On July 27, 2023 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2023 (Press release, AbbVie, JUL 27, 2023, View Source [SID1234633446]).

"AbbVie’s second quarter results were well ahead of our expectations as we continue to demonstrate outstanding operational execution. The strong performance was driven predominantly by our non-Humira business, which delivered high single-digit sales growth, in line with our long-term outlook," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We continue to make progress across all stages of our pipeline and based upon the strong momentum of our diversified portfolio, we are once again raising our full year guidance."

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Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Second-Quarter Results

•Worldwide net revenues were $13.865 billion, a decrease of 4.9 percent on a reported basis, or 4.2 percent on an operational basis.

•Global net revenues from the immunology portfolio were $6.813 billion, a decrease of 5.5 percent on a reported basis, or 5.0 percent on an operational basis.
◦Global Humira net revenues of $4.012 billion decreased 25.2 percent on a reported basis, or 24.8 percent on an operational basis. U.S. Humira net revenues were $3.452 billion, a decrease of 26.0 percent. Internationally, Humira net revenues were $560 million, a decrease of 19.8 percent on a reported basis, or 17.0 percent on an operational basis.
◦Global Skyrizi net revenues were $1.883 billion, an increase of 50.4 percent on a reported basis, or 51.0 percent on an operational basis.
◦Global Rinvoq net revenues were $918 million, an increase of 55.1 percent on a reported basis, or 56.7 percent on an operational basis.

•Global net revenues from the hematologic oncology portfolio were $1.478 billion, a decrease of 10.4 percent on a reported basis, or 9.8 percent on an operational basis.
◦Global Imbruvica net revenues were $907 million, a decrease of 20.8 percent, with U.S. net revenues of $666 million and international profit sharing of $241 million.
◦Global Venclexta net revenues were $571 million, an increase of 13.1 percent on a reported basis, or 15.0 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $1.885 billion, an increase of 13.6 percent on a reported basis, or 14.2 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $748 million, an increase of 10.2 percent on a reported basis, or 11.3 percent on an operational basis.
◦Global Vraylar net revenues were $658 million, an increase of 33.9 percent.
◦Global Ubrelvy net revenues were $196 million, an increase of 5.9 percent on a reported basis, or 6.0 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.384 billion, an increase of 1.0 percent on a reported basis, or 2.9 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $685 million, a decrease of 1.4 percent on a reported basis, or an increase of 0.7 percent on an operational basis.
◦Global Juvederm net revenues were $368 million, an increase of 6.9 percent on a reported basis, or 9.7 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the second quarter was 69.4 percent. The adjusted gross margin ratio was 84.7 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 23.6 percent of net revenues. The adjusted SG&A expense was 23.2 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 12.5 percent of net revenues. The adjusted R&D expense was 12.5 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

•Acquired IPR&D and milestones expense was 2.0 percent of net revenues.

•On a GAAP basis, the operating margin in the second quarter was 32.5 percent. The adjusted operating margin was 47.0 percent.

•Net interest expense was $454 million.

•On a GAAP basis, the tax rate in the quarter was 22.3 percent. The adjusted tax rate was 15.8 percent.

•Diluted EPS in the second quarter was $1.14 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.91. These results include an unfavorable impact of $0.15 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
2

Recent Events

•AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. The approval is based on results from three studies in which Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This is the seventh FDA approved indication for Rinvoq across gastroenterology, rheumatology and dermatology.

•AbbVie announced Skyrizi (risankizumab) met the primary and key secondary endpoints in a 52-week Phase 3 maintenance study in patients with moderately to severely active ulcerative colitis (UC). In UC patients with a clinical response to Skyrizi induction treatment, a significantly higher proportion of patients treated with Skyrizi (180 mg or 360 mg) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52 compared to withdrawal from Skyrizi treatment. Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of Skyrizi compared to Otezla among adult patients with moderate plaque psoriasis (PsO) eligible for systemic therapy. In the study, significantly more patients achieved co-primary endpoints of psoriasis area and severity index (PASI) 90 and static physician’s global assessment (sPGA) 0/1 at week 16 with Skyrizi versus Otezla. Skyrizi was well-tolerated with no new safety signals identified.

