On May 18, 2021 Isofol Medical AB’s (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol or the "Company") Board of Directors reported that , pursuant to the authorization granted by the extraordinary general meeting held on May 14, 2021 ("the EGM"), resolved on an issue of shares of a maximum of 62,524,474 shares with preferential rights for the Company’s existing shareholders (the "Rights Issue") (Press release, Isofol Medical, MAY 18, 2021, View Source [SID1234580206]). The subscription price in the Rights Issue is SEK 6.40 per share. If the Rights Issue is fully subscribed, the Company will receive approximately SEK 400 million before transaction costs related to the Rights Issue. In addition to the Rights Issue, and provided the Rights issue is oversubscribed, the Board of Directors is authorized to carry out a directed share issue with deviation from the shareholders’ preferential rights of up to SEK 100 million (the "Over-Allotment Option").

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Summary

The net proceeds from the Rights Issue and the potential Over-Allotment Option will be used for i) funding the ongoing AGENT study beyond top-line and final results and activities for finalization of the NDA application, (ii) finalizing the development and validation of CMC, iii) global preparedness activities including the development of medical affairs and commercial launch packages, as well as continued partnering activities, iv) clinical development activities, including gene expression analysis and initiation of studies in potentially additional indications and (v) general corporate purposes.
The net proceeds from the Rights Issue and the potential Over-Allotment Option will be used for i) funding the ongoing AGENT study beyond top-line and final results and activities for finalization of the NDA application, (ii) finalizing the development and validation of CMC, iii) global preparedness activities including the development of medical affairs and commercial launch packages, as well as continued partnering activities, iv) clinical development activities, including gene expression analysis and initiation of studies in potentially additional indications and (v) general corporate purposes.
Existing shareholders in the Company will receive 1 (one) subscription right for each share held as of the record date. 4 (four) subscription rights entitle the holder to subscribe for 3 (three) new shares in the Rights Issue.
The record date for participation in the Rights Issue is May 25, 2021.
Subscription period of the Rights Issue is May 27 – June 10, 2021.
If the Rights Issue is fully subscribed, the Company will receive approximately SEK 400 million before deduction of transaction costs related to the Rights Issue.
The subscription price in the Rights Issue is SEK 6.40 per share, which corresponds to a discount of approximately 32.2 percent compared with the theoretical price after separation of subscription rights, based on the closing price of the Isofol share on Nasdaq First North Premier Growth Market on May 18, 2021.
For existing shareholders not participating in the Rights Issue, a dilution effect corresponding to 42.9 percent of the total number of shares and votes in the Company following the Rights Issue will arise.
The Rights Issue is fully guaranteed, including commitments from members of the Board of Directors and Management to subscribe for their pro rata shares amounting to SEK 1.8 million, as well as several existing shareholders, including The Fourth Swedish National Pension Fund ("AP4").
In addition to the Rights Issue, and provided the Rights Issue is oversubscribed, the Board of Directors is authorized to exercise the potential Over-Allotment Option, which would provide Isofol with a maximum of SEK 100 million before transaction costs.
The Over-Allotment Option can be exercised to meet potential additional demand from strategic investors, thereby broadening Isofol’s shareholder base and is conditional upon the Rights Issue being oversubscribed.
Background and intention

Isofol is a clinical stage biotech company developing arfolitixorin to improve the efficacy of standard of care chemotherapy for advanced colorectal cancer by increasing tumor response and progression free survival.

Arfolitixorin – the key active metabolite of widely used folate-based drugs – can potentially benefit more patients with advanced colorectal cancer as it does not require complicated metabolic activation to become effective. Arfolitixorin is currently being studied in the global Phase III AGENT study.

The AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. The study is designed to show superiority for arfolitixorin over leucovorin.

The AGENT study is fully recruited and is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan, where Isofol currently has 15 active sites.

Isofol raised approximately SEK 180 million in June 2020 through a rights issue and an over-allotment option. Since the June 2020 capital raise, Isofol has reached the mentioned and critical milestones for that capital raise, such as; the study is fully recruited, the interim result has been presented and the Company has signed licensing agreements with Solasia in Japan and Endo/Paladin in Canada. These licensing agreements are expected to positively affect Isofol’s financial position over time.

