1stOncology™: Cancer Intelligence Service – Page 5722 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Clinical Microbiomics receives EUR 10 million investment from Seventure Partners

On October 11, 2022 Seventure Partners, a worldwide leading microbiome venture capital, and Clinical Microbiomics A/S, a pioneering microbiome research company, reported the completion of a financing in the Danish growth company (Press release, Biosortia Pharmaceuticals, OCT 11, 2022, View Source [SID1234621981]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The transaction confirms Seventure Partners position as leading investor in the fast-developing microbiome field, where they have backed growth companies with funding through "Health for Life I" and "Health for Life II" since 2013.

Microbiome science is widely proposed as the next frontier in addressing our most urgent health challenges. Organisations worldwide are exploring the potential for microbiome science to help people live better lives; from novel nutritional products and next-generation probiotics to new ways to diagnose, treat and prevent disease. However, the complexity of microbiome science remains a challenge in bringing new solutions to market.

Since its foundation in 2015, Clinical Microbiomics has been innovating at the forefront of microbiome science. The company is working with the world’s leading food and consumer health companies and is supporting the pharmaceutical industry in phase 3 clinical trials through its GCP-compliant microbiome research services. Importantly Clinical Microbiomics hosts the richest data-warehouse on the market with 30k+ samples linking 3M+ bacterial strains to clinical phenotypes. Clinical Microbiomics is a premium quality microbiome analysis company, particularly known for its pioneering work on clonal-level microbiome profiling that is recognized as the most sensitive, precise, and comprehensive in the field.

Together with researchers from the world’s most prominent academic institutions and innovative companies, microbiome scientists at Clinical Microbiomics are constantly pushing the boundaries of science to find the answers needed to impact health and disease.

Isabelle de Cremoux, CEO and managing partner at Seventure Partners, commented: "Incredible progress has been made in understanding the link between the microbiota and our health in the past years, but there is still much more to be accomplished. There is a lot of data available, but we need better tools to get more insights and standards for how to put it to practice. Clinical Microbiomics has a track-record of developing tools that can untangle the complexity of the microbiome and help researchers worldwide understand the mechanisms that impact health and disease. Our investment will enable Clinical Microbiomics to invest even further to lead the way with innovative concepts and services at pharma standards for this field, and we believe their work will play a critical role in unleashing the potential of microbiome science".

The funds raised will be invested to further advance Clinical Microbiomics’ leading microbiome profiling and systems biology platform, and to expand the service offering within multi-omics data integration, as well as to build further presence in key markets starting with the US.

Anders Grøn, CEO at Clinical Microbiomics, commented: "Our vision is a world where people are healthier because we understand how to improve our inner ecology – the microbiome. We challenge the idea that the complexity of the microbiome prevents us from exploring its potential to tackle the most pressing health questions of our time. Seventure Partners brings valuable experience across the microbiome field that will help us identify and address challenges across the sector, and their investment will enable us to expand our innovation programs, quality management systems, and strategic collaborations at a high pace to help researchers worldwide to bring new products and treatments to market."

Clinical Microbiomics’ is located in Medicon Valley, one of the largest centres for microbiome research in the World, but the Company’s microbiome analysis services are offered worldwide to clients across sectors such as pharma, biotech, nutrition, food, feed, personal care, and consumer testing.

BIOGEN TO REPORT THIRD QUARTER 2022 FINANCIAL RESULTS OCTOBER 25, 2022

On October 11, 2022 Biogen Inc. (Nasdaq:BIIB) reported it will report third quarter 2022 financial results Tuesday, October 25, 2022, before the financial markets open (Press release, Biogen, OCT 11, 2022, View Source [SID1234621957]).

Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. Following the live webcast, an archived version of the call will be available on the website.

Lantern Pharma to Present at The MicroCap Rodeo Presents The Windy City Roundup 2022 on Wednesday, October 12 at 11:00 a.m. ET

On October 11, 2022 Lantern Pharma Inc. (NASDAQ:LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it has been invited to present at the Microcap Rodeo presents The Windy City Roundup 2022 conference, which is being held live, in-person on October 12th – 13th, 2022 (Press release, Lantern Pharma, OCT 11, 2022, View Source [SID1234621955]). CEO & President, Panna Sharma will present at the conference.

Lantern Pharma is scheduled to present on Wednesday, Oct. 12th at 11:00 a.m. ET/10:00 a.m. CT. Management will be available for one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay at View Source

To receive additional information, request an invitation or to schedule a one-on-one meeting, please email [email protected].

Investors can register here.

About the MicroCap Rodeo Best Ideas Conferences:
The second-annual, live in-person MicroCap Rodeo is back. Join us as we go on the road and participate in the Windy City Roundup 2022 in Chicago, Illinois. Over two days in October, investors can harness top stocks for their portfolios. They’ll meet with executive management teams from approximately 60-plus microcap companies across a wide variety of industries and gain an understanding into the key value drivers and potential trends for 2023. Complementing the interactive, in-depth 25-minute one-on-one meeting format will be four tracks of company presentations.

