Diffusion Pharmaceuticals to Present at H.C. Wainwright Global Investment Conference??

On May 17, 2022 Diffusion Pharmaceuticals Inc.(NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., the Company’s President and Chief Executive Officer, will be presenting at the H.C. Wainwright Global Investment Conference being held at the Fontainebleau Miami Beach Hotel from May 23-26, 2022 (Press release, Diffusion Pharmaceuticals, MAY 17, 2022, https://www.diffusionpharma.com/press-release/diffusion-pharmaceuticals-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234615256]).

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The presentation will be virtual and will provide an overview of recent business and corporate achievements at Diffusion, including an update on TSC clinical trials.

Details of the presentation are as follows:

Date & Time: On demand, beginning 7.00 a.m. ET, Tuesday, May 24, 2022

A replay of the presentation will be available under the presentations section of the Company website at www.diffusionpharma.com. In addition, Dr. Cobuzzi will be available for one-on-one meetings during the conference. Registered investors will be able to request a meeting with management via the conference portal.

ATX-Gx™ Biotech Licensee Discovering Novel Therapeutics

On May 17, 2022 Alloy reported that has more than 130 partners in the drug discovery ecosystem across academic, biotech, and large biopharma teams (Press release, Alloy Therapeutics, MAY 17, 2022, View Source [SID1234615175]). Early in our history, we connected with Dren Bio, Inc., an emerging biopharmaceutical company headquartered in Northern California that specializes in the discovery of therapeutic antibodies engineered to selectively deplete pathologic cells and other disease-causing agents. Dren Bio’s pipeline encompasses two distinct drug discovery programs. Their initial product candidates are currently in development for the treatment of a variety of oncology and autoimmune diseases.

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At the time we were introduced to the founders of Dren Bio, they were in the process of raising their first round of financing and were looking for an antibody discovery partner that was both affordable and agile. After considering multiple alternative solutions, the Dren Bio team ultimately selected Alloy for what they perceived as an accessible, transparent business model, notably one that did not include undue royalties for products that they discovered under our ATX-Gx license. After initially licensing the ATX-Gx mouse platform for use at one of our certified third-party service providers’ facilities, the team at Dren Bio eventually transitioned the work directly to Alloy, becoming one of the first customers for our Antibody Discovery Services offering that we launched in early 2020. Through close collaboration, our Alloy Discovery Services team was able to generate an antibody candidate that required no further optimization following initial discovery and characterization. From there, we made sure to remain responsive, offering materials and guidance to continue supporting the Dren Bio team’s internal efforts after shipment. Like all of our collaborations, we tried to treat the program like it was our own. Our CEO was never more than a text message away from Dren’s CEO if there were any questions.

"Alloy Discovery Services acted as a trusted partner and extension of our team, collaborating with us to optimize an antibody that has now become the lead product candidate for our Enhanced ADCC Program," said Nenad Tomasevic, PhD, Dren Bio ‘s Founder and CEO.
Dren Bio has had an incredible run, assembling a highly experienced executive leadership team, securing an impressive $1 billion partnership with Pfizer using its Targeted Myeloid Engager and Phagocytosis Platform, and most recently this year clearing its first clinical IND application with the FDA. Alloy’s relationship with Dren Bio is a shining example of our commitment to providing robust antibody discovery services to companies possessing novel insights into disease biology and that are passionate about developing therapeutic antibodies against today’s most exciting targets.

If you are an early stage biotech looking to explore an ATX-Gx license or run a full discovery campaign with our services group, you can connect with our business development team here to learn more.

Zealand Pharma Announces Asset Purchase Agreement with MannKind Corporation for V-Go® Insulin Delivery Device

On May 17, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, reported it has entered into an asset purchase agreement with MannKind Corporation (Nasdaq: MNKD) to sell the V-Go insulin delivery device for $10 million and additional sales-based milestones. Certain inventory and employees are also included under the terms of the agreement (Press release, Zealand Pharmaceuticals, MAY 17, 2022, View Source [SID1234614910]).

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V-Go is a once-daily, wearable, insulin delivery device that helps provide blood sugar control for everyday lifestyles. Designed to be patient-friendly, V-Go is worn like a patch and eliminates the need for taking multiple daily shots.

