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]).

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!

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."

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]).

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!

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.

On October 11, 2022 Jinxi Jemincare, a China pharma formed in 1999, reported that out-licensed global rights for its androgen receptor degrader to Roche in a $650 million agreement (Press release, Shanghai Jemincare Pharmaceutical, OCT 11, 2022, View Source [SID1234621924]). JMKX002992 is being developed to treat prostate cancer patients who have developed resistance to current therapies. The oral small molecule candidate, which was developed in Shanghai Jemincare’s 500-scientist R&D center, is currently in preclinical testing. Jemincare will receive $60 million upfront and the rest in milestones, plus royalties. Roche said the agreement was the first global in-licensing between its Genentech subsidiary and a China biopharma. The deal was originally announced in August.

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!

On October 11, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a collaboration with Merck, known as MSD outside the United States and Canada, to engineer up to four enzymes for use as biocatalysts in Merck’s active pharmaceutical ingredient (API) manufacturing efforts (Press release, Ginkgo Bioworks, OCT 11, 2022, View Source [SID1234621923]). Through this collaboration, Ginkgo will leverage its extensive experience in cell engineering and enzyme design, as well as its capabilities in automated high throughput screening, manufacturing process development/optimization, bioinformatics and analytics to deliver optimal strains for expression of targeted biocatalysts.

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!

Biocatalysis is a sustainable and often more effective alternative to some chemical synthesis steps in industrial chemical synthesis. The inherent stereospecificity of enzyme biocatalysts can reduce costly synthesis and purification steps, thereby decreasing production costs. Through this collaboration, Ginkgo aims to optimize several biocatalysts by leveraging its world-class proprietary fungal strains, cell line development, enzyme engineering and optimization, and multiomics expertise.

"Ginkgo’s fungal strains present a major opportunity for improving biocatalysis. E. coli is currently the mainstay host for expressing enzymes, but a large number of enzymes will not express properly in E. coli, and those that do express in E. coli may have better homologs that only express in fungal strains," said Behzad Mahdavi, Senior Vice President of Biopharma Manufacturing and Life Sciences Tools at Ginkgo. "This enzyme optimization project with Merck has the potential to help reduce the cost of goods and enable a more robust supply chain for APIs."

"Merck is a pioneer in biocatalysis, improving manufacturing of crucial medicines. We’re thrilled to be partnering with Merck, and to be leveraging our platform capabilities for improved enzyme activity and production" said Jason Kelly, co-founder and CEO at Ginkgo. "Ginkgo’s platform model enables us to identify improved enzymes and develop powerful fungal strains and fermentation processes for enzyme manufacturing, empowering downstream API production for our customers."

Under the terms of the collaboration, Ginkgo will earn an upfront research and development fee and is eligible for success-based research and development milestone payments. In addition, Ginkgo is eligible to earn commercial milestone payments for each of a specified number of biocatalysis targets, which have the potential to total, in the aggregate, up to $144 million. To learn more about Ginkgo’s work in enzyme discovery, visit ginkgobioworks.com/our work/enzyme-discovery.

On October 11, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize health care, reported that The University of Tennessee Medical Center’s (UTMC) Cancer Institute has joined Caris’ Precision Oncology Alliance (POA) (Press release, Caris Life Sciences, OCT 11, 2022, View Source [SID1234621921]). The POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

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!

UTMC, a Magnet recognized hospital, Level I Trauma Center and regional academic medical center, serves as a major referral center for East Tennessee, Southeast Kentucky and Western North Carolina. As the largest provider of cancer care in the region, the Cancer Institute offers the broadest spectrum of cancer specialists and services to care for the local adult population, with research as its cornerstone of knowledge.

"We are proud to join the Caris Precision Oncology Alliance," said John L. Bell, M.D., Director of the Cancer Institute at The University of Tennessee Medical Center. "As cancer treatments become more sophisticated and personalized, having access to the most recent, ever-changing molecular testing helps our providers choose the best cancer treatment for each patient. It is truly an honor to join this prestigious group of institutions and make this testing available to patients in East Tennessee and beyond through cutting-edge precision oncology research."

"We’re excited to welcome The University of Tennessee Medical Center’s Cancer Institute into the growing Caris Precision Oncology Alliance network and look forward to collaborating with its clinicians and investigators to advance clinical and translational research," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The University of Tennessee Medical Center’s addition to the POA advances our precision oncology research portfolio aiming to improve the outcomes of patients with cancer."

The Caris Precision Oncology Alliance includes 73 cancer centers and academic institutions. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and advance research in cancer precision medicine. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and clinical outcomes data for over 275,000 patients covering over 1 million data points per patient.