Jacobio Announces Phase I Clinical Data of KRAS G12C Inhibitor JAB-21822 at 2022 ASCO Annual Meeting

On June 5, 2022 Jacobio Pharma (1167.HK) announced the phase I clinical data of KRAS G12C inhibitor JAB-21822 at the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Jacobio Pharmaceuticals, JUN , 2022, View Source [SID1234615590]).

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As of April 1, 2022, the Phase I clinical data of non-small cell lung cancer patients with KRAS G12C mutation shows that the overall response rate (ORR) is 56.3% (18/32) and the disease control rate (DCR) is 90.6% (29/32). In 400mg QD and 800mg QD cohorts, the ORR is 66.7% (8/12) and the DCR is 100% (12/12).

JAB-21822 was well tolerated with no dose limited toxicity (DLTs) in the dose escalation phase. The study of the clinical trial is still ongoing and remains open to enrollment.

The e-poster presentation materials has been available at 8:00 a.m. (Central Time) on June 5, 2022 at www.asco.org.

Conference Call Information
Jacobio will host JAB-21822 data discussion and business update call on June 6 9:00am-10:00am (HKT).
Registration link: View Source

About JAB-21822
JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer in a front-line setting; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and Cetuximab.

UCLB spinout, KIT-AR, announces €2m in seed stage funding round

On July 1, 2022 KIT-AR, the augmented worker platform for the manufacturing industry, reported the completion of a €2m seed stage funding round (Press release, UCLB, JUL 1, 2022, View Source [SID1234616439]).

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This investment was co-led by Armilar Venture Partners and Caixa Capital Risc, with participation from RKKVC and Techtree fund (managed by Iberis Semper) and follow-on investment from Sintef Venture V and Best Horizon.

This round of financing will help KIT-AR push onwards with its goal to become the premier augmented worker platform for the manufacturing industry.

Incorporated in the United Kingdom, with a subsidiary in Portugal, KIT-AR has strong roots in applied research and innovation having spun out of UCL (University College London) and SINTEF, the largest research institute in Norway.

Marina Santilli, Associate Director of Physical Science and Engineering at UCLB, said: "Having followed the development of the team and the evolution of the product platform from its initial roots as a collaborative research project between UCL computer scientists and SINTEF engineers, I am delighted that KIT-AR has secured this significant seed funding award. I look forward to seeing the company evolve and grow even further."

PHARMAXIS STRENGTHENS CLINICAL DEVELOPMENT ONCOLOGY CAPABILITY WITH THE APPOINTMENT OF DR JANA BASKAR AS CHIEF MEDICAL OFFICER

On July 1, 2022 Pharmaxis Limited (ASX:PSX), a clinical stage drug development company developing novel therapies to treat inflammatory and fibrotic diseases, reported the appointment of Dr Jana Baskar to the role of Chief Medical Officer (Press release, Pharmaxis, JUL 1, 2022, View Source;utm_campaign=Appointment%20of%20Jana%20Basker&utm_content=Appointment%20of%20Jana%20Basker+CID_bca45eeb80226d41b6b06560a3261988&utm_source=Campaign%20Monitor&utm_term=View%20Full%20Media%20Release [SID1234616441]).

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Dr Baskar is a highly experienced executive who has worked in both pharmaceutical and contract research companies.

"We are delighted to welcome Dr Baskar to Pharmaxis, where his deep experience leading clinical programs will be an asset to the continued advancement of our pipeline," commented Gary Phillips, Chief Executive Officer of Pharmaxis. "Dr Baskar brings significant oversight, clinical development and strategic expertise, having previously guided numerous programs through all phases of development. His extensive background and experience will be particularly valuable as the Company progresses its lead asset, PXS‐5505, towards clinical proof of concept in myelofibrosis and other oncology indications."

Dr Jana Baskar has over two decades of experience including overseeing more than 70 phase I‐III trials of oncology treatments in his 6 years as Medical Director at Novartis Oncology in Australia. In his most recent role, he served as Medical Director for IQVIA in Australia and New Zealand where he also co‐ chaired the IQVIA ANZ Oncology Advisory Board providing strategic advice to Biopharma companies. Dr Baskar received his Bachelor of Medicine degree (MBBS) from the University of Western Australia. He holds a Master of Medical Science in Drug Development from the University of New South Wales, Sydney (MMedSc) and a Masters of Business Administration (MBA) from the Australian Graduate School of Management.

