On December 21, 2021 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage biopharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported the closing of its Recapitalization Share Exchange resulting in its initial public listing of 8,075,824 shares of its common stock and listing on the U.S Nasdaq Stock Market under the trading symbol "ALLR (Press release, Allarity Therapeutics, DEC 21, 2021, View Source [SID1234597545])."

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Simultaneously with the closing of its Recapitalization Share Exchange, the Company closed on a $20 million PIPE investment, in which the Company issued 20,000 shares of preferred stock ("Preferred Stock") at $1,000 per share and a common stock purchase warrant (the "Warrant") to purchase 2,018,958 shares of common stock to 3i, LP, a Delaware limited partnership.

A registration statement relating to the Recapitalization Share Exchange, filed previously with the Securities and Exchange Commission ("SEC"), became effective on November 5, 2021. An additional registration statement was filed on September 13, 2021, and declared effective by the SEC on December 20, 2021, with respect to the resale of shares of Allarity common stock issued upon conversion of our Preferred Stock or the exercise of the Warrant. Copies of the registration statements can be accessed through the Securities and Exchange Commission’s website at www.sec.gov.

LifeSci Capital acted as exclusive placement agent for the PIPE Investment.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On December 21, 2021 XOMA Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its Chief Executive Officer, Jim Neal, will present at the following upcoming investor conferences (Press release, Xoma, DEC 21, 2021, View Source [SID1234597543]):

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Biotech Showcase 2022 held virtually January 10-12 and January 17-19, 2022. Mr. Neal will hold a fireside chat titled, "Royalty Licenses: An Economic Asset Often Ignored." on Monday, January 10, 2022 at 10:30 AM PT.
H.C. Wainwright BioConnect Virtual Conference held January 10-13, 2022. The presentation will be available on demand beginning January 10, 2022 at 4:00 AM PT and can be accessed at https://bit.ly/3DWWNs8. The presentation can also be accessed by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

On December 21, 2021 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported the finalization of the basket clinical study evaluating maveropepimut-S (MVP-S, previously known as DPX-Survivac) in combination with Merck’s KEYTRUDA in patients with metastatic bladder and Micro-Satellite Instability High (MSI-H) solid tumors (Press release, IMV, DEC 21, 2021, View Source [SID1234597542]).

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"The top line clinical data from both the bladder and MSI-Hi cohorts are promising, further showcasing the potential of MVP-S as an immune-educating therapy in multiple cancer indications," said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV. "We are particularly encouraged by the responses in patients previously treated with immune checkpoint inhibitors and look forward to meeting with our key opinion leaders to map out follow-on studies in these indications."

Olivier Rixe, M.D., Ph.D., Director, Principal Investigator at Quantum Santa Fe in New Mexico, and Principal Investigator of the study, commented, "We are especially motivated by the responses observed in advanced, metastatic bladder cancer, where patients previously treated with an immune checkpoint inhibitor demonstrated clinical response, including complete responses."

All clinical benefit were evaluated according to the iRECIST/RECIST criteria. A more complete set of data, including evaluation of PD-L1 and other measures will be presented at an upcoming scientific conference.

About the basket Study

This Phase 2 basket trial is an open label, multi-center study, evaluating MVP-S across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC (Non-Small Cell Lung Cancer) and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

Subjects received MVP-S in combination with pembrolizumab and/or intermittent low dose cyclophosphamide (CPA). The study was designed to assess primary endpoints of safety and objective response rate (ORR), with multiple secondary and exploratory measures. IMV enrolled 131 patients across clinical sites in the U.S. and Canada. Monitoring is ongoing for patients on treatment, but enrollment is now closed.

Data from the other basket indications have been previously communicated.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

On December 21, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported the presentation of preclinical data from its theranostic in development, VMT-alpha -NET, at the 2021 International Chemical Congress of Pacific Basin Societies (Pacifichem 2021 Congress), taking place virtually, December 16-21, 2021 (Press release, Viewpoint Molecular Targeting, DEC 21, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-presents-preclinical-data-from-vmt-net-theranostic-in-development-for-the-treatment-and-diagnosis-of-neuroendocrine-tumors-at-the-pacifichem-2021-congress/ [SID1234597538]).

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The abstract titled, "Chemical structure modifications to chelator and linker compositions for improved pharmacokinetics of 203/212Pb peptide-based radiopharmaceuticals," was presented

In the Advancements in the Chemistry of Targeted Alpha Therapy (#180) symposium session by Michael K. Schultz, PhD, Chief Science Officer of Viewpoint.

"Emerging evidence suggests that alpha-particle therapy has the potential to significantly improve tumor response. The preclinical data from VMT-alpha -NET demonstrated to-date provides strong evidence that our VMT- -NET image-guided approach can meet the need for an effective therapy with a promising toxicity profile. We are pleased with the progress of VMT-alpha -NET and are committed to advancing the development of this important theranostic forward," commented Dr. Schultz.

The preclinical study was designed to explore chemical modifications to the chelator and chelator-peptide linker of SSTN analogs to optimize for 203Pb/212Pb image-guided alpha-particle radionuclide therapy for SST2R expressing tumors. PEG linkers of varying length were explored to improve tumor cell binding/internalization, in vivo tumor targeting, and renal clearance. In vitro and in vivo performance properties (e.g., radiolabeling, renal clearance) were compared to DOTATOC (203Pb/212Pb).

VMT-a-NET was identified with significantly improved performance. [203Pb]VMT-alpha-NET significantly improved: (1) SST2R IC50 binding affinity (>2-fold); (2) cellular uptake and internalization (a factor of 20); (3) tumor accumulation/retention; and (4) renal clearance compared to [203Pb]DOTATOC. With these improvements, the tumor:kidney ratio (%ID/ gram) improved more than 8-fold (24 h post injection) in AR42J tumor bearing mice compared to [203Pb]DOTATOC. [212Pb]VMT-alpha-NET therapy was effective and well-tolerated in mice (renal injury biomarkers NGAL’ CREA), achieving a 70% complete response rate in tumor bearing mice.

Based on the preclinical data seen to-date, Viewpoint believes that VMT- -NET is well-positioned to apply the new transformative power of alpha-particle treatment to NET tumors and other cancers that express the SST2R biomarker.

The Company recently commenced an investigator-initiated Phase 1 imaging study of VMT-alpha -NET for imaging somatostatin receptor subtype 2 (SSTR2)-positive neuroendocrine tumors, being conducted at the University of Iowa Hospitals and Clinics. The images obtained from the Phase 1 imaging study will inform future therapeutic trials of [212Pb]VMT-alpha-NET alpha-particle therapy for this tumor type. In parallel to this investigator-initiated imaging trial, the Company plans to move forward with a Phase 1/2a therapy study of VMT- -NET for the treatment of neuroendocrine tumors.

About the Pacifichem 2021 Congress

The 2021 International Chemical Congress of Pacific Basin Societies will take place virtually, December 16-21, 2021. Pacifichem 2021 will be the eighth in the series of successful cosponsored scientific conferences of Pacific Basin Chemical Societies. Founded in 1984, these conferences have been held in Honolulu, Hawaii about every five years.

About Neuroendocrine Tumors

Neuroendocrine tumors are rare forms of cancers that occur most commonly in the pancreas or other areas of the gut such as the stomach, small intestine, rectum, colon, or appendix. A neuroendocrine tumor may grow slowly or aggressively and spread to other parts of the body. Diagnosis and treatment of neuroendocrine tumors depend on the type of tumor, its location, whether it produces excess hormones, how aggressive it is and whether it has spread to other parts of the body. Some approaches may include surgery, radiation, and chemotherapy.

On December 21, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, reported that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, DEC 21, 2021, View Source [SID1234597537]).

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The objective of this Phase 3b study, which aims to enroll up to ten patients across four centers, is to demonstrate whether UGN-102 can be administered at home by a qualified home health professional, avoiding the need for repeated visits to a healthcare setting for instillation.

"The ease of UGN-102 instillation is of great benefit to these patients who are generally older, suffer from multiple comorbidities, and often rely on caregivers to drive them to medical appointments," said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "Home instillation is especially convenient for the patient and less burdensome for caregivers as they navigate persistent challenges caused by repeated medical appointments. We look forward to demonstrating the versatility of UGN-102 in this study as we prepare to initiate the single-arm, pivotal Phase 3 ENVISION Study of UGN-102 in early 2022."

Patients in the ongoing Phase 3b study will receive six once-weekly intravesical instillations of UGN-102. The initial treatment visit will occur at the investigative site and instillation will be performed by a qualified physician. Treatment visits two to six will take place at the patient’s home and instillation will be performed by a properly trained and qualified home health professional. The primary endpoint of the study is the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, discontinuations from at home study treatment, and clinically significant abnormalities in laboratory tests (hematology, serum chemistry, and urinalysis).

About UGN-102 (mitomycin for intravesical solution)
UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

About LG-IR-NMIBC
With 80,000 estimated cases of bladder cancer per year, approximately 35,000 are low-grade NMIBC patients comprised of both low-risk (approximately 15,000) and intermediate risk (approximately 20,000). These patients face a future of recurrence and additional surgeries. Recurrence in LG-IR-NMIBC is a pervasive and often underestimated problem. In patients who recur, it is estimated that 68 percent will experience two or more recurrence episodes throughout the course of their disease, a considerably high and frequent rate in contrast to other non-metastatic cancers.

Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of the bladder (TURBT). The more the procedure is performed, the more it imposes burden and serious risks on patients. Research shows that 25 percent of patients are not appropriate for TURBT due to physical factors such as age and comorbid conditions or an unwillingness to undergo surgery. Major challenges exist with the current standard of care and these patients deserve a new primary, non-surgical treatment option.