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AnaptysBio, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 10:00 AM

2022-06-03 04:03:00

AnaptysBio, Inc. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 10:00 AM. Venue: Marriott Marquis, New York City, New York, United States. Speakers: Daniel R. Faga, Interim President & CEO and Director, Paul F. Lizzul, Chief Medical Officer.

AnaptysBio, Inc., Annual General Meeting, Jun 23, 2022

2022-04-29 20:15:00

AnaptysBio, Inc., Annual General Meeting, Jun 23, 2022, at 09:00 Pacific Standard Time. Location: 10770 Wateridge Circle, Suite 210 San Deigo California United States Agenda: To elect three Class II directors, each to serve three-year terms through the third annual meeting of stockholders following this meeting and until a successor has been elected and qualified or until earlier resignation or removal; to ratify the appointment of KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; to conduct a non-binding advisory vote on the compensation of named executive officers; and to consider and vote upon such other business as may properly come before the meeting or any adjournment or postponement thereof.

Anaptysbio, Inc. Announces Positive Anb032 (Anti-Btla Agonist) Top-Line Phase 1 Data and Provides Pipeline Updates

2022-04-27 20:15:00

AnaptysBio, Inc. announced positive top-line data from a Phase 1 trial of ANB032, its investigational wholly owned anti-BTLA agonist antibody. Top-line data demonstrated favorable safety, tolerability, and a rapid and sustained pharmacokinetic and pharmacodynamic profile that supports advancement of ANB032 into subsequent patient trials. AnaptysBio has a strategic portfolio review ongoing while continuing to execute on the development of its three wholly owned clinical stage antibody programs: Imsidolimab (anti-IL-36R Ab) top-line data from the GEMINI-1 Phase 3 trial in GPP is anticipated in the fourth quarter of 2023; Imsidolimab top-line data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa is anticipated in the third quarter of 2022; Rosnilimab (anti-PD-1 agonist Ab) top-line data from the AZURE Phase 2 trial in moderate-to-severe alopecia areata is anticipated in the first half of 2023; ANB032 (anti-BTLA agonist Ab) IND filing of a Phase 2 clinical trial is anticipated in the second half of 2022. A total of 96 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (SAD) cohorts received subcutaneous or intravenous single doses of ANB032 or placebo, while multiple ascending dose (MAD) cohorts received four weekly subcutaneous doses of ANB032 or placebo. ANB032 was generally well-tolerated, no dose limiting toxicities were observed and there were no discontinuations due to adverse events, other than one patient quarantined for potential COVID infection.  No serious adverse events (SAEs) were reported.  Most adverse events were considered to be mild-to-moderate, of short duration, resolved without sequelae and occurred sporadically in a dose-independent manner.   Three severe adverse events (2 blood creatine phosphokinase (CPK) increase and 1 aspartate aminotransferase (AST) increase), none of which were treatment-related, were reported in two subjects in the lowest dose MAD cohort. Three subjects had mild-to-moderate single injection site reactions (ecchymosis; erythema; and pain) of short duration. Pharmacokinetic analyses demonstrated a favorable profile for ANB032 including an approximate two-week half-life for subcutaneous and intravenous routes of administration. Full BTLA receptor occupancy was observed rapidly within hours and was maintained for greater than 30 days following IV or subcutaneous ANB032 dosing. ANB032 pharmacodynamic activity resulted in reduction of cell surface BTLA expression on T cells and B cells following dosing. A portion of the cell surface BTLA was shed from the cells as soluble BTLA (sBTLA), while the residual approximately 60% of baseline BTLA on T cells and B cells remained occupied by ANB032. The duration of reduced BTLA expression correlated with receptor occupancy in a dose-dependent manner and was maintained for greater than 30 days following IV or subcutaneous ANB032 dosing.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

AnaptysBio, Inc. has filed a Shelf Registration in the amount of $300 million.

2021-12-30 00:00:00

AnaptysBio, Inc. has filed a Shelf Registration in the amount of $300 million. Security Name: Common Stock Security Name: Preferred Stock Security Name: Debt Security Security Name: Warrant Security Name: Subscription Right Security Name: Unit Transaction Features: Omnibus/Universal Shelf Registration

AnaptysBio, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.

2021-12-30 00:00:00

AnaptysBio, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market Offering

AnaptysBio, Inc. Announces Appointment of Daniel Faga to Board of Directors

2021-11-29 21:05:00

AnaptysBio, Inc. announced the appointment of Mr. Daniel Faga to the company’s Board of Directors. Most recently, he was the chief operating officer at Mirati Therapeutics responsible for leading the company’s strategy, corporate finance, legal and other business operations.

AnaptysBio, Inc. Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021

2021-11-16 11:51:00

AnaptysBio, Inc. Presents at 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov-16-2021 . Speakers: Paul F. Lizzul, Chief Medical Officer.

