On May 5, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Company has received centralized Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming Acclaim-1 clinical trial in non-small cell lung cancer (NSCLC) (Press release, Genprex, MAY 5, 2021, View Source [SID1234579219]). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the Company’s lead drug candidate, REQORSA immunogene therapy, with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso.

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"The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research," said Rodney Varner, President and Chief Executive Officer of Genprex. "With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial, and look forward to its commencement."

An IRB is a U.S. Food and Drug Administration (FDA) registered constituted group of medical professionals that are responsible for reviewing and monitoring biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. IRB group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial can rely on the review of a centralized IRB, other than the IRB affiliated with each individual research site. The goal of the centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB review at each site participating in the centralized review process.

In January 2020, the Company received FDA Fast Track Designation for its Acclaim-1 patient population. Genprex has recently completed the manufacturing and scaled-up clinical grade production of REQORSA to supply drug product for its upcoming Acclaim clinical trials.

The Company expects to conduct the Acclaim-1 clinical trial at approximately 15 U.S. clinical sites with participation of approximately 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component). An interim analysis will be performed after 25 clinical events (i.e., disease progression or death). Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

On May 5, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a virtual fireside chat at the BofA Securities 2021 Healthcare Conference on Wednesday, May 12, 2021 at 2:45 p.m. ET (7:45 p.m. BST) (Press release, Alkermes, MAY 5, 2021, View Source [SID1234579236]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On May 5, 2021 InDex Pharmaceuticals reported that interim report January – March 2021 (Press release, InDex Pharmaceuticals, MAY 5, 2021, View Source [SID1234579151])

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Period January – March 2021
Net sales amounted to SEK 0.0 (0.0) million
Operating loss amounted to SEK –9.3 (–24.0) million
Result after tax amounted to SEK –9.3 (–24.0) million, corresponding to SEK –0.02 per share (–0.10) before and after dilution
Cash flow from operating activities amounted to SEK –8.5 (–21.9) million
Cash and cash equivalents at the end of the period amounted to SEK 532.5 (104.6) million
Number of employees at the end of the period was 7 (7)
Number of shares at the end of the period was 532,687,650
All comparative amounts in brackets refer to the outcome during the corresponding period 2020.

Significant events during January – March 2021
The Board resolved on a fully guaranteed rights issue of approximately SEK 533 million
InDex’s rights issue was oversubscribed and the company received approximately SEK 488 million net
Significant events after the reporting period
No significant events have occurred after the reporting period
Other events during the reporting period
InDex entered an agreement for services with global clinical research organization (CRO) Parexel Biotech for the phase III study CONCLUDE
CEO statement
It has been an intensive beginning of 2021 for InDex, where the crucial pieces of the puzzle for the start of phase III now have fallen into place. In February, we completed a successful rights issue of approximately SEK 533 million. The subscription ratio amounted to as much as 153 percent and more than 99 percent was subscribed for by exercise of subscription rights. HBM Healthcare Investments and Handelsbanken Funds came in as new large owners in the rights issue. These are two internationally recognized and successful life sciences specialists that chose to invest significant amounts, which not only strengthens the ownership base, but also constitutes a strong validation of the potential of InDex.

The rights issue will primarily fund the important initial induction study in a sequential phase III program with cobitolimod for left-sided moderate to severe ulcerative colitis. The results of this induction study will constitute a significant value inflection point and the remaining program can be optimised according to the outcome of the study. We estimate that the study will take 18 to 24 months to complete from initiation.

The study, which has been named CONCLUDE, will be a global study with approximately 400 patients at a few hundred clinics. The primary endpoint, clinical remission, will be measured at week 6. Apart from the dosing 250 mg x 2, which was the highest dose and the one that showed the best efficacy in the phase IIb study CONDUCT, cobitolimod’s excellent safety profile allows to also evaluate a higher dose, 500 mg x 2, in an adaptive study design. This higher dose has the potential to provide an even better efficacy than what was observed in the CONDUCT study.

With the financing in place, we entered into an agreement for services at the end of March with Parexel Biotech for the phase III study. After the successful collaboration in CONDUCT, we are very pleased to collaborate once again with them as our clinical development partner. They are a leading global CRO with considerable experience managing phase III studies in inflammatory bowel disease, which will ensure an efficient execution of CONCLUDE. The clinical study must now be approved by the authorities of each participating country. The goal is to start the study in the second quarter of 2021, but it is subject to the development of the Covid-19 pandemic if authorities and healthcare providers will be able to prioritize the start of new clinical studies in the near future.

On June 3 we have the annual general meeting in InDex, but unfortunately there will not be a physical meeting this year either due to the pandemic. I will present the company at Redeye Growth Day the day before the annual general meeting, on June 2, for those who want an update. I will also present the company at Erik Penser Bank tomorrow, on May 6. You can follow the presentations live or watch them afterwards on our updated website.

I would also like to highlight the recent annual report for 2020. It provides a good overview of ulcerative colitis, cobitolimod, the phase III design and the company in general. Strong stories like our patient interview with 23-year-old Felicia confirm the need for new effective and safe treatment options for ulcerative colitis.

I look forward to a continued eventful year with the start of the phase III study CONCLUDE as the next important milestone.

On May 5, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported financial results for the first quarter ended March 31, 2021 (Press release, Personalis, MAY 5, 2021, View Source [SID1234579184]).

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First Quarter Highlights

Record quarterly revenue of $20.9 million in the first quarter of 2021 compared with $19.2 million in the first quarter of 2020, a 9% increase
Revenue of $7.7 million from biopharma and all other customers, excluding VA MVP, in the first quarter of 2021 compared with $4.4 million in the first quarter of 2020, a 74% increase
Announced a collaboration with Natera in the field of personalized oncology; Personalis to provide the exome sequence data for Natera to pair with their personalized ctDNA platform, SignateraTM
Announced a collaboration with MapKure, LLC, a company jointly owned by BeiGene, Ltd. and SpringWorks Therapeutics, Inc., LLC for use of the NeXT PlatformTM for clinical trials and companion diagnostic development
Added approximately $162 million of cash to balance sheet from public offering of common stock financing in the first quarter of 2021; ended the quarter with cash, cash equivalents, and short-term investments of $353.4 million as of March 31, 2021
"I’m proud to say that we were able to report record revenue once again this quarter and achieved our nineteenth consecutive quarter of growth, as we converted an increasing number of orders into revenue. Biopharma and all other customer revenue grew 74% year-over-year, and orders from customers exceeded revenues reported once again this quarter," said John West, Chief Executive Officer. "Recently, we announced a partnership with Natera in the field of personalized oncology, and a companion diagnostics collaboration with MapKure. Both collaborations further validate our NeXT platform as a leading front end tissue-sequencing platform, capable of detecting cancer cell mutations that conventional exome tests often miss. Our tissue offering complements our whole exome liquid biopsy product that we launched in August 2020 and NeXT Personal, our Minimal Residual Disease (MRD) offering that we expect to launch in 2021, providing Personalis with access to three distinct revenue opportunities in the rapidly growing cancer monitoring market."

First Quarter 2021 Financial Results

Revenues were $20.9 million in the three months ended March 31, 2021, up 9% from $19.2 million in the same period of the prior year.

Gross margin was 35.6% in the three months ended March 31, 2021, compared with 21.1% in the same period of the prior year.

Operating expenses were $19.9 million in the three months ended March 31, 2021, compared with $13.7 million in the same period of the prior year.

Net loss was $12.4 million in the three months ended March 31, 2021 and net loss per share was $0.29 based on a weighted-average basic and diluted share count of 42.3 million, compared with a net loss of $9.1 million and a net loss per share of $0.29 on a weighted-average basic and diluted share count of 31.3 million in the same period of the prior year.

Business Outlook

Personalis expects the following for the second quarter of 2021:

Total Company revenues to be approximately $21.3 million
Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $7.3 million to $7.7 million
Net Loss to be in the range of $16 million to $17 million; estimated outstanding shares of 43 million
Personalis expects the following for the full year of 2021:

Total Company revenues to be approximately $85 million
Revenues from biopharma and all other customers, excluding VA MVP, to be in the range of $30 million to $32 million
Net Loss to be in the range of $70 million to $75 million; estimated outstanding shares of 44 million
Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 5, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 6587766. The live webinar can be accessed at View Source

On May 5, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported ZYNLONTA (loncastuximab tesirine-lpyl) has been included in the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in oncology for B-cell Lymphomas (Press release, ADC Therapeutics, MAY 5, 2021, View Source [SID1234579402]). Specifically, the NCCN Guidelines now include ZYNLONTA as a category 2A designation as a treatment option for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

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"We were pleased to learn that less than two weeks after accelerated FDA approval, ZYNLONTA was added to the NCCN treatment guidelines with a category 2A recommendation," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "Inclusion in the NCCN treatment guidelines highlights the high unmet medical need for a differentiated, targeted therapy in relapsed and refractory diffuse large B-cell lymphoma."

"The rapid inclusion of ZYNLONTA in the NCCN guidelines reinforces our work on behalf of patients who have been heavily pretreated and have difficult-to-treat disease," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "Importantly, there is a broad range of pretreated patients needing new therapies, including those who are transplant eligible and ineligible, and patients who previously received stem cell transplant or CAR-T cell therapy."

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication was based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

DLBCL, the most common type of non-Hodgkin lymphoma in the United States, is a rapidly progressing, aggressive disease that is heterogeneous with multiple subtypes.1 More than 40% of first-line DLBCL treatments fail.2 For patients who fail first-line therapy, prognoses are poor, worsening with each line of therapy as the chance for cure or long-term disease-free survival diminishes.3, 4

NCCN is a not-for-profit alliance of 31 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives.

The updated NCCN guidelines are available at www.nccn.org.

About ZYNLONTATM (loncastuximab tesirine-lpyl)

ZYNLONTATM is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.