On November 4, 2021 NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended September 30, 2021 (Press release, NGM Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594432]).

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"This quarter we made notable progress advancing NGM’s oncology portfolio, now four assets strong, all generated by our in-house discovery engine and wholly owned by NGM," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We reported the first preliminary human data from our NGM120 trial at ESMO (Free ESMO Whitepaper) 2021 and also unveiled our third myeloid reprogramming program, NGM831. Over the past 12 months, we have pulled back the curtain on the intensive discovery work in oncology that has been underway at NGM for several years. Leveraging integrated world-class target discovery research and protein engineering, we’ve created multiple oncology product candidates each with the potential to become next-generation treatment options to help patients mobilize their own immune systems to fight cancer more effectively. We strongly believe myeloid cell reprogramming can be an important additional approach to augment anti-tumor immunity and our portfolio of product candidates provide multiple opportunities to harness that biology."

Key Third Quarter and Recent Highlights

Cancer

Presented preliminary findings from ongoing Phase 1a/1b dose escalation study of NGM120, a first-in-class anti-GDNF family receptor alpha like (GFRAL) antagonist antibody, in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress. Preliminary results showed that treatment with the drug was well tolerated with no dose-limiting toxicities. All six evaluable metastatic pancreatic cancer patients in the Phase 1b combination cohort (NGM120 in combination with gemcitabine + Nab-paclitaxel) demonstrated disease control at 16 weeks, with three partial responses (PR) and three stable disease (SD). Four metastatic pancreatic cancer patients in the Phase 1b cohort continued to exhibit PR/SD beyond 36 weeks at the July 26 data cut-off, compared to the historic median progression-free survival in metastatic pancreatic cancer of 22 weeks1. As of September 16, 2021, three of those four patients remained on drug, with two patients exhibiting PR and one patient exhibiting SD beyond 44 weeks.
Continued enrollment in a Phase 2 placebo-controlled component of the ongoing Phase 1/2 PINNACLES study, with the Phase 2 component testing NGM120 as a first-line treatment in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer. In March 2021, NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled component of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer as part of the ongoing Phase 1/2 trial. The Phase 2 component of the study is designed to enroll approximately 60 patients and will assess the efficacy, safety and tolerability of NGM120 or placebo in combination with gemcitabine and Nab-paclitaxel against both cancer and cancer-related cachexia endpoints.
Initiated the Phase 1 component of a Phase 1/2 Study of NGM707, a novel dual antagonist antibody that inhibits the Immunoglobulin-like Transcript 2 (ILT2) and Immunoglobulin-like Transcript 4 (ILT4) receptors, for the treatment of patients with advanced solid tumors. The Phase 1 portion (n≅60) of the study includes a monotherapy dose escalation arm (Part 1a) and a dose-finding arm in combination with KEYTRUDA (pembrolizumab) (Part 1b). The Phase 2 portion (n≅120) of the study will employ a basket design that will include expansion cohorts of patients treated with NGM707 monotherapy (Part 2a) or NGM707 in combination with KEYTRUDA (Part 2b) in a variety of selected solid tumor types.
Disclosed fourth oncology development candidate, NGM831, coinciding with a publication on the ILT3-fibronectin pathway in Cancer Immunology Research. In August 2021, NGM disclosed its fourth oncology development candidate, NGM831, an antagonist antibody designed to block the interaction of Immunoglobulin-like transcript 3 (ILT3) with fibronectin, a key component of tumor stroma, as well as with other ligands. ILT3-fibronectin interactions within the tumor microenvironment may form a stromal checkpoint that actively suppresses myeloid cell function and inhibits tumor activity. NGM plans to advance NGM831 into a Phase 1 study in the first half of 2022. NGM831 joins NGM438 to become the second program in the Company’s oncology portfolio being studied for the potential to impact the tumor microenvironment by releasing stromal checkpoints.
Retinal disease

Completed enrollment in the Phase 2 CATALINA study of NGM621 in patients with geographic atrophy. NGM completed enrollment in the Phase 2 CATALINA study, a multi-center, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal, or IVT, injections of NGM621 every four weeks or every eight weeks in 320 patients with geographic atrophy in one or both eyes secondary to age-related macular degeneration. The primary efficacy endpoint is the rate of change in geographic atrophy lesion area, as measured by fundus autofluorescence imaging over 52 weeks of treatment. NGM anticipates reporting topline data from the CATALINA study in the second half of 2022. Upon completion of a proof-of-concept study in humans, Merck has a one-time option to license NGM621 and its related molecules or to license NGM621 and its related molecules together with all other ophthalmology compounds included within the scope of our ongoing collaboration with Merck.
Liver and metabolic diseases

Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with compensated non-alcoholic steatohepatitis (NASH) cirrhosis (liver fibrosis stage 4, or F4). The 48-week study is designed to assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
Merck continued enrollment in its Phase 2b study of MK-3655 in patients with NASH and liver fibrosis stage 2 or 3 (F2 or F3). In November 2020, Merck initiated a global Phase 2b multicenter study of MK-3655 for the treatment of patients with F2 or F3 NASH. The 52-week randomized, double-blind study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg once monthly doses of MK-3655 compared to placebo. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM’s completion of a proof-of-concept study. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue sharing arrangement of up to 50%.
Third Quarter 2021 Financial Results

NGM reported a net loss of $28.9 million for the quarter ended September 30, 2021, compared to a net loss of $29.8 million for the same period in 2020.
Related party revenue from our collaboration with Merck was $18.6 million for the quarter ended September 30, 2021, compared to $23.5 million for the same period in 2020. Related party revenue decreased $4.9 million in the quarter ended September 30, 2021 as compared to the prior year period, primarily due to a decrease in research and development revenue.
R&D expenses were $38.7 million for the quarter ended September 30, 2021, compared to $47.0 million for the same period in 2020. R&D expenses decreased $8.3 million in the quarter as compared to the prior year period, primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $8.9 million for the quarter ended September 30, 2021, compared to $6.5 million for the same period in 2020. The $2.4 million increase in general and administrative expenses in 2021 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations.
Cash, cash equivalents and short-term marketable securities were $383.4 million as of September 30, 2021, compared to $295.2 million as of December 31, 2020.

On November 4, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the third quarter ended September 30, 2021 and provided pipeline updates (Press release, AnaptysBio, NOV 4, 2021, View Source [SID1234594448]).

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"Our wholly-owned pipeline continues to make progress with the recent initiation of our imsidolimab GEMINI-1 Phase 3 trial in GPP and anticipated initiation of our rosnilimab AZURE alopecia areata Phase 2 trial during the remainder of 2021," said Hamza Suria, president and chief executive officer of AnaptysBio. "We believe the recent royalty monetization transaction with Sagard validates the future revenue stream anticipated from JEMPERLI sales and further supports AnaptysBio’s capital-efficient business model."

Imsidolimab (Anti-IL-36 Receptor) Program

Following an end-of-Phase 2 meeting with the FDA in Q2 2021, we publicly disclosed Phase 3 trial designs for imsidolimab in generalized pustular psoriasis (GPP), GEMINI-1 and GEMINI-2. The primary endpoint of our GEMINI-1 Phase 3 trial is the proportion of patients achieving a score of clear (0) or almost clear (1) skin on the Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) at week 4 in 45 patients randomized against placebo. GEMINI-2 will assess 6 months of monthly subcutaneous dosing and safety follow-up of those same patients. GEMINI-1 was initiated in Q3 2021.
Full data from the Phase 2 GALLOP trial in GPP, including efficacy and safety of imsidolimab treatment through week 16, was disclosed in an oral presentation by Dr. Johann Gudjonsson, professor of Dermatology at the University of Michigan, at the European Academy of Dermatology and Venereology (EADV) Congress on October 2nd, 2021. Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) GPP patients achieving the primary endpoint at week 4 and 16. We also observed early reduction of erythema with pustules by 60% at week 1, 94% reduction at week 4, 98% reduction at week 16, each versus baseline.
We anticipate top-line data from the ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1 2022 and from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program

We anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer trial of rosnilimab, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of rosnilimab in single and multiple ascending dose cohorts.
We plan to initiate a randomized, placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs

JEMPERLI (dostarlimab), our proprietary anti-PD-1 antagonist antibody under an immune-oncology partnership with GSK, was approved in a second clinical indication by the FDA in August 2021 for the treatment of pan-deficient mismatch repair tumors. We received $20 million from GSK upon this approval.
We announced the signing of a royalty monetization agreement with Sagard Healthcare Royalty Partners where AnaptysBio will receive a $250 million payment upon closing in exchange for JEMPERLI royalties due to AnaptysBio on annual commercial sales below $1 billion and certain future milestones starting October 2021. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment. The closing of the transaction is subject to the satisfaction of customary closing conditions and is anticipated by year-end 2021.
Third Quarter Financial Results

Cash, cash equivalents and investments totaled $389.3 million as of September 30, 2021, compared to $411.2 million as of December 31, 2020, for a decrease of $21.9 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $20.9 million and $62.2 million for the three and nine months ended September 30, 2021. The $20.9 million earned during the third quarter primarily relates to milestone and royalty revenue for the US approval of JEMPERLI (dostarlimab), compared to zero and $15.0 million of milestone revenue for the three and nine months ended September 30, 2020.
Research and development expenses were $22.2 million and $71.7 million for the three and nine months ended September 30, 2021, compared to $19.5 million and $58.5 million for the three and nine months ended September 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.4 million and $16.1 million for the three and nine months ended September 30, 2021, compared to $4.8 million and $13.8 million for the three and nine months ended September 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $6.7 million and $25.3 million for the three and nine months ended September 30, 2021, or a net loss per share of $0.24, and $0.92, compared to a net loss of $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96.
Financial Guidance

Following the anticipated closing of the Sagard royalty monetization transaction by the end of 2021, we anticipate ending 2021 with approximately $600 million in cash and will continue to operate in a capital-efficient manner.

On November 4, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results for the third quarter 2021, and provided a corporate update on recent highlights and anticipated near-term milestones (Press release, Surface Oncology, NOV 4, 2021, View Source [SID1234594483]).

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"Surface continues to make considerable progress across our pipeline of novel cancer immunotherapies, highlighted by the announcement of our planned randomized Phase 2 study evaluating SRF388, our potential first-in-class antibody therapy against IL-27, in combination with Roche’s atezolizumab and bevacizumab," said Rob Ross, M.D., chief executive officer of Surface Oncology. "We believe more than ever in our approach targeting the adenosine pathway for the treatment of cancer and the potential of our next-generation antibody therapies in promoting immune activation in the tumor microenvironment. Looking ahead, we remain on track to provide clinical updates on our wholly-owned clinical programs, both as a single-agent and combination therapy, with data from SRF617 expected later this year, and SRF388 data expected in early 2022."

Third Quarter and Subsequent Corporate Highlights:

On November 2, 2021, Surface announced that two abstracts were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021, in Washington D.C. and virtually. The two abstracts will highlight new preclinical data from the Company’s two wholly-owned clinical-stage programs, SRF617 and SRF388.

On October 4, 2021, Surface announced details about its plan to initiate a randomized Phase 2 clinical study evaluating SRF388 in combination with Roche’s atezolizumab and bevacizumab, in patients with treatment-naïve hepatocellular carcinoma (HCC). Initiation-enabling activities are underway and the Company expects to dose the first patient in early 2022.

On July 8, 2021, Surface announced the appointment of Denice Torres to its board of directors as lead independent director. Ms. Torres has over 25 years of executive leadership experience in healthcare across the consumer, biopharmaceutical and medical device sectors.
Selected Anticipated Near-term Corporate Milestones:

Investigational New Drug (IND) filing for GSK4381562, formerly SRF813, targeting the PVRIG checkpoint and partnered with GlaxoSmithKline, will be filed in Q4 2021.

Data update for SRF617 anticipated at the European Society for Medical Oncology Immuno-Oncology Congress taking place December 8-11, 2021.

Data update for SRF388 anticipated in early 2022.
Financial Results:

As of September 30, 2021, cash, cash equivalents and marketable securities were $149.7 million, compared to $175.1 million on December 31, 2020.

Research and development (R&D) expenses were $14.0 million for the third quarter ended September 30, 2021, compared to $9.5 million for the same period in 2020. This increase was primarily driven by progress on both our SRF617 and SRF388 Phase 1 clinical trials. R&D expenses included $0.8 million in stock-based compensation expense for the third quarter ended September 30, 2021.

General and administrative (G&A) expenses were $5.8 million for the third quarter ended September 30, 2021, compared to $4.9 million for the same period in 2020. This increase was primarily due to increases in personnel and facility related costs. G&A expenses included $1.2 million in stock-based compensation expense for the third quarter ended September 30, 2021.

For the third quarter ended September 30, 2021, net loss was $19.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.44. Net loss was $15.8 million for the same period in 2020, or basic and diluted net loss per share attributable to common stockholders of $0.39.

Financial Outlook:

In October 2021, Surface expanded its existing debt facility with K2 HealthVentures, increasing the capacity to $50M. Based upon its current operating plan and an anticipated near-term milestone from GSK, Surface maintains a projected cash runway through 2023.