Pharmaxis founding scientist and Medical Director, Dr Brett Charlton, is retiring after more than 20 years’ service with the company during which time he has overseen development programs that lead to two products achieving global regulatory approval and the transition of several pipeline products into clinical development including Pharmaxis’ two lead assets in myelofibrosis (PXS‐5505) and scarring (PXS‐6302). Page 2 of 3 Gary Phillips said, "I’d like to recognise and sincerely thank Dr Charlton for his extensive contribution to the Pharmaxis business and to advances in patient care. His experience and knowledge of transitioning drugs into early phase development has been extremely valuable and we will continue to seek his advice in a part time consultancy capacity until the end of 2022."

Philips incorporates Biodesix blood-based proteomic nodule risk assessment testing into Lung Cancer Orchestrator to advance early lung cancer diagnosis

On June 30, 2022 Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, reported it has teamed up with Biodesix, Inc. (Colorado, U.S.) (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, to incorporate the results of Biodesix’s Nodify Lung blood-based lung nodule risk assessment testing into Philips Lung Cancer Orchestrator lung cancer patient management system (Press release, Biodesix, JUN 30, 2022, View Source [SID1234616404]). The incorporation of proteomics data, along with the radiologic and patient history data currently used to determine the treatment decisions, can help create diagnostic efficiency for cancer care centers in the management of a growing number of lung nodule cases. Philips Lung Cancer Orchestrator solution is designed to enable health systems to operationalize lung cancer screening and lung nodule management programs at scale.

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Lung cancer remains the leading cause of cancer deaths worldwide [1], with current 5-year survival rates after diagnosis typically less than 20% [2]. If detected and treated early, however, research shows 10-year survival rates could increase to more than 90% [3]. Thanks to the adoption of low-dose CT (computer tomography) screening and better management of incidental lung nodule findings, early-stage diagnosis and treatment is now possible, but has resulted in rapidly increasing caseloads. For example, recent changes in U.S. guidelines have nearly doubled the number of people now eligible for lung cancer screening [4].

"By incorporating Biodesix’s Nodify Lung testing, we take another step in leveraging integrated diagnostics from imaging, genomics, and now proteomic results from a simple blood draw to address key moments in the lung cancer patient journey, support care team decision-making, and help health systems learn from their practice patterns," said Louis Culot, General Manager Oncology Informatics and Genomics at Philips. "We expect the inclusion of Biodesix’s ground-breaking technology in Philips Lung Cancer Orchestrator to help drive more confident decisions for the care team, and ultimately benefit patients."

As a next-step after radiologic lung nodule assessment, minimally-invasive biopsy procedures such as endobronchial biopsy (accessing a nodule via the patient’s airways), are already helping early-stage diagnosis. With 62% of biopsies conducted on benign nodules, by detecting the presence of blood-based biomarkers combined with clinical and radiomic factors, Biodesix’s Nodify Lung blood-based proteomic tests help clinicians to reclassify the risk of malignancy to better target resources to those who need them. If a nodule is malignant, the delay in surgical care for cancer patients by four weeks increases the mortality by 6-8% [5].

"We are delighted that our tests are being incorporated into Philips’ vision for end-to-end cancer care management using a multi-diagnostic approach," said Scott Hutton, Chief Executive Officer at Biodesix. "By integrating our Nodify tests in Philips Lung Cancer Orchestrator we hope to make these tests more accessible to physicians and patients and more easily utilized by care teams with the ultimate goal of improving patient care and outcomes."

Philips Lung Cancer Orchestrator is an integrated patient management system for CT lung cancer screening programs and incidental lung nodule findings that keeps track of patients, appointments, diagnostic images, test results, and clinical decisions for every step of a lung cancer patient’s screening and treatment journey. Fitting seamlessly into conventional screening and diagnostic workflows, it coordinates the end-to-end patient journey to create a fully traceable, fully documented timeline of scheduled actions, and aggregates data on tumor staging, radiology, pathology, and biomarker analyses for informed decision-making. The ability to order and receive the results expedites Biodesix’s proteomic testing directly to and from the Lung Cancer Orchestrator at the same time it adds new insights on nodule risk of malignancy to further support the decision-making process.

