On August 2, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard-to-treat cancers, and VolitionRx Limited (NYSE AMERICAN:VNRX) ("Volition"), a multi-national epigenetics company, reported a research and development collaboration to develop Neutrophil Extracellular Traps ("NETs") targeted, adoptive cell therapies for the treatment of cancer (Press release, Xenetic Biosciences, AUG 2, 2022, View Source [SID1234617250]).

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The collaboration is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q NETs Test and Xenetic’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid cancers.

Under the terms of the collaboration agreement, Volition will fund a research program and the two parties will share proceeds from commercialization or licensing of any products arising from the collaboration.

"Since we in-licensed the DNase-based oncology platform in April of this year, our team is intently focused on driving the technologies forward with the goal of improving outcomes of existing therapeutic agents in multiple solid tumor indications. We are pleased to enter into our first industry research and development collaboration just a few short months after acquiring the technology platform. We have gotten to know the Volition team and are impressed by their technical expertise and creativity. We are therefore very excited to advance the development of this exciting new technology with an aligned strategic partner with the capabilities of Volition," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Epigenetically modified nucleosomes are present on tumor cell surfaces and within the tumor microenvironment of multiple types of solid cancers, and thus these nucleosomes may represent generalizable tumor antigens that are not limited to a single cancer type. Volition’s Nu.Q technology can specifically recognize and target epigenetically modified nucleosomes, while Xenetic’s DNase-Armored CAR T platform is designed to enhance the function of CAR T cells within solid tumor microenvironments.

Jake Micallef, Volition’s Chief Scientific Officer, added, "Elevated levels of NETs are associated with poor patient outcomes in a range of diseases, such as COVID-19, sepsis and cancer. NETs are specifically implicated in metastatic cancer and removing them has been shown to prevent the spread of disease. Consequently, there’s an urgent need to develop treatments aimed at reducing the production of NETs or removing them from the body. Our CE marked Nu.Q NETs test is the only analytically validated test for the detection and evaluation of NETs. We are delighted to be working with Xenetic, employing our Nucleosomics technology to measure the level of NETs and help monitor the efficacy of their pioneering cancer therapies. It’s an exciting time ahead!"

On August 2, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in a fireside chat at the 2022 Wedbush Pacgrow Healthcare Conference (Press release, Karyopharm, AUG 2, 2022, View Source [SID1234617271]). The conference is being conducted in a virtual format and the fireside chat will take place on Tuesday, August 9, 2022 at 4:05 p.m. ET.

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A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 90 days following the event.

On August 2, 2022 Amplia Therapeutics Limited (ASX: ATX) (Amplia or the Company) reported to advise that the first patient has been dosed in the Company’s Phase 1b/2a ACCENT clinical trial of focal adhesion kinase inhibitor AMP945 (Press release, Amplia Therapeutics, AUG 2, 2022, View Source;[email protected] [SID1234617287]). AMP945 targets focal adhesion kinase (FAK) and its use in the ACCENT trial is intended to enhance the efficacy of gemcitabine/nab-paclitaxel chemotherapy for people with advanced pancreatic cancer undergoing first-line treatment. Patients in the trial will receive AMP945 in addition to a standard treatment regimen with gemcitabine/nab-paclitaxel.

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In a prior Phase 1 clinical trial of AMP945, conducted in healthy volunteers and completed in 2021, once daily oral doses of AMP945 showed excellent safety, tolerability and pharmacokinetic properties. AMP945 was also shown to inhibit FAK in skin samples provided by the healthy volunteers.

Dr John Lambert, Amplia’s CEO and Managing Director commented that "This is another exciting milestone marking the achievements and growth of our Company and we’re very proud of our team’s efforts in starting up the ACCENT trial. The work we have done to date with AMP945 both in the clinic and in preclinical models of pancreatic cancer tells us that AMP945 deserves to be clinically tested in this dangerous type of cancer. We are also grateful to our first patient and their family for consenting to join the trial. It is our sincere hope that addition of AMP945 to a standard of care in pancreatic cancer improves outcomes for all patients."

About the ACCENT Trial

The protocol for the ACCENT trial is entitled "A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients".

The trial is to be conducted in two stages. The first, Phase 1b stage of the trial, is a single-arm open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and nab-paclitaxel (Abraxane) in first-line patients with advanced pancreatic cancer. Approximately 12 patients will be recruited across 4-5 sites in Australia where ascending oral doses of AMP945 will be given together with a fixed dose combination of gemcitabine and nab-paclitaxel. It is expected that for each dose level of AMP945, three patients will be recruited. After each group of three patients has completed their first 28-day treatment cycle, the Company and an independent data monitoring committee will review the data before authorising progression to the next dose level of AMP945. The Company assumes that up to four dose levels of AMP945 will be assessed and that, assuming all four dose levels are required, the Phase 1b stage of the trial will take approximately 9 months to complete.

The second, Phase 2a, stage of the trial is also a single-arm open-label study and is designed to perform an assessment of the optimal dose of AMP945 (selected in the Phase 1b part of the trial) in combination with gemcitabine and nab-paclitaxel. The primary endpoint of the Phase 2a trial is the Objective Response Rate (ORR) of patients to treatment. Further endpoints will assess efficacy by other means as well as safety and tolerability. To determine whether addition of AMP945 to gemcitabine/nab-paclitaxel improves the ORR in this patient population, data from the ACCENT trial will be compared to a historical control of 23% ORR which was established in the original pivotal trial of gemcitabine/nab-paclitaxel. The Phase 2a trial uses a Simon 2-Stage design in which approximately 26 patients with advanced pancreatic cancer will be recruited across sites in Australia and South ABN 16 165 160 841 Level 17, 350 Queen Street, Melbourne VIC 3000 Email [email protected] www.ampliatx.com Korea before an interim efficacy analysis is performed. Assuming the interim analysis concludes that adding AMP945 to gemcitabine/nab paclitaxel may be beneficial, the trial will continue to recruit a further 24 patients across Australian, South Korean and US sites.

