On February 15, 2022 ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximize patient health reported an abstract comparing concurrent measures using ImpediMed’s SOZO Digital Health Platform and dual x-ray absorptiometry (DXA) for assessing bone mineral content in cancer patients was accepted for poster presentation at the 39th Annual Miami Breast Cancer Conference on 3-6 March 2022 in Miami Beach, Florida, USA (Press release, ImpediMed, FEB 15, 2022, View Source [SID1234608159]).

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The abstract, titled, "The Routine Use of Bioimpedance Spectroscopy Measurements in the Clinic as a Surrogate for Bone Mineral Content in Oncology Patients: Practical Application of the SOZO Device," analyzes data collected using both SOZO and DXA in healthy participants and cancer patients.

The Miami Breast Cancer Conference draws the multidisciplinary cancer care team for in-depth discussion about current topics and technologies for breast cancer care. The poster will be presented to registered attendees in-person and online. Abstracts will be published online following the conference in the journal Oncology.

"The Miami Breast Cancer Conference is run by leaders in breast cancer care from every oncology specialty," commented Richard Carreon, Managing Director and CEO of ImpediMed. "This is the ideal venue to present the new data evaluating SOZO to assess changes in bone in cancer patients during and after treatment. We continue to stay focused on lymphedema in the near term while exploring new ways to use SOZO in caring for cancer patients as part of our long-term oncology growth strategy."

Expanding the use of SOZO to help care for cancer patients is central to ImpediMed’s growth strategy in the oncology marketplace. Lymphedema provides a strong entry point for adoption of SOZO into oncology practices. Developing new indications creates opportunity to expand SOZO utilization by placing additional SOZO devices and adding new licenses to existing devices. New indications also support the strategy for building large corporate accounts, many of which have interest in co-development and regulatory clearance for new ways to use SOZO to benefit their cancer patients and improve health economics.

There are 16.9 million cancer survivors in the US and approximately 32 million worldwide. The majority of survivors are women with early-stage breast cancers and men with nonmetastatic prostate cancers. These patients frequently receive hormonal manipulation therapies that can significantly impact their bone mineral content. These patients have a higher risk bone fractures potentially leading to hospitalization and death.

About SOZO Digital Health Platform

SOZO, the world’s most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed’s BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single device.

On February 15, 2022 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 technology, engineering, and science company, reported financial results for the fourth quarter and fiscal year 2021 (Press release, Leidos, FEB 15, 2022, View Source [SID1234608102]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented: "2021 was a banner year for Leidos, with industry-leading organic revenue growth and expanded profitability. In addition, we enhanced our market presence during the year with strategic acquisitions and investments that added important technical capabilities. Despite the ongoing impact of COVID-19 and an extended Continuing Resolution, we are positioned to grow in 2022, bolstered by our scale, differentiated technical offerings, and dedicated workforce."

As of December 31, 2021, Leidos ended the three-year forecast period laid out at its 2019 Investor Day, exceeding or achieving all financial targets. Over the period, Leidos grew revenues at a compound annual growth rate of 10%, achieved a net income margin of 5.5% and converted 164% of its net income attributable to Leidos stockholders into cash flows from operations. In addition, Leidos grew organically at a compound annual growth rate of 7% (versus 5% target), achieved an adjusted EBITDA margin of 10.8% (versus 10% or greater target) and converted 116% of its adjusted net income into free cash flow (versus 100% or greater target).

Summary Operating Results

Revenues were $3.49 billion for the quarter and $13.74 billion for the year, up 7% and 12% over the comparable 2020 periods, respectively. Excluding acquired revenues of $52 million for the quarter and $325 million for the year, organic revenues increased 6% and 9%, respectively. For the year revenues grew organically across all reportable segments. The largest contributors for the quarter and the year were the increase in veterans’ disability examinations after the pause from the COVID-19 pandemic and the ramp-up of the Navy Next Generation Enterprise Network Recompete (NGEN-R) Service Management, Integration and Transport (SMIT) contract.