Inceptua Early Access and Sentynl Therapeutics Inc. Announce the Launch of the Early Access Program for Nulibry® (fosdenopterin) for Pediatric Patients with Molybdenum Cofactor Deficiency (MoCD) Type A

On October 11, 2022 Inceptua Early Access (a business unit of the Inceptua Group), and Sentynl Therapeutics Inc. ("Sentynl"), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases reported that they have entered into a partnership to make Sentynl’s Nulibry available via an Early Access Program for eligible patients with molybdenum cofactor deficiency (MoCD) Type A (Press release, Sentynl Therapeutics, OCT 11, 2022, View Source;utm_medium=rss&utm_campaign=inceptua-early-access-and-sentynl-therapeutics-inc-announce-the-launch-of-the-early-access-program-for-nulibry-fosdenopterin-for-pediatric-patients-with-molybdenum-cofactor-deficiency-mocd [SID1234621936]).

MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae including seizures, difficulty feeding, severe developmental delays, and death within the first 4 years of life if left untreated. Nulibry is the first approved treatment option for MoCD Type A. Nulibry was approved by the FDA in 2021, and in September 2022 the European Commission granted marketing authorisation for Nulibry under exceptional circumstances.

Early Access Programs (also known as expanded access, early access, compassionate use, named patient supply) are a compliant route through which medicines which are either still under development or not approved in their country of intended use, can be made available for patients who either have no alternative treatment option, or have exhausted all other treatment options available in their country of residence.

"Inceptua Early Access is delighted to be supporting Sentynl with the Nulibry Early Access Program to allow appropriate patients with MoCD Type A the opportunity to access the first approved therapeutic option for this disease. MoCD Type A is a devastating disease with significant unmet need and anything we can do to support early access to this new treatment option will give hope to the families of the children affected by this condition." said Stuart Bell, Vice President, Early Access, Inceptua Group.

Grant Castor, Senior Vice President, Commercial Strategy and Operations at Sentynl, said, "We are pleased to be partnering with Inceptua Early Access to provide a formal centralized process for handling requests where there are suspected and confirmed cases of MoCD Type A globally. A presumptive diagnosis of MoCD Type A and rapid initiation of treatment is critical for all children with this ultra-rare disease worldwide."

Kinnate Biopharma Inc. Announces Recent Corporate Updates, Including on the Ongoing KIN-2787 Monotherapy Dose Escalation from Global Phase 1 Trial

On October 11, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported an update from the ongoing global Phase 1 KN-8701 trial evaluating KIN-2787, an investigational pan-RAF inhibitor, in patients with BRAF-altered solid tumors and/or who have NRAS mutant melanoma (Press release, Kinnate Biopharma, OCT 11, 2022, https://investors.kinnate.com/news-releases/news-release-details/kinnate-biopharma-inc-announces-recent-corporate-updates [SID1234621929]).

Key monotherapy updates to date include:

Enrolled patients with BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma, into six KIN-2787 dose levels: 25 mg bid, 50 mg bid, 100 mg bid, 200 mg bid, 300 mg bid and 400 mg bid.

KIN-2787 cleared the predicted efficacious dose at 300 mg bid.

Enrollment in the dose escalation portion continues; currently at the 400 mg bid dose with the maximum tolerated dose not yet determined.

KIN-2787 achieved meaningful exposures that were dose proportional and exceeded the predicted efficacious thresholds based on preclinical models.

Encouraging initial clinical responses observed thus far.
Initial site activation was slower than expected due to COVID-19. This has resulted in a limited number of efficacy evaluable patients to-date in the relevant population at the predicted efficacious dose. The company anticipates sharing detailed dose escalation data with additional efficacy evaluable patients in the first half of 2023.

Subsequent to the KIN-2787 data release, the company will announce the next pipeline program, which is anticipated to enter the clinic in 2023.

As of September 30, 2022, Kinnate’s total cash and cash equivalents and investments were approximately $262 million, exclusive of its China joint venture Kinnjiu’s cash, and is expected to fund current operations into mid-2024.

Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, "We are encouraged by what we are seeing in the clinic with KIN-2787 monotherapy thus far. Enrollment in the dose escalation portion of the trial is ongoing at sites globally, with increasing momentum. In addition, with $262 million cash on hand and a cash runway into mid-2024, we remain well-capitalized to progress our portfolio of precision oncology programs. We look forward to announcing the next program from our discovery engine, which we expect to enter the clinic next year."

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating KIN-2787, a pan-RAF inhibitor, in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is actively enrolling patients at 24 sites across the globe. KN-8701 contains a two-part dose escalation phase: in Part A1, KIN-2787 is being evaluated as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating KIN-2787 in combination with binimetinib, a MEK inhibitor, in NRAS mutant melanoma. Part B, the dose expansion phase, will evaluate KIN-2787 at a selected dose in three cohorts: melanoma, non-small cell lung cancer and other advanced or metastatic solid tumors, each driven by BRAF Class II or Class III alterations.