Lung Cancer Orchestrator is part of Philips’ expanding portfolio of integrated cancer care solutions that seamlessly connect data, technology, operations, and clinical workflows to enable pivotal decision-making. Visit Philips Oncology to learn how Philips combines smart diagnostic and imaging technologies with connected workflows that integrate patient data from disparate systems, to provide solutions that put expert information at clinicians’ fingertips to help expand the quality and reach of personalized cancer care.

Inhibrx Announces Completion of Phase 1 Combination Dose Escalation for INBRX-105, a Novel Targeted 4-1BB Agonist, and Draws an Additional $60 Million from Oxford Finance

On June 30, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a robust preclinical pipeline, reported the completion of Phase 1 dose escalation of INBRX-105, a novel targeted 4-1BB agonist, in combination with Keytruda (Press release, Inhibrx, JUN 30, 2022, View Source [SID1234616421]). It also reported the funding of an additional $60 million from its Loan and Security Agreement, as amended (the "Loan Agreement"), with Oxford Finance, LLC ("Oxford"), to bring its cash balance to approximately $176 million as of June 30, 2022.

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"We are very encouraged by the results observed in Part 3 and believe the Part 4 expansion cohorts have been designed to demonstrate the potential of INBRX-105," commented Mark Lappe, Inhibrx’s CEO. "The additional debt provided by Oxford provides non-dilutive financing and, we believe, the time needed to mature our programs ahead of various potential strategic options."

Phase 1 Dose Escalation Results for INBRX-105 in Combination with Keytruda
INBRX-105 is a precisely engineered multi-specific therapeutic candidate based on our single domain antibody ("sdAb") platform designed to agonize 4-1BB selectively in the presence of programmed death ligand 1 ("PD-L1"), a protein typically enriched in the tumor microenvironment and lymphoid tissues.

The study is a first-in-human, multicenter, open-label, non-randomized, Phase 1 trial in patients with locally advanced or metastatic solid tumors. This four-part trial is designed to determine the safety profile and identify the maximum tolerated dose and the recommended Phase 2 dose of INBRX-105 administered in combination with Keytruda, a programmed death receptor-1 checkpoint inhibitor. Part 3, dose escalation in combination with Keytruda, has concluded with a total of 30 patients enrolled. Patients were not pre-screened for PD-L1 expression. INBRX-105 in combination with Keytruda was reasonably well-tolerated and we observed durable responses in checkpoint-naïve and relapsed refractory patients. These results informed what we believe to be the optimal dose level for INBRX-105 in combination with Keytruda in Part 4. Additionally, single agent responses have been observed at this same dose level in both checkpoint-naïve and relapsed/refractory patients.

Part 4, dose expansion cohorts of INBRX-105 in combination with Keytruda, initiated enrollment in May 2022. This will include a total of approximately 90 patients in five separate cohorts and we expect to announce initial data from these cohorts in the first half of 2023.

Additional $60 Million in Debt from Oxford
On June 29, 2022, Inhibrx drew two additional term loans from its Loan Agreement with Oxford for an aggregate principal amount of $60.0 million. The two additional term loans were based on the completion of the following:

$30 million upon the receipt of positive topline data from the Phase 1 clinical trial of INBRX-101, our AAT-Fc fusion protein for the treatment of Alpha-1 antitrypsin deficiency, which we released in May 2022; and
$30 million upon initiation of Part 4 of the Phase 1 clinical trial of INBRX-105, our PD-L1x4-1BB tetravalent conditional agonist.
Inhibrx has one additional $30 million tranche available under the Loan Agreement, which will be available to fund upon the initiation of a potential registration-enabling clinical trial of INBRX-101. To date, the aggregate balance of Inhibrx’s outstanding term loans, which mature in January 2027, is $170.0 million. The repayment schedule provides for interest-only payments until March 2025 with a potential 12-month extension.