On May 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported financial results for the first quarter 2021, recent business highlights and key catalysts over the next 18 months (Press release, Atara Biotherapeutics, MAY 4, 2021, View Source [SID1234579064]).

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"Atara is off to a strong start in 2021, advancing all three strategic priorities to deliver on key value drivers," said Pascal Touchon, President and Chief Executive Officer of Atara. "We look forward to several milestones in 2021, including the expected tab-cel BLA and MAA filings, progress on the ATA188 program – especially the presentation of clinical and translational data from the Phase 1 OLE study, and the first clinical data on our mesothelin CAR T franchise."

Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

Atara is in active discussions with the FDA and progressing toward alignment on the content of CMC Module 3, including methodologies to assess comparability between the product used in the pivotal ALLELE study and the intended commercial product
A recent analysis shows that duration of response (DoR) in its ALLELE study is maturing as anticipated with a larger number of responders followed for at least six months and a safety profile consistent with previously published data with no new safety signals
Atara is working toward completing a BLA submission in Q3 2021 pending alignment with the FDA
The Company has submitted a letter of intent to the European Medicines Agency (EMA), starting the process for a submission of an EU Marketing Authorization Application (MAA) for tab-cel in patients with EBV+ PTLD expected in Q4 2021
Atara has data at two medical congresses from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel demonstrating that patients with EBV+ PTLD, following both HCT (hematopoietic cell transplantation) and SOT (solid organ transplant), that is relapsed or refractory (R/R) to initial treatment, derived similar OS benefit greater than 80 percent at two years whether they achieved complete or partial response (CR or PR) with tab-cel
Data from the Phase 3 ALLELE study will be presented at an appropriate congress in Q4 2021
The Company is continuing to invest in U.S. commercial readiness activities in anticipation of tab-cel approval and planned launch in H1 2022. In addition, Atara is in discussions with potential partners for the commercialization of tab-cel in Europe
Tab-cel for Potential Additional Indications

Atara is actively opening sites in the Phase 2 multi-cohort study for patients with other EBV-driven cancers
ATA188 for Progressive Forms of Multiple Sclerosis (MS)

Atara continues to make progress enrolling the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (RCT) evaluating the efficacy and safety of ATA188 in patients with progressive forms of MS (PMS)
Atara plans to conduct an interim analysis (IA) in H1 2022 including efficacy and safety from the Phase 2 RCT in patients with PMS, and following the IA, expects to complete enrollment of the study in H1 2022
The Company plans to present long-term, two-year clinical data from the Phase 1 open-label extension (OLE) and translational data from the Phase 1 study in H2 2021
In the first quarter of 2021, Atara filed and received approval of a Clinical Trial Application (CTA) for the Phase 2 RCT in Canada
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration with Bayer including ATA2271 and ATA3271 is progressing well with successful launch of joint governance and activities
Enrollment of the first cohort in the Phase 1 clinical study of ATA2271 for patients with advanced mesothelioma has completed and the Company anticipates presentation of first clinical data in an appropriate forum in Q4 2021
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting mesothelin using a PD-1 DNR and 1XX CAR co-stimulatory signaling domain through its EBV T-cell platform, and expects an IND filing in Q2/Q3 of 2022
ATA3219 (B-cell Malignancies)

Atara expects to submit an IND for ATA3219, its next-generation off-the-shelf, allogeneic CAR T using a 1XX CAR co-stimulatory signaling domain through its EBV T-cell platform for patients with B-cell malignancies, in Q4 2021 / Q1 2022
First Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2021 totaled $435.2 million, as compared to $500.7 million as of December 31, 2020
Atara believes that its cash as of March 31, 2021 together with projected revenue from U.S. tab-cel sales is sufficient to fund its operations into 2023, including expenses related to the BLA filing and commercial launch of tab-cel in the U.S.
License and collaboration revenue was $3.6 million for the first quarter 2021 and consisted of revenue from activities performed under the Bayer Collaboration Agreements. Atara did not recognize any license and collaboration revenue for the same period in 2020
Net cash used in operating activities was $65.7 million for the first quarter 2021, as compared to $67.0 million for the same period in 2020
Atara reported net losses of $78.3 million, or $0.86 per share, for the first quarter 2021, as compared to $73.5 million, or $1.20 per share, for the same period in 2020
Total operating expenses include non-cash expenses of $14.4 million for the first quarter 2021, as compared to $14.5 million for the same period in 2020
Research and development expenses were $64.1 million for the first quarter 2021, as compared to $57.7 million for the same period in 2020
The increase in the first quarter 2021 was primarily due to higher employee-related costs from increased headcount, increased spending on the Company’s ATA188 and CAR T programs and increased facilities and information technology expenses allocated to research and development
Research and development expenses include $7.5 million of non-cash stock-based compensation expenses for the first quarter 2021, as compared to $7.7 million for the same period in 2020
General and administrative expenses were $17.7 million for the first quarter 2021, as compared to $17.0 million for the same period in 2020
General and administrative expenses include $4.7 million of non-cash stock-based compensation expenses for the first quarter 2021, as compared to $5.0 million for the same period in 2020

