On September 15, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported its support of legislation recently introduced into the U.S. House of Representatives and the U.S. Senate (Press release, Blue Earth Diagnostics, SEP 15, 2021, View Source [SID1234587765]). The bicameral, bipartisan bill, known as the "Facilitating Innovative Nuclear Diagnostics Act," or the FIND Act of 2021 (H.R. 4479/S. 2609), would reform the current Medicare payment system to improve Medicare beneficiaries’ access to innovative technologies and safeguard appropriate payment to hospitals for innovative diagnostic radiopharmaceuticals.

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The U.S. healthcare system relies on diagnostic imaging radiopharmaceuticals and nuclear medicine to inform patient management and assess disease severity and progression across a wide variety of medical conditions. According to the Society of Nuclear Medicine and Molecular Imaging (SNMMI), more than 20 million Americans benefit each year from nuclear medicine procedures1.

Although diagnostic radiopharmaceuticals are appropriately defined by the U.S. Food and Drug Administration as drugs, the Centers for Medicare and Medicaid Services (CMS) categorizes them as "supplies" by packaging them, after an initial three-year period, alongside nuclear medicine services, into "bundles" for procedures that are conducted in hospital outpatient settings. Bundling payment often reimburses only a fraction of the actual cost of newer diagnostic radiopharmaceuticals and impedes the scientific advancement of new products that can help patients. Procedural bundling results in hospitals not receiving appropriate payment, and patients’ access to advanced diagnostic imaging radiopharmaceuticals may be restricted or denied. The FIND Act, if passed, would help give patients greater access to a wide range of advanced diagnostic radiopharmaceuticals for conditions such as prostate and breast cancers, heart disease, Alzheimer’s and Parkinson’s disease, and neuroendocrine tumors.

"Blue Earth Diagnostics is the recognized leader in diagnostic PET prostate cancer imaging, and in line with our commitment to deliver innovative solutions that inform patient care, we fully support legislative passage of the FIND Act," said Terri Wilson, President, Blue Earth Diagnostics, Inc. "The FIND Act can correct CMS payment policies to provide patients with equity in access and payment, and encourage ongoing development of targeted radiopharmaceuticals that can have transformative effects in patient lives."

Further information about the FIND Act of 2021 is available at www.congress.gov (H.R.4479; S.2609).

On September 15, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the outcome of the exercise of the warrants of series ALLR TO 3 that were issued in connection with the Company’s issue of units in June 2021 (Press release, Allarity Therapeutics, SEP 15, 2021, View Source [SID1234587827]). In total, 13,719,266 warrants of series TO 3 were exercised, corresponding to approximately 9.5 percent of the total number of outstanding warrants, for subscription of 13,719,266 shares at a subscription price of SEK 1.7 per share. Through the exercise of the warrants, Allarity will receive approximately SEK 23.3 million (U.S. $2.7 million) before issuing costs amounting to approximately SEK 1.4 million.

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UPDATE on the outcome of the exercise of the warrants of series ALLR TO 2 that were issued in connection with the Company’s issue of units in December 2019. In total, 8,820 warrants of series TO 2 were exercised, corresponding to approximately 0.02 percent of the total number of outstanding warrants, for subscription of 8,820 shares at a subscription price of SEK 6.0 per share. Through the exercise of the TO 2 warrants, Allarity will receive approximately SEK 53,000 before issuing costs. The final exercise period for the warrants of series TO 2 took place from September 1 up to and including September 15, 2021.

Chairman of Allarity’s Board of Directors Duncan Moore (who exercised 283,407 warrants) and the Company’s largest shareholder, Sass & Larsen ApS, were among the subscribers.

The exercise period for the warrants of series TO 3 took place from August 30 up to and including September 13, 2021. The accelerated exercise period was established, as previously announced, due to the Board of Directors’ determination that it was in the best interest of all shareholders as part of the Company’s plan to move to the U.S. Nasdaq stock market and to meet the requirements of the previously announced U.S. $20 Million recapitalization investment with 3i LP (New York).

Exercised warrants will be replaced with interim shares, pending registration with the Danish Business Authority. The interim shares are expected to be converted to shares within approximately two (2) weeks. Through the exercise, the number of shares in the Company increase from 390,063,114 shares to 403,791,200 shares, and the share capital increase by DKK 686.404,30, from DKK 19.503.155,70 to DKK 20,189,560,00.

On September 15, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that members of the senior management team will present at the following upcoming virtual investor conferences (Press release, Aurinia Pharmaceuticals, SEP 15, 2021, View Source [SID1234587732]):

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit Monday, September 20, 2021 at 2:55 pm ET. (access here)
Cantor Global Healthcare Conference on September 30, 2021 at 12:40 pm ET. (access here)
In order to participate in the audio webcasts, interested parties can also register and access presentations under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcasts will be available on Aurinia’s website.

On September 15, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drugs for the treatment of cancer and fibrosis, reported it has completed the design for a Phase 2 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945 (Press release, Amplia Therapeutics, SEP 15, 2021, View Source;[email protected] [SID1234587748]). This trial will be conducted in newly diagnosed patients receiving first-line therapy for pancreatic cancer.