In March 2021 the independent Data Safety and Monitoring Board ("iDSMB") recommended continuation of the AGENT study with 440 patients, in accordance with the study design for arfolitixorin. The interim analysis was the fifth time the iDSMB has assessed safety data. Isofol views the iDSMB’s recommendation to continue the study without any amendments to the study protocols as an important signal that the treatment is safe. The treatment of enrolled patients will continue with follow-ups and repeated tumor measurements according to the study’s protocol. After 300 PFS events have taken place, either with tumor growth or that the patient has passed away, a data read out is initiated, with compilation and statistical analysis to present top line results. The Company expects these events to occur during the first and second halves of 2022.

Use of Proceeds

The Board of Directors intends to carry out the Rights Issue and the potential Over-Allotment Option to ensure the continued and successful development of the Company, in accordance with its business plan and strategy. The intention of the Rights Issue and the potential Over-Allotment Option is primarily for i) funding the ongoing AGENT study beyond top-line and final results and activities for finalization of the NDA application, (ii) finalizing the development and validation of CMC, iii) global preparedness activities including the development of medical affairs and commercial launch packages, as well as continued partnering activities, iv) clinical development activities, including gene expression analysis and initiation of studies in potentially additional indications and (v) general corporate purposes.

Through the potential Over-Allotment Option, if exercised in full, the Company will receive an additional financing of approximately SEK 100 million before transaction costs. The potential Over-Allotment Option is conditional upon the Rights Issue being oversubscribed. The reason to deviate from the shareholders’ preferential rights is that the Board of Directors, in the event of strong interest from investors, wishes to further strengthen the Company’s capital as well as broaden the Company’s shareholder base with new strategic investors.

The Rights Issue

The Board of Directors of the Company has today, pursuant to the authorization granted by the extraordinary general meeting held on May 14, 2021, resolved on a new share issue of up to a maximum of SEK 400,156,634 with preferential rights for the Company’s existing shareholders in proportion to their shareholdings as of the record date May 25, 2021.

Shareholders will receive 1 (one) subscription right for each share held on the record date. 4 (four) subscription rights entitle to subscription of 3 (three) shares in the Rights Issue, at a subscription price of SEK 6.40 per share. The subscription price corresponds to a discount of approximately 32.2 percent compared to the theoretical price after the separation of subscription rights, based on the closing price of the Isofol share on May 18, 2021 on Nasdaq First North Premier Growth Market. The Rights Issue will provide Isofol with a maximum of SEK 400,156,634, before transaction costs, by issuing a maximum of 62,524,474 shares.

The Rights Issue will result in an increase of the share capital of a maximum of
SEK 1,914,363.6. Upon full subscription, the number of shares in Isofol, after the Rights Issue, will amount to a maximum of 145,890,440 shares and the share capital will amount to a maximum of SEK 4,466,848.5. For existing shareholders not participating in the Rights Issue, a dilution effect corresponding to approximately 42.9 percent of the total number of shares and votes in the Company following the Rights Issue will arise. Shareholders who choose not to participate in the Rights Issue have the opportunity to compensate for the economic dilution effect by selling their subscription rights.

The last day of trading in Isofol’s shares, including the right to receive subscription rights in the Rights Issue, is May 21, 2021. Subscription of shares with subscription rights shall be made by cash payment during the period from May 27 – June 10, 2021. Subscription of shares without subscription rights shall be made on a special subscription list during the period from May 27 – June 10, 2021. Payment for shares subscribed without subscription rights shall be made in cash no later than two banking days following the issue of the settlement note, which indicates notification of allocation. The Board of Directors is entitled to extend the subscription period and the last day for payment.

If all of the new shares are not subscribed for with subscription rights, allotment of new shares shall be made as follows:

Shares not subscribed for with pre-emption rights shall firstly be allocated to those who have applied for subscription and subscribed for new shares by virtue of subscription rights (regardless of whether the subscriber was a shareholder on the record date or not), and, in case of over subscription, pro rata in relation to the number of subscription rights used by such persons for subscription of new shares, and where this is not possible, by drawing of lots.
Thereafter, allocation shall be made to others who have applied for subscription without subscription rights (it being understood that this shall not include the investor commitments) and, in case of over subscription, allocation shall be made following the number of shares applied for in each subscription form, and, where this is not possible, by drawing of lots.
Any remaining shares shall be allocated to investors who has entered into guarantee commitments and thus have undertaken to subscribe for new shares in the issue, with allocation to be made in proportion to the guarantee commitments.
In connection with the Rights Issue, the Company, the Board of Directors and members of Company’s management have entered into customary lock-up agreements for a period ending on the date falling 180 days after the announcement of the outcome in the Rights Issue.

The full terms and conditions of the Rights Issue and information about the Company will be included in a prospectus expected to be published on the Company’s website on or around May 25, 2021.

Subscription undertakings and guarantee commitments

The Rights Issue is fully guaranteed through subscription undertakings and guarantee commitments.

A number of investors have provided guarantee commitments, which together with subscription undertakings from several existing shareholders, including The Fourth Swedish National Pension Fund ("AP4"), in total represent SEK 400 million. In addition, certain shareholders including Handelsbanken Fonder and Swedbank Robur have expressed that they support the Rights Issue and that they intend to subscribe for their respective pro rata shares.

Members of the Board of Directors and Management, comprising Ulf Jungnelius, Pär-Ola Mannefred, Gustaf Albèrt and Anna Belfrage, who jointly hold approximately 0.4 percent of the Company’s outstanding shares have committed to subscribe their respective pro rata shares in the Rights Issue amounting to approximately SEK 1.8 million.

Timetable for the Rights Issue

Last day of trading in shares including right to receive subscription rights

May 21, 2021

First day of trading in shares excluding right to receive subscription rights

May 24, 2021

Prospectus published on the Company’s webpage

May 25, 2021

Record date for participation in the Rights Issue

May 25, 2021

Subscription period

May 27 – June 10, 2021

Trading in subscription rights

May 27 – June 7, 2021

Trading in BTAs

May 27 – June 14, 2021

Announcement of final outcome in the Rights Issue

Around June 14, 2021

Delivery of and trading in new shares subscribed with subscription rights

Around June 18, 2021

Delivery of and trading in new shares subscribed without subscription rights

Around June 30, 2021

The Over-Allotment Option

The Board of Directors is also authorized to decide upon a directed issue with deviation from the shareholders’ preferential rights whereby the Company will receive a maximum of SEK 100,000,000 before transaction costs. The Over-Allotment Option can only be exercised if the Rights Issue is oversubscribed and to meet the interest from strategic investors.

Upon the potential exercising of the Over-Allotment Option, the subscription price will equal that of the subscription price in the Rights Issue. Exercising the Over-Allotment Option would provide Isofol a maximum of SEK 100,000,000, before transaction costs, by issuing a maximum of 15,625,000 shares.

The Rights Issue and the Over-Allotment Option would result in an increase of the share capital of a maximum of approximately SEK 2,392,767.2. Upon exercising the Over-Allotment Option, the number of shares in Isofol, after the Rights Issue and the Over-Allotment Option, will amount to a maximum of 161,515,440 shares and the share capital will amount to a maximum of approximately SEK 4,945,252.1. For existing shareholders not participating in the Rights Issue and Over-Allotment Option, a dilution effect corresponding to approximately 48.4 percent of the total number of shares and votes in the Company following the Rights Issue and Over-Allotment Option will arise.

The reason to deviate from the shareholders’ preferential rights is that the Board of Directors, in the event of strong interest from investors, wishes to further strengthen the Company’s capital as well as broaden the Company’s shareholder base with strategic investors.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Schjødt law firm acts as legal adviser to the Joint Bookrunners. Ashurst LLP acts as legal adviser to the Joint Bookrunners as to US securities law.

This is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 21:10 CEST on May 18, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On May 18, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel (Press release, Iovance Biotherapeutics, MAY 18, 2021, View Source [SID1234580205]). Previously, the company reported the submission of assay data to the FDA and recently the FDA provided comments regarding the data package.

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Following FDA feedback, Iovance will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet with the FDA in the second half of 2021. The company’s biologics license application (BLA) submission for lifileucel is now expected to occur during the first half of 2022.

"TIL is a first-in-class, one-time administration cell therapy and the first potential BLA for a cell therapy in solid tumors," stated Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "As such, TIL product is complex by nature and alignment with FDA on a potency assay is an important step toward BLA submission. With a regenerative medicines advanced therapy (RMAT) designation for lifileucel, FDA recognizes the unmet need for patients with metastatic melanoma who progress after anti-PD1 therapy."

On May 18, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended March 31, 2021 (Press release, Immatics, MAY 18, 2021, View Source [SID1234580204]).