Net income was $176 million, or $1.23 per diluted share, for the quarter, and $759 million, or $5.27 per diluted share, for the year. Net income margin for the quarter was 5.0%. The weighted average diluted share count for the quarter was 142 million, compared to 144 million in the prior year quarter. For the year net income and diluted EPS were both up 21% compared to fiscal year 2020. Net income margin for the year increased to 5.5% from 5.1% in fiscal year 2020 as a result of strong program management, higher volumes on certain fixed price programs and $26 million net benefit from an adjustment to legal reserves related to the Mission Support Alliance joint venture recorded in the first quarter of fiscal year 2021.

Adjusted EBITDA was $359 million for the fourth quarter, representing an adjusted EBITDA margin of 10.3%. For the year adjusted EBITDA was $1.51 billion (11.0% margin), up 14% over fiscal year 2020. Non-GAAP net income was $224 million for the quarter and $952 million for the year, which generated non-GAAP diluted EPS of $1.56 for the quarter and $6.62 for the year. For the year non-GAAP net income and non-GAAP diluted EPS were up 13% and 14%, respectively, compared to fiscal year 2020.

Cash Flow Summary

Net cash provided by operating activities for the quarter was $210 million for an operating cash flow conversion ratio of 121%. After adjusting for payments for property, equipment and software, quarterly free cash flow was $177 million for a free cash flow conversion ratio of 80%. For the year net cash provided by operating activities was $1.03 billion (137% conversion) and free cash flow was $927 million (98% conversion).

For the quarter Leidos used $37 million in investing activities and $69 million in financing activities. For the year Leidos used $730 million in investing activities and $113 million in financing activities. On November 22, 2021, Leidos signed a definitive agreement within the Defense Solutions segment to dispose of its Aviation & Missile Solutions LLC ("AMS") business to focus on leading-edge and technologically advanced services, solutions and products. The sales price will be approximately $18 million, subject to certain adjustments, and the sale is expected to be completed during the first quarter of fiscal year 2022.

During fiscal year 2021, Leidos made open market repurchases of common stock for an aggregate purchase price of $237 million and returned $199 million to shareholders as part of its regular quarterly cash dividend program. In addition, Leidos borrowed $380 million, paid down $106 million of debt and completed strategic acquisitions and investments for preliminary purchase consideration of approximately $627 million. As of December 31, 2021, the Company had $727 million in cash and cash equivalents and $5.1 billion in debt.

On February 11, 2022, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on March 31, 2022, to stockholders of record at the close of business on March 15, 2022. In addition, the Board authorized a stock repurchase program under which Leidos may repurchase up to 20 million shares of its common stock, which supersedes the prior February 2018 share repurchase authorization. Stock repurchases may be made on the open market at prevailing market prices or in privately negotiated transactions including through accelerated share repurchase or derivative transactions, transactions with Leidos retirement and deferred compensation plans, transactions under 10b5-1 plans or 10b-18 plans or any of the foregoing combined or otherwise. Whether repurchases are made and the timing and actual number of shares repurchased depends on a variety of factors including price, corporate capital requirements, other market conditions and regulatory requirements. The repurchase program may be accelerated, suspended, delayed or discontinued at any time.

New Business Awards

Net bookings totaled $3.2 billion in the fourth quarter of fiscal year 2021 and $15.5 billion for fiscal year 2021, representing a book-to-bill ratio of 0.9 and 1.1, respectively. As a result, backlog at the end of fiscal year 2021 was $34.5 billion, of which $7.4 billion was funded. Included in the quarterly bookings were several notable awards:

Air Combat Command Intelligence, Surveillance and Reconnaissance Program. Leidos was awarded a task order by the Air Combat Command (ACC) Acquisition Management and Integration Center (AMIC) to continue its support to ACC intelligence, surveillance and reconnaissance (ISR) operations. Under the contract, Leidos will provide subject matter expertise and threat mitigation support for ACC ISR operations along with a full range of intelligence support and ISR operational services that encompass analysis and assessment support, ISR training support and intelligence support for HQ ACC Staff, subordinate NAF Staffs, Centers and Wings. The single-award, firm-fixed price task order has a one-year base period of performance, four one-year options and a total contract value of up to approximately $531 million if all options are exercised.
Hypersonic Thermal Protection System Capability. Dynetics, a wholly owned subsidiary of Leidos, was awarded a contract to develop Hypersonic Thermal Protection System (TPS) prototypes for the U.S. Army’s Rapid Capabilities and Critical Technologies Office (RCCTO). Under the contract, Dynetics will also support materials research, novel inspection and acceptance efforts. The cost-plus-fixed fee award has a total value of up to $479 million over six years.
Federal Parent Locator Service. Leidos was awarded a new prime contract to continue supporting the Office of Child Support Enforcement (OCSE) within the Department of Health and Human Services, Administration of Children and Families. Under the contract, Leidos will continue to support OCSE’s Federal Parent Locator Service (FPLS) with operations and maintenance, continuation of system development and enhancement, data center operations and a disaster recovery center. The single award contract has a maximum value of $76 million and a period of performance of approximately five years if all options are exercised.
Forward Guidance

Leidos is initiating fiscal year 2022 guidance as specified in the table below.

Measure

A provision of the Tax Cuts and Jobs Act of 2017 went into effect on January 1, 2022, that requires companies to capitalize and amortize research and development costs over five years rather than deducting such costs in the year incurred for tax purposes. The guidance for cash flows provided by operating activities does not take into account the effects of this legislative change, because it assumes that the provision will be deferred, modified or repealed. If the provision remains in effect, Leidos currently estimates that cash flows provided by operating activities would decrease by approximately $150 million in fiscal 2022 and net deferred tax assets would increase by a similar amount. The actual impact on cash flows provided by operating activities will depend on the amount of research and development costs the Company will incur, on whether Congress modifies or repeals this provision and on whether new guidance and interpretive rules are issued by the US Treasury, among other factors.

For information regarding adjusted EBITDA margin and non-GAAP diluted EPS, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income margin or diluted EPS, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income margin, diluted EPS or net income attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income margin, net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8 A.M. eastern time on February 15, 2022. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (U.S. dial-in) or +1 (201) 689-8261 (international dial-in).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international) and entering conference ID 13726189.

On February 15, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, CRISPR Therapeutics, FEB 15, 2022, View Source [SID1234608125]).

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"2021 was a productive year for CRISPR Therapeutics on all fronts. We and our partner Vertex completed enrollment in the CTX001 clinical trials and are on track for planned regulatory submissions in late 2022," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "Concurrently, we advanced our wholly-owned immuno-oncology pipeline, and have initiated dosing of patients in our CTX110 pivotal trial. Further, we and our partner ViaCyte, recently announced the dosing of the first patient in the Phase 1 clinical trial of VCTX210 for the treatment of type 1 diabetes. This investigational therapy has the potential to be a transformative treatment for patients with all insulin-requiring forms of diabetes. Looking ahead, we expect a productive 2022 with continued progress across our portfolio as we enter a new phase of growth for our Company. Given the breadth of our portfolio and our strong capital position, we remain well positioned to advance our pipeline and platform to develop transformative medicines for patients suffering from serious diseases."

Recent Highlights and Outlook

Beta Thalassemia and Sickle Cell Disease Programs

More than 70 patients have been dosed with CTX001 across both trials to date. Target enrollment has been achieved in the ongoing clinical trials for CTX001 in transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD), with planned regulatory submissions in late 2022.
In June 2021, data from 22 patients with at least three months of follow-up after CTX001 infusion were presented at the Annual European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress (EHA) (Free EHA Whitepaper) and continued to build the profile of a potentially functional cure for patients with TDT and SCD, showing consistent and durable benefit with longer term data from a larger population of patients.

In April 2021, CRISPR Therapeutics and Vertex announced an amendment to their collaboration for CTX001. In connection with the completion of the transaction in June, Vertex made a $900 million upfront payment to CRISPR Therapeutics.

In April 2021, CRISPR Therapeutics and Vertex announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to CTX001 for the treatment of TDT. CTX001 was granted PRIME designation for the treatment of SCD in 2020.

