On July 11, 2022 Halo Labs , a leading life science instrumentation company reported it has raised $6M in series C financing (Press release, Research Corporation Tech, JUL 11, 2022, View Source [SID1234616611]). The round was led by Agilent Technologies Inc. and includes participation from existing investors Research Corporation Technologies, Broad Oak Capital Partners, BioAdvance, and members of the Board of Directors and senior management.

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"We are excited to have Agilent as a partner in this journey as we scale our business in some exciting new directions."

This new funding will be used for continued commercialization of Halo Labs’ Aura platform , increasing manufacturing capacity and developing innovative new products to meet the current and new needs of pharmaceutical researchers.

"For the past two years, Halo Labs has deployed an aggressive growth strategy and has raised the bar for innovation in our market," said Rick Gordon , CEO of Halo Labs. "The fact that we were able to close on a funding round in the current economic environment demonstrates the success of that strategy. Our instruments have been adopted by virtually every major biopharmaceutical company and are now one of the leading tools in cell and gene therapy. With this capital, we will continue our current trajectory and scale our business in some exciting new directions. We are excited to have Agilent as a partner in that journey."

First launched in 2017, Aura from Halo Labs has disrupted pharmaceutical product development by combining multiple stability, quality, and safety assays into one instrument. Now available in six different models, representing tools specific for different therapeutic modalities and development stages, Aura instruments give pharmaceutical scientists access to an unprecedented amount of data in a matter of minutes, allowing for new therapies to move from the lab to the clinic faster and more safely.

On July 11, 2022 Innoviva, Inc. (Nasdaq: INVA), a diversified holding company with a portfolio of royalties and a growing portfolio of innovative healthcare assets, and La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, reported that they have entered into a definitive merger agreement whereby Innoviva will acquire La Jolla (Press release, La Jolla Pharmaceutical, JUL 11, 2022, View Source [SID1234616577]). Innoviva has agreed to pay $5.95 per share for La Jolla, representing a premium of approximately 70% to the 30-day volume-weighted average price (VWAP), and an incremental $0.28 per share for additional cash proceeds received in connection with the divestiture of a non-core asset. Under the terms of the merger agreement, Innoviva, through a wholly owned subsidiary, will commence a tender offer on or before July 25, 2022 to acquire all of the outstanding shares of La Jolla for $6.23 per share in cash, or an implied enterprise value of approximately $149 million.

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La Jolla’s lead product, GIAPREZA (angiotensin II), was approved by the Food and Drug Administration (FDA) in December 2017 to increase blood pressure in adults with septic or other distributive shock. La Jolla’s second asset, XERAVA (eravacycline), was approved by the FDA in August 2018 for the treatment of complicated intra-abdominal infections (cIAIs) in patients 18 years of age and older. This acquisition strengthens Innoviva’s portfolio in infectious diseases, anchored by the company’s recent purchase of Entasis Therapeutics Holdings Inc., an advanced late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products.

"This acquisition represents a significant step forward in advancing our strategy to diversify operations and adds a highly complementary commercial franchise to our portfolio to accelerate long-term growth," said Pavel Raifeld, Chief Executive Officer of Innoviva. "We look forward to welcoming the La Jolla team to Innoviva and building upon the success of GIAPREZA and XERAVA."

"We are pleased to announce the acquisition of La Jolla by Innoviva, which we believe provides our stockholders with immediate value at a compelling premium," said Larry Edwards, President and Chief Executive Officer of La Jolla. "With Innoviva’s shared commitment to improve outcomes in patients suffering from life-threatening diseases, Innoviva can continue to advance our mission and maximize the potential of our innovative therapies."

Assuming the minimum tender condition is met, any shares not tendered in the tender offer will be acquired in a second-step merger at the same cash price as paid in the tender offer. Closing of the transaction is subject to specified closing conditions, including that a majority of La Jolla’s shares of common stock are validly tendered and not validly withdrawn. On closing, La Jolla will become a wholly owned subsidiary of Innoviva, and shares of La Jolla’s common stock will no longer be listed on any public market.

The transaction was unanimously approved by the La Jolla and Innoviva boards of directors and is expected to close within 30 business days. Additionally, certain La Jolla stockholders holding approximately 40% of La Jolla’s outstanding shares of common stock, have signed a support agreement under which such stockholders agreed, among other things, to tender their shares in the tender offer and support the merger.

Cowen and Company, LLC is acting as financial advisor to La Jolla and Gibson, Dunn & Crutcher LLP is acting as its legal advisor. Moelis & Company LLC is acting as financial advisor to Innoviva and Willkie Farr & Gallagher LLP is acting as legal advisor to Innoviva.

On July 11, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), reported that its long-standing partner, Roche, will license and advance IONIS-FB-LRx, an investigational antisense medicine, into a Phase 3 clinical study in patients with immunoglobulin A nephropathy (IgAN) (Press release, Ionis Pharmaceuticals, JUL 11, 2022, View Source [SID1234616596]). IgAN is a rare and serious condition that often leads to chronic kidney disease and renal failure. Roche’s decision to advance the program comes after positive data from a Phase 2 clinical study in which IONIS-FB-LRx met its primary endpoint of change in 24-hour urinary protein at 29 weeks compared to baseline.

