On March 1, 2023 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, reported that the first patient has been enrolled in BeyondSpring’s Phase 2 investigator-initiated trial with lead asset, Plinabulin, in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) and Docetaxel for previously treated patients with metastatic non-small cell lung cancer (NSCLC) and progressive disease after immunotherapy (anti-PD-1 / PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy (Press release, BeyondSpring Pharmaceuticals, MAR 1, 2023, View Source;utm_medium=rss&utm_campaign=beyondspring-enrolls-first-patient-in-phase-2-study-with-plinabulin-keytruda-and-docetaxel-in-patients-with-metastatic-non-small-cell-lung-cancer-who-progressed-after-immunotherapy [SID1234627969]).

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Most patients experience disease progression after immune checkpoint inhibitor-based (ICI) treatment regimens. BeyondSpring’s triple-combination therapy has the potential to improve ICI resistance and provide a new treatment option for metastatic NSCLC patients previously treated with an immunotherapy. The study1 is actively recruiting at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine, as principal investigator. Patients will receive the following doses during each three-week cycle (via IV infusions)2:

Plinabulin at 30 mg / m2 on Days 1 and 8
Keytruda at 200 mg on Day 1
Docetaxel at 75 mg / m² on Day 1
"While PD-1 / PD-L1 inhibitors have significantly advanced cancer treatment, patients still experience disease progression even after receiving these therapies," said Dr. Wang. "This triple combination study is bringing us one step closer to helping with this unmet medical need. Plinabulin’s unique, immune-enhancing mechanism of action has a proven anti-cancer benefit that we believe will synergize with Docetaxel and Keytruda and re-sensitize patients who progressed after immunotherapy. In fact, Plinabulin has shown a 40 percent response rate in its immune-oncology combination in small-cell lung cancer patients who experienced disease progression after immunotherapy3. I look forward to evaluating this treatment further in the clinic to ensure that cancer patients all over the world have access to the most advanced, cutting-edge therapies."

"As 25 to 30 percent of patients suffering from metastatic NSCLC have a life expectancy of under three months4, it is our mission to find better treatments that extend these patients’ lives so that they can see a child being born or a graduation from high school – every moment matters. Enrolling the first patient in this trial is a pivotal moment as we look to bring more promising therapies to patients in need. This new combination approach has the potential to make meaningful differences in patient quality of life and survival," added Dr. Lan Huang, Co-Founder, Chairman and CEO at BeyondSpring.

Liu J, et al. Study protocol of KeyPemls-004: A phase 2 study of pembrolizumab in combination with plinabulin and docetaxel in previously treated patients with metastatic non-small cell lung cancer and progressive disease (PD) after immunotherapy (PD-1/PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy. Thoracic Cancer, 2023 Feb 1.doi: 10.1111/1759-7714.14806. Online ahead of print.
A Phase 2 Study of Pembrolizumab in Combination With Plinabulin and Docetaxel in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer and Progressive Disease (PD) After Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) Alone or in Combination With Platinum-doublet Chemotherapy (KeyPemls-004). gov identifier: NCT05599789. Conducted by Peking Union Medical College Hospital, BeyondSpring Pharmaceuticals Inc., and Merck Sharp & Dohme LLC.
Guo H, et al. "How Long Have I Got?" in Stage IV NSCLC Patients With at Least 3 Months Up to 10 Years Survival, Accuracy of Long-, Intermediate-, and Short-Term Survival Prediction Is Not Good Enough to Answer This Question. Frontiers in Oncology 2021 Dec 21; 11:761042. doi: 10.3389/fonc. 2021.761042. eCollection
Malhotra J, et al. A phase I trial of plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer (SCLC): Big Ten Cancer Research Consortium (BTCRC-LUN17-127) study. JCO, 39(15), suppl.8570 (2021 ASCO (Free ASCO Whitepaper) Meeting).

On March 1, 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 that Pascal Touchon, President and Chief Executive Officer, will participate in a cell therapy panel discussion at the Cowen 43rd Annual Health Care Conference on Wednesday, March 8, 2023 at 11:10 a.m. PST / 2:10 p.m. EST (Press release, Atara Biotherapeutics, MAR 1, 2023, View Source [SID1234627968]).

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A live webcast of the presentation will be available by visiting the Investors and Media section of atarabio.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation.

On March 1, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the fourth quarter and year ended December 31, 2022 and provided business updates (Press release, AnaptysBio, MAR 1, 2023, View Source [SID1234627967]).