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Amplia’s planned Phase 2 clinical trial will add AMP945 to chemotherapy with gemcitabine and nabpaclitaxel, which is a standard of care currently used to treat the majority of newly diagnosed advanced pancreatic cancer patients. In the trial, designated AMP945-202, AMP945 will be administered orally to patients prior to each dose of their standard gemcitabine/nab-paclitaxel chemotherapy. The design of this trial is based on studies conducted in collaboration with Professor Paul Timpson’s group at the Garvan Institute of Medical Research, Sydney, where it has been shown that intermittent dosing of AMP945 makes tumours more responsive to standard chemotherapy treatments in animal models of pancreatic cancer.

Conducting the Phase 2 clinical trial in first-line patients is expected to expedite recruitment for the trial and provides the best opportunity to detect any efficacy signal from the addition of AMP945 to chemotherapy. The ability to test AMP945 in a first-line setting is also made possible by the excellent safety and tolerability profile demonstrated in Amplia’s recent Phase 1 clinical trial.

Dr Adnan Nagrial, of Sydney’s Westmead Hospital and lead investigator on the trial, commented that "Patients with advanced pancreatic cancer have very limited treatment options and we desperately need new therapies with novel mechanisms of action. Based on the evidence we have seen so-far, FAK inhibitors deserve to be tested in the clinic and I am excited to be part of this trial".

The Phase 2 trial of AMP945 will be an open-label single arm trial conducted in two stages. In the first stage, an optimal dose of AMP945 will be selected and a preliminary assessment of efficacy will be performed in approximately 40 pancreatic cancer patients. In the second stage, up to an additional 24 pancreatic cancer patients will be recruited in order to increase confidence in the preliminary results. All patients are expected to receive multiple rounds of treatment.

The Company plans to initiate patient recruitment at Australian sites in the first quarter of 2022. Currently, the Company expects that recruitment will take 18-24 months but is working with vendors to accelerate key aspects of the trial. The primary endpoint for the trial will be based on the objective response rate from treatment compared to historical controls. In addition, multiple other signals of efficacy will be assessed in the trial’s secondary and exploratory endpoints including duration of response, disease progression rates, survival and effects on biomarkers of disease.

"Clinical evaluation of AMP945 as part of a first-line treatment for pancreatic cancer significantly de-risks the program and makes the drug relevant for a much larger patient base." said Dr John Lambert, CEO of Amplia Therapeutics. "If we are able to see positive signs that AMP945 improves the leading current treatment option we will commence discussions with regulators and potential partners concerning future trials required to support product approval."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On September 15, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus), a tumor re-engineering company, reported that they will present key safety and translational data from their first-in-human phase 1 FORTITUDE clinical study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 this week (Press release, PsiOxus Therapeutics, SEP 15, 2021, View Source [SID1234587766]). Data from the completed monotherapy dose-escalation part of the FORTITUDE study, initiated in 2019 to assess the safety and tolerability of the NG-350A T-SIGn vector, will be presented on Friday 16th September 2021, with the poster available in full at www.psioxus.com shortly afterwards.

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NG-350A is a T-SIGn vector designed to re-engineer cancers by selectively expressing a CD40 agonist monoclonal antibody, a potent activator of immuno-inflammatory responses, within the tumour microenvironment. PsiOxus is developing this agent as one of several products within its T-SIGn portfolio of vectors that combine systemic delivery with localized production of powerful transgene payloads to allow the selective re-engineering of both primary and metastatic tumors.

The data to be presented at the ESMO (Free ESMO Whitepaper) Congress show that IV delivery of NG-350A results in sustained elevations of inflammatory cytokines in the phase 1 FORTITUDE trial. In particular, marked and persistent dose-dependent increases in both IL-12 and IFNγ were observed after a single 1-week course of NG-350A, indicative of robust activation of antigen presenting cells via CD40 agonism generated within the tumor. Expansion of new T cell clones, a high proportion of which were new clones, was also observed following a single cycle of NG-350A. Safety data from the 25 patients treated with NG-350A as part of the now completed monotherapy dose-escalation part of FORTITUDE demonstrated that NG‑350A was well-tolerated, with few of the adverse events associated with systemic delivery of anti-CD40 agonists observed.

Together, these data suggest NG-350A contributes to the re-programming of the tumour microenvironment while avoiding the toxicity associated with systemic non-localized dosing of anti-CD40 antibodies.

"The headline data shared at the ESMO (Free ESMO Whitepaper) Congress confirms previous findings that our T-SIGn vector replicates selectively in primary tumor cells and metastases and persists for several months after intravenous delivery. Even more importantly, the biomarker data indicates that ongoing vector replication in tumors effectively translates into sustained production of the transgene payload, in this case a CD40 agonistic antibody. This translational data is a first in class demonstration of a downstream effect of tumor re-engineering, using T-SIGn vectors to turn the patient’s tumor cells into small drug factories," said Tom Lille, M.D., Ph.D., Chief Medical Officer, PsiOxus.

Based on these highly promising data, NG-350A will be assessed in combination with an anti–PD-1 checkpoint inhibitor in Part B of FORTITUDE.