On June 5, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported updated effectiveness and safety data for tabelecleucel (tab-cel or EBVALLO) from the multicenter Expanded Access Program (EAP) study in Europe (Press release, Atara Biotherapeutics, JUN 5, 2023, View Source [SID1234632460]). The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6 in Chicago.

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Atara supported 27 EAP requests in Europe for patients with relapsed or refractory (r/r) Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT). 24 EBV+ PTLD patients, 16 SOT recipients and eight HCT recipients, consented to use of data and received at least one dose of tab-cel, including four patients with EBV+ primary central nervous system (PCNS) PTLD.

An objective response rate (ORR) of 66.7% (16/24) was observed for both SOT and HCT groups (95% CI: 44.7, 84.4), 56.3% (9/16) for patients following SOT (95% CI: 29.9, 80.2) and 87.5% (7/8) for HCT patients (95% CI: 47.3, 99.7) with a best overall response of Complete Response (CR; 33.3%; n=4, SOT, n=4, HCT) or Partial Response (PR; 33.3%; n=5, SOT, n=3, HCT).

"These real-world results affirm the favorable risk-benefit profile seen in the pivotal Phase 3 ALLELE study which supported tab-cel as the first-ever allogeneic T-cell immunotherapy approved," said AJ Joshi, MD, Chief Medical Officer at Atara. "Tab-cel was well tolerated and delivered a one-year survival rate of nearly 91% in responders, reinforcing its potential to address an urgent unmet medical need for EBV+ PTLD patients."

The median time to response (TTR) in all patients was 1.0 month (range: 0.8–2.2). Of the subgroup of patients with EBV+ PCNS PTLD, three out of four (75%; 95% CI: 19.4, 99.4) treated patients achieved a response with one CR and two PRs.

One-year survival rates were 73.7% (95% CI: 47.3, 88.3) across both groups, 66.5% for SOT patients (95% CI: 32.7, 86.2) and 87.5% for HCT patients (95% CI: 38.7, 98.1). EBV+ PTLD patients responding to tab-cel had longer one-year survival compared to the non-responders, with a one-year survival rate of 90.9% (95% CI: 50.8, 98.7) versus 34.3% (95% CI: 4.8, 68.5) for non-responders.

"These data provide important insights on the effectiveness of EBVALLO in the real-world treatment setting," said Dr. Sylvain Choquet, Head of the Clinical Hematology Department at Pitié-Salpêtrière, Paris, France. "Findings further reinforce the clinical profile already established for EBVALLO, underscoring its potential as new treatment option for an ultra-rare and highly aggressive form of lymphoma that occurs in some transplant patients."

Safety findings in this real-world program were consistent with previously published data from clinical studies. All treatment-emergent adverse events (TEAEs) were assessed as unrelated to tab-cel by the treating physician and were consistent with patients’ underlying diseases. Detailed results on baseline demographics and disease characteristics, and additional safety data including tab-cel exposure details, will be shared at the conference.

Pierre Fabre leads all commercialization, distribution, medical and regulatory activities for EbvalloTM in Europe, Middle East, Africa and other selected markets.

Poster Presentation Details:

Title: Effectiveness and safety outcomes in patients with EBV+ PTLD treated with allogeneic EBV-specific T-cell immunotherapy (tabelecleucel) under an expanded access program (EAP) in Europe
Presenting Author: Ralf Trappe, M.D., DIAKO Evangelisches Diakonie-Krankenhaus Bremen, Bremen, Germany
Date & Time: June 5, 2023, at 8-11 a.m. CDT / 6-9 a.m. PDT
Abstract Number: 7521
Poster Number: 72
Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Location: McCormick Place Convention Center Chicago, Hall A

On June 5, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in two upcoming investor conferences (Press release, Arvinas, JUN 5, 2023, View Source [SID1234632459]):

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Jefferies Healthcare Conference on Thursday, June 8. A live audio webcast of the fireside chat at 11 a.m. ET will be available here and on the Events + Presentations section of the Company’s website.
Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12.

A live audio webcast of the fireside chat at 5:40 p.m. ET / 2:40 p.m. PT will be available here and on the Events + Presentations section of the Company’s website.

On June 5, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease reported that Gail McIntyre, Ph.D., DABT, Chief Executive Officer and Rudy Howard, Chief Financial Officer will be presenting a corporate overview and participating in 1×1 meetings at the Jefferies Global Healthcare Conference being held on June 7-9, 2023 in New York, NY (Press release, Aravive, JUN 5, 2023, View Source [SID1234632458]).

