On August 5, 2021 Shanghai Promega Biological Products Co., Ltd. and Shanghai Henlius Biotech, Inc. reported that will develop and commercialize a microsatellite instability (MSI) companion diagnostic IVD kit to identify cancer patients likely to benefit from serplulimab, a novel anti-PD-1 monoclonal antibody (mAb) developed by Henlius for the potential treatment of microsatellite instability-high (MSI-H) solid tumors (Press release, Promega, AUG 5, 2021, View Source [SID1234585940]). The kit will be available to doctors in the Chinese Mainland to screen for MSI and inform immunotherapy options.

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The collaboration agreement, announced today, allows the companies to leverage complementary strengths. The New Drug Application (NDA) of serplulimab was recently granted priority review by the National Medical Products Administration (NMPA) in China. Promega has more than 15 years of experience in MSI research, and its MSI assay has been applied to several clinical studies around the world. The companion diagnostic method being co-developed is multiplex polymerase chain reaction (PCR) by capillary electrophoresis, which is regarded as the "gold standard" of MSI testing in the industry with high accuracy and specificity.

MSI Status

MSI is a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair (MMR) system to correct these errors. MSI status is a measure of MMR deficiency commonly found in solid tumors.

MSI-H occurs in several cancer types, such as endometrial, colorectal, gastric, renal cell carcinoