On January 10, 2022 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported an update on recent business highlights and its outlook for 2022 (Press release, Epizyme, JAN 10, 2022, View Source [SID1234598530]).

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"For Epizyme, 2021 was defined by key organizational changes that reduced our overall operating expenses while we accelerated TAZVERIK commercial adoption. As most recently reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021, substantial progress on tazemetostat combination trials was made throughout 2021. Additionally, we initiated SET-101, the first-in-human study of EZM0414, our novel, first-in-class, oral SETD2 inhibitor and consummated a commercialization and development collaboration with HUTCHMED intended to bring TAZVERIK to patients in greater China and accelerate development of tazemetostat in combination with other active agents," said Grant Bogle, President and Chief Executive Officer of Epizyme.

"Looking ahead to 2022, we plan to continue our focus on accelerating commercial adoption of TAZVERIK and advancing key clinical trial programs. We look forward to initiating the global Phase 3 portion of our SYMPHONY-1 study, which compares tazemetostat plus R2 to R2 plus placebo in R/R FL patients, gaining a greater understanding and insight into the ability of TAZVERIK to combine safely with other active agents both in hematological and solid tumor indications and sharing the initial safety results for EZM0414 from the SET-101 study. I look forward to providing updates on these important areas as we seek to progress our vision for growth."

Recent TAZVERIK (tazemetostat) Commercial Progress

Epizyme expects TAZVERIK net product revenue of between $11.2-11.7 million for the fourth quarter of 2021, including between $4.1-4.3 million related to the sale of TAZVERIK commercial product for third-party pharmaceutical company use in clinical trials. TAZVERIK commercial net sales in the fourth quarter of 2021 are expected to be between $7.0-7.5 million, representing an increase of approximately 35% when compared to $5.2 million in the third quarter of 2021.
For the full-year ended December 31, 2021, Epizyme expects TAZVERIK net product revenue of between $30.6-31.1 million, including between $7.3-7.5 million related to sales of TAZVERIK commercial product for third-party pharmaceutical company use in clinical trials. TAZVERIK commercial net sales for the full-year 2021 are expected to be between $23.2-23.7 million.
The amount of free goods supplied to patients through Epizyme’s patient assistance program is expected to represent approximately 30% of total end user demand for the fourth quarter of 2021 and 25% for the full-year 2021.
Total end user demand in the fourth quarter of 2021 is expected to represent at least a 14% increase over third quarter 2021 levels. This increase was driven primarily by sales for follicular lymphoma (FL).
Recent Pipeline Highlights

SYMPHONY-1: During the December 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, Epizyme shared encouraging updated safety and activity data from the Phase 1b portion of its Phase 1b/3 confirmatory study, SYMPHONY-1. The ongoing study is evaluating tazemetostat in combination with rituximab + lenalidomide (R2) in patients with relapsed or refractory (R/R) FL previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have progression of disease within two years (POD24). Based on the Phase 1b safety run-in results, in December 2021 Epizyme submitted a protocol amendment to the FDA with 800mg twice-daily (BID) as the tazemetostat dose for the global Phase 3 portion of the trial.
EZH-1301 (Solid Tumor) and EZH-1501 (Hematological) Basket Studies: During the fourth quarter of 2021, Epizyme initiated two basket studies – EZH-1301 and EZH-1501, to evaluate tazemetostat combinations in patients with solid tumors and hematological malignancies, respectively.
SET-101: Epizyme announced the initiation of its first-in-human study of EZM0414, Epizyme’s novel, first-in-class, oral SETD2 inhibitor, which is being developed for the treatment of adult patients with R/R multiple myeloma (MM) or R/R diffuse large B-cell lymphoma (DLBCL) in November 2021, and that the FDA granted Fast Track designation for EZM0414 in adult patients with DLBCL. Epizyme also shared preclinical data on EZM0414 along with the SET-101 Phase 1/1b clinical trial design at the 2021 ASH (Free ASH Whitepaper) conference.
2022 Projected Milestones