•At the 2023 European Congress of Rheumatology (EULAR), AbbVie presented results from the Phase 2 SLEek study which demonstrated that Rinvoq, alone or as combination therapy, met the primary and key secondary endpoints in adults with moderately to severely active systemic lupus erythematosus (SLE). AbbVie also presented long-term data further supporting the efficacy and safety profile of Rinvoq across additional rheumatic diseases. Presentations included five-year results from the SELECT-COMPARE clinical trial evaluating Rinvoq and Humira (adalimumab), both in combination with methotrexate (MTX), in adult patients with moderate to severely active rheumatoid arthritis (RA) who had an inadequate response to MTX; three-year results from the SELECT-PsA 1 clinical trial evaluating Rinvoq in psoriatic arthritis (PsA) patients with prior inadequate response or intolerance to one or more non-biologic disease-modifying antirheumatic drugs (DMARDs); and one-year results from the SELECT-AXIS 2 clinical trial evaluating Rinvoq in patients with active ankylosing spondylitis (AS) who had an inadequate response to biologic DMARD therapy.

•At the 2023 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 29 abstracts demonstrating the breadth of its gastroenterology portfolio. Notable presentations highlighted efficacy and safety outcomes from the Rinvoq and Skyrizi clinical trial programs in adults with moderately to severely active CD as well as investigational use of Linzess (linaclotide) in treating functional constipation in pediatric patients aged 6 to 17 years.

•AbbVie and Genmab announced that the FDA approved Epkinly (epcoritamab) as the first bispecific antibody for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma, after two or more lines of systemic therapies. Additionally, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Tepkinly (epcoritamab) for the treatment of adults with r/r DLBCL. Epkinly/Tepkinly is being co-developed by AbbVie and Genmab.

Recent Events (Continued)

•AbbVie and Genmab announced positive topline results from the follicular lymphoma (FL) cohort of the Phase 1/2 EPCORE NHL-1 clinical trial evaluating Epkinly in patients with r/r FL. The topline results showed an overall response rate (ORR) of 82 percent, which exceeded the protocol prespecified threshold for efficacy, and the median duration of response (DOR) was not reached and longer follow-up will be required. No new safety signals were observed with Epkinly and full study results will be submitted for presentation at a future medical meeting. Based on the topline results, AbbVie and Genmab will engage global regulatory authorities to discuss next steps.

•At the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, AbbVie announced new data from two studies which continued to show sustained progression free survival (PFS) in chronic lymphocytic leukemia (CLL) patients after fixed-duration treatment with Venclexta (venetoclax) combination regimens across different lines of therapy. The findings were from a six-year median follow-up from the Phase 3 CLL14 study as well as a final seven-year follow-up from the Phase 3 MURANO trial. Venclexta is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

•AbbVie announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. The positive CHMP opinion is based on results from two pivotal Phase 3 studies evaluating atogepant for the prophylaxis of migraine in adults with episodic or chronic migraine. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist treatment spanning both episodic and chronic migraine in the European Union (EU).

•Allergan Aesthetics announced that the FDA approved Skinvive by Juvederm for improved skin smoothness of the cheeks. Skinvive is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months with optimal treatment.

•AbbVie and Calibr announced an expanded strategic collaboration to advance several innovative preclinical and early-stage clinical assets across AbbVie’s core therapeutic areas including immunology, oncology, neuroscience and other areas of interest. This partnership is an expansion of the collaboration AbbVie and Scripps Research formed in 2019 to develop a broad range of potential new and novel therapeutics.

Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.57 – $10.97 to $10.90 – $11.10, which includes an unfavorable impact of $0.23 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2023. The company’s 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2023, as both cannot be reliably forecasted.

On July 27, 2023 Astrazeneca reported that high-level results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2-expressing advanced solid tumours, two secondary endpoints of the trial (Press release, AstraZeneca, JUL 27, 2023, View Source [SID1234633438]).