On November 4, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported clinical results and real world data from its hematology program to be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, including two oral presentations on the Phase 3 SEQUOIA trial comparing BRUKINSA (zanubrutinib) to bendamustine and rituximab (B+R) in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, NOV 4, 2021, View Source [SID1234594500]). The ASH (Free ASH Whitepaper) meeting will take place on December 11-14, 2021, as a hybrid event in Atlanta, GA and in a virtual format.

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Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene, commented: "Together with ALPINE, the positive SEQUOIA trial provides evidence that BRUKINSA can improve treatment outcomes for patients with CLL. Data at ASH (Free ASH Whitepaper) this year reinforce our belief that BRUKINSA’s differentiated design can bring patients clinical benefits, including those who experience treatment discontinuation with other BTK inhibitors. We look forward to sharing more details on our clinical progress in our hematology portfolio with the medical community in Atlanta."

BRUKINSA Shows Promise in Improving CLL Treatment Outcomes with Positive Results in SEQUOIA (vs. B+R) and ALPINE (vs. Ibrutinib)

Following the positive ALPINE trial of BRUKINSA versus ibrutinib in patients in the relapsed or refractory (R/R) setting in June 2021, BRUKINSA demonstrated superiority over B+R as a first-line treatment for patients with CLL in SEQUOIA, the second positive Phase 3 trial of BRUKINSA in CLL.

Data from the randomized Cohort 1 of SEQUOIA met the primary endpoint at interim analysis, with BRUKINSA achieving a highly statistically significant improvement in progression-free survival (PFS) compared to B+R regimen. Efficacy results were consistent between independent review committee (IRC) and investigator assessments, with a hazard ratio (HR) of 0.42 for both, and were observed across patient characteristics. The data also demonstrated superiority in efficacy measured by overall response rate (ORR) as assessed by both IRC and investigator. Similar to data observed in its broad global clinical program, BRUKINSA was generally well-tolerated in patients with CLL. In particular, low rates of a key safety measurement—atrial fibrillation—were observed in the SEQUOIA trial, consistent with data from ASPEN and ALPINE, the two head-to-head Phase 3 trials of BRUKINSA versus ibrutinib.

In addition, early safety results from the ongoing Cohort 3 (Arm D) evaluating BRUKINSA in combination with Bcl-2 inhibitor venetoclax for CLL patients with del(17p), a high-risk characteristic, suggested a good tolerability profile of the combination.

Additional Data at ASH (Free ASH Whitepaper) Support BRUKINSA’s Potential as an Alternative for Patients Intolerant to Other BTK Inhibitors

To address tolerability issues commonly seen in other BTK inhibitors, BRUKINSA was purposefully designed to optimize selectivity to avoid off-target effects. In the ongoing Phase 2 trial BGB-3111-215 in patients with relapsed or refractory (R/R) B-cell malignancies who were intolerant to prior treatment with other approved BTK inhibitors, continued disease control or improved responses were observed with BRUKINSA treatment. The majority of patients (73%) on BRUKINSA did not experience recurrence of adverse events that led to treatment discontinuation with other BTK inhibitors.

BeiGene Presentations at the 63rd ASH (Free ASH Whitepaper) Annual Meeting

Abstract Information

Date and Time

Presenting Author

Oral Presentations

#396: SEQUOIA: Results of a Phase 3 Randomized Study of Zanubrutinib versus Bendamustine + Rituximab (BR) in Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I

Sun, Dec 12

10:45 AM ET

Constantine Tam

#67: Zanubrutinib in Combination with Venetoclax for Patients with Treatment-Naïve (TN) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with del(17p): Early Results from Arm D of the SEQUOIA (BGB-3111-304) Trial

642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I

Sat, Dec 11

10:45 AM ET

Alessandra Tedeschi

Poster or Mini Oral Presentations

#1410: Phase 2 Study of Zanubrutinib in BTK Inhibitor-Intolerant Patients (Pts) With Relapsed/Refractory B-cell Malignancies

626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I

Sat, Dec 11

5:30 PM ET

Mazyar Shadman

#1419: Preliminary Safety and Efficacy Data from Patients (Pts) With Relapsed/Refractory (R/R) B-cell Malignancies Treated with the Novel B-cell Lymphoma 2 (BCL2) Inhibitor BGB-11417 in Monotherapy or in Combination with Zanubrutinib

626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I

Sat, Dec 11

5:30 PM ET

Constantine Tam

#3540: Preliminary Safety and Efficacy from a Multicenter, Investigator-Initiated Phase II Study in Untreated TP53 Mutant Mantle Cell Lymphoma with Zanubrutinib, Obinutuzumab, and Venetoclax (BOVen)