SYMPHONY-1: Epizyme continues to follow the 40 patients treated in the Phase 1b safety run-in portion of the study. Follow-up data from the safety run-in are anticipated to be presented at a medical conference later this year. Global startup activities for the Phase 3 randomized portion of the study are currently underway.
CELLO-1: CELLO-1, an open-label, randomized Phase 1b/2 study, is evaluating tazemetostat plus enzalutamide compared to enzalutamide monotherapy in metastatic castration-resistant Prostate Cancer patients (mCRPC). The Phase 2 efficacy portion of the study is more than one-half enrolled towards a target of 80 patients. Epizyme expects to complete enrollment in 2022. Patients from the Phase 1b portion of the study continue to be followed and Epizyme expects to present updated data from these patients in 2022.
LYSA Study: Patient enrollment is expected to complete in the ongoing Lymphoma Study Association (LYSA) Phase 2 clinical trial investigating tazemetostat plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone) in front-line high-risk FL and DLBCL in the first quarter of 2022. Epizyme expects that interim results from the trial in DLBCL and FL patients will be presented at a medical conference in 2022.
EZH-1301 (Solid Tumor) and EZH-1501 (Hematological) Basket Studies: The Company recently opened sites for these two basket studies, which sites are actively screening patients for enrollment in each of the studies. Epizyme plans to provide updates as the studies reach key enrollment milestones, as well as preliminary data in 2022.
Additional Tazemetostat Studies: Epizyme continues to advance additional clinical studies evaluating tazemetostat, including FDA post-marketing commitments.
SET-101: Epizyme recently opened sites for the dose escalation portion of the SET-101 trial, which are actively screening patients for enrollment in this first-in-human study and which Epizyme expects will enroll between 30-36 patients. Epizyme plans to provide updates as the study reaches key enrollment milestones along with preliminary safety data in 2022.
Cash Runway: Epizyme continues to expect its current cash runway to extend into the fourth quarter of 2022.
2022 Operating Expense Guidance: The Company expects 2022 non-GAAP adjusted operating expenses of between $170-190 million.
The Company’s estimates of net product revenue and commercial net sales of TAZVERIK and its ability to fund operations are preliminary and unaudited, represent management estimates as of the date of this release and are subject to completion of the Company’s financial closing procedures. As a result, the Company’s actual financial results may differ materially from the preliminary estimated financial information set forth above. The Company’s independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the estimates of net product revenue of TAZVERIK, commercial net sales, end user demand or estimates as to cash runway and operating expenses.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measure: total non-GAAP adjusted operating expenses on a projected basis. Epizyme derives this non-GAAP financial measure by excluding certain expenses and other items from the GAAP financial measure that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measure excludes stock-based compensation expense and depreciation and amortization of intangibles. The Company’s management believes that this non-GAAP financial measure is useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of this non-GAAP financial measure to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, this non-GAAP financial measure may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to projected GAAP adjusted operating expenses is not available without unreasonable effort primarily due to the Company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com

About EZM0414

EZM0414 is a potent, selective, oral, small molecule, investigational drug agent that inhibits the histone methyltransferase, SETD2, which plays a role in oncogenesis. SETD2 methylates histone as well as non-histone proteins, and this activity is involved in several key biological processes including transcriptional regulation, RNA splicing, and DNA damage repair. Based on the preclinical data on SETD2 inhibition by EZM0414 in multiple settings, including high risk t(4;14) multiple myeloma (MM) and in other B-cell malignancies such as diffuse large B-cell lymphoma (DLBCL), the Company is conducting SET-101, a Phase 1/1b study of EZM0414, for the treatment of adult patients with relapsed or refractory MM and DLBCL.

On January 10, 2022 Novocure (NASDAQ: NVCR) reported preliminary unaudited financial results and operational updates for the quarter and full year ended December 31, 2021 (Press release, NovoCure, JAN 10, 2022, View Source [SID1234598529]).* Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). TTFields are electric fields that disrupt cancer cell division.

