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GlycoMira Therapeutics Awarded $2.8M from the National Institutes of Health to Advance Lead Compound Towards the Clinic

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."

Newly-Formed Ancora Biotech Will Continue Operations of Teneobio Spin-offs After Successful Acquisition of Teneobio by Amgen

On October 26, 2021 Ancora Biotech reported, in connection with the closing of the acquisition of Teneobio, Inc., by Amgen Inc., that Teneobio’s former shareholders and their representatives will provide oversight of three previous affiliates of Teneobio, including TeneoTwo, Inc. (TNB-486, anti-CD19xCD3), TeneoFour, Inc. (anti-CD38 enzyme inhibitor TNB-738) and TeneoTen, Inc. (anti-HBVxCD3) (Press release, Amgen, OCT 26, 2021, View Source [SID1234611557]). These spin-offs were not part of the acquisition by Amgen of Teneobio.

TeneoTwo’s TNB-486 is currently in phase I clinical studies for the treatment of B-cell malignancies, while TeneoFour’s TNB-738, targeting inflammatory diseases, will enter Phase I in early 2022. TeneoTen’s anti-HBVxCD3 involves a new approach to potentially cure chronic hepatitis B.

Roland Buelow, former CEO of Teneobio, Inc., and CEO of Ancora Biotech said, "We are excited that Amgen will advance Teneobio’s pipeline of assets in the clinic and further apply Teneobio’s technologies. In parallel, Teneobio’s former shareholders and their representatives will oversee development of the former Teneobio affiliates that were not part of the Amgen transaction. We strongly believe in the potential of TNB-486 which targets malignant B-cells, TNB-738 targeting inflammation and our anti-HBVxCD3 that will target liver cells chronically infected with Hepatitis B virus."

In 2016 Lightspeed Venture Partners led Teneobio’s Series A Preferred round, Teneobio’s only institutional financing, along with Sutter Hill Ventures. Jonathan MacQuitty, Head of Life Science Sector at Lightspeed who joined Teneobio‘s Board at the time of the Series A Preferred round, commented, "With the Amgen acquisition and the recent exercise by Abbvie of its option to acquire TeneoOne, Roland and the team at newly formed Ancora Biotech LLC can now focus on these remaining spin-offs."

Dr. MacQuitty continued, "The vision that Roland brought to Lightspeed in 2016 of a novel bispecific platform that could provide life changing therapies was compelling. It has now borne fruit and with the help of Amgen, Abbvie and now Ancora, we look forward to its potential use in helping patients with several different life-threatening diseases."

Theratechnologies Announces Reimbursement Agreement in Italy for Trogarzo® for Eligible Patients With Multi-Drug Resistant HIV-1

On October 26, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has reached an agreement with the Italian Medicines Agency, AIFA, for the reimbursement of Trogarzo for eligible people aged 18 and older living with multi-drug resistant (MDR) HIV-1 (Press release, Theratechnologies, OCT 26, 2021, View Source [SID1234596237]).

"This agreement is an important milestone for Trogarzo and for HIV-1 patients in Italy," said Conor Walshe, General Manager, Europe. "Italy is the first country with a universal healthcare plan that has approved the formal reimbursement of Trogarzo for all patients in need. We expect to launch Trogarzo in Italy during the current quarter and look forward to its wider commercial availability in Europe over the coming months."

Trogarzo was first approved by the U.S. Food and Drug Administration (FDA) in March 2018 and was the first long-acting agent approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with MDR HIV-1 infection failing their current antiretroviral regimen. Trogarzo was approved by the European Medical Agency (EMA) in September 2019 for the treatment of adults infected with MDR HIV-1 for whom it is otherwise not possible to construct a suppressive antiviral regimen and is also commercially available in Germany. A number of patients are also being treated with Trogarzo in other European countries through early access programs. Theratechnologies plans to launch Trogarzo on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo and is working to secure pricing and reimbursement.

About Trogarzo1
Trogarzo a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.

Trogarzo blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with the post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion. Trogarzo is administered every 2 weeks via intravenous infusion.

The most frequently reported adverse reactions were rash (9.2%), diarrhea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).

Enveric Biosciences to Participate in Wonderland: Miami Conference

On November 26, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in the upcoming Wonderland: Miami conference (Press release, Jay Pharma, OCT 26, 2021, View Source [SID1234594557]):

Microdose Presents Wonderland: Miami to be held in-person in Miami, Florida from November 8-9, 2021. Dr. Tucker will be speaking on the Next-Generation Psychedelics panel live on Monday, November 8th at 3:10 p.m. ET. Register to attend here.
For more information about the conferences, or to schedule a one-on-one meeting with Enveric’s management team, please contact your Microdose representatives directly, or send an email to KCSA Strategic Communications at [email protected].

Selecta Biosciences and Ginkgo Bioworks Announce Partnership to Advance Treatments for Orphan and Rare Diseases

On October 26, 2021 Selecta Biosciences, Inc. (Nasdaq: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a collaboration to design novel and improved enzymes with transformative therapeutic potential to advance treatments for orphan and rare diseases. This partnership leverages the unique platforms of both companies (Press release, Selecta Biosciences, OCT 26, 2021, View Source [SID1234593960]).

"We are excited to partner with Ginkgo and expect that our ImmTOR technology, in combination with Ginkgo’s high throughput enzyme discovery, design, and screening capabilities will bring us one step closer to improving the sustained efficacy of novel biologic therapeutics," said Carsten Brunn, PhD, CEO at Selecta Biosciences. "Further, this collaboration builds on extensive preclinical as well as strong clinical data from Selecta’s Phase 2 COMPARE trial for the treatment of chronic refractory gout that further supports ImmTOR’s potential for sustained therapeutic benefit when combined with immunogenic enzymatic therapies. We look forward to expanding our pipeline and ultimately delivering on our shared mission to improve the lives of patients in need."

Jason Kelly, CEO at Ginkgo Bioworks, commented, "Ginkgo works with a growing list of industry leaders that are addressing outstanding medical challenges with diverse therapeutic modalities, and we are thrilled to partner with Selecta in an effort to discover, engineer, and develop next generation therapeutic enzymes. We are excited to support Selecta in its mission to improve the quality of life for patients with unmet medical needs by expediting and maximizing Selecta’s capabilities."

Under the terms of the collaboration, Ginkgo is eligible to earn upfront research and development fees and milestones, including certain milestone payments in the form of Selecta common stock, clinical and commercial milestone payments of up to $85M in cash, as well as further downstream value in the form of royalties on sales.