On May 4, 2021 Invectys, Inc., a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of products for cancer patients, reported the appointment of Praveen Tyle, PhD, as President & CEO and election to its Board of Directors (Press release, Invectys, MAY 4, 2021, View Source [SID1234579087]). Dr. Tyle brings over 35 years of experience in both large and small pharma and biotech companies, most recently serving as Executive V.P. for Research and Development of the public company, Lexicon Pharmaceuticals, Inc. Earlier, Dr. Tyle served as the Corporate Senior Vice President and Chief Scientific Officer of Bausch and Lomb and then as Senior Vice President and Global Head of Business Development and R&D at Novartis OTC. Subsequently, Dr. Tyle joined Osmotica Pharmaceutical Corp. serving as President and CEO where he led the successful merger of the Company into Avista Partners in 2016.

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Cary McNair, Chairman of the Board of Invectys and Chairman/CEO of the Houston-based McNair Interests stated: "We are delighted to welcome Praveen as CEO of Invectys. Having served over 3 decades at the intersection of pharma deep science and biopharma business development, Praveen is well poised to lead the commercial development of Invectys’ innovative immunotherapy platforms. His proven management skills and past commercial success bodes well for his new leadership role to steer Invectys into a new stage of commercial development."

Founding investor Shannon Fairbanks, Chair of the Fairbanks Investment Fund Holdings LLC noted: "This is an exciting period producing an explosion of new ideas in the health care sector which is starting to deliver innovative products to cancer patients. Praveen’s vision and leadership will help to deliver a next generation of breakthrough advances in immunotherapy".

Dr Tyle noted, "I am excited to take the helm at Invectys at this propitious time and I look forward to working with the talented team at Invectys to deliver products based on the Company’s strong scientific promise. I intend to apply my biotech and pharma management and product development experience to bring exciting new immunotherapy solutions to market."

In 2020, Invectys was awarded a $14.5 million product development research grant from the prestigious Cancer Prevention and Research Initiative of Texas ("CPRIT") for clinical development of its pathbreaking CAR-T treatment for solid tumors.

On May 4, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported further strides toward the elimination of toxic debt and dilution risk with the preemptive settlement of its outstanding convertible note liability (the "Note") held by Harbor Gate Capital LLC ("Harbor Gate") (Press release, Nascent Biotech, MAY 4, 2021, View Source [SID1234579106]).

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Under the terms of the Note, Harbor Gate had the right to redeem the outstanding liability in the form of an equity conversion that presented dilution risk for Nascent shareholders. The Note’s total value at the time of preemptive settlement was $115,000, which includes principal, accrued interest, and prepayment value.

In addition, as of April 1, 2021, all preferred shares associated with prior convertible financing instruments have already been converted. Only one convertible note remains open, which will not come due until August 2021.

"We continue to advance in our mission to eliminate all remaining dilution risk from prior funding rounds, and our latest note payoff represents a substantial step in that process," noted Sean Carrick, CEO of Nascent Biotech. "With all prior conversions already effective in our outstanding share supply, and the Harbor Gate note now settled, we have almost entirely eliminated outstanding dilution risk for shareholders."

On May 4, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that patient dosing was initiated in a Phase 2 trial intended to assess the efficacy and safety of vidutolimod (CMP-001) in combination with nivolumab for the treatment of patients with anti-PD-1 refractory advanced melanoma. Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. Checkmate previously announced initiation of dosing in patients in an additional trial which is evaluating the efficacy and safety of vidutolimod in combination with nivolumab compared to nivolumab monotherapy in patients with first-line metastatic or unresectable melanoma (Press release, Checkmate Pharmaceuticals, MAY 4, 2021, View Source [SID1234579122]). The data from these two trials are intended to support a biologics license application for the treatment of patients with anti-PD-1 refractory advanced melanoma.

