On October 5, 2022 Humanetics Corporation (Humanetics) reported that it has received FDA clearance of its Investigational New Drug (IND) application for BIO 300 to mitigate erectile dysfunction in men undergoing radiation treatment for prostate cancer (Press release, Humanetics, OCT 5, 2022, View Source [SID1234621742]). This is the second IND for BIO 300 in oncology patients, and the fourth IND overall for the Company.

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Aside from non-melanoma skin cancer, prostate cancer is the most common cancer in men and is often treated with radiation. Unfortunately, greater than 50 percent of men treated with radiation will experience radiation-induced erectile dysfunction (RiED). RiED greatly affects patient quality of life and, in most cases, is permanent and unresponsive to drugs such as Viagra and Cialis. The chance of developing RiED, especially in younger men, can alter treatment decisions and can push patients toward less effective treatment options. Currently, there are no treatments available to mitigate RiED in these patients.

BIO 300 is an oral drug that is self-administered at home by the patient prior to their radiation treatments. It has shown potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. Previously, Humanetics published nonclinical studies demonstrating that BIO 300 can prevent RiED. Additionally, nonclinical research with BIO 300 has shown that it may help improve the effectiveness of radiation against multiple types of tumors. BIO 300 was the recent subject of an early-stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Humanetics is continuing the development of BIO 300 on behalf of DOD for use by military personnel, first responders, and civilian populations who may be threatened with radiation exposure. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage. The drug is also being evaluated in a phase 2 trial of long COVID patients to determine if it can mitigate pulmonary damage.

"Continuing to expand the use of BIO 300 with cancer radiation therapy is one of our major goals," said Ronald J. Zenk, President and CEO of Humanetics. "We believe that BIO 300 may improve treatment

On October 5, 2022 Medikine, Inc., a biopharmaceutical company developing transformative therapeutics for cancer, autoimmune disorders, and infectious diseases using its novel PEPTIKINE technology, reported that it will deliver two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting (SITC 2022), taking place virtually and in Boston on November 8-12 (Press release, Medikine, OCT 5, 2022, View Source [SID1234621741]).

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The first poster presentation will highlight preliminary Phase 1 safety, tolerability, and pharmacokinetic/pharmacodynamic data on Medikine’s lead program, MDK-703, an Fc-peptide fusion protein incorporating an IL-7 PEPTIKINE discovered using Medikine’s innovative platform technology. A second poster will detail preclinical data on MDK-1654, Medikine’s dual-acting agonist that incorporates both IL-7 and non-alpha IL-2/15 PEPTIKINEs.

Details on the poster presentations are as follows:

Title: A Phase 1 Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamic Effects of MDK-703, an IL-7 Mimetic With Extended Half-life

Abstract #: 625
Presenter: Ron Barrett, PhD, Medikine
Date/Time: Thursday, November 10, 2022, from 9:00 a.m. to 9:00 p.m. EST
Title: MDK1654: A Branched Synthetic Peptide that Activates Both the IL-7 Receptor and the βγc Form of the IL-2/15 Receptor

Abstract #: 1097
Presenter: Angie Park, PhD, Medikine
Date/Time: Thursday, November 10, 2022, from 9:00 a.m. to 9:00 p.m. EST
Full abstracts will be made available online and will be included in the Journal for ImmunoTherapy of Cancer (JITC) supplement on November 7. Posters will also be available on the Medikine website at www.Medikine.com following the poster presentations.

On October 5, 2022 AbCellera (Nasdaq: ABCL) reported a presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting, to be held virtually and at the Boston Convention & Exhibition Center from November 8 to 12, 2022 (Press release, AbCellera, OCT 5, 2022, View Source [SID1234621740]).

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"T-cell engagers have tremendous potential as precision oncology therapeutics by redirecting cancer-killing T cells to specific tumor targets," said Bo Barnhart, Ph.D., VP, Translational Research at AbCellera. "We’re looking forward to presenting new data further validating our extensive CD3 panel and T-cell engager program and demonstrating how we’ve leveraged our OrthoMabTM bispecific platform to address key technological challenges that hinder discovery of effective and scalable CD3 T-cell engagers."

On October 5, 2022 Thermo Fisher Scientific Inc., the world leader in serving science, reported that introduced the Thermo Scientific Glacios 2 Cryo-Transmission Electron Microscope (Cryo-TEM), a powerful microscope with new automation and high-resolution imaging capabilities designed to help cryo-electron microscopy (cryo-EM) researchers of varying experience levels accelerate structure-based drug discovery (Press release, Thermo Fisher Scientific, OCT 5, 2022, View Source [SID1234621739]). This advanced, fast and cost-efficient method for drug design may enable customers to accelerate the pace of research for debilitating disorders like Alzheimer’s, Parkinson’s, and Huntington’s diseases, as well as research for cancer and gene mutations.

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The Glacios 2 Cryo-TEM includes automation features designed to extend accessibility to a range of cryo-EM techniques, including single particle analysis, cryo-electron tomography (cryo-ET) and microcrystal electron diffraction (MicroED). Additional highlights include fringe-free imaging for the acquisition of more usable images per foil hole, increased throughput compared to other commercially available optical alignment solutions and a new enclosure and hardware improvements built to offer enhanced performance compared to prior models.

This next generation solution can generate <2 angstrom 3D reconstructions and produce images faster than its predecessor. These capabilities can help users of all experience levels increase productivity at a time when rapid innovation and emerging cryo-EM applications are placing increasing demands on expert microscopists.

"Using the Glacios 2 Cryo-TEM, we developed a workflow that enables us to determine structures of small, asymmetric complexes at high resolution and with high throughput," said Basil Greber, principal investigator for The Greber Laboratory at the Institute of Cancer Research and beta user of the new Glacios 2 Cryo-TEM. "Uncovering such structures provides us with detailed insight into inhibitor binding and suggests a mechanism for target selectivity in cancer therapeutics that we are currently testing."

The new system also includes Thermo Scientific Smart EPU Software, which contains components needed for automated data acquisition, including microscope alignment and readiness assistance, plus an open API to allow for the development of solutions tailored to a user’s needs.

"As the demand for cryo-EM continues to surge, automated, high-throughput instruments are critical to advancing life science research around the world—especially in the fast-paced pharmaceutical and biotech industries," said Trisha Rice, vice president and general manager of life sciences at Thermo Fisher Scientific. "The Glacios 2 Cryo-TEM meets these needs by delivering high-quality structures quickly, taking some of the pressures away from microscope operation and giving time back to the scientists to focus on their groundbreaking research."

For pharma and biotech companies, the Glacios 2 Cryo-TEM offers high-throughput screening and imaging to enable the routine structure generation of druggable targets, including key targets of <120 kDA in size. For labs with growing demand for cryo-EM, the Glacios 2 solution helps increase accessibility to near atomic resolution structures, while improving ease-of-use and reproducibility across a variety of workflows.

On October 5, 2022 Massive Bio, a leader in AI-powered cancer clinical trial enrollment, reported a strategic partnership with Perthera.ai, a pioneer in connecting oncologists and patients with biomarker-based therapy options. Perthera.ai’s patented ranked therapy recommendations complement Massive Bio’s screening and analysis to empower more cancer patients to find an appropriate clinical trial (Press release, Massive Bio, OCT 5, 2022, View Source [SID1234621738]).

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Less than three percent of cancer patients today are matched and enrolled in a clinical trial. By combining the advanced computational methods and artificial intelligence capabilities of both companies, more physicians and patients will be able to confidently access the benefits of investigational precision oncology treatments from FDA-approved and novel therapies that are specific to patients’ unique molecular and genetic biomarkers. Perthera.ai combines multi-omic testing results (DNA, RNA, IHC and phosphoproteomics) to advise oncologists and their patients and simplify the decision-making process to increase the chance that the best therapy is used the first time.

"We are excited to partner with Massive Bio to leverage the most advanced science and technology to help as many cancer patients as possible," said Albert Kelley, CEO of Perthera.ai. "Increasing access to genomic and multi-omic testing and patient-trial matching solutions is the best way to advance cancer care for all. We believe in collaboration where it can help more patients and by combining forces with Massive Bio, we can improve data acquisition and the accuracy of patient-trial matching."

"Our mission is to create hope and empower cancer patients by helping them find their best treatment options, which often requires access to clinical trials," said Selin Kurnaz, co-founder and CEO of Massive Bio. "By combining Perthera.ai’s focus on biomarker-based algorithms with our AI-powered clinical trial matching platform, we can create more options for patients and physicians to find the best trials. We can also pursue additional innovations together around real-world data, biomarker discovery, and diagnostic and commercial collaborations with industry stakeholders."

Dr. Arturo Loaiza-Bonilla, co-founder and Chief Medical Officer of Massive Bio, added: "We are excited to expand our data sets and leverage our technologies and combined networks to offer more precise treatment paths, which will have an immediate and positive impact to identify more treatment options for more patients."