"This transaction is an important step forward in executing on the strategic refocusing we outlined at the end of March, as we find partners for our commercial and late-stage assets and prioritize the research and development of innovative new peptide therapeutics," said Adam Steensberg, MD, Chief Executive Officer of Zealand Pharma. "We believe MannKind is the right partner to fully leverage the value of V-Go and ensure its continued availability for the patients and prescribers who need it."

"MannKind is committed to bringing innovative solutions to the diabetes patient community to potentially ease daily disease management," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Acquiring V-Go will help us to address an unmet need while strategically leveraging our infrastructure in the diabetes space and positioning MannKind’s endocrine business for additional growth."

The acquisition of V-Go by MannKind is anticipated to close in May 2022, subject to the satisfaction of certain closing conditions.

Today’s news does not impact Zealand Pharma’s Financial Guidance for 2022 as reiterated in the company’s Interim Report for the First Quarter 2022 announced on May 12, 2022.

New Guidelines from AUA and ASTRO Support Inclusion of Genomic Testing in Localized Prostate Cancer

On May 17, 2022 Myriad Genetics reported that According to the American Cancer Society, in 2022 more than 268,000 men in the United States will be diagnosed with prostate cancer, making it the second most common cancer in men (Press release, Myriad Genetics, MAY 17, 2022, View Source [SID1234614908]). Tragically, close to 35,000 men will die from prostate cancer in 2022. About 1 in 8 men will be diagnosed with prostate cancer during his lifetime.

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Last week, we attended the 2022 American Urological Association (AUA) National Meeting. It was an informative three days spent exploring the latest advancements in urology and showcasing the power of genetic insights to personalize prostate cancer treatment.

While at the meeting, AUA and American Society for Radiation Oncologists (ASTRO) shared updated guidelines that support including genomic testing in localized prostate cancer.

For the first time, prognostic biomarker tests, such as Myriad Genetics’ Prolaris Prostate Cancer Test, are specifically cited in the guidelines as a potential tool that can be used to incorporate personalized genomic insights into prostate cancer care and clinical treatment decision-making. Additionally, the guidelines recommend physicians perform a risk assessment to help guide the decision to offer germline testing, including an analysis of mutations associated with aggressive prostate cancer or are known to have implications for treatment.  

The inclusion of tumor prognostic and germline testing represents another step forward to offer a clearer and more personalized treatment path for men with prostate cancer.

Genetic insights for more actionable and personalized prostate cancer treatment

Myriad Genetics is the only lab offering the combination of both prognostic tumor analysis and germline testing for individuals affected by prostate cancer.

 Prolaris is a prognostic, tumor-based mRNA expression test that measures the aggressiveness of a man’s prostate cancer. It combines a genomic tumor aggressiveness score with traditional, diagnostic features like Prostate-Specific Antigen (PSA), Gleason, and tumor stage, helping physicians identify which patients are safe for active surveillance, would benefit from a single mode of therapy, or require greater intensity of treatment.  Prolaris has already been broadly recommended by the National Comprehensive Cancer Network (NCCN) for use in low, intermediate and high-risk disease.

Myriad offers germline testing with its MyRisk Hereditary Cancer Test, as well as its FDA-approved companion diagnostic test, BRACAnalysis CDx, which helps identify patients that are most likely to benefit from PARP-inhibitor therapy based on germline BRCA1/BRCA2 status.

More than three million patients have been tested to date with our MyRisk, Prolaris, and companion diagnostic tests.  Prognostic tests, like Prolaris, and germline companion diagnostic tests, like BRACAnalysis CDx, can help better determine the behavior of a patient’s tumor, providing actionable data-driven information physicians need to create an individualized treatment plan.

For more information on how Myriad Genetics continues to innovate and improve the health and well-being for men with prostate cancer. Click here: View Source

Kelun Out-Licenses Global Rights for Candidate to Merck/MSD in $1.4 Billion Deal

On MAY 17, 2022 Sichuan Kelun Pharmaceutical reported that out-licensed global rights (ex-China) for a large molecule candidate to Merck in a deal worth nearly $1.4 billion (Press release, Kelun, MAY 17, 2022, View Source [SID1234614905]). Kelun will receive $47 million in upfront payments and up to $1.36 billion in milestones. Although the candidate was not identified, it is expected to be SKB264, a third-gen TROP2-targeting antibody-drug conjugate in Phase II trials in the US and China. The candidate is being developed by KLUS Pharma, Kelun’s New Jersey-based novel drug developing subsidiary. Merck is known as MSD outside of North America.

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