On September 6, 2024 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, reported that management will host a webcast and conference call at 8:00 a.m. ET (5:00 a.m. PT) on Monday, September 9, 2024 to introduce new XmAb programs in development for the treatment of patients with autoimmune diseases and to provide updates on continued progress in dose escalation with first-in-class oncology programs, including XmAb819 (ENPP3 x CD3) in patients with advanced clear cell renal cell carcinoma and XmAb808 (B7-H3 x CD28) in patients with advanced solid tumors (Press release, Xencor, SEP 6, 2024, View Source [SID1234646395]).

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The live webcast may be accessed through "Events & Presentations" in the Investors section of the Company’s website, located at investors.xencor.com. Telephone participants may register to receive a dial-in number and unique passcode that can be used to access the conference call. A recording will be available for at least 30 days.

On September 6, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the grant of 3,700 restricted stock units of Atara’s common stock to one newly hired employee (Press release, Atara Biotherapeutics, SEP 6, 2024, View Source [SID1234646400]). This award was approved by the Compensation Committee of Atara’s Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of September 3, 2024, as an inducement material to the new employee entering into employment with Atara, in accordance with Nasdaq Listing Rule 5635(c)(4).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date and the remainder vesting in 12 approximately equal quarterly installments over the following three years, subject to the employee being continuously employed by Atara as of such vesting dates.

Atara is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On September 5, 2024 Leapfrog Bio, a clinical-stage precision oncology company, accelerating oncology drug development by identifying novel therapies for undruggable cancer-driving mutations, reported a publication in Nature PJ Precision Oncology describing and validating its Precision PGx Platform, a novel pharmacogenomic approach to screening and discovering drug-genotype combinations that are clinically actionable and demonstrate the potential to significantly impact overall survival for cancer patients (Press release, Leapfrog Bio, SEP 5, 2024, View Source [SID1234646371]). The platform evaluates cancers resulting from LoF mutations and leverages real driver biology to expose hidden vulnerabilities that accompany these mutations and finds the drugs that exploit those vulnerabilities to destroy cancer cells.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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As outlined in the paper, the approach employs driver-focused CRISPR screens with and without drug in a pool of isogenically controlled cell lines, using next-generation sequencing (NGS) to identify genes that cause cells to ‘drop out’ of the pool when mutated and treated with a particular drug. Proof-of-concept experiments using PARP (poly-ADP ribose polymerase) inhibitors – the only drug class currently directed at cancers with LoF mutations – allowed the team to technically optimize their pharmacogenetic approach. They then applied the platform to approved cancer drugs for which real-world data was available and showed that platform-discovered genetic sensitizers impacted patient survival.

"This was a pivotal moment for me," says Tomas Babak, CSO of Leapfrog Bio and corresponding author. "Not only did we see 100% validation in mouse xenografts, but our platform was able to point out which patients would respond best to specific drugs based on the genetic drivers of their tumors. Unlike traditional synthetic lethality screening, which is based on testing combinations of gene knockouts, pharmacogenomic interactions capture the effects of drugs, which can be far more complex than a simple genetic knockout."

"Two-thirds of cancers are caused by a loss of function mutation in a tumor suppressor gene, where the absence of a functional protein results in tumor growth. Due to the challenge of developing a targeted drug that treats a disease caused by the absence of a protein target, most patients with tumors caused by loss-of-function mutations do not have access to genetically targeted therapies," said Greg Vontz, CEO of Leapfrog Bio. "Our precision PGX Platform addresses this area of tremendous patient and clinician need."

Mr. Vontz continued, "There are more than 2,400 clinical stage cancer therapeutics that have not advanced to FDA approval due to lack of efficacy but were generally safe and well tolerated. After screening only a small portion of these molecules, Leapfrog has identified several compelling opportunities and has filed corresponding intellectual property applications around the discoveries."

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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."