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"In the first quarter of 2021, we reported first anti-tumor activity at the initial dose levels of our ACTengine IMA200 clinical trial series which indicates the potential of our engineered Adoptive Cell Therapy approach. We continue to scale up enrollment by initiating additional trial sites in the US and Europe – and now look forward to treating patients at target dose levels and provide a next update in the second half of 2021," said Harpreet Singh, Ph.D., CEO of Immatics. "In addition, we are on track with our first clinical trial application for TCER towards the end of this year. By engaging two therapeutic modalities, Adoptive Cell Therapy and TCR Bispecifics, we are aiming to address a broad cancer patient population with an urgent need for new therapeutic options."

First Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine T cells. Overall, the product candidates demonstrated a manageable safety and tolerability profile.
The ACTengine trials continue to recruit according to plan with eight trial sites active in both Europe and the US. A data update is expected in H2 2021 with additional patients being treated, including initial data from patients treated at the target dose.
The fourth program of the ACTengine IMA200 series, IMA204, is directed at the novel tumor stroma target COL6A3 exon 6 expressed in a large variety of solid cancers. IMA204 is utilizing a next-generation CD8-independent T cell receptor. Following a scientific advice meeting2 with Paul-Ehrlich-Institute (PEI) in May, the Federal German regulatory authority, submission of a clinical trial application (CTA) remains on track for Q4 2021.

TCR Bispecifics Programs

IMA402 – Immatics provided preclinical proof-of-concept data for its second TCER program, IMA402, at the Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May. The IMA402 candidate targets an Immatics-validated peptide derived from PRAME, a protein that is frequently expressed in many solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. IMA402 demonstrated tumor cell killing in vitro and lead to consistent tumor reduction including complete regression of established tumors in an in vivo mouse model. Immatics has selected a clinical lead candidate for the IMA402 program and initiated manufacturing activities to advance this program towards the Investigational New Drug (IND) stage and clinical development.
The company’s first TCER program, IMA401 remains on track for submission of a clinical trial application (CTA) by year end 2021. The company had announced preclinical proof-of-concept data for IMA401 in last quarter of 2020.
First Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €216.7 million ($254.0 million1) as of March 31, 2021. compared to €232.0 million ($272.0 million1) as of December 31, 2020.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €7.4 million ($8.7 million1) for the three months ended March 31, 2021, compared to €7.0 million ($8.2 million1) for the three months ended March 31, 2020.

Research and Development Expenses: R&D expenses were €23.0 million ($27.0 million1) for the three months ended March 31, 2021, compared to €12.2 million ($14.4 million1) for the three months ended March 31, 2020. The increase is mainly due to increased share-based compensation (€4.5 million; $5.3 million1) as well as higher operating expenses due to increased clinical and manufacturing activities.

General and Administrative Expenses: G&A expenses were €8.4 million ($9.9 million1) for the three months ended March 31, 2021, compared to €6.2 million ($7.3 million1) for the three months ended March 31, 2020. The increase is mainly due to increased share-based compensation (€3.1 million; $3.7 million1), partly offset by one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July 2020.

Net Loss: Net loss was €21.6 million ($25.3 million1) for the three months ended March 31, 2021, compared to €8.6 million ($10.1 million1) for the three months ended March 31, 2020.

Upcoming Investor Conferences

Jefferies Virtual Healthcare Conference – June 1-3, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference – June 8-11, 2021
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.
Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under View Source

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2021 (1 EUR = 1.1725 USD).
2 Equivalent to a pre-IND meeting at FDA.

About ACTengine IMA200 series
Each of the product candidates of the IMA200 series is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.

On May 18, 2021 Idera Pharmaceuticals, Inc. ("Idera" or the "Company") (Nasdaq: IDRA) reported that it will not continue ILLUMINATE-301, the Company’s trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, to its overall survival (OS) primary endpoint (Press release, Idera Pharmaceuticals, MAY 18, 2021, View Source [SID1234580203]). The Company reported in March 2021 that the trial did not meet its primary endpoint of objective response rate (ORR). Full results from the study will be presented in a future publication.