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"Since our founding over 20 years ago, we have generated tremendous scientific data, technological knowledge and commercial experience supporting the clinical impact of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "With over a half a billion dollars in global annual revenues and numerous late-stage trials nearing completion, Novocure is approaching a critical inflection point for our company and cancer patients."

Financial and operational updates:

Total preliminary net revenues for the year ended December 31, 2021, were $535.0 million, up 8% over the prior year.
Total preliminary net revenues for the fourth quarter 2021 were $133.2 million. In the fourth quarter, the company did not recognize material revenue from its Medicare backlog. This compares to $11 million received from successful appeal of previously denied Medicare claims in the fourth quarter of 2020.
Preliminary fourth quarter 2021 net revenues from the United States, EMEA and Japan contributed $92.0 million, $26.5 million and $8.8 million, respectively. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
The number of active patients on therapy and the amount of net revenue recognized per active patient are our principal revenue drivers.
In the fourth quarter 2021, Novocure initiated contract negotiations with several large German payers that drove an update to the net revenue recognized per active patient, which negatively impacted fourth quarter revenue by approximately $4.0 million. Novocure believes this negotiated pricing is sustainable, will reduce the burden of case-by-case appeals and can be leveraged as the company expands into additional European markets.
As of December 31, 2021, there were 3,587 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,272, 1,008 and 307, respectively.
In the quarter ended December 31, 2021, 1,430 prescriptions were received. Prescriptions from North America, EMEA and Japan contributed 966, 349 and 115, respectively.
In 2022, the company expects to achieve active patient growth rates of 2% to 5%, in-line with the growth rate experienced in the fourth quarter 2021. Longer term, the company continues to expect further adoption in its core glioblastoma business.
Cash, cash equivalents and short-term investments were $937.7 million as of December 31, 2021.
Clinical and Product Development:

Given the limited total number of events seen to date in the fast-recruiting INNOVATE-3 pivotal trial in platinum-resistant ovarian cancer, Novocure anticipates the independent Data Monitoring Committee (DMC) will conduct its interim analysis in early Q2 2022. Timing of final data is unchanged and expected in 2023.
Today, Novocure is announcing its next generation array designed to increase Tumor Treating Fields dose delivery while limiting heat generation, thereby potentially increasing clinical efficacy. The next generation array design is complete, a healthy volunteer study is underway, and the company is working towards a limited market release in the EU later this year.
Novocure reiterates 2022 guidance for final data from its phase 3, pivotal LUNAR trial in non-small cell lung cancer and its phase 2 pilot EF-31 trial in gastric cancer.
Fourth quarter and full year 2021 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2021 financial results at 8 a.m. EST on Thursday, February 24, 2022. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8879093.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

* The unaudited results in this press release are preliminary and subject to the completion of the Company’s annual independent audit and, therefore, are subject to adjustment.

On January 10, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported an update on its clinical development programs and outlined its strategic priorities and upcoming expected milestones (Press release, Syros Pharmaceuticals, JAN 10, 2022, View Source [SID1234598528]).

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"2022 promises to be a transformative year as we continue to advance our studies of tamibarotene, SY-2101, and SY-5609. We are looking forward to three clinical data readouts this year as well as pivotal data from the SELECT-MDS-1 trial in late 2023 or early 2024," said Nancy Simonian, M.D., Syros’ Chief Executive Officer. "Additionally, in the second half of this year we expect to nominate our new development candidate from our CDK12 program, highlighting the productivity of our gene control discovery engine and our expertise in CDK inhibition. Together, we believe these upcoming milestones will provide insight into the clinical potential of our development-stage assets and lay the foundation for our long-term growth as we advance Syros into a fully integrated biopharmaceutical company."