Immuno-Oncology Programs

CRISPR Therapeutics has begun dosing patients in the pivotal trial of CTX110, its wholly-owned allogeneic chimeric antigen receptor T cell (CAR-T) investigational therapy targeting CD19+ B-cell malignancies. Enrollment is ongoing and the Company expects to report additional data in 2022. The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX110 in November 2021.

In October 2021, CRISPR Therapeutics announced positive results from its ongoing Phase 1 CARBON trial evaluating the safety and efficacy of CTX110. The data showed early evidence of a dose dependent response to CTX110, with overall response rates (ORR), complete response rates (CR) and durability similar to approved autologous CD19 CAR-T therapies on an intent-to-treat (ITT) basis. A single dose of CTX110 at DL2 and above resulted in a 58% ORR and 38% CR rate in large B-cell lymphoma (LBCL) patients on an ITT basis. The pharmacokinetic data provide a strong rationale that consolidation dosing can improve on an already competitive profile for CTX110. Based on the safety and efficacy profile, the Company has expanded the current trial into a pivotal trial that incorporates consolidation dosing and has begun dosing patients in this pivotal arm. The Company expects to report additional data in 2022.

In addition to CTX110, CRISPR Therapeutics has ongoing Phase 1 clinical trials assessing safety and efficacy of several dose levels for the following CAR-Ts: (i) CTX120, its wholly-owned allogeneic CAR-T investigational therapy targeting B-cell maturation antigen for the treatment of relapsed or refractory multiple myeloma; and (ii) CTX130, its wholly-owned allogeneic CAR-T investigational therapy targeting CD70 for the treatment of both solid tumors and certain hematologic malignancies. The Company expects to report top-line data in the first half of 2022.

In May 2021, CRISPR Therapeutics and Nkarta, Inc. announced a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer. Under the agreement, the companies will co-develop and co-commercialize two CAR-NK cell product candidates, one targeting the CD70 tumor antigen and the other target to be determined. In addition, the companies will bring together their complementary cell therapy engineering and manufacturing capabilities to advance the development of a novel NK+T product candidate harnessing the synergies of the adaptive and innate immune systems.

Regenerative Medicine and In Vivo Programs

Earlier this month, CRISPR Therapeutics and its partner ViaCyte announced the first patient had been dosed in the Phase 1 clinical trial of VCTX210 for the treatment of T1D. VCTX210 is an investigational, allogeneic, gene-edited, stem cell-derived product developed in collaboration by applying CRISPR Therapeutics’ gene-editing technology to ViaCyte’s proprietary stem cell capabilities for the generation of pancreatic cells designed to evade recognition by the immune system. This immune-evasive cell replacement therapy is designed to enable patients to produce their own insulin.

In June 2021, CRISPR Therapeutics and Capsida Biotherapeutics, Inc. announced a strategic partnership to research, develop, manufacture and commercialize in vivo gene editing therapies delivered with engineered AAV vectors for the treatment of familial amyotrophic lateral sclerosis (ALS) and Friedreich’s ataxia. Under the agreement, CRISPR Therapeutics will lead research and development of the Friedreich’s ataxia program and perform gene-editing activities for both programs, and Capsida will lead research and development of the ALS program and conduct capsid engineering for both programs.

The Company continues to make progress with its in vivo approaches for liver gene editing utilizing both viral and non-viral delivery vehicles. The Company expects to move multiple programs utilizing in vivo approaches into the clinic in the next 18 to 24 months.