AnaptysBio, Inc. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-18-2021 03:00 AM

2021-11-16 00:24:00

AnaptysBio, Inc. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-18-2021 03:00 AM. Venue: London, United Kingdom. Speakers: Hamza Suria, President, CEO & Director.

AnaptysBio, Inc. Announces Positive Rosnilimab Healthy Volunteer Phase 1 Top-Line Data

2021-11-15 14:00:00

AnaptysBio, Inc. announced positive top-line data from a randomized placebo-controlled healthy volunteer single and multiple ascending dose Phase 1 trial of rosnilimab, its investigational wholly-owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030. Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results that support advancement of rosnilimab into subsequent patient trials. A total of 144 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (SAD) cohorts were administered single subcutaneous or intravenous doses of rosnilimab ranging between 0.02mg to 600mg or placebo, while multiple ascending dose (MAD) cohorts received four weekly subcutaneous doses of rosnilimab ranging between 60mg and 400mg or placebo. Dose escalation was conducted subsequent to data safety monitoring board review of safety and tolerability parameters following each single and multiple ascending dose level. Rosnilimab was generally well-tolerated and no dose limiting toxicities were observed. The most frequent adverse event reported among SAD cohorts was increased circulating C-reactive protein levels of mild severity in nine (10%) rosnilimab-dosed subjects occurring sporadically in a dose-independent manner and a severe occurrence in one (3.3%) placebo-dosed subject. MAD cohorts reported headache as the most frequent adverse event with mild occurrences in three (12.5%) rosnilimab-dosed subjects and none in placebo subjects. Mild injection site reactions were observed in two subjects (11.1%) administered with multiple subcutaneous rosnilimab doses. Two serious adverse events were reported in single dose cohorts, including obstructive pancreatitis in a placebo-dosed subject and COVID-19 infection in a rosnilimab-dosed subject leading to discontinuation which was deemed unrelated to treatment. No serious adverse events were reported in subjects receiving multiple doses of rosnilimab or placebo. Pharmacokinetic analyses demonstrated a favorable profile for rosnilimab with an estimated two-week half-life for subcutaneous and intravenous routes of administration and approximately 80% bioavailability. Low-titer anti-drug antibodies were detected at low single dose levels in 19 (21%) rosnilimab-dosed subjects, but none were detected in high single dose or multiple dose subjects. Full PD-1 receptor occupancy was observed rapidly during the first week following single subcutaneous rosnilimab doses at or above 60mg, and was maintained for at least 30 days at or above 200mg single subcutaneous doses. These data support monthly subcutaneous dosing of rosnilimab for future patient trials. Rosnilimab’s pharmacodynamic activity resulted in rapid and sustained reduction in the quantity and functional activity of PD-1+ T cells, which are known to be pathogenic drivers of inflammatory diseases. Conventional T (Tcon) cells (CD3+, CD25 low) expressing PD-1, which represented approximately 25% of peripheral T cells at baseline, were reduced by 50%, including in both CD4+ and CD8+ subsets, in a dose-dependent manner and in correlation with receptor occupancy (Table 1). This effect was maximized on high-PD-1 expressing Tcon cells, which represented approximately 5% of peripheral T cells, with 90% reduction relative to baseline. Conversely, total T cells (CD3+), total Tcon cells (CD3+, CD25low) and total regulatory T (Treg) cells (CD3+, CD4+, CD25 bright, CD127-) were unchanged (<5% change from baseline), resulting in a favorable shift in the ratio of PD-1+ Tcon cells to total Treg cells post-treatment. No effect (<5% reduction from baseline) was observed on any of the aforementioned cell types in placebo-dosed subjects. In addition, an antigen-specific functional T cell recall response, measured as ex vivo interferon-gamma released in response to tetanus toxoid challenge, was inhibited in a receptor occupancy dependent manner and was consistent with the observed reduction of PD-1+ Tcon cells, to a maximum of approximately 90% relative to baseline within 30 days following single rosnilimab dose, while placebo administration had no effect.

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021

2021-11-15 12:30:00

Hanson Wade Limited, 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, Nov 16, 2021 through Nov 18, 2021.