Dr. Simonian continued, "We are pleased with our recent interactions with the U.S. Food and Drug Administration on the Phase 3 clinical trial design of SY-2101, which we now expect to initiate in the first quarter of 2023. In addition, based on preclinical data that supports CDK7 inhibition’s potential across a range of hematologic malignancies, we expect to start in the second half of this year a Phase 1 single agent study of SY-5609 in patients with relapsed blood cancers, including B-cell lymphomas, prior to moving into specific indications. We are excited to be the first company to advance a CDK7 inhibitor into hematology clinical development. The trial results have potential to benefit a broader patient population as well as demonstrate CDK7 inhibition as a novel approach for many difficult-to-treat hematologic cancers."

CLINICAL PROGRAM UPDATES AND UPCOMING MILESTONES

Targeted Hematology

Tamibarotene: Oral RARa agonist

Syros is evaluating tamibarotene in patients with RARA-positive newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). The Company expects to report data from the ongoing SELECT-MDS-1 Phase 3 trial evaluating tamibarotene in combination with azacitidine in HR-MDS in the fourth quarter of 2023 or first quarter of 2024, with a potential NDA filing expected in 2024.

Syros is also evaluating tamibarotene for the treatment of patients with RARA-positive newly diagnosed unfit acute myeloid leukemia (AML). The Company expects to report data from the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial evaluating tamibarotene in combination with azacitidine and venetoclax in the second half of 2022.

SY-2101: Oral arsenic trioxide (ATO)

Syros is evaluating SY-2101 in patients with newly diagnosed acute promyelocytic leukemia (APL). The Company expects to report PK and safety data from its ongoing dose confirmation trial in mid-2022. The feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) in November 2021 continues to support molecular complete response rate as the primary endpoint for accelerated approval and event free survival as the primary endpoint for full approval, in each case compared to historic IV ATO data. Additionally, based on the feedback, Syros now expects the trial to enroll approximately 215 patients randomized two to one to receive SY-2101 or intravenously administered (IV) ATO. The IV ATO arm will allow safety and tolerability comparisons. Syros now expects to initiate the Phase 3 trial in the first quarter of 2023 and to announce data in 2025.

Selective CDK Inhibition

SY-5609: Oral CDK7 inhibitor

In the fourth quarter of 2021, Syros initiated the expansion cohort evaluating SY-5609 in combination with chemotherapy in patients with second-line metastatic pancreatic cancer. The cohort is expected to enroll approximately 50 pancreatic cancer patients who have progressed following first-line treatment with FOLFIRINOX. Patients will receive either SY-5609 in combination with gemcitabine, or SY-5609 in combination with gemcitabine and nab-paclitaxel, at the approved doses of the combination agents. The study will evaluate safety and tolerability, as well as efficacy measures such as disease control rate and progression free survival. Syros expects to report safety lead-in data of SY-5609 in combination with chemotherapy in the second half of 2022.

Syros also plans to evaluate the potential of SY-5609 in hematologic tumors. Based on mechanistic rationale and preclinical data, which support the potential of CDK7 inhibition in a broad range of blood cancers, Syros will evaluate the maximum tolerated dose of SY-5609 in patients with relapsed hematologic malignancies, including B-cell lymphomas, such as mantle cell lymphoma, before starting a focused expansion cohort. The Phase 1 trial is expected to begin in the second half of 2022, with data expected mid-2023, which will inform further development in specific hematologic cancers.

In August 2021, Syros entered into an agreement with Roche to explore SY-5609 in combination with atezolizumab in patients with BRAF-mutant colorectal cancer (CRC), and Roche plans for this arm of its ongoing Phase 1/1b INTRINSIC trial to be open for enrollment in the first half of this year. Under the terms of this agreement, Roche is the sponsor of the trial and Syros is supplying SY-5609.

Gene Control Discovery Engine

Syros announced today that the next development candidate from its gene control discovery engine will be a CDK12 inhibitor. Syros plans to nominate this candidate in the second half of 2022.