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"Since receiving the disappointing ORR results from ILLUMINATE-301, we have interrogated the full data set and consulted with our study Steering Committee, our partners at Bristol Myers Squibb (BMS), and other stakeholders regarding next steps for the trial. Our conclusion is that the totality of the data, with all patients having completed the study treatment, does not support the likelihood that the combination of tilsotolimod with ipilimumab would achieve a statistically significant OS benefit over ipilimumab alone," stated Vincent Milano, Idera’s Chief Executive Officer. "I want to personally thank all the patients and investigators for their dedication to the study."

Added Mr. Milano, "We remain committed to our additional trials and are continuing to enroll and treat patients in ILLUMINATE-206, our Phase 2 study of tilsotolimod in combination with BMS’s nivolumab and ipilimumab for patients with microsatellite-stable colorectal cancer and to support AbbVie in the form of study drug in their trial for patients with head and neck squamous cell carcinoma."

Continued Mr. Milano, "As we turn our attention toward the future, we continue to be active in our goal to identify and secure new development or commercial-stage assets. We have an exceptional team with a strong track record and passion for helping patients that I believe can be beneficial in delivering results from promising compounds."

The Company is also announcing that Elizabeth Tarka, M.D., the Company’s Chief Medical Officer since July 2019, will be leaving the Company on May 28, 2021. Dr. Tarka will continue working with Idera on a consulting basis.

"I want to thank Liz for helping us deliver ILLUMINATE-301 and for her many other contributions over the past two years," stated Mr. Milano. "We wish her all the best in her future endeavors."

On May 18, 2021 The United States Preventive Services Task Force (USPSTF) reported its final colorectal cancer screening recommendation that screening begin at age 45 (Press release, Exact Sciences, MAY 18, 2021, View Source [SID1234580201]). Exact Sciences’ (NASDAQ: EXAS) Cologuard, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.

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Colorectal cancer is the second leading cause of cancer death in the United States, in part because many cancers go undetected until later stages when treatment options are limited.1 Colorectal cancer can be prevented or detected early through screening. However, approximately 44 million average-risk adults 45-74 are currently eligible for screening, including ˜19 million between the ages of 45 and 49.2§

According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer. Colorectal cancer incidence has been increasing in American adults under the age of 50.3 Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.4 More than half of these cases were diagnosed at later stages (stages III or IV), which are associated with lower survival rates than earlier stages (stages I or II).4 Only about one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.1

"Health care providers often turn to the USPSTF guidelines when discussing cancer prevention with their patients," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "These final guidelines will encourage more clinicians to offer colorectal cancer screening to their patients starting at age 45."

Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test used to screen for colorectal cancer in average risk patients. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,5 including 94% in stages I and II.5,6,7* In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

A recent study showed that among average-risk adults between the ages of 45 and 49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions.7 In patients with negative colonoscopy findings, Cologuard demonstrated specificity of 96.3%.7 According to the authors, using Cologuard to screen these younger individuals could help mitigate risks and reduce costs from unnecessary diagnostic procedures.

USPSTF guidelines play a key role in addressing the public health crisis caused by colorectal cancer. Under these final guidelines, colorectal cancer screening remains a Grade A recommendation for people ages 50-75 and screening for ages 45 to 49 is a Grade B recommendation. The task force continues to include Cologuard (referred to in the guidelines as sDNA-FIT) among the recommended screening test options. Since it was first included in the 2016 USPSTF recommendation, Cologuard has been used to screen more than 5 million Americans.

"We are proud of the role Cologuard has played in getting more people screened for colorectal cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The task force’s recommendation that colorectal cancer screening begin at age 45 for all average risk people means that Cologuard can continue to positively impact screening rates as people work with their healthcare providers to choose the option that is right for them."

Making sure people have full access to using stool-based tests like Cologuard is critical to reaching the unscreened. A recent study conducted by researchers at Mayo Clinic showed that when given a choice, most individuals at average risk of colorectal cancer said they would prefer a stool-based screening test for colorectal cancer over colonoscopy.8

*Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1

§ Estimates based on US population aged 45-74 and 45-49 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

1 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654

2 Piscitello A, Edwards DKV. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448. doi:10.1158/1940-6207.CAPR-19-05

3 Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281. doi:10.3322/caac.21457

4 Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;25(21):3828-3835. doi:10.1002/cncr.32347

5 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. doi:10.1056/NEJMoa1311194

6 Ahlquist DA. Multi-target stool DNA test: a new high bar for non-invasive screening. Dig Dis Sci. 2015;60(3):623-633. doi:10.1007/s10620-014-3451-5

7 Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

8Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res. 2021;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294

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