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"2022 was a significant year of transition for AnaptysBio as we refocused the company on broadly advancing our portfolio of best-in-class immune cell modulators. We are excited by the near-term initiation of our two global Phase 2b trials across rosnilimab, our PD-1 agonist, in rheumatoid arthritis and ANB032, our BTLA agonist, in atopic dermatitis. We believe their mechanisms of action have the potential to meaningfully impact large and significantly underserved patient populations, to restore immune balance by acting directly on cell types mediating disease pathology," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "As we continue to progress our strategic portfolio review, we are well capitalized to deliver on multiple Phase 2 readouts across our wholly owned checkpoint agonists, as well as to advance ANB033, our anti-CD122 antagonist, through clinical proof-of-concept."

Rosnilimab (PD-1 agonist antibody)

•Rosnilimab, its investigational wholly owned PD-1 agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation, reduction in inflammatory cytokine secretion (Th1, Th2, Th17) and depletion of PD-1+ T cells via effector function compared to Lilly PD-1 agonist
•PD-1+ T cells are clinically validated drivers of disease in rheumatoid arthritis (RA)
◦RA patient synovial biopsies have dense T cell infiltrates, with >80% of T cells expressing PD-1 and insufficient PD-L1 expression to down-regulate T cell activity
◦Rosnilimab targets multiple distinct inflammatory mechanisms addressed by approved therapies to treat RA
•Initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe RA
◦Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for approximately 6 months on well-established endpoints including ACR20/50/70 and DAS28
◦Top-line interim data anticipated by mid-year 2025
•Second global Phase 2 trial, in an indication to be announced, with study initiation anticipated by year-end 2023

ANB032 (BTLA agonist antibody)
•ANB032, its investigational wholly owned BTLA agonist, demonstrates best-in-class activity in vitro with superior inhibition of T cell proliferation and reduction in inflammatory cytokine secretion (Th1, Th2, Th17) compared to Lilly BTLA agonist
•While Th2 targeted therapies provide benefit to patients with chronic moderate-to-severe atopic dermatitis (AD), there is compelling evidence that AD is broader than a Th2 driven disease, as Th1, Th17 and other cell types, including dendritic cells, may contribute significantly to its pathogenesis
◦ANB032 inhibits inflammatory activity of Th1, Th2 and Th17 and modulates additional cell types such as B cells and dendritic cells, with the potential for broader, deeper and more durable responses than more narrowly targeted interventions
•Initiation in Q2 2023 of a global Phase 2b trial in moderate-to-severe AD
◦160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for 12 weeks on well-established endpoints, including EASI75 and IGA 0/1
◦Top-line interim data anticipated by year-end 2024
ANB033 (anti-CD122 antagonist antibody)
•ANB033, its investigational wholly owned anti-CD122 antagonist antibody, targets the common beta subunit shared by the IL-15 and IL-2 receptors
◦IL-15 signaling mediates the survival and maintenance of tissue resident memory T cells (TRM)
◦The presence of long-lived and persistent TRM have been shown to drive tissue-specific immune-mediated inflammation
•IND anticipated H1 2024
Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing
•Imsidolimab, its investigational wholly owned anti-IL-36R antagonist antibody, is in Phase 3 trials for generalized pustular psoriasis (GPP)
◦Top-line data from the GEMINI-1 Phase 3 trial anticipated Q4 2023
◦Plan to out-license imsidolimab prior to potential FDA approval
•Etokimab, its investigational wholly owned anti-IL-33 antagonist antibody, is Phase 2/3-ready for the treatment of respiratory disorders
◦No further internal investment in etokimab is being pursued
GSK Immuno-Oncology Financial Collaboration
•Dostarlimab, an anti-PD-1 antagonist antibody, cobolimab, an anti-TIM-3 antagonist antibody, and GSK4074386, an anti-LAG-3 antagonist antibody, were discovered at AnaptysBio and licensed by GSK
•JEMPERLI (dostarlimab-gxly) has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
◦Regulatory submissions anticipated H1 2023
◦GSK expects to publish full results in a medical journal and present at an upcoming scientific meeting