Syros also announced today that small molecule inhibitors of CDK11 and WRN are the focus of two additional oncology programs in discovery.

Financial Guidance

Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into 2023.

On January 10, 2022 Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, reported that Michael Gilman, Ph.D., Chief Executive Officer, will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 8:30 a.m. ET (Press release, Arrakis Therapeutics, JAN 10, 2022, View Source [SID1234598527]).

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On January 10, 2022 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the exercise of its option to acquire Adaptate Biotherapeutics ("Adaptate"), a UK company focused on developing antibody-based therapeutics for the modulation of variable delta 1 (Vδ1) gamma delta (γδ) T cells (Press release, Takeda, JAN 10, 2022, View Source [SID1234598526]). Through the acquisition, Takeda will obtain Adaptate’s antibody-based γδ T cell engager platform, including pre-clinical candidate and discovery pipeline programs. Adaptate’s γδ T cell engagers are designed to specifically modulate γδ T cell-mediated immune responses at tumor sites while sparing damage to healthy cells.

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The planned acquisition of Adaptate follows Takeda’s recently exercised option to acquire GammaDelta Therapeutics ("GammaDelta") and is intended to further accelerate the development of innovative γδ T cell-based therapies. Combining GammaDelta’s cell therapy-based platform and Adaptate’s antibody-based γδ T cell engager platform with Takeda’s strong research and development organization positions Takeda to be at the leading edge in deploying the full potential of γδ T cells in the fight against cancer. The planned acquisition complements Takeda’s ongoing efforts to research and develop cell engagers for solid tumor applications, bolstered by the novel T cell engager COBRA platform, which was acquired from Maverick Therapeutics in another successful build-to-buy collaboration.

"Partnering with early-stage innovators to access cutting-edge platforms in the fight against cancer is at the center of our R&D strategy," said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "Adaptate’s γδ T cell engager platform and the team’s deep understanding of γδ T cell biology gives us an opportunity to develop a new class of therapeutics that tap into powerful innate immune mechanisms. The planned acquisition will strengthen our immuno-oncology R&D efforts as part of our ongoing pursuit of life-transforming medicines for patients with cancer."

Adaptate was formed in 2019 as a spin-out company from GammaDelta with investment from Abingworth LLP and Takeda, in which Takeda received an exclusive right to purchase Adaptate for a pre-negotiated upfront payment. The acquisitions of Adaptate and GammaDelta are expected to be finalized in Q1 of Takeda’s fiscal year 2022, pending completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.

"Our acquisition by Takeda recognizes the tremendous work put in over the last two years by Adaptate’s incredibly talented team," said Dr. Natalie Mount, CEO of Adaptate. "We have rapidly demonstrated, in preclinical models, the therapeutic potential of our novel Vδ1-targeting antibodies, and this move brings us an exciting step closer to realizing the full potential for Vδ1 T cell targeted therapies to improve treatment outcomes for cancer patients."

In addition, Tim Haines, Chair & Managing Partner at Abingworth noted, "Having played an instrumental role in creating Adaptate, we are delighted to see the impressive developments of its γδ T cell therapeutic antibody portfolio to date, under the leadership of Natalie Mount. We look forward to seeing Takeda progress Adaptate’s very promising therapeutic antibodies into the clinic."

Takeda’s oncology pipeline focuses on novel strategies that leverage the power of the immune system, with a focus on innate immunity. Innate immune responses serve as the body’s first defense mechanism against disease and involve the orchestration of a broad arsenal of mechanisms and cell types, including γδ T cells and natural killer (NK) cells, that may help to overcome cancer’s ability to evade immune recognition. Adaptate has discovered a unique set of antibodies that selectively modulate γδ T cell activity in the tumor microenvironment. The antibodies provide a precisely targeted signal to the immune system, thereby offering the opportunity for superior efficacy and safety compared to conventional immuno-oncology approaches in solid tumors.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com