On May 18, 2021 Sibylla Biotech reported a research collaboration with Takeda Pharmaceutical Company Limited to discover novel small molecules that modulate the activity of selected pharmacological targets (Press release, Sibylla Biotech, MAY 18, 2021, View Source [SID1234641500]).

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Sibylla Biotech is the sole licensee of PPI-FIT (Pharmacological Protein Inactivation by Folding Intermediate Targeting), a novel technology that can predict the existence of druggable pockets in the folding intermediates of proteins. PPI-FIT has been invented by Sibylla‚ academic founders and is a striking example of technology transfer. PPI-FIT can be applied to any therapeutic area.

Many previously‚ undruggable‚ pharmacological targets can be newly analyzed and druggable pockets may be found, which disappear in the native state. Small molecules capable of binding these pockets can be developed into new drugs to solve long-lasting and unmet medical needs. The technology has been validated by generating small molecules that impair the folding process of the prion protein, thus inactivating it. The prion protein, when misfolded, is responsible for the Creutzfeld-Jakob disease and other lethal neurodegenerative diseases.

Under the terms of the agreement, Sibylla will use the PPI-FIT technology to identify druggable binding pockets in the folding intermediates of proteins of interest to Takeda. Once these pockets have been identified, Sibylla will also generate small molecules that can bind such pockets and will test the biological effects of those novel molecules.

"We are very excited to collaborate with Takeda where we have the opportunity to discover novel pharmacological targets with the potential to open the door to new treatments for neurological and neurodegenerative diseases with significant need. This is just a first step, yet a big one" said Dr. Lidia Pieri, CEO and co-founder of Sibylla Biotech.

The financial terms and the scientific details of the agreement remain undisclosed.

On May 18, 2021 Calliditas Therapeutics reported that Summary of Q1 2021 January 1 – March 31, 2021 (Press release, Calliditas Therapeutics, MAY 18, 2021, View Source [SID1234580180])

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No net sales for the three months ended March 31, 2021 were recognized. For the three months ended March 31, 2020 net sales amounted to SEK 0.5 million.
Operating loss amounted to SEK 150.8 million and SEK 72.3 million for the three months ended March 31, 2021 and 2020, respectively.
Loss before income tax amounted to SEK 136.2 million and SEK 63.7 million for the three months ended March 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 2.51 and SEK 1.65, for the three months ended March 31, 2021 and 2020, respectively.
Cash amounted to SEK 867.3 million and SEK 728.6 million as of March 31, 2021 and 2020, respectively.
Significant events during Q1 2021, in summary
In January 2021, Calliditas announced a positive readout of the Phase 1 study with setanaxib, which enables clinical trials with higher dosing levels.
In January 2021, Calliditas shared the clinical development plan for setanaxib, including planned trials in Primary biliary cholangitis (PBC) and head and neck cancer, and additional data from Part A of NeflgArd study at its R&D Day.
In March 2021, Calliditas announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon in patients with primary IgA Nephropathy (IgAN).
Significant events after the end of reporting period, in summary
In April 2021, Calliditas was granted accelerated assessment procedure by the European Medicine Agency’s (EMA) Committee for Human Medicinal Products (CHMP) reducing the maximum timeframe for review of the application for marketing authorization. If approved, Nefecon could be available to patients in Europe in first half of 2022.
In April 2021, Calliditas announced that the FDA accepted the submission and granted Priority Review for the NDA for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. Subject to approval, this would enable commercialization of Nefecon in the US in Q4, 2021.
Investor presentation May 18, 14:30 CET
Audio cast with teleconference, Q1 2021, May 18, 2021, 14:30 (Europe/Stockholm)

Webcast: View Source

Teleconference: SE: +46850558366 UK: + 443333009271 US: 18335268381

Financial calendar
Interim Report for the period January 1 – June 30, 2021 August 19, 2021

Interim Report for the period January 1 – September 30, 2021 November 18, 2021

Year-end Report for the period January 1 – December 31, 2021 February 24, 2022

On May 18, 2021 Iktos, a company specializing in Artificial Intelligence for new drug design, reported that it has entered into a Research Collaboration Agreement with Kadmon, a clinical-stage biopharmaceutical company based in New York, USA, pursuant to which, Iktos’s generative modelling artificial intelligence (AI) technology will be used to enable the rapid and cost-effective design of novel drug candidates for an undisclosed Kadmon drug discovery program (Press release, Kadmon, MAY 18, 2021, View Source [SID1234580216]). Under the agreement, Iktos will use its de novo structure-based generative modelling technology to identify novel compounds that match a pre-defined target product profile, with the aim of expediting Kadmon’s early phase discovery efforts.

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Kadmon discovers, develops and delivers small molecules and biologics to treat human diseases. Kadmon is expanding and integrating novel drug discovery platforms, with the aim of identifying and developing new product candidates for significant unmet medical needs. "Our collaboration with Iktos provides an exciting opportunity for Kadmon to combine Iktos’ innovative artificial intelligence (AI)-driven technology with Kadmon’s expertise in medicinal chemistry and structure-based drug design (SBDD) to accelerate novel target validation and to facilitate drug discovery", said Jean (Ji-In) Kim, Senior Vice President, Head of Chemistry at Kadmon.

Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process. Iktos’ technology automatically designs virtual novel molecules that have all of the characteristics of a successful drug molecule. This approach, now validated through Iktos’ other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple critical drug criteria, such as potency, selectivity, safety, and project-specific properties. In early-stage discovery projects, Iktos’ technology allows the design of novel hits with optimal protein-ligand interactions, as predicted by molecular modelling technology. This approach enables the exploration of chemical space in a unique way and produces innovative molecule designs with greater Freedom to Operate. Furthermore, it drastically shortens the hit finding and hit-to-lead optimization phases by enabling multi-parametric in silico optimization from the start of a project.

"We are thrilled that Kadmon is engaging with Iktos to try expedite the discovery of a drug candidate on a promising target," commented Yann Gaston-Mathé, President and CEO of Iktos. "We are proud to have earned the trust of our collaborators and are confident that Iktos’ software will improve Kadmon’s medicinal chemists’ ability to identify promising novel chemical matter and solve complex multi parametric optimization problems. The feedback from Kadmon’s research team will be highly valuable as we work to improve our product offering. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

On May 18, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY, the "Company") reported that it has fully placed the new shares from the capital increase resolved on April 27, 2021 (Press release, Epigenomics, MAY 18, 2021, View Source [SID1234580181]). The offer was oversubscribed multiple times. Accordingly, the Company’s share capital will be increased from currently EUR 9,852,690.00 by EUR 1,970,537.00 to EUR 11,823,227.00 by 1,970,537 new registered shares of the Company against cash contributions.

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The gross proceeds from the capital increase amount to approximately EUR 2.2 million.

The capital increase needs to be registered in the commercial register, which the Executive Board will apply for shortly. The inclusion of the new shares under the Company’s existing listing (ISIN DE000A3H2184) of the remaining shares is currently expected to take place at or around May 26, 2021.

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

9Zhu X, Parks PD, Weiser E. National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences. Cancer Prev Res. 2021;14(5):603-614. doi: 10.1158/1940-6207.CAPR-20-0524