On August 2, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Roche’s Phase III IMscin001 study evaluating a subcutaneous (SC) formulation of Tecentriq (atezolizumab) with Halozyme’s ENHANZE technology met its co-primary endpoints (Press release, Halozyme, AUG 2, 2022, View Source [SID1234617288]).

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The study showed non-inferior levels of Tecentriq in the blood (pharmacokinetics), when injected subcutaneously, compared with intravenous (IV) infusion in cancer immunotherapy-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) for whom prior platinum therapy has failed. The safety profile of the SC formulation was consistent with IV Tecentriq.

"These positive results further demonstrate the opportunity for a coformulation of ENHANZE to potentially benefit patients by reducing the treatment time of Tecentriq to 3-8 minutes as a SC delivery from 30-60 minutes for IV treatment," commented Dr. Helen Torley, president and chief executive officer of Halozyme. "We are delighted to announce these positive results, which represent our second positive Phase III trial announcement this year for our Wave Three products."

Roche will share detailed findings of the IMscin001 study at an upcoming medical meeting and submit the data for regulatory approval to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections.

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 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that the company’s management team will be participating in one-on-one meetings at the upcoming BTIG Biotechnology Conference, which is taking place both virtually and at the St. Regis New York Hotel in New York City, August 8-9, 2022 (Press release, DiaMedica, AUG 2, 2022, View Source [SID1234617286]).

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For those interested in meeting with DiaMedica at the conference, please reach out to your BTIG representative to schedule a meeting.

On August 2, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that financial results for the second quarter ended June 30, 2022 (Press release, Veracyte, AUG 2, 2022, View Source [SID1234617282]).

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"Our second quarter results reflect our continued focus on execution, and as a result, our portfolio delivered robust revenue growth," said Marc Stapley, Veracyte’s chief executive officer. "In addition, we significantly expanded the library of clinical evidence demonstrating the performance and utility of our genomic tests and biopharma offerings, which we believe will help drive further test adoption and partnerships. We remain firmly focused on exercising financial discipline as we continue to invest in our near- and long-term growth opportunities to deliver on our strategic vision of improving outcomes for patients all over the world."

Key Business Highlights:

Increased second quarter total revenue by 32% to $72.9 million, compared to the second quarter of 2021;
Grew total test volume to 24,904, an increase of 19% compared to the second quarter of 2021;
Announced that an updated clinical guideline from the American Urological Association and American Society for Radiation Oncology features a favorable statement for genomic testing, including Decipher Prostate, to help guide care for men with localized prostate cancer.
Unveiled key clinical evidence across Veracyte’s portfolio:
Decipher Prostate – Data was published in Annals of Oncology reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy. Additionally, data unveiled at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated that population-based prostate cancer treatment patterns are independently associated with Decipher classifier score;
Afirma Genomic Sequencing Classifier – Meta-analysis of independent, real-world studies were presented at ENDO 2022 demonstrating consistent and enhanced Afirma GSC performance, compared to the test’s original clinical validation study;
Prosigna Breast Cancer Assay – New consensus survey data presented at the ESMO (Free ESMO Whitepaper) Breast annual meeting showed that leading breast cancer oncologists in Europe agree on the value of gene expression profiling tests, such as Prosigna, and on the importance of molecular subtype information to help inform treatment decisions for patients with early-stage breast cancer;
Biopharma – New study findings presented orally at ASCO (Free ASCO Whitepaper) and in a paper published in Lancet Oncology showed the Immunoscore Immune Checkpoint (IC) biomarker’s ability to identify which patients will benefit from immune checkpoint inhibitors in metastatic non-small cell lung cancer and metastatic colorectal cancer, respectively; and
Percepta Nasal Swab – Data presented at the ATS annual meeting showed that the noninvasive genomic test performed similarly well across the spectrum of tobacco-related risk.
Ended the second quarter of 2022 with cash, cash equivalents and short-term investments of $164.0 million, compared to $166.4 million at the end of the first quarter of 2022.
Second Quarter 2022 Financial Results

Total revenue for the second quarter of 2022 was $72.9 million, an increase of 32% compared to $55.1 million in the second quarter of 2021. Testing revenue was $59.7 million, an increase of 18% compared to $50.8 million in the second quarter of 2021 driven primarily by the strong performance of our urology tests. Product revenue was $3.1 million, an increase of 16% compared to $2.7 million in the second quarter of 2021. Biopharmaceutical and other revenue was $10.0 million, an increase of $8.4 million compared to $1.6 million in the second quarter of 2021, driven primarily by the contribution of the HalioDx acquisition.

Total gross margin for the second quarter of 2022, including the amortization of acquired intangible assets, was 59%, compared to 62% in the second quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 66%, compared to 68% in the second quarter of 2021.

Operating expenses, excluding cost of revenue, were $53.7 million, an increase of 29% compared to the second quarter of 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets and other acquisition related expenses, were $49.0 million compared to $38.0 million in the second quarter of 2021.

Second quarter 2022 net loss was $9.5 million, an increase of 5% compared to the second quarter of 2021. Basic and diluted net loss per common share was $0.13, flat to the second quarter of 2021. Net cash used by operating activities in the first six months of 2022 was $9.2 million, an improvement of $29.4 million compared to the same period in 2021.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2022 Financial Outlook

The company is currently projecting full-year 2022 total revenue of $272 million to $280 million, representing year-over-year growth of 24% to 28% compared to the prior year, assuming currency rates as of August 2, 2022. This represents an improved outlook compared to our prior guidance of $265 million to $275 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On August 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, August 9, 2022 to report its second quarter 2022 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, AUG 2, 2022, View Source [SID1234617281]).

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To access the live conference call, please dial (833) 636-1323 (domestic) or (412) 902-4279 (international) and refer to the "Syros Pharmaceuticals Conference Call." A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.