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In the Phase 2 study (NCT04014335), IONIS-FB-LRx demonstrated a favorable safety and tolerability profile. The study data are consistent with the clinical profile seen across Ionis’ other LICA programs, further validating how advancements in the company’s LIgand-Conjugated Antisense technology platform position Ionis to deliver potentially transformative treatments for a range of unmet medical needs. Data from the Phase 2 study of IONIS-FB-LRx in patients with IgAN has been submitted for presentation at an upcoming medical meeting.

IgAN occurs when too much IgA protein accumulates in the kidneys, causing inflammation and tissue damage, which is the root cause of the disease. IONIS-FB-LRx was designed by Ionis to reduce the production of complement factor B (FB), which is associated with the development of several complement-mediated diseases, including IgAN.

"Roche’s decision to advance the program reaffirms our shared confidence in the ability of Ionis’ antisense medicines to effectively target the root cause of difficult to treat diseases like immunoglobulin A nephropathy," said Michael McCaleb, Ph.D., vice president, clinical development at Ionis. "The results of the Phase 2 study provide initial clinical evidence that IONIS-FB-LRx reduces complement and protein levels in the urine of patients with IgAN."

Roche will lead and be responsible for the Phase 3 study of IONIS-FB-LRx in patients with IgAN and for future global development, regulatory and commercialization activities.

IONIS-FB-LRx is also being evaluated in GOLDEN (NCT03815825), a Phase 2 clinical study to determine whether the medicine can slow or halt the progression of geographic atrophy due to age-related macular degeneration, or AMD. Ionis will receive $55 million from Roche for licensing IONIS-FB-LRx for IgAN and achieving a development milestone in the GOLDEN study.

About IgA Nephropathy (IgAN)
Immunoglobulin A nephropathy (IgAN) is an important cause of chronic kidney disease and renal failure. Also known as Berger’s disease, IgAN is characterized by deposition of IgA and Complement 3 (C3) activation products in the glomerular mesangium of the kidneys, resulting in inflammation and tissue damage. Although IgAN may occur at any age, it generally presents in the second or third decade of life. The clinical presentation, disease progression and histologic findings are highly variable among affected individuals. Current therapies are aimed at reduction of protein levels in the urine with administration of angiotensin inhibitors and control of blood pressure. Sometimes immunosuppressive therapies are given; however, this practice is not universally accepted.

On July 10, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has dosed the final patient and completed recruitment into the Phase III pivotal study ZIRCON (Zirconium in Renal Cancer Oncology, NCT03849118) of its investigational renal (kidney) cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) (Press release, Telix Pharmaceuticals, JUL 10, 2022, View Source [SID1234616573]). This global study has dosed 300 patients to date, exceeding the target enrolment of 252 patients, announced on 8 March 2022.

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TLX250-CDx, which has received "Breakthrough Designation" from the U.S. Food and Drug Administration (FDA)1, is being developed as an imaging agent for use in the characterization of indeterminate renal masses previously identified on computed tomography (CT) or magnetic resonance imaging (MRI) as clear cell renal cell cancer (ccRCC) or non-ccRCC.

The detection of renal masses is increasing due to widespread use of cross-sectional imaging. Many of these are small renal masses and represent a diagnostic challenge as current imaging cannot reliably distinguish benign or malignant lesions from renal cell carcinoma, leading to invasive biopsy or partial nephrectomy to confirm the diagnosis. These procedures are not always necessary and can lead to complications2. It is estimated that up to 80% of small renal masses are malignant3.

If the study is successful, TLX250-CDx may provide a non-invasive method to aid in diagnosis and staging of ccRCC and the identification of metastatic disease through whole body imaging, ultimately leading to improved patient management by minimizing the need for surgical intervention for diagnosis and guiding treatment decisions.

In addition to its potential use as a diagnostic and staging tool, Telix is considering the potential for TLX250-CDx to also be used as an active surveillance tool for patients not deemed surgical candidates.

Brian M Shuch, MD, Director of the Kidney Cancer program at UCLA said: "We may well be on the cusp of a paradigm shift in how we manage renal masses. The incidence of small renal masses is increasing, yet there is currently no imaging tool that can effectively diagnose or stage clear cell renal cancer. Most patients are scheduled for the operating room without a firm diagnosis and often surgery is found to be unnecessary. Should this study report positive results, it may provide the non-invasive imaging tool to aid in accurate diagnosis that patients and clinicians have been waiting for. Congratulations to Telix for completing this ambitious international trial."

Renal cell carcinoma (RCC) is the deadliest of all urological cancers with a late-stage 5-year survival rate of 14%4. ccRCC is the most common sub-type and accounts for approximately 80% of all renal cell carcinoma cases5. RCC is also an increasingly frequent cancer, having more than doubled in incidence in the developed world over the last 50 years.6 Worldwide, there were more than 400,000 new cases in 2020, and >175,000 people died from their disease.7

TLX250-CDx will be available in selected countries to eligible patients under an Expanded Access Program (EAP) (also known as early access, pre-approval access or emergency use), in accordance with Telix’s Compassionate Use Policy and subject to jurisdictional regulatory requirements.8

Dr Colin Hayward, Telix’s Chief Medical Officer said, "The completion of this trial will bring us a step closer to commercialization for this diagnostic imaging agent which may address a significant unmet need in the diagnosis and management of ccRCC. It also builds on Telix’s commitment to urologic oncology, with the potential of delivering a major new imaging indication. This milestone could have not been achieved without the support of our many collaborators including the 36 clinical sites who participated in the trial, our global manufacturing teams and the associated auxiliary team who have supported this study. Most of all we wish to thank the patients who have volunteered to participate in this study."

ZIRCON is a confirmatory, prospective, open-label, multi-centre phase III study to evaluate sensitivity and specificity of 89Zr-TLX250-CDx PET/CT imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IDRM), scheduled for partial or total nephrectomy. Telix expects to report the outcome from the ZIRCON study in 2H, 2022.

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with "indeterminate renal masses" (IDRMs) are, typically identified based on CT or MRI imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the characterization of indeterminate renal masses previously identified on CT or MRI as ccRCC or non-ccRCC. , ccRCC is the most common and aggressive form of kidney cancer.

About the ZIRCON Study

ZIRCON (Zirconium Imaging in Renal Cancer Oncology, NCT03849118) is an international multicentre Phase III study at 34 sites in Europe, Australia, Turkey, Canada and the United States. ZIRCON is a prospective imaging trial in renal cancer patients undergoing kidney surgery with the objective of determining the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic "standard of truth" determined from surgical resection specimens.

On July 8, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported preliminary results from the second cohort of the Company’s first-in-human Phase 1a study of WP1122 (Press release, Moleculin, JUL 8, 2022, View Source [SID1234616561]). This cohort consisted of 8 subjects dosed with 16 mg/kg or placebo in the dose escalation trial evaluating the safety and pharmacokinetics (PK) of WP1122 in healthy volunteers in the United Kingdom (UK). Based on the overall results in Cohort 2, the Company deemed the cohort dose safe and well-tolerated and began its SAD Cohort 3 with a dose escalation to 32 mg/kg.

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The Phase 1a, first-in-human, randomized, double-blind, placebo-controlled, overlapping SAD and MAD is investigating the effects of WP1122 administered as an oral solution in healthy human volunteers. It is the first step in a planned investigation of WP1122 for the treatment of COVID-19. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has successfully completed at least 3 dosing cohorts. This study in healthy volunteers will explore safety and PK, and subsequent antiviral clinical development is expected to be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 subjects in this trial.

Walter Klemp, Chairman and Chief Executive Officer of Moleculin commented, "We continue to be encouraged by the safety data demonstrated by WP1122 in the SAD portion of our first-in-human Phase 1a study of WP1122. With two of the SAD cohorts now completed with promising preliminary results, we are working to enroll and complete Cohort 3 at 32 mg/kg in order to proceed to the MAD phase of the trial toward establishing a maximum tolerated dose. To date, WP1122 has demonstrated no dose escalating stopping criteria, and we look forward to taking the next step in studying the potential of WP1122 for the treatment of certain viral diseases, including COVID-19, and cancers."

During the SAD portion of this study, dose escalation will proceed up to a maximum dose of 64 mg/kg as a single dose. Dosing of WP1122 began in SAD at 8 mg/kg as a single dose and has escalated in two-fold increments (i.e., to 16 and now to 32 mg/kg as single doses, etc.) in subsequent cohorts. Dosing of WP1122 in the MAD cohorts will start after a dose of 32 mg/kg has been shown to be safe in the single dose cohort. The first dose administered in MAD will be 16 mg/kg every 12 hours (32 mg/kg/day) for 7 days and dosing in the second MAD cohort will escalate to 32 mg/kg every 12 hours (64 mg/kg/day) for 7 days.

For more information about the study, please visit clinicaltrials.gov and reference identifier NCT05195723. Moleculin is also in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies could occur.

About WP1122
WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a greater antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells in culture. The improved pharmacokinetic and pharmacodynamic (PK/PD) profile of WP1122 compared to 2-DG was noted in female mice following oral dosing at equimolar (i.e., equivalent levels of 2-DG) doses.

While the Company is in the process of identifying additional countries where potential future Phase 2 COVID-19 clinical studies might occur, the volatility and unpredictability of COVID-19 incidence in various countries may limit the ability to recruit certain subjects and could make it infeasible to conduct a Phase 2 clinical trial in a given country. Additionally, Moleculin recently received IND clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 study of WP1122 for the treatment of Glioblastoma Multiforme (GBM). The Company is seeking collaborators with the intent to commence clinical trials of WP1122 in cancer indications including GBM, pancreatic cancer and others.