Other Corporate Matters

Under the June 2019 collaboration agreement with Vertex to discover and develop gene editing therapies for the treatment of Duchenne Muscular Dystrophy (DMD) and Myotonic Dystrophy Type 1 (DM1), CRISPR Therapeutics received a payment of $12.5 million from Vertex related to the achievement of a research milestone in the DM1 program. CRISPR Therapeutics is eligible to receive additional milestone payments from Vertex of up to $775 million for these two programs.
Fourth Quarter and Full Year 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $2,379.1 million as of December 31, 2021, compared to $1,690.3 million as of December 31, 2020. The increase in our cash position of $688.8 million was primarily driven by an upfront payment of $900.0 million in connection with the Amended and Restated Joint Development and Commercialization Agreement with Vertex. Additionally, cash provided by financing activities was $250.9 million, primarily related to common shares issued in connection with utilizing the Company’s at-the-market (ATM) financing facility as well as option exercises. These increases were offset by continuing operating expenses to support ongoing research and development of the Company’s clinical and pre-clinical programs as well as capital investments in our manufacturing facility.
Revenue: Total collaboration revenue was $12.3 million for the fourth quarter of 2021 compared to $0.2 million for fourth quarter of 2020, and $913.1 million for the year ended December 31, 2021, compared to $0.5 million for the year ended December 31, 2020. The increase in collaboration revenue is primarily attributable to revenue recognized in connection with the aforementioned payments received from Vertex.
R&D Expenses: R&D expenses were $134.5 million for the fourth quarter of 2021 compared to $82.4 million for the fourth quarter of 2020, and $438.6 million for the year ended December 31, 2021, compared to $266.9 million for the year ended December 31, 2020. The increase in expense for the year was driven by development activities supporting the advancement of the hemoglobinopathies program and wholly-owned immuno-oncology programs, as well as increased headcount and supporting facilities-related expenses.
G&A Expenses: General and administrative expenses were $24.1 million for the fourth quarter of 2021 compared to $25.8 million for the fourth quarter of 2020, and $102.8 million for the year ended December 31, 2021, compared to $88.2 million for the year ended December 31, 2020. The increase in general and administrative expenses for the year was driven by headcount-related expense.
Net Income / Loss: Net loss was $141.2 million for the fourth quarter of 2021 compared to a net loss of $107.0 million for the fourth quarter of 2020, and net income was $377.7 million for the year ended December 31, 2021, compared to a net loss of $348.9 million for the year ended December 31, 2020.
About CTX001
CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patient’s hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate or eliminate transfusion requirements for patients with TDT and reduce or eliminate painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published as a Brief Report in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. CTX001 has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About the CRISPR-Vertex Collaboration
Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program. Under a recently amended collaboration agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 and split program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About CLIMB-111

The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121
The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-131
This is a long-term, open-label trial to evaluate the safety and efficacy of CTX001 in patients who received CTX001 in CLIMB-111 or CLIMB-121. The trial is designed to follow participants for up to 15 years after CTX001 infusion.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

About CTX120
CTX120, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting B-cell maturation antigen, or BCMA. CTX120 is being investigated in an ongoing Phase 1 single-arm, multi-center, open-label clinical trial designed to assess the safety and efficacy of several dose levels of CTX120 for the treatment of relapsed or refractory multiple myeloma. CTX120 has been granted Orphan Drug designation from the FDA.

About CTX130
CTX130, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. CTX130 is being investigated in two ongoing independent Phase 1, single-arm, multi-center, open-label clinical trials that are designed to assess the safety and efficacy of several dose levels of CTX130 for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively.

About VCTX210
VCTX210 is an investigational, allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of T1D. VCTX210 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and ViaCyte, Inc.

On February 15, 2022 Susan G Komen reported A first-of-its-kind tool may be able to help doctors better diagnose inflammatory breast cancer (IBC) (Press release, Susan G Komen, FEB 15, 2022, View Source [SID1234608142]). The novel tool and the findings of the analysis have been recently published in Breast Cancer Research and Treatment.

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The tool was developed through a collaborative effort between Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and the Milburn Foundation, which brought together a team of leading breast cancer experts including clinicians, researchers and IBC patients.

"IBC has historically been difficult to diagnose and no changes to diagnostic approach have been made since the 1960’s. It is a rare and aggressive type of breast cancer that develops rapidly and can easily be confused with a breast infection and often goes underdiagnosed or misdiagnosed," said Dr. Reshma Jagsi, lead author, Komen Scholar and radiation oncologist.

Before the development of this tool, IBC lacked a formal, objective medical definition and diagnosis was often delayed, misdiagnosed or missed. IBC usually presents as swelling or redness of the breast, and not a lump, so it can be missed on a mammogram.

As the team began their work, it became evident that without a clear definition of IBC that included all the characteristics of this complicated disease, accelerating research would continue to be a significant challenge.

