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.

On May 17, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the first patient has been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib (Press release, Calliditas Therapeutics, MAY 17, 2022, View Source [SID1234614701]).

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The trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study. It will investigate the effect of setanaxib 800 mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks (the standard treatment regimen for this immunotherapy), in approximately 50 patients with moderate or high CAF-density tumours. A tumour biopsy will be taken prior to randomization and then again after at least 9 weeks of treatment. Treatment will continue until unacceptable toxicity or progression, as is typical for oncology trials.

"Today marks an important milestone for Calliditas, with the enrolment of the first patient into our proof-of-concept study in SCCHN. We believe that a successful translation into the clinic of the promising pre-clinical observations of co-administration of setanaxib and check point inhibitors, could result in important new treatment approaches for patients with CAF rich solid tumors, and we look forward to working with our clinical trial sites, investigators and site staff to successfully execute the study," said CMO Richard Philipson.

Interim biomarker analysis is targeted for Q4 2022, and the study is expected to read out final data (including impact on tumour size) in 2023. Further details of this study can be found at www.clinicaltrials.gov, with the reference NCT05323656.

On May 17, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, VBL Therapeutics, MAY 17, 2022, View Source [SID1234614719]).

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"We continue to execute on our development and strategic objectives, which we believe have positioned us for a potentially transformational year," said Dror Harats, M.D., Chief Executive Officer of VBL. "Completion of enrollment in the Phase 3 OVAL trial in recurrent platinum-resistant ovarian cancer in the first quarter of 2022 was a major milestone, and we look forward to the progression free survival primary endpoint top-line data readout expected in the second half of 2022. We are also expecting preliminary clinical data from the ofra-vec Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme in 2022. In parallel with these oncology programs, we are advancing our pipeline and plan to enter the clinic in the second half of the year with VB-601, the first product candidate from our novel anti-inflammatory program targeting monocytes."

First Quarter of 2022 and Recent Corporate Highlights

Ofra-vec Oncology Program

Completed enrollment in the Phase 3 OVAL registration-enabling trial evaluating ofra-vec (ofranergene obadenovec; `VB-111`) in recurrent platinum-resistant ovarian cancer, with a total of 409 patients enrolled globally.
The U.S. Food and Drug Administration (FDA) granted fast track designation for ofra-vec in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer.
The Independent Data Safety Monitoring Committee (iDSMC) conducted a pre-planned safety review of the 370 patients randomized in the OVAL trial by December 31, 2021, and unanimously recommended that the trial continue as planned.
VBL hosted a key opinion leader (KOL) event on ovarian cancer in New York City, NY on April 11 featuring KOLs Bradley J. Monk, M.D., FACS, FACOG (University of Arizona College of Medicine; Creighton University School of Medicine), Richard Penson, M.D., MRCP (Massachusetts General Hospital) and Kathleen Moore, M.D. (University of Oklahoma College of Medicine). A replay of the event is archived here.
Ofra-vec Phase 2 clinical trials in recurrent glioblastoma multiforme (rGBM) and metastatic colorectal cancer (mCRC) continue as planned, with preliminary data from both trials expected in 2022.
VB-601 Inflammation Program

Presented for the first time molecular mechanistic data on the Monocyte Targeting Technology (MTT) and lead candidate VB-601 at the IMMUNOLOGY 2022 conference in Portland, OR on May 8, 2022. Data explained how VB-601 inhibited the migration of monocytes into inflamed tissues, providing a novel and differentiated approach with potential applications in various chronic inflammatory indications.
Prof. Dror Harats delivered a presentation on VB-601 at the LifeSci Partners Immunology & Inflammation Symposium on May 12, 2022. The presentation is archived here.
IND-enabling toxicology studies have been successfully completed for VB-601 and VBL expects to initiate a first-in-human clinical trial for the program in the second half of 2022.
Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Two abstracts highlighting ofra-vec clinical research have been selected for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting taking place June 3-7, 2022. These Trial in Progress posters will highlight the Phase 3 OVAL trial of ofra-vec in platinum-resistant ovarian cancer and the Phase 2 trial in surgically accessible rGBM.
Corporate

Strengthened the management team with the appointment of Matthew Trudeau to the newly created position of Chief Commercial Officer and initiated the build out of U.S. operations to further advance VBL’s strategic plan to become a commercial organization.
Financial Results for the First Quarter of 2022

At March 31, 2022, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $44.8 million. VBL expects that its cash, cash equivalents, short-term bank deposits, and restricted bank deposits will be sufficient to fund currently planned operating expenses and capital expenditures for at least a year beyond the Phase 3 OVAL trial top-line progression free survival (PFS) results.
For the quarter ended March 31, 2022, VBL reported a net loss of $10.4 million, or ($0.13) per basic share, compared to a net loss of 6.3 million, or ($0.12) per basic share, in the comparable period in 2021.
For the quarter ended March 31, 2022, total operating expenses were approximately $10.7 million, consisting of $7.5 million in research and development expenses, net, and $3.2 million in general and administrative expenses. This compares with total operating expenses of $6.5 million in the first quarter ended March 31, 2021, which was comprised of $4.8 million in research and development expenses, net, and $1.7 million in general and administrative expenses.

About the OVAL Phase 3 Clinical Trial

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; `VB-111`) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.

On May 17, 2022 QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153 DOTMP (CycloSam), for the treatment of bone cancer and related diseases, reported that financial results for the first quarter ended March 31, 2022, as filed with the SEC on May 16, 2022 in the Company’s Form 10-Q, and provides a corporate update (Press release, QSAM Biosciences, MAY 17, 2022, View Source [SID1234614736]).

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Recent Corporate Highlights:

●Dosed first patient in its Phase 1 clinical trial for CycloSam for the treatment of metastatic bone cancer in April. Completion of the first cohort of patients in the trial is expected this quarter. The Phase 1 study consists of 17 patients divided into four dose-escalating cohorts in an open-label trial to evaluate the safety, tolerability, dosimetry and preliminary efficacy of CycloSam.
●Advanced the onboarding process of three additional clinical trial sites for CycloSam; expects to report further definitive information and details over following months.
●Awarded Rare Pediatric Disease designation from the FDA for CycloSam in the treatment of osteosarcoma in children. This designation qualifies a future study for a transferable Priority Review Voucher that is inclusive of fast-track FDA review process.
●Added two distinguished healthcare industry veterans with significant finance, public company and operational experience to the Board of Directors .
●Postponed contemplated NASDAQ "uplisting" and public offering due to adverse market conditions.

"As previously highlighted, the recent dosing of our first patient with CycloSam was a milestone event for QSAM. We are very pleased with the progress we have made in under 24 months – advancing from a preclinical asset to a drug candidate treating patients with metastatic bone cancer, receiving both Orphan and Rare Pediatric Disease designations from the FDA, performing a successful single patient study at a world-renowned medical institution, and establishing our supply chain, manufacturing and executive team – efficiently utilizing under $2 million," stated Douglas R. Baum, CEO and co-founder of the Company.

"Given highly challenging market conditions, in particular for small cap biotechnology companies, we made the prudent decision in May to suspend our planned equity raise and NASDAQ uplisting. We did not believe the valuation we would have received at this time reflects the real intrinsic value of our technology and market opportunity. We are committed to bringing CycloSam to market, and this will require additional capital; but we are also committed to raising such capital in a manner that limits dilution and provides a clear path to increasing shareholder value. In line with this, management has agreed to defer over 50% of the cash component of our salaries so that our current capital and that which we raise in the short-term can primarily be used to advance our clinical trial and provide data that supports our strong belief that CycloSam can have a meaningful impact on children and adults suffering from bone cancer," added Baum.

Financial Results for the Quarter Ended March 31, 2022:

Net loss attributable to common stockholders for the quarter ended March 31, 2022 was $1,873,879, compared to approximately $4,956,458 for the quarter ended March 31, 2021.

Operating expenses were $1,770,109 for the three months ended March 31, 2022, as compared to $3,333,857 for the three months ended March 31, 2021. The majority of the $1,563,748 decrease in operating expenses was due to other income and expenses related to the loss on debt extinguishment of $744,505, loss on conversion of debt to equity of $390,067, and non-cash stock-based compensation expense related to stock issued for services, all in the 2021 period.

As of March 31, 2022, the Company had cash of approximately $872,066. The Company believes this is sufficient to support operations at the current pace into the third quarter of 2022. The Company expects to raise additional capital through equity or debt offerings in 2022.

As of May 16, 2022, the Company had 1,686,587 common shares outstanding. In the first quarter of 2022, the Company issued 34,219 shares of common stock to a service provider and a director for prior services, and to retire the remaining outstanding convertible debentures. At the end of the first quarter of 2022 there were 488,235 shares of common stock that could be issued upon the conversion of preferred stock, warrants and convertible debt, excluding employee stock options.

On May 17, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present virtually at the H.C. Wainwright Global Investment Conference being held May 23-25, 2022 (Press release, Biodesix, MAY 17, 2022, View Source [SID1234614770]).

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H.C. Wainwright Global Investment Conference
Date: Tuesday, May 24, 2022
Pre-recorded on-demand presentation available beginning at 7:00 AM ET

The on-demand presentation will be available under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.