623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III

Mon, Dec 13

6:00 PM ET

Anita Kumar

#4078: Real-World Testing Patterns for Risk Assessment and Implications on the Adoption of Novel Therapeutics in Chronic Lymphocytic Leukemia: IGHV Mutation Status, FISH Cytogenetic, and Immunophenotyping

905. Outcomes Research—Lymphoid Malignancies: Poster III

Mon, Dec 13

6:00 PM ET

Asher Chanan-Khan

#3046: Real-World Bruton Tyrosine Kinase Inhibitor Treatment Patterns, Compliance, Costs, and Hospitalizations in Patients with Mantle Cell Lymphoma in the United States

905. Outcomes Research—Lymphoid Malignancies: Poster II

Sun, Dec 12

6 PM ET

Bijal Shah

#4009: Productivity Loss and Indirect Costs Among Non-Hodgkin Lymphoma Patients and Their Caregivers

902. Health Services Research—Lymphoid Malignancies: Poster III

Mon, Dec 13

6:00 PM ET

Asher Chanan-Khan

#4077: Impact of Atrial Fibrillation on Cardiovascular and Economic Outcomes in Patients with Chronic Lymphocytic Leukemia

905. Outcomes Research—Lymphoid Malignancies: Poster III

Mon, Dec 13

6:00 PM ET

Anjana Mohan

#4079: Real-World Treatment Patterns, Adherence and Healthcare Resource Utilization for Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia Among Veterans in the United States

905. Outcomes Research—Lymphoid Malignancies: Poster III

Mon, Dec 13

6:00 PM ET

Asher Chanan-Khan

#3048: Real-World Disease Burden, Costs and Resource Utilization of Hospital-Based Care Among Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Marginal Zone Lymphoma and Chronic Lymphocytic Leukemia: Disparities and Risk Factors

905. Outcomes Research—Lymphoid Malignancies: Poster II

Sun, Dec 12

6 PM ET

Asher Chanan-Khan

#1968: Factors Associated with Treatment Among Older Adults Diagnosed with Chronic Lymphocytic Leukemia: An Analysis Using Medicare Claims Data

905. Outcomes Research—Lymphoid Malignancies: Poster I

Sat, Dec 11

5:30 PM ET

Eberechukwu Onukwugha

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**;
For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);
For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);
For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);
For the treatment of adult patients with WM (United States, August 2021);
For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;
For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021);
For the treatment of MCL in patients who have received at least one prior therapy (Israel, October 2021);
For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021);
For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021); and
For the treatment of adult patients with MCL who have received at least one previous therapy (Russia, October 2021).
*

This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

To-date, more than 30 marketing authorization applications in multiple indications have been submitted in the United States, China, the European Union, and more than 20 other countries or regions.

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On November 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that Aviad Pato, Ph.D., Head of Immunology Research, presented data on two nicotinamide (NAM)-enabled NK cell therapies, GDA-501 and GDA-301, at the Protein & Antibody Engineering Summit (PEGS) Europe taking place in Barcelona, Spain, and virtually November 2-4, 2021 (Press release, Gamida Cell, NOV 4, 2021, View Source [SID1234594517]).

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The presentation included data from early-stage studies of GDA-501, Gamida Cell’s investigational cell therapy comprised of CAR-engineered NK cells designed to enhance homing and activation against cancers with HER2 overexpression such as breast, ovarian, lung, bladder, and gastric cancers. Data were also presented on GDA-301, which combines a CRISPR/Cas9 knockout of the CISH (cytokine inducible SH2 containing protein) gene in NK cells with a membrane-bound IL-15/IL-15Ra CAR, which is designed to improve tumor killing by promoting activation and inhibiting negative feedback signals and has potential application in a range of solid tumors and hematologic malignancies.

Data presented by Gamida Cell demonstrated that the engineered GDA-501 NK enhances potency and cytotoxicity against a HER2-expressing tumor cell line. Data also showed that GDA-301 has cytotoxic activity against a chronic myelogenous leukemia cell line (K562) and a multiple myeloma cell line (RPMI).

"The field of NK cell immunotherapy is advancing beyond what has previously been understood from T cell gene editing," said Yona Geffen, Ph.D., Vice President, Research and Development at Gamida Cell. "We are pleased to share this important update on two key potential therapies in Gamida Cell’s robust NK pipeline that show their potential as clinical immunotherapy agents."

The full presentation shared at PEGS Europe is available at www.gamida-cell.com.