"If you want to study a disease, you have to ask, ‘What causes the disease and is this treatment better than that treatment?’ It’s harder to answer those questions if you haven’t clearly defined the disease," said Dr. Kathy Miller, senior author, Komen Scholar and medical oncologist. "It sounds so simple, but having a diagnosis really is the first step toward tackling the problem."

The group identified "defining characteristics" – including clinical, pathologic and imaging features – of IBC that led them to develop a quantitative scoring system for diagnosis. The system, or tool, is intended to increase diagnostic accuracy, predict outcomes, guide treatment decisions and inclusion criteria for clinical trials.

This tool will also enable researchers to study the biology of IBC and make discoveries to advance progress towards personalized care for all breast cancer patients.

"Komen has been able to see further into the future about how this definition isn’t just about writing something in a dictionary. This is about something that is essential to undergird future research," added Jagsi.

IBC is aggressive and can spread quickly, resulting in approximately 30 percent of patients being diagnosed at stage IV, or with metastatic disease, meaning their breast cancer has already spread to other parts of their body.

Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and Milburn Foundation raised more than $1.4 million in a fundraising campaign last year to support the IBC cohort and the research that was recently published.

"With aggressive breast cancers like IBC, patients need more treatment options, and they need them now. This collaboration is helping us get closer to finding more effective treatments for a type of breast cancer that is difficult to diagnose and treat," said Victoria Wolodzko, Senior Vice President of Mission at Susan G. Komen.

"This partnership illustrates our continued leadership in funding critical IBC research," said Bryon Davis, CEO of the Milburn Foundation. "The impressive results of our campaign have helped us reach this key milestone. Working with Susan G. Komen and the Inflammatory Breast Cancer Research Foundation, we brought together an exceptional team to help define a path forward in the fight against IBC."

"Patient advocacy is about taking an active role in defining the critical conversations that will accelerate research discoveries and drive results for patients," said Ginny Mason, Executive Director of the Inflammatory Breast Cancer Foundation. "In our more than 20 years of work in IBC patient advocacy and research, this partnership with Susan G. Komen and Milburn is critical to push key issues forward."

Susan G. Komen, the Inflammatory Breast Cancer Research Foundation and Milburn Foundation continue to raise funds to support ongoing research studies to validate the new scoring system.

The next step is to perform further studies to validate the scoring system.

Co-authors along with Dr. Jagsi and Dr. Miller include: G. Mason, B.A. Overmoyer, W.A. Woodward, S. Badve, R.J. Schneider, J.E. Lang, M. Alpaugh, K.P. Williams, D. Vaught, A. Smith and K. Smith.

On February 15, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a global, multi-year definitive licensing agreement whereby it granted Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology (Press release, ImmunoGen, FEB 15, 2022, View Source [SID1234608103]). ImmunoGen retains full rights to the camptothecin platform for all targets not covered by the Lilly license.

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As part of the agreement, Lilly will pay ImmunoGen an upfront payment of $13 million, reflecting initial targets selected by Lilly. Lilly may select a pre-specified number of additional targets, with ImmunoGen eligible to receive an additional $32.5 million in exercise fees if Lilly licenses the full number of targets. ImmunoGen is eligible to receive up to $1.7 billion in potential target program exercise fees and milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen is also eligible for tiered royalties as a percentage of worldwide commercial sales by Lilly. Lilly is responsible for all costs associated with research and development.

Camptothecins are an important class of anticancer drugs targeting Type I topoisomerase. ImmunoGen’s proprietary class of camptothecin linker-payloads are designed to optimize existing camptothecin technology to potentially deliver a wider therapeutic window with enhanced safety and efficacy.

"Lilly has a proven track record of bringing transformative oncology medicines to market, and we are pleased that they selected our novel camptothecin technology to integrate with their efforts to develop next-generation ADCs," said Stacy Coen, ImmunoGen’s Senior Vice President and Chief Business Officer. "This licensing agreement demonstrates ImmunoGen’s continued innovation in ADCs, creates value from our intellectual property around a proprietary platform, and further enhances our ability to re-invest in our business as we build out our pipeline and accelerate our transformation into a fully-integrated oncology company."