On October 27, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its third quarter 2021 financial results before the market opens on Wednesday, November 3, 2021 (Press release, United Therapeutics, OCT 27, 2021, View Source [SID1234591997]).

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United Therapeutics will host a public webcast Wednesday, November 3, 2021, at 9:00 a.m. Eastern Time. The webcast will be accessible via United Therapeutics’ website at View Source A rebroadcast of the webcast will be available for one week and can be accessed at the same location.

On October 27, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application to initiate a Phase 1/1b clinical trial of prexigebersen-A (liposomal Grb2-A or BP1001-A) in patients with solid tumors, including ovarian, endometrial, pancreatic and triple negative breast cancer (Press release, Bio-Path Holdings, OCT 27, 2021, View Source [SID1234591996]).

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"This IND clearance for prexigebersen-A marks an important regulatory milestone for Bio-Path, as we progress our fourth drug candidate into the clinic. Given the formulation enhancements, encouraging pre-clinical data and safety profile we have seen to-date, we are eager to begin this first-in-human study," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We are particularly encouraged as prexigebersen-A has been shown to enhance chemotherapy efficacy in preclinical solid tumor models and we look forward to confirming these earlier results."

Prexigebersen-A is a modified drug product with the same drug substance as prexigebersen but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement was to produce smaller drug nanoparticles that could pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness.

In April 2018, data were presented demonstrating the treatment of solid tumors in gynecologic malignancies with prexigebersen-A at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data showed an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen-A/paclitaxel group compared with control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the control group. This work was subsequently published in the journal Oncotarget in 2020.

"Given the encouraging pre-clinical results that have been generated to-date, we are optimistic that prexigebersen-A may offer much needed respite to patients suffering with solid tumors who face limited treatment options," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center and the Mary Crowley Research Center. Eventually, we expect to have six sites to conduct the clinical trial. Initially, a total of six evaluable patients are scheduled to be treated with prexigebersen-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of prexigebersen-A monotherapy cohorts and will assess the safety and efficacy of prexigebersen-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors.

The IND review process was performed by the FDA’s Division of Oncology 1, Office of Oncologic Diseases and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.

On October 27, 2021 Abcam (AIM:ABC; NASDAQ:ABCM), a global innovator in life sciences reagents and tools, reported the successful completion of its acquisition of BioVision and the expansion of its immunoassay capacity in Eugene, OR (Press release, Abcam, OCT 27, 2021, View Source [SID1234591995]).

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Across the life sciences sector, the events of the last 18 months have amplified the need for efficient workflows and robust data generation, to enable the faster delivery of positive outcomes for science and health. Widespread access to high-performance, reproducible, off-the-shelf assays and kits has become invaluable to enable the biopharma industry and academia to achieve meaningful advances at pace. To further support the growing demand of the sector and to strengthen its position in the assay market, Abcam today announces two significant developments, accelerating the execution of its strategic growth plan.

The addition of BioVision enhances Abcam’s in-house innovation and adds scale to support the biochemical assay and cellular assay markets. The successful acquisition brings BioVision’s product portfolio, capabilities, and 70-strong expert development and manufacturing teams into Abcam. The global research community will gain ready access to this portfolio of biochemical and cell-based assays via Abcam’s global commercialization network.

Supplementing the acquisition, Abcam has doubled the footprint of its immunoassay kit R&D and manufacturing facility in Eugene, OR. This enhanced capacity is another component of Abcam’s growth journey in the US and will further enable its commitment to support the research and biopharma sector globally.

"We are delighted to welcome our new colleagues to Abcam. Providing a platform for future growth and addition of new product lines, the acquisition of BioVision and expansion of our Eugene facility reinforce our commitment to the acceleration of scientific breakthroughs. Enabling scientists to reproducibly generate the robust results they need, faster, is essential for the delivery of new innovations that can positively impact us all."

On October 27, 2021 EpiAxis Therapeutics reported at three conferences this week – Australia Biotech Invest & Partnering 2021; Europe’s largest life science partnering conference, BIO-Europe 2021; and Wholesale Investor’s STEM 2021 Conference (Press release, EpiAxis Therapeutics, OCT 27, 2021, View Source;utm_medium=rss&utm_campaign=epiaxis-headlines-three-key-biotech-conferences [SID1234591993]).

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CEO of EpiAxis Therapeutics, Dr Jeremy Chrisp, presented at the Australia Biotech Invest & Partnering 2021 earlier this week which is Australia’s premier life sciences investment conference. It’s an interactive digital showcase, designed to foster growth and drive business-to-business investment and collaboration in what continues to be a significant time for life sciences and medical research. The conference was held online on Tuesday, October 26, 2021. Engaging capital with innovation, it was an opportunity for companies to present their technology and story to a network of potential international partners and investors. Investors include those in venture capital, private equity, HNW individuals, research analysts and brokers, as well as industry executives from major global pharmaceutical companies. The program also featured keynote sessions from investment leaders on industry trends and market updates.

The international BIO-Europe 2021 gathering is being held digitally from October 25-28, bringing the global biopharma and investment leaders together to build partnerships that facilitate innovation and medical breakthroughs.

Chrisp will also appear at Wholesale Investor’s STEM 2021 Conference on Thursday, October 28. EpiAxis recently joined Wholesale Investor, Australasia’s leading investment platform for connecting innovative, emerging companies that are looking to raise capital with an active, engaged and growing ecosystem of more than 29,300 high-net-worth investors, fund managers, family offices, PE and VC firms, government bodies and industry participants. The showcase includes everything investors need to capitalise on STEM investment opportunities.

"We are delighted to be presenting at these conferences with our biotech peers to raise the profile of EpiAxis and the importance of epigenetic therapies as a new approach to treating cancer," Chrisp said. "It has also been an excellent opportunity to network with potential investors and familiarise them with our novel approach, which targets cancer stem cells that can evade chemotherapy and immunotherapy, to ‘reprogram’ them back to normal cells."

On October 26, 2021 GlycoMira Therapeutics reported that it received a $2.8M award from the National Institutes of Health to develop its lead compound, GM-1111, as a therapeutic for oral mucositis arising from radiation treatment of head and neck cancers (Press release, GlycoMira Therapeutics, OCT 26, 2021, View Source [SID1234632164]). The award will enable the completion of the requisite pre-clinical studies necessary for filing an Investigational New Drug (IND) application to initiate human clinical trials.

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Oral mucositis is a common, debilitating complication characterized by painful, severe ulcerations of the mouth that develop in head and neck cancer patients receiving chemoradiation therapy. The disease substantially degrades quality of life and compromises treatment and prognosis. Over 67K new head and neck cancer cases occur annually in the U.S., and the global market for the treatment of such cancers is projected to reach $2.3B by 2025.

GlycoMira’s pivotal studies in pre-clinical models demonstrate a significant reduction in the occurrence and severity of oral mucositis. Significant reductions in tumor volume were additionally observed in head and neck squamous cell carcinoma models when GM-1111 was administered as an adjuvant to radiation therapy. GM-1111 is believed to suppress tumor growth by blocking innate immune receptors and angiogenic factor-mediated cell signaling, as well as inhibiting cancer stem cell growth which is expected to improve therapeutic outcomes.

Dr. Stephen Sonis, Professor of Oral Medicine at Harvard stated, "Oral mucositis remains a common and devastating side effect of radiation therapy for head and neck cancers. Critically, it is often a reason why patients are unable to complete optimal anti-cancer treatment. I am excited to collaborate with the GlycoMira team so that we can accelerate the move of their innovative technology into the clinic."