•Dostarlimab plus ZEJULA in the pivotal FIRST Phase 3 trial in 1st line ovarian cancer is ongoing with an interim analysis expected in H2 2023
•Dostarlimab plus cobolimab plus chemotherapy vs. dostarlimab plus chemotherapy is in the pivotal COSTAR Lung Phase 3 trial in advanced non-small cell lung cancer in patients who have progressed on prior anti-PD-(L)1 therapy
Stock Repurchase Plan
•In January 2023, the Board of Directors authorized a Stock Repurchase Plan under which the Company may repurchase up to $50.0 million of the Company’s outstanding common stock. The Stock Repurchase Plan will expire on December 31, 2023, may be suspended or discontinued at any time, and does not obligate the company to acquire any amount of common stock.
Fourth Quarter Financial Results
•Cash, cash equivalents and investments totaled $584.2 million as of December 31, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $31.0 million. The decrease relates primarily to cash used for operating activities offset by cash received from the Zejula royalty sale and stock option exercises.
•Collaboration revenue was $6.8 million and $10.3 million for the three and twelve months ended December 31, 2022, compared to $1.0 million and $63.2 million for the three and twelve months ended December 31, 2021. The increase for the three months ended December 31, 2022 relates primarily to one development milestone achieved for cobolimab and no development milestones achieved during the three months ended December 31, 2021. The decrease for the twelve months ended December 31, 2022 relates primarily to four development milestones achieved for JEMPERLI for the twelve months ended December 31, 2021, and one development milestone achieved during the twelve months ended December 31, 2022.
•Research and development expenses were $23.4 million and $88.8 million for the three and twelve months ended December 31, 2022, compared to $26.8 million and $98.5 million for the three and twelve months ended December 31, 2021. The decrease for the three and twelve months ended December 31, 2022 was due primarily to reduced clinical and manufacturing costs for the Company’s programs. The R&D non-cash, stock-based compensation expense was $1.8 million and $6.8 million for the three and twelve months ended December 31, 2022, as compared to $1.5 million and $5.9 million in the same period in 2021.
•General and administrative expenses were $9.4 million and $36.6 million for the three and twelve months ended December 31, 2022, compared to $5.4 million and $21.5 million for the three and twelve months ended December 31, 2021. The increase was primarily due to stock compensation expense and $3.8 million of costs incurred from personnel changes in the first quarter of 2022. The G&A non-cash, stock-based compensation expense was $4.9 million and $20.6 million for the three and twelve months ended December 31, 2022, which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.5 million and $9.5 million in the same period in 2021.
•Non-cash interest expense was $4.3 million and $21.1 million for the three and twelve months ended December 31, 2022, compared to $1.5 million for the three and twelve months ended December 31, 2021. The increase in non-cash interest expense during the period is directly related to the interest expense accrued on the liability related to the sale of future royalties, of which we had a full year of expense during 2022 as compared to one month of expense during 2021. We also had an additional sale of future royalties in 2022 compared to period in 2021.
•Net loss was $26.4 million and $128.7 million for the three and twelve months ended December 31, 2022, or a net loss per share of $0.93 and $4.57, compared to a net loss of $32.5 million and $57.8 million for the three and twelve months ended December 31, 2021, or a net loss per share of $1.18 and $2.11.

On March 1, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has received authorization from Health Canada to proceed with a feasibility and safety study of Alpha DaRT in the treatment of liver metastases, subject to final approval by an institutional Research Ethics Board, which the Company expects to receive in the coming weeks (Press release, Alpha Tau Medical, MAR 1, 2023, View Source [SID1234627966]). The study is planned to be conducted at the McGill University Health Center in Montreal, Canada.

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The trial will seek to recruit 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. Specifically, in the first stage, as many metastatic tumors as possible will be surgically removed in a non-curative intervention while Alpha DaRT sources will be inserted into a separate tumor, and in the second stage, after allowing for the resected liver to regenerate naturally, the portion of the liver with the Alpha DaRT sources will be surgically removed.

The study primarily aims to examine the feasibility of delivering Alpha DaRT sources into the liver metastases, as well as the safety of utilizing the Alpha DaRT sources in the liver by assessing the frequency and severity of related adverse events. The study will also examine Alpha DaRT’s efficacy in terms of radiological response, assessed after insertion of the Alpha DaRT sources, and via pathological response assessed after the second stage of surgery.

Alpha Tau CEO Uzi Sofer commented, "The authorization by Health Canada for this study to proceed represents an important milestone for the Company. This trial examining the use of Alpha DaRT in liver metastases for the first time signifies a big step forward in our overall strategy to broaden the use of the Alpha DaRT in hard-to-treat indications, including other cancers such as those of the brain, lung, pancreas, vulva and breast."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On March 1, 2023 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that management will participate in the following upcoming investor conferences (Press release, Alector, MAR 1, 2023, View Source [SID1234627965]).

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Cowen 43rd Annual Health Care Conference (Boston, Massachusetts)
Tuesday, March 7, 2023, at 10:30 a.m. ET, panel
Stifel 2023 CNS Days (Virtual)
Tuesday, March 28, 2023, at 12:00 p.m. ET, fireside chat
A webcast of each conference presentation will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the Cowen and Stifel webcasts will be available on the Alector website for 30 and 90 days, respectively, following the presentation dates.