407]). Capital from the investor group, which included an investment from FACIT’s Compass Rose Oncology Fund, will empower HDAX to address the debilitating neuropathic pain frequently experienced by patients with cancer.

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HDAX’s successes to date exemplify the importance of FACIT’s Ontario First commercialization strategy, providing a continuum of much needed capital and additional supports to advance early-stage cancer innovations. After securing initial capital from FACIT’s Prospects Oncology Fund to support the intellectual property developed at the University of Toronto, HDAX met and surpassed key preclinical milestones while cultivating highly skilled talent and entrepreneurial skills in Ontario. Furthermore, HDAX is one of very few life science start-ups led by two women entrepreneurs, and FACIT is proud to continue its industry leadership in backing women-led companies. Congratulations to HDAX and their continued growth in Ontario!

To learn more about this exciting Ontario startup and the potential impact for patients with cancer, read the company’s news release here.

On September 5, 2024 Nerviano Medical Sciences S.r.l. (NMS), a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc., a wholly owned subsidiary of NMS S.r.l, focused on the discovery and development of oncology drugs and the largest oncological R&D company in Italy, reported an agreement with funds managed by Blue Owl Capital ("Blue Owl") (Press release, Nerviano Medical Sciences, SEP 5, 2024, View Source [SID1234646373]). This investment will enable NMS to monetize $80 million or more in potential future BRAFTOVI royalties, with Blue Owl providing in excess of $50 million in upfront cash and contingent proceeds. Under the terms of the agreement, NMS retains all subsequent royalties tied to BRAFTOVI ‘s global net sales once a specific multiple of Blue Owl’s investment has been met, which in NMS’s estimation are anticipated to exceed $30 million.

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"This non-dilutive capital infusion allows us to strengthen our balance sheet to focus on our strategic priorities, after an important exercise to further prioritize and reinforce efforts on our core clinical programs." said Hugues Dolgos, Pharm.D., Chief Executive Officer, NMS. "Main part of the proceeds will be used to advance and expand our pipeline and accelerate the development of our ADC platform. We are delighted to see that our confidence in the commercial opportunity of BRAFTOVI is aligned with that of Blue Owl through this transaction."

"We are delighted to enter into this royalty monetization transaction with NMS, whose foundational IP contributed to the development and commercialization of Pfizer’s BRAFTOVI." said Sandip Agarwala, Managing Director at Blue Owl. "Our structurally flexible approach to investing in the life sciences allowed us to design a mutually rewarding transaction, and we are excited for the company to reinvest these proceeds into high potential R&D programs."

Transaction Terms
Upon closing the BRAFTOVI royalty agreement, NMS will receive in excess of $50 million in upfront cash and contingent payments based on a U.S. Food and Drug Administration approval milestone. The transaction allows NMS to maintain royalties in excess of a multiple of Blue Owl’s purchase price, with NMS projecting these earnings to surpass $30 million.

Advisors
Morgan Stanley & Co. LLC acted as the sole structuring agent. Fenwick provided legal counsel to NMS Group, and Ice Miller and Cooley LLP provided legal counsel to Blue Owl.

On September 5, 2024 Abdera Therapeutics Inc., a biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable, precision radiopharmaceuticals for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma (Press release, Abdera Therapeutics, SEP 5, 2024, View Source [SID1234646389]). ABD-147 is a next-generation precision radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing DLL3, a protein found on the surface of neuroendocrine tumors, but rarely expressed on the surface of normal cells or tissues. In 2024, Abdera plans to initiate a first-in-human Phase 1 clinical trial with ABD-147 in patients with small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) who previously received platinum-based therapy.

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"Neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies," said Philippe Bishop, M.D., chief medical officer. "By delivering a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered PK properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors. Along with FDA recently granting Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, this Orphan Drug Designation for neuroendocrine carcinoma further underscores the potential of ABD 147 development to offer a significant advantage beyond approved drugs."

The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics for rare diseases that meet certain criteria. Orphan Drug Designation provides various incentives including tax credits for qualified clinical trials, exemption from user fees, and the potential for seven years of market exclusivity after approval.

About Neuroendocrine Carcinoma

Neuroendocrine carcinoma is a type of cancer that originates from neuroendocrine cells, which have characteristics of both nerve cells and hormone-producing cells. These cancers can develop in various parts of the body, including the lungs (SCLC and LCNEC), the digestive tract, pancreas, prostate, and other endocrine glands and share similar clinical and pathologic traits characterized by higher mitotic rates with extensive necrosis, high tumor mutational burden, and neuroendocrine gene expression.

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

About the ROVEr Platform

Abdera’s Radio Optimized Vector Engineering (ROVEr) platform enables the company to custom-engineer targeted radiopharmaceuticals with tunable pharmacokinetic (PK) properties to achieve high tumor uptake while minimizing renal exposure and mitigating other systemic radiotoxicities such as myelosuppression. Abdera can optimize the delivery and therapeutic index of potent radioisotopes capable of emitting powerful alpha or beta particles to selectively destroy tumor cells while sparing healthy cells, providing patients with potentially transformative new cancer treatments.

Abdera’s approach offers the ability to design radiotherapeutics against virtually any cancer target expressed on the cell surface. Coupled with a highly potent mechanism of cell killing, the ROVEr platform is uniquely poised to exploit both high- and low-expressing targets to selectively deliver therapeutic levels of radioisotope to cancer cells.