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"Initiation of dosing in this pivotal trial is an important milestone as we move towards potential registration of vidutolimod in melanoma," said Barry Labinger, President and Chief Executive Officer of Checkmate. "Melanoma is estimated to be the fifth most diagnosed cancer in the United States, with more than 100,000 new cases and 7,000 deaths per year. There is a significant unmet medical need for patients who have progressed following treatment with anti-PD-1 therapy since there is no well-established standard of care."

Checkmate previously announced initiation of patient dosing in a Phase 2 trial of vidutolimod in combination with pembrolizumab to evaluate safety and efficacy in patients with first-line head and neck cancer.

Additional information about the Phase 2 anti-PD-1 refractory melanoma trial and the Phase 2/3 melanoma study, including participating investigative sites, can be found here: View Source

Information about Checkmate’s HNSCC trial can be found here: View Source

On May 4, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the University Hospital Erlangen reported a partnership regarding molecular analyses of biospecimens from the German Chronic Kidney Disease ("GCKD") cohort study (Press release, Evotec, MAY 4, 2021, View Source;announcements/press-releases/p/evotec-and-the-gckd-study-enter-into-strategic-collaboration-to-build-a-unique-molecular-patient-database-6059 [SID1234579038]). Under the agreement, the research team will make use of Evotec’s proprietary EVOpanOmics and EVOpanHunter platforms to facilitate deep molecular profiling of patient samples. The Evotec platforms combine enhanced throughput proteomics, high-throughput transcriptomics and integrated data analysis.

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Initiated in 2009, GCKD was designed to be the world’s largest cohort study on chronic kidney disease. Scientists from eleven universities work together with more than 150 practicing nephrologists to monitor more than 5,000 patients with CKD with biospecimens being taken and supporting interviews being conducted multiple times during the interval. Evotec will also financially support GCKD, which will enable the extension of this important cohort study beyond the initial term of 10 years, allowing future follow-up visits and additional sample analysis.

The multi-omics analysis of the biospecimens from the GCKD cohort study is expected to lead to a deeper understanding of different kidney disease etiologies, their respective disease mechanisms, progression and potential complications. Together with Evotec’s existing molecular patient database, this systematic integrated exploitation of the GCKD biobank will open the door to novel starting points for drug discovery and the identification of biomarkers, enabling precision medicine approaches for highly effective treatment options for clearly defined patient populations.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We continue to work towards our goal to build a highly comprehensive molecular patient database. This collaboration is a major step forward towards this goal and we are very excited about the opportunity to work with this unique network. The GCKD cohort not only complements and expands our already leading kidney disease data base with well-documented long-term survey of CKD patients and corresponding patient samples. The more comprehensive the data base, the more impactful it will be in re-defining patient populations according to disease mechanisms rather than symptoms, identify suitable molecular targets for intervention and stratify patient populations for clinical trials."

Prof. Dr Kai-Uwe Eckardt, Director of the Department of Nephrology and Medical Intensive Care at the Charité – Universitätsmedizin Berlin, and Principal Investigator of the GCKD Study, said: "CKD is a severe health problem that affects 10% of the population. The underlying mechanisms are complex and strong efforts are urgently needed to better understand this complexity. We are very excited to enter this collaboration with Evotec, which creates novel synergies and provides the prospect for innovative diagnostic and therapeutic approaches that can be translated into patient care."

Prof. Dr Anna Köttgen, Head of the Institute of Genetic Epidemiology at the University of Freiburg, and Member of the GCKD Steering Committee added: "We are looking forward to expand the spectrum of molecular analyses in this cohort, which will greatly facilitate the discovery of robust associations between complex molecular phenotypes and clinical outcomes."

"One of the challenges in studying CKD is the gradual decline of kidney function that may eventually lead to kidney failure. The GCKD study is unique as a long-term observational study and its extension will further increase the value of this huge research project," added Prof. Dr Mario Schiffer, Director of the Department of Nephrology and Hypertension at the Friedrich-Alexander-Universität Erlangen-Nürnberg, and also Member of the GCKD Steering Committee.