On July 27, 2022 Humanetics Corporation reported that paper in Radiation Research, the official journal of the Radiation Research Society, details the results from a series of pharmacokinetics (PK) studies conducted with it’s (Humanetics) new radioprotective drug, BIO 300 (Press release, Humanetics, JUL 27, 2022, View Source [SID1234617025]). The studies, which were conducted by researchers at the University of Maryland Schools of Medicine and Pharmacy (UMB), compared the PK of BIO 300 using oral, subcutaneous, and intramuscular dosing. These nonclinical studies also examined the effect of radiation exposure on the PK of BIO 300. The researchers concluded that the effect of irradiation on the PK of BIO 300 is minimal, an important finding for use of the drug during radiation emergencies or during cancer radiotherapy treatments.

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Exposure to radiation can lead to acute radiation syndrome (ARS), which consists of numerous serious and life-threatening injuries. Survivors of ARS are at risk of developing delayed effects of acute radiation exposure (DEARE), which include a multitude of chronic injuries, notably to the lungs. There are currently no FDA-approved drugs that prevent ARS or DEARE. Humanetics is developing BIO 300 as a medical countermeasure (MCM) for use by the military, first responders, and in civilian populations that have been exposed, or may become exposed, to radiation to prevent or mitigate both ARS and DEARE.

"Our ongoing collaboration with colleagues at UMB has been instrumental in the development of BIO 300 for use as a MCM," said Ronald Zenk, CEO of Humanetics. "Current events in Ukraine and global threats of nuclear incidents point to the urgent need for drugs like BIO 300."

BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799). In addition, a phase 2b trial is currently in progress evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

On July 27, 2022 AKSO Biopharmaceutical, Inc. ("AKSO"), a global biopharmaceutical company with an innovative and comprehensive approach to treat cancer, autoimmune disease, and genetic disorder, reported the publication in the Journal of Experimental Medicine of preclinical data demonstrating that AKSO’s late preclinical stage molecule AB001 effectively inhibits growth of Multiple Myeloma ("MM") and Diffuse Large B Cell Lymphoma ("DLBCL") in mice (Press release, AKSO Biopharmaceutical, JUL 27, 2022, View Source [SID1234617024]). Importantly, AB001 was also found to be nontoxic in non-human primates.

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"AB001 is a first-in-class and potentially best-in-class ligand trap targeting APRIL and BAFF, which are known to be difficult to sequester due to high native binding affinities to their receptors, but also critical regulators of B cell development and survival," said Professor Amato Giaccia, AKSO’s Chairman and Senior Scientific Strategist. "Our study demonstrated the novel mechanism of APRIL and BAFF in modulating protein translation; and suggest that engineered soluble BCMA could be a superior alternative to therapeutics either approved or in development for MM and DLBCL."

"Safe and effective targeted therapies are urgently needed for MM and DLBCL patients who exhaust currently available treatment options," said Dr. Rebecca Miao, AKSO’s Chief Scientific Officer. "Collectively, our data support AB001 as a clinically viable candidate for the treatment of MM and DLBCL. Furthermore, the biological functions of BAFF and APRIL are not limited to B cell malignancies but extend to autoimmune disorders and other diseases triggered by pathological B cells, indicating a broad clinical application of AB001."

Key findings from the study performed under the guidance of Professor Giaccia and Dr. Miao, reported in the publication titled "Developing High-Affinity Decoy Receptor Optimized for Multiple Myeloma and Diffuse Large B Cell Lymphoma Treatment", include:

APRIL and BAFF mediated signalling is required for MM progression;
When compared to the wild-type soluble BCMA receptor, AB001 shows 500-fold stronger binding toward BAFF and 4-fold stronger binding toward APRIL;
AB001 is capable of neutralizing APRIL and BAFF and their receptor activities, impacting protein translation and production in MM and DLBCL cells;
Treatment with AB001 led to enhanced antitumor activity in a number of MM and DLBCL mouse models;
AB001 also demonstrated an adequate toxicity profile and on-target mechanism of action in nonhuman primate studies.
ABOUT AB001

AB001 is a late preclinical stage first-in-class and best-in-class engineered soluble BCMA decoy receptor. AB001 traps APRIL and BAFF with ultra-high binding affinities thereby inhibiting ligand mediated activation of receptors BCMA, BAFF Receptor and TACI.

On July 27, 2022 Agenus (NASDAQ: AGEN) an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported it will release its second quarter 2022 financial results before the market opens on Tuesday, August 9, 2022 (Press release, Agenus, JUL 27, 2022, View Source [SID1234617023]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET that morning to discuss the results and to provide a corporate update.

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Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On July 27, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), reported that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022 (Press release, vTv Therapeutics, JUL 27, 2022, View Source [SID1234617022]). Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors.

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Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D.

Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia.

Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399.

"While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his."

Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera.

"During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials."

On July 26, 2022, Mr. Sekhri was granted stock options (the "Options") to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the "Inducement Award Agreement"). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4).

On July 27, 2022 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it will release second quarter 2022 financial results after the market closes on Wednesday, August 3, 2022 (Press release, Xencor, JUL 27, 2022, View Source [SID1234617021]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at investors.xencor.com and will be archived for at least 30 days. Participants may register for the conference call at the following link: register.vevent.com/register/BI8b3886bf9772414c8dd5900d3aa4457b.