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In the primary analysis, Enhertu continued to show durable responses based on investigator-assessed confirmed objective response rate (ORR), the primary endpoint of the trial, and duration of response (DoR), a secondary endpoint; reinforcing results from an interim analysis of the trial recently presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "The progression-free survival and overall survival results for Enhertu alongside the continued robust and durable tumour responses seen with further follow up underscore the potential value of this important medicine for patients with HER2-expressing cancers who currently have no targeted treatment options. With a high unmet need in these cancers, we are working with health authorities to bring Enhertu to patients with HER2-expressing cancers that could potentially benefit from this medicine as quickly as possible."

Mark Rutstein, Global Head, Oncology Development, Daiichi Sankyo, said: "These updated results from the DESTINY-PanTumor02 trial are important as we work to reshape the clinical landscape in HER2-expressing advanced cancers, where patients currently have limited treatment options and face a poor prognosis. The overall survival demonstrated by Enhertu in these patients is a significant step forward in the potential to advance current standards of care and offer new options for patients with HER2-expressing cancers."

The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy and safety of Enhertu in patients with previously treated locally advanced, unresectable, or metastatic HER2-expressing solid tumours not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and other cancers.

The safety profile observed in the primary analysis was consistent with prior data and with other trials of Enhertu with no new safety concerns identified. Interstitial lung disease (ILD) rates and severity were consistent with those observed in other trials of Enhertu, with a low rate of Grade 5 ILD events observed as determined by an independent adjudication committee.

These data will be presented at a forthcoming medical meeting and will support ongoing discussions with global health authorities.

Notes

HER2 expression in solid tumours
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.1,2 In some cancers, HER2 expression is amplified or the cells have activating mutations.1,3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis.4

While HER2-directed therapies have been used to treat breast, gastric, lung and colorectal cancers, more research is needed evaluating their potential role in treating other HER2-expressing tumour types.2,5,6

HER2 is an emerging biomarker in biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers.3 Testing is not routinely performed in these additional tumour types and as a result, available literature is limited. HER2 overexpression (IHC3+) has been observed at rates from 1% to 28% in these solid tumours.7,8 There is an unmet need for effective therapies for certain HER2-expressing solid tumours, particularly for those who have progressed on or are refractory to standard of care therapies as there are currently no approved HER2-directed therapies for these cancers.2,9

DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort, open-label Phase II trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) for the treatment of previously treated HER2-expressing tumours, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer and other tumours.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DoR, disease control rate, PFS, OS, safety, tolerability and pharmacokinetics.

DESTINY-PanTumor02 has enrolled 267 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 50 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in Israel and under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive global development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

On July 27, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC") (Press release, Checkpoint Therapeutics, JUL 27, 2023, View Source [SID1234633437]). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:

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Parametera Locally Advanced cSCC
(n=31) Metastatic cSCC
(n=78)
Data cutoff Mar 2022 Jan 2023 Nov 2021 Jan 2023
Objective response rate
(95% confidence interval) 55%
(36%, 73%) 55%
(36%, 73%) 47%
(36%, 59%) 50%
(39%, 62%)
Complete response rate 10 % 23 % 8 % 13 %
Partial response rate 45 % 32 % 39 % 37 %
Response ongoing 82 % 82 % 73 % 69 %
Median duration of response Not reached Not reached Not reached Not reached
a As assessed by independent central review.

"We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We believe cosibelimab’s strong efficacy and response durability are driven by its unique two-fold mechanism of action in which cosibelimab binds to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce antibody-dependent cell-mediated cytotoxicity of tumor cells, resulting in a powerful one-two punch to eradicate tumors. We expect this dual mechanism of action to benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who continue to suffer poor outcomes with currently available treatments."

Updated safety data across 247 patients enrolled and treated with cosibelimab in all cohorts of the ongoing study remain consistent with those previously reported, with only 2% of patients experiencing a severe immune-related adverse event ("irAE") and less than 1% of patients discontinuing treatment due to an irAE of any severity, both substantially lower than the rates observed with currently approved immunotherapies.

Mr. Oliviero continued, "Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year. If our Biologics License Application ("BLA") is approved in the coming months, based on its unique mechanism of action and compelling efficacy and safety profile, we believe cosibelimab, as a differentiated and possibly best-in-class treatment, has the potential to become the market leading immunotherapy for patients with cSCC, which we estimate to be a $1.6 billion annual U.S. market opportunity."

In January 2023, Checkpoint submitted a BLA to the U.S. Food and Drug Administration ("FDA") seeking approval of cosibelimab as a treatment for patients with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or radiation. The application is filed and under review with a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024.

Checkpoint plans to present these updated results at an upcoming medical conference.

On July 26, 2023 GlaxoSmithKline reported its second quarter 2023 results (Press release, GlaxoSmithKline, JUL 26, 2023, View Source [SID1234634669]).

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On July 26, 2023 The University of Texas MD Anderson Cancer Center and Nexo Therapeutics reported a multi-year strategic collaboration that aligns the innovative technology and capabilities of each organization at the earliest stages of drug discovery and development to rapidly advance impactful new cancer therapies against previously undruggable targets (Press release, Nexo Therapeutics, JUL 26, 2023, View Source [SID1234633476]).

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The agreement brings together Nexo’s unique drug discovery platform, which combines innovative covalent chemistry and chemical biology, with the translational research and drug development expertise of MD Anderson’s Translational Research to AdvanCe Therapeutics and Innovation in ONcology (TRACTION) platform. MD Anderson and Nexo will work together from discovery through investigational new drug-enabling studies to accelerate development of small-molecule therapies for patients with limited treatment options.

"We are excited to work with the team of researchers at MD Anderson to discover and develop novel cancer medicines targeting some of the fundamental drivers of cancer that have eluded past efforts," said Andrew Phillips, Ph.D., founder and chief executive officer of Nexo Therapeutics. "By joining our complementary skills and capabilities at the earliest stages of drug discovery, we aim to enhance the prospects of rapidly advancing novel therapies to the clinic."

Many promising cancer targets present significant hurdles for conventional drug development approaches based on the structure of the target as well as selectivity and pharmacological properties of the drug. The Nexo platform aims to systematically address each of these issues by combining a chemistry engine with chemical biology capabilities.

Nexo’s chemistry engine, CODON (Covalent Discovery and Optimization), combines a proprietary library that leverages chemical diversity and innovative covalent chemistries with scalable biochemical and in-cell proteomics. This allows the company to identify promising hit compounds and to conduct rapid optimization to produce compounds for in vivo studies.

The company’s unique chemical biology approach, INFINI-T (Informed Profile Before Initiation of Target), uses the power of chimeric fusion proteins to address target biology and pharmacology questions. The function of these chimeric proteins can be controlled by small molecules in cellular and in vivo models to generate detailed information about the required depth, duration and selectivity of target inhibition. Importantly, the INFINI-T platform provides target product profiles for medicinal chemistry well in advance of lead optimization. This is expected to decrease the time and capital needed to bring drug candidates to the clinic.

"Together with Nexo’s innovative platform, our integrated approach to translational research and drug development is poised to design and rapidly advance novel therapies against high priority oncology targets," said Tim Heffernan, Ph.D., vice president of Oncology Research for TRACTION at MD Anderson. "This collaboration highlights our commitment to advancing innovative new medicines that address critical unmet needs for our patients."

MD Anderson established the TRACTION platform to overcome traditional hurdles in oncology drug development and to quickly and safely advance the right treatments for the right patients. The platform incorporates a variety of cutting-edge technologies, disease modeling approaches and data analytics tools to better inform drug development, from discovery into clinical trials. The TRACTION platform is a core component of MD Anderson’s Therapeutics Discovery division, an integrated team of clinicians, researchers and drug development experts working to advance impactful therapies for cancer.

Beginning at the first stages of drug discovery and target identification, TRACTION researchers will collaborate with Nexo to characterize susceptible cancers, to identify potential combination treatment strategies and to evaluate biomarkers that can optimize patient selection.

Nexo and MD Anderson will collaborate on discovery and translation efforts, with the option to extend the collaboration into clinical development. Nexo will provide research support funding, and MD Anderson is eligible to receive certain royalties and payments based on a range of future development, regulatory, commercial and business milestones. Nexo will retain all rights to programs under the collaboration and will have sole responsibility for development, manufacturing and commercialization.