More information about the ACCENT trial, including a list of participating sites, can be found at ClinicalTrials.gov NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.

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

On August 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant Reveal molecular residual disease (MRD) test (Press release, Guardant Health, AUG 2, 2022, View Source [SID1234617303]). Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after surgery to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy. It is the first blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC).

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The decision means Guardant Reveal is covered for fee-for-service Medicare patients in the United States with stage II or III CRC whose testing is initiated within three months following curative intent therapy. "We are pleased that Medicare has taken this important step to make MRD testing more widely available and help oncologists make more informed treatment decisions for their patients with colorectal cancer," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360 assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA also conveyed coverage for Guardant360 TissueNext, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

On August 2, 2022 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported financial results for the second quarter ended June 30, 2022 and recent corporate highlights (Press release, Apollo Endosurgery, AUG 2, 2022, View Source [SID1234617256]).

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Second Quarter 2022 Selected Financial Results

Second Quarter and Recent Corporate Highlights
•Grew second quarter 2022 U.S. revenue by 18% and OUS revenue by 15% (23% in constant currency) over the same period in 2021;
•Grew second quarter 2022 Endoscopic Suturing System (ESS) revenue 23% (27% in constant currency) over the same period in 2021;
•Grew second quarter 2022 Intragastric Balloon (IGB) revenue 6% (9% in constant currency) over the same period in 2021;
•Increased second quarter 2022 revenue from the Company’s top 10 direct accounts by 53% over the same period in 2021;
•Received FDA De Novo marketing authorization in July 2022 for Apollo ESGTM and Apollo REVISETM, new endoscopic systems for the treatment of patients with obesity
•Announced publication of the MERIT Study on July 28, 2022 in The LANCET; and
•Appointed Sharon O’Keefe to the Board of Directors, deepening Apollo’s Board-level expertise in hospital systems and health care delivery.
"This was a solid quarter for Apollo, with record revenue driven by growth across all products, both domestic and international," said Chas McKhann, Apollo’s president and CEO. "Importantly, we also secured De Novo marketing authorization from the FDA for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision (REVISE). This authorization positions Apollo to play a leading role in the market for next generation weight loss solutions. We remain focused on driving our business as a whole, in addition to preparing to take advantage of our new weight loss indication in the U.S. market, which we believe will be an important growth driver."
Selected GAAP and Non-GAAP Financial Results for Second Quarter 2022 Compared to Second Quarter 2021
Total worldwide revenues of $19.3 million for the second quarter of 2022 reflected an increase of 16% compared to $16.6 million in revenue during the second quarter of 2021. Revenue results in the second quarter include $0.6 million of foreign currency impact. On a constant currency basis, total revenue in the second quarter of 2022 increased 20% compared with the prior year second quarter. Compared to the second quarter of 2021, U.S. product sales increased 18% and OUS increased 15% (or 23% on a constant currency basis).

Compared to the second quarter of 2021, total ESS product sales increased $2.4 million, or 23%, due to the continued strong demand for OverStitch and X-Tack products. Total IGB product sales increased $0.3 million compared to the prior year quarter.
Gross margin increased to 57% for the second quarter of 2022, from 55% in the second quarter of 2021, due to higher product sales resulting in overhead efficiencies and improved variable gross margin on ESS products, net of 200 basis points of foreign exchange headwinds.
Total operating expenses increased $3.2 million compared to the second quarter of 2021. The increase primarily was due to the expansion of the U.S. salesforce in the latter half of 2021, and an increase in marketing spend to drive increased revenue as the Company scales the business and focuses on driving increased utilization of its products.
Net loss for the second quarter of 2022 was $10.4 million compared to $3.0 million for the second quarter of 2021 due to changes in unrealized foreign exchange of $3.3 million between periods and the $2.9 million gain on forgiveness of PPP loan in the prior year.
Non-GAAP adjusted EBITDA, which excludes interest, taxes, depreciation, amortization, unrealized foreign exchange and stock-based compensation, and gain on forgiveness of PPP loan, in the second quarter 2022 was a loss of $4.3 million, compared to a loss of $1.9 million in the second quarter 2021.
The Company had $140.7 million in cash and committed cash at June 30, 2022, including cash, cash equivalents and restricted cash of $75.7 million.
"We continue to manage cash investment prudently, with a focus on near-term growth initiatives," said Jeff Black, Chief Financial Officer. "We saw a $2.1 million sequential improvement in cash flow over the first quarter of 2022. We exited the second quarter with a multi-year runway and clear line of sight to a cash flow break-even business."
2022 Outlook
The Company is reiterating fiscal year 2022 revenue guidance to be in the range of $73 million to $75 million, inclusive of up to $3 million in foreign currency headwinds. The Company continues to monitor the potential and uncertain impact of adverse economic conditions in the U.S. and OUS. Continued or sustained COVID-19 pandemic, inflationary or recessionary pressures could impact the Company’s ability to achieve these financial projections.
Conference Call
Apollo will host a live webcast audio call with slides today at 3:30 p.m. CT / 4:30 p.m. ET. Investors are invited to join the live call via webcast from the Investors section of the Company’s corporate website at www.apolloendo.com. An audio-only option is available is available by dialing +1-973-528-0011 and referencing access code 481278 or the "Apollo Endosurgery Second Quarter 2022 Earnings Call." Investors who opt for audio-only will need to download the related slides at www.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com, shortly after completion of the call.