AnaptysBio Announces Agreement with Sagard Healthcare Royalty Partners

2021-10-25 20:37:00

AnaptysBio, Inc. announced the signing of an agreement with Sagard Healthcare Royalty Partners to monetize a portion of AnaptysBio’s future JEMPERLI royalties and milestones. AnaptysBio intends to utilize the proceeds of the transaction towards funding of its wholly-owned preclinical and clinical-stage antibody programs. Upon closing of this transaction, which is anticipated by the end of 2021, Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under its GSK collaboration on annual global net sales of JEMPERLI below $1 billion starting October 2021. The royalty rate applicable below the $1 billion annual net sales threshold is 8%. Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future JEMPERLI regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to JEMPERLI achieving the $1 billion in annual global net sales threshold. Royalties payable above $1 billion JEMPERLI annual global net sales, which are paid by GSK at 12% to 25%, and certain milestones payable on annual sales at or above $1 billion are retained by AnaptysBio and are not subject to this Agreement. Royalties and milestones due upon development and commercialization of the AnaptysBio-generated anti-TIM-3 antagonist (cobolimab) or anti-LAG-3 antagonist (GSK4074386) antibodies under the GSK collaboration, including in combination with JEMPERLI, are also not subject to this Agreement. In addition, royalties due to AnaptysBio from GSK’s global net sales of ZEJULA (niraparib) are excluded from this Agreement. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment based upon time. Once Sagard receives an aggregate of either $312.5 million (125% of the upfront) by the end of 2026, or $337.5 million (135% of the upfront) during 2027 or $412.5 million (165% of the upfront) at any time after 2027, the Agreement will expire resulting in AnaptysBio regaining all subsequent JEMPERLI royalties and milestones. The closing of the transaction is subject to the satisfaction of customary closing conditions.

AnaptysBio, Inc. Presents at Antibody Engineering & Therapeutics US, Dec-12-2021 01:00 PM

2021-10-06 12:38:00

AnaptysBio, Inc. Presents at Antibody Engineering & Therapeutics US, Dec-12-2021 01:00 PM. Venue: Marriott Marquis San Diego, San Diego, California, United States. Speakers: Stephen Parmley, Vice President, Molecular Biology & Protein Sciences.

AnaptysBio Presents Updated Data From Imsidolimab Phase 2 GALLOP Trial in Generalized Pustular Psoriasis

2021-10-02 16:00:00

AnaptysBio, Inc. announced that week 16 data from the GPP GALLOP Phase 2 trial of imsidolimab, its investigational anti-interleukin-36 receptor (IL-36R) therapeutic antibody, was presented at the 2021 European Academy of Dermatology and Venereology (EADV) Congress. The oral presentation, titled “Imsidolimab, an Anti-IL-36 Receptor Monoclonal Antibody, in the Treatment of Generalized Pustular Psoriasis: Results from a Phase 2 Trial”, was presented by Dr. Johann Gudjonsson, professor of Dermatology at the University of Michigan. Key data available to date from the 8 patients enrolled in the GALLOP trial are as follows: Six of 8 (75%) patients treated with imsidolimab monotherapy achieved the primary endpoint of response on the clinical global impression (CGI) scale at week 4 and week 16 (Table 1), without requiring rescue medication. Two of 8 (25%) patients were considered to have not met the primary endpoint because they dropped out of the trial prior to Day 29. Modified Japanese Dermatology Association severity index total score (mJDA-SI), which incorporates both dermatological and systemic aspects of GPP, decreased on average by 29% at week 1, 54% at week 4 and 58% at week 16. Erythema with pustules, which clinically defines GPP, decreased by 60% at week 1, 94% by week 4 and 98% by week 16. Dermatology Life Quality Index (DLQI), which is a patient-reported measure, achieved a reduction of 6 points at week 4 and 11 points by week 16, each of which exceeded the minimal clinically importance difference (MCID) of 4 points. GPP Physician Global Assessment (GPPPGA) scale was implemented by protocol amendment during the course of the trial and was assessed in 4 of the 8 enrolled patients, where zero (clear) or 1 (almost clear) response was achieved in 2 (50%) patients at week 4 and 3 (75%) patients at week 16. Genotypic testing indicated homozygous wild-type IL-36RN, CARD14 and AP1S3 alleles for all 7 tested patients. Through week 16, anti-drug antibodies were only detected in one patient, which occurred at week 12 and did not impact imsidolimab pharmacokinetics or efficacy.

AnaptysBio, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM

2021-09-09 20:05:00

AnaptysBio, Inc. Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 07:00 AM. Venue: Lotte New York Palace Hotel, New York City, New York, United States. Speakers: Hamza Suria, President, CEO & Director.

AnaptysBio, Inc. Announces FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors

2021-08-17 20:32:00

AnaptysBio, Inc. announced that the U.S. Food and Drug Administration (FDA) approved a second indication for GSK’s JEMPERLI (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date. JEMPERLI is the first AnaptysBio-generated antibody to obtain FDA approval, and this is the second indication for JEMPERLI to be approved by the FDA in 2021. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). JEMPERLI is also being developed by GSK for the treatment of other tumor types and treatment settings, including currently ongoing phase III trials in recurrent or primary advanced endometrial cancer in combination with chemotherapy standard of care (RUBY) and the phase III FIRST study of platinum-based therapy with JEMPERLI and niraparib versus standard of care platinum-based therapy as first-line treatment of stage III or IV non-mucinous epithelial ovarian cancer. In addition, JEMPERLI is being evaluated as monotherapy and in combination therapy across multiple tumor types and other cancers, including platinum-resistant ovarian cancer, non-small cell lung cancer, multiple myeloma and melanoma. In the US, prevalence of dMMR across solid tumors has been estimated at 14%. Mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Tumors with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumors.