On May 25, 2021 MaaT Pharma reported that final results from its Phase 1/2 ODYSSEE clinical trial have been published in the journal, Nature Communications (Press release, MaaT Pharma, MAY 25, 2021, View Source [SID1234580549]). The data demonstrated that the company’s initial product candidate, MaaT011, an autologous fecal microbiota transfer treatment, was safe and effective in fully restoring the gut microbiota in the 20 per-protocol analysis set of acute myeloid leukemia (AML) patients . In addition, the MaaT011 treatment showed short- and long-term signs of positive clinical outcomes including the reduction of both intestinal inflammation and gut carriage of antibiotic resistance genes. Topline data from the study had been previously presented in a poster presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

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Follow-up results from the trial also showed that only 17% (3/18) of the AML patients who received the MaaT011 intervention and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) developed gastrointestinal- graft -versus-host disease (GI-GvHD), a serious complication often resulting in high morbidity and mortality rates of up to 80%, suggesting a potential long-term protective effect of MaaT011 in these patients. The overall survival (OS) rate in the trial was 92% at six months and 72% at two years, which compares favorably with previously published studies in which the two-year OS ranged from 41.9% to 60% in this setting[1].

"The publication of peer-reviewed data in this renowned journal is a validation of the scientific rigor behind MaaT Pharma’s full-ecosystem restoration approach. The initial positive data from ODYSSEE paved the way for our enema and capsule formulations, MaaT013 and MaaT033, respectively, which are derived from pooling the intestinal microbial ecosystems of healthy donors. The full results from the study support our premise that a full-ecosystem microbiome therapeutic that can restore the high diversity and richness of the gut microbiota can provide a positive impact for patients with liquid tumors, including possibly in a prophylactic setting," commented John Weinberg, MD, Chief Medical Officer of MaaT Pharma. "We recently announced positive results for MaaT013 from our Phase 2 HERACLES clinical trial in graft-vs-host disease and our oral formulation, MaaT033, is currently being evaluated in a Phase 1b clinical study in acute myeloid leukemia patients; we expect to complete that trial in the fourth quarter of this year."

The standard treatment regimen for AML relies on intensive induction chemotherapy and treatment with antibiotics, which has been shown to dramatically alter the rich and diverse composition of the gut microbiome. As a result, host-microbiome interactions can be disrupted, resulting in pathological conditions including uncontrolled local immune responses, systemic inflammation, and increased incidence of comorbidities and complications. The study demonstrated that MaaT011 treatment successfully reestablished the disrupted gut microbiota back to baseline levels, qualitatively and quantitatively. Moreover, it drastically reduced proinflammatory bacteria that have been shown to dominate after intensive chemotherapy.

Professor Mohamad Mohty, MD, PhD, Professor of Hematology at Sorbonne University and Head of the Hematology and Cellular Therapy Department at the Saint Antoine Hospital in Paris, and senior corresponding author of the article added: "The results from the ODYSSEE study are profound because they suggest that restoring a functional gut microbiome ecosystem in heavily pre-treated acute myeloid leukemia patients can improve their outcomes. It is also impressive that MaaT011 treatment could likely reduce the risk of GvHD in the patients that received stem cell transplantation compared to standard expectations in this population."

The article titled, "Restoration of gut microbiota diversity with autologous fecal microbiota transfer in acute myeloid leukemia patients " summarizes the findings of the ODYSSEE trial (NCT02928523), a Phase 1/2 single-arm, multicenter, prospective, interventional trial in hospitalized patients with AML or high-risk myelodysplastic syndrome (MDS). A total of 25 patients were treated with MaaT011 and the efficacy results published were from those 20 patients that met the per-protocol analysis profile.

The Nature Communications publication is available online.

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a rare and aggressive cancer of the myeloid cells – immune cells that fight bacterial infections, defend the body against parasites, and prevent the spread of tissue damage – that progresses quickly and aggressively, and usually requires immediate treatment. The risk of developing AML increases with age; it is most common in people over 75 years.

On May 25, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported that it will host a virtual R&D Day today to detail the development strategy for its spleen tyrosine kinase (SYK) inhibitor portfolio, and highlight the momentum of its cyclin-dependent kinase 9 (CDK9) inhibitor program and the company’s ability to target transcription factors and transcriptional regulatory networks that drive cancer (Press release, Kronos Bio, MAY 25, 2021, View Source [SID1234580548]). The webinar will begin at 1:00 p.m. ET and can be accessed here.

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"Transcription factors and their associated regulatory networks have long been known to drive cancerous cell growth but have eluded therapeutic approaches. We are excited to present our progress in understanding and targeting transcriptional regulatory networks that drive small cell lung cancer and castration-resistant prostate cancer. We also look forward to sharing our roadmap for the continued development of novel cancer therapeutics that have the potential to address high unmet needs," said Norbert Bischofberger, Ph.D., president and CEO. "Today, we are announcing our plans to initiate two Phase 1/2 clinical trials for LANRA in patients with relapsed/refractory FLT3-mutated AML and in patients newly diagnosed with NPM1-mutated AML who are not candidates for intensive induction chemotherapy. The LANRA trials build upon the significant progress we have made over the past year, which includes advancing ENTO toward a registrational Phase 3 clinical trial that may support accelerated approval to treat newly diagnosed NPM1-mutated AML patients eligible for intensive induction chemotherapy and initiating a Phase 1/2 clinical trial for KB-0742, our oral CDK9 inhibitor targeting MYC-dependent solid tumors."

"ENTO and LANRA are differentiated clinical-stage SYK inhibitors that have the potential to address patients with mutations present in more than two-thirds of AML. Our development strategy for these complementary therapies seeks to leverage their properties to address the treatment needs of patients – ENTO in the induction setting for a defined duration of therapy and LANRA for potential treatment to progression," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, clinical development. "During today’s event, we also look forward to outlining our development strategy for our CDK9 inhibitor KB-0742 and sharing recent preclinical data that highlight the drug’s unique properties and potential anti-tumor activity in MYC-dependent cancers that develop in the breast, lungs, stomach and esophagus and in other transcriptionally addicted tumors like sarcoma and chordoma."

Select R&D Day Highlights

Unveils SYK Inhibitor Portfolio Development Strategy
Kronos Bio will unveil the development strategy for the company’s SYK inhibitor portfolio comprised of differentiated clinical-stage inhibitors ENTO and LANRA. The strategy will leverage the unique pharmacological properties of each inhibitor to expand the potential impact of SYK inhibition in AML beyond patients who are newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy.

The company’s SYK inhibitor portfolio, in combination with standard of care backbone regimens, could ultimately address both fit and unfit newly diagnosed AML patients with NPM1 and/or FLT3 mutations. In addition, rational combinations of SYK inhibitors with other targeted agents in the relapsed/refractory setting may eventually provide new treatment options for patients with genetically defined subtypes of AML. Specifically, the company plans to initiate the following trials:

Mid-2021 – Registrational Phase 3 trial for ENTO in patients who are newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy
Late 2021 – Phase 1/2 trial for LANRA in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated AML
Early 2022 – Phase 1/2 trial for LANRA in combination with venetoclax/azacitidine in patients with newly diagnosed NPM1-mutated and/or FLT3-mutated AML who are older than 75 years old or are not eligible for intensive induction chemotherapy
The company’s development strategy seeks to maximize the impact of these complementary investigational therapies, which have the potential to address patients with mutations present in more than two-thirds of AML.

Identifies KB-0742 Potential Target Indications Based on Additional Preclinical Data
The company will outline potential target indications for KB-0742, a highly selective, orally bioavailable CDK9 inhibitor in development to treat MYC-dependent, including MYC-amplified, solid tumors and other transcriptionally addicted cancers, based on recent preclinical data demonstrating activity in several tumor types. These data build upon research presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting that showed CDK9 inhibition on an intermittent dosing schedule resulted in sustained inhibition of tumor growth in multiple cancers.

The company plans to share initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from dose escalation cohorts of the Phase 1/2 clinical trial in the fourth quarter of 2021. Following these data, which will be used to establish a recommended dose and schedule, the company plans to initiate testing in expansion cohorts to assess KB-0742’s anti-tumor activity in non-small cell lung cancer, small cell lung cancer, triple-negative breast cancer, gastric/gastroesophageal cancer and in other transcriptionally addicted tumors such as sarcoma and chordoma.

Highlights Unique Capabilities of Discovery Product Engine
Today, Kronos Bio will highlight the unique aspects of its product engine that support the mapping of the transcriptional regulatory networks that drive tumor subtypes and response to treatment, which is critical to discovery efforts. The company will also explain how its small molecule microarray (SMM) screening platform, a key component of its product engine, allows for the identification of highly selective compounds, and will discuss how continuous optimization of the SMM platform for throughput and quality results in a versatile product engine that may allow for the targeting of transcription factors using multiple modalities.

Virtual R&D Day Agenda
The following topics and speakers will be featured at Kronos Bio’s Virtual R&D Day (all times are Eastern Time):

1:00 – 1:10 p.m.
Welcome and Introduction
Norbert Bischofberger, Ph.D.​, President and CEO

1:10 – 1:30 p.m.
Acute Myeloid Leukemia in 2021
Eytan M. Stein, M.D., Director, Program for Drug Development in Leukemia, Leukemia Service, Memorial Sloan Kettering Cancer Center

1:30 – 2:00 p.m.
SYK Inhibition: An opportunity to address mutations present in more than 2/3 of AML
Jorge DiMartino, M.D., Ph.D., Chief Medical Officer and EVP, Clinical Development
Yasir Al-Wakeel, BM BCh, Chief Financial Officer and Head of Corporate Development

2:00 – 2:20 p.m.
Q&A Session #1

2:20 – 2:30 p.m.
Break

2:30 – 3:00 p.m.
CDK9 Inhibition: An opportunity to target the master regulator MYC
Jorge DiMartino

3:00 – 3:30 p.m.
Discovery Pipeline: Maximizing the value of our platform
Charles Lin, Ph.D., SVP, Biology
Christopher Dinsmore, Ph.D., Chief Scientific Officer

3:30 – 3:50 p.m.
Q&A Session #2

3:50 – 4:00 p.m.
Summary and Close
Yasir Al-Wakeel

Virtual R&D Day Webcast Information
The live webcast will begin at 1:00 p.m. ET and conclude at approximately 4:00 p.m. ET. The webcast is accessible from the Investors & Media section of the company’s website at www.kronosbio.com. A replay of the event will be available for a limited time on Kronos Bio’s website.

About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow and can quickly lead to death as a result of bone marrow failure. Approximately 20,000 Americans are diagnosed with AML each year,1 with the NPM1 genetic mutation found in approximately 30% of cases.2 Relapse in AML is common,3 and despite available treatments, nearly 11,000 Americans will die from the disease each year.1

About Entospletinib (ENTO)
Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy. ENTO is a selective inhibitor targeting spleen tyrosine kinase (SYK), a critical node in a dysregulated transcription regulatory network within AML defined by persistent high expression of the transcription factors HOXA9 and MEIS1 (HOX/MEIS).4 Multiple AML driver mutations, including NPM1 and MLL gene rearrangements, have been associated with elevation of HOX/MEIS.5,6 ENTO has been investigated in more than 700 patients with a variety of hematologic malignancies, including AML, with clinical results observed in AML patients with NPM1 and FLT3 mutations and MLL rearrangements that support further development of the therapy.6,7

About Lanraplenib (LANRA)
Kronos Bio is developing LANRA, a next-generation selective inhibitor targeting spleen tyrosine kinase (SYK), for the treatment of patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) and patients newly diagnosed with NPM1-mutated and/or​ FLT3-mutated AML ​who are older than 75 years old or are not eligible for intensive induction chemotherapy. LANRA has been investigated in more than 250 patients with autoimmune diseases. In preclinical studies, LANRA was shown to have anti-leukemic activity against NPM1-mutated and FLT3-mutated AML samples. Two Phase 1/2 clinical trials for LANRA in AML are scheduled to begin in late 2021 and early 2022.

About KB-0742
KB-0742 is a highly selective, orally bioavailable inhibitor of cyclin dependent kinase 9 (CDK9) in development for the treatment of MYC-dependent, including MYC-amplified, solid tumors. CDK9 is a global regulator of transcription and plays an essential role in both the expression and function of MYC, a well-characterized transcription factor and a long-recognized driver of cancer that is amplified in approximately 30% of solid tumors, including those affecting the lungs, ovaries, esophagus, breast, stomach, pancreas and liver.8 KB-0742 was generated and optimized from a compound that was identified using the company’s proprietary small molecule microarray (SMM) screening platform.

About the Small Molecule Microarray (SMM) Screening Platform
Kronos Bio leverages its SMM screening platform to conduct high-throughput screens against traditionally undruggable target proteins, in particular transcription factors. The SMM platform directly addresses the historical challenges of targeting transcription factors by screening in conditions that preserve their associated context-dependent structures and multi-protein complexes. Using the company’s library of approximately 240,000 compounds in microarray format on slides, Kronos Bio screens for small molecule binders of the target transcription factor in context-relevant tumor nuclear lysates. Hits derived from SMM screening have the potential to act through a variety of mechanisms against various members of a transcription factor’s complex and, as such, hits are characterized for their ability to selectively modulate an oncogenic transcription factor’s activity as important criteria for further lead selection and optimization.

On May 25, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that Nima Farzan, Chief Executive Officer of Kinnate, will provide a company overview at the Goldman Sachs 42nd Annual Global Healthcare Conference, being held virtually from June 8-11, 2021 (Press release, Kinnate Biopharma, MAY 25, 2021, View Source [SID1234580547]).

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Event: Goldman Sachs 42nd Annual Global Healthcare Conference
Location: Virtual
Date: Thursday, June 10, 2021
Time: 2:10 PM ET/ 11:10 AM PT

Members of the Kinnate management team will also host investor meetings during the conference.

A live webcast of the Goldman Sachs presentation will be available in the Investors and Media section of the Kinnate website at www.kinnate.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

On May 25, 2021 Isofol Medical AB’s (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol or the "Company") Board of Directors reported on May 18, 2021, 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 25, 2021, View Source [SID1234580546]). If the Rights Issue is fully subscribed, the Company will receive approximately SEK 400 million before transaction costs related to the Rights Issue. In connection with the Rights Issue, the Company publishes a prospectus which today has been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).

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Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the United Kingdom, US, Canada, Japan, Australia, Hong Kong, New Zealand or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

Timetable for the Rights Issue

Prospectus

For full information regarding the Rights Issue, please refer to the prospectus, which is available on Isofol’s website, www.isofolmedical.com. Link to the application form is available on the same link at the start of the subscription period at the latest, and on Carnegie Investment Bank AB (publ)’s website, www.carnegie.se. The prospectus is also available on the Swedish Financial Supervisory Authority’s (Sw. Finansinspektionen) website, www.fi.se.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue. 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.

The information was submitted for publication, through the agency of the contact person set out above, at 10:30 CEST on May 25, 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 25, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company,reported that multiple studies in multiple cancer types at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showing all cancer patients can benefit from germline genetic testing to guide their care (Press release, Invitae, MAY 25, 2021, View Source [SID1234580545]). The use of genetic information informs changes in cancer care, increases access to precision therapies and guides screening for high-risk individuals and their family members. Earlier detection and precision therapies are critical to increase survivorship for people with cancer, yet the oncology community has been slow to adopt routine testing.

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1 in 8 people with cancer have a risk-causing change in their genes

"Cancer is a disease of genetics, yet clinical practice has struggled to keep pace with rapid advancements in research, particularly with respect to the role of germline genetics. Testing guidelines and medical policy often codify barriers, further lengthening the path to adoption of widespread testing and in some cases restricting access to precision therapies and clinical treatment trials," said Ed Esplin, M.D., Ph.D., FACMG, FACP, clinical geneticist at Invitae. "Research presented at ASCO (Free ASCO Whitepaper) shows that cancer-linked genetic changes are common across cancer types and when patients do receive germline testing, over two thirds of those with positive results are eligible for changes to their treatment plans. It’s clear that incorporating germline testing alongside tumor profiling can help oncologists better tailor treatment for each patient."

Data from 250 pancreatic cancer patients from the landmark INTERCEPT study conducted at the Mayo Clinic found that nearly one in six patients with pancreatic cancer (n=38) showed cancer-linked genetic changes and, importantly, receiving germline testing was associated with improved survival.

A separate study of prostate cancer patients confirmed similar findings in other cancer types that limiting testing deprives patients and clinicians of actionable information. In the first-ever presentation of the PROCLAIM study, which was conducted primarily in community urology clinics, of patients diagnosed with prostate cancer, a significant number of cancer-linked variants were missed if testing was done based on NCCN guidelines. Of the 532 patients with clinician-reported data, nearly half, 45% (n=239), did not meet NCCN criteria. Overall, 59 patients had a cancer-linked variant; one in 10 of them did not meet the criteria (9.6%, n=23), and 12.3% (n=36) of patients met the criteria. When a 12-gene panel was used, only 29 patients were found to have a cancer-linked variant and one third of these patients were missed by guidelines.

A third study showed simply changing medical policy is not enough to drive changes in clinician adoption. In a review of two independent datasets, including commercially insured and Medicare Advantage enrollees, only 3% (n=1,675) of the 55,595 colorectal cancer patients received germline genetic testing, despite medical policy recommending germline genetic testing for all colorectal cancer patients (consistent with the INTERCEPT colorectal cancer study). Of the patients who received testing, 18% (n=143) had a cancer-linked variant and two thirds, or 67% (n=96), of those patients were potentially eligible for precision therapy and/or clinical trials.

"The data have been available for years that show knowing what changes patients have in their genes is beneficial to treating their cancer. Yet the oncology community has been slower to adopt germline testing than tumor profiling, for reasons that are not entirely clear. These data presented at ASCO (Free ASCO Whitepaper) highlight the need for oncologists to embrace germline genetic testing as routine practice for all cancer patients," said Robert Nussbaum, M.D., chief medical officer at Invitae. "A positive germline genetic result may enable patients to enroll in clinical trials or gain access to new precision medicines. And equally important, the discovery of an inherited variant can alert relatives to seek out earlier cancer screening, helping avoid later-stage diagnoses and offering a treatment benefit if cancer develops."

Invitae aims to help overcome obstacles to the adoption of genetic testing by providing physicians with clinical consults to help interpret results and reducing cost as a barrier to genetic information. Invitae also provides patients direct access to genetic counselors, helping to integrate routine genetic testing into patient care with GIA, a HIPAA-compliant chatbot. Family members are also able to receive no-charge genetic testing if a positive result is found.

Details of the 2021 ASCO (Free ASCO Whitepaper) presentations:

Oral Abstract Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10504: Underdiagnosis of germline genetic prostate cancer: Are genetic testing guidelines an aid or an impediment? Presented by Neal Shore, M.D.
On-demand discussion will take place on June 4, 2021 from 9:00 – 11:30 a.m. ET.
Poster Discussion Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10514: Clinical impact of medical policy supporting universal germline testing for patients with colorectal cancer. Presented by Sarah Nielsen, M.S., L.C.G.C
Abstract #10515: Limitations of direct-to-consumer (DTC) genetic testing for hereditary breast and ovarian cancer. Presented by Neelam V. Desai, M.D.
On-demand poster discussions will take place on June 4, 2021 from 9:00 – 10:00 a.m. ET.
Poster Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10534: Germline alterations among Hispanic men with prostate cancer. Presented by Justin Shaya, M.D.
The poster will be available on-demand beginning June 4, 2021.
Poster Session: Gastrointestinal Cancer–GastroesophageaI, Pancreatic, and Hepatobiliary

Abstract #4118: Clinical impact of pathogenic germline variants in pancreatic cancer: Results from a multicenter prospective universal genetic testing study. Presented by Pedro L. Uson Junior, M.D.
The poster will be available on-demand beginning June 4, 2021.