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Jefferies Global Healthcare Conference – June 7-9, 2023
Format: Aravive (ARAV) Company Presentation
Date/Time: Friday, June 9, 2023 at 8:30 AM EST
Session: Track 4
Presenter: Gail McIntyre, Ph.D., DABT, CEO, Aravive
Webcast: Registration Link – Click Here

A replay of the session will be available following the conference through the Aravive Events & Presentations section of the website View Source

On June 5, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported that the Company effected a reverse stock split on May 24, 2023 at a ratio of 15-to-1 (the "Reverse Stock Split") (Press release, Aptose Biosciences, JUN 5, 2023, View Source [SID1234632457]).

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Both the Nasdaq Capital Market ("Nasdaq") and the Toronto Stock Exchange ("TSX") have approved the Reverse Stock Split and have informed the Company that its common shares (the "Common Shares") will commence trading on a post-Reverse Stock Split basis at market open on Tuesday, June 6, 2023. The Common Shares continue to trade on the Nasdaq and the TSX under the existing ticker symbols. The new CUSIP number for the Common Shares is 03835T309 and the new ISIN is CA03835T3091.

As previously announced, the Reverse Stock Split, at a ratio in the range between 10-to-1 and 20-to-1, was approved at the Company’s annual and special meeting of shareholders held on May 23, 2023 and is described in the proxy statement dated April 18, 2023. The Company’s Board of Directors then approved a ratio of 15-to-1 on May 23, 2023.

As a result of the Reverse Stock Split, every 15 Common Shares issued and outstanding were automatically reclassified into one new Common Share. No fractional Common Shares will be issued as a result of the Reverse Stock Split and shareholders will not receive any compensation in lieu thereof.

On June 5, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that data from the ongoing OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, June 2-6 (Press release, Alligator Bioscience, JUN 5, 2023, View Source [SID1234632456]).

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The presentation, entitled "Efficacy and Safety of mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): an interim analysis of the OPTIMIZE-1 phase 1b/2 study", outlines comprehensive data from the interim analysis announced in January 2023.

The data presented at ASCO (Free ASCO Whitepaper) demonstrate that mitazalimab in combination with mFOLFIRINOX is a feasible treatment regimen for 1st line pancreatic cancer patients with encouraging interim efficacy and well-manageable safety profile, consistent with mFOLFIRINOX monotherapy. Combination with mFOLFIRINOX had no impact on mitazalimab pharmacokinetics and the pharmacodynamic biomarker profile in peripheral blood confirmed the immune activation profile typical of mitazalimab.

When administered at 900 μg/kg in combination with mFOLFIRINOX, mitazalimab showed robust anti-tumor activity in 23 mPDAC patients, meriting continued development. An objective response rate (ORR) of 52% was demonstrated with clinically meaningful tumor reduction in 12 of the 23 evaluable patients, which compares favorably to the 31.6%[1] reported with FOLFIRINOX in a similar patient population. The analysis also revealed:

8 patients achieved stable disease resulting in a 91% disease control rate (DCR)
6 of the 7 patients who began treatment at least 6 months prior to the interim analysis cutoff were still on treatment, and of these, 2 patients had been receiving treatment for over 11 months.
With these encouraging results, the OPTIMIZE-1 study passed the futility analysis. Subsequently, the study has completed its full accrual, and top-line data are expected in early Q1 2024.

"ASCO is the most prominent global scientific platform in the field of clinical oncology. Presentation of these strong clinical data for our lead pipeline asset mitazalimab in a very challenging indication highlight the potential of Alligator’s novel immuno-oncology pipeline," said Søren Bregenholt, CEO of Alligator Bioscience. "Mitazalimab is a unique CD40 agonist that is demonstrating not only highly encouraging anti-tumor activity in the treatment of first-line pancreatic cancer, but also a much improved safety profile compared to the previous generations of CD40 agonists. We are truly encouraged by these data and look forward to reporting updated interim data from a larger number of patients and a longer treatment and follow-up later this month, followed by top-line results at the beginning of next year. "

Presentation Details
Abstract Number for Publication: 4139
Abstract Title: Efficacy and Safety of mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): an interim analysis of the OPTIMIZE-1 phase 1b/2 study
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Date/Time: Monday 5 June, 2023, 8.00 – 11.00 am CDT
Presenter: Hans Prenen, Head of the Oncology Department at University Hospital, Antwerp, and Investigator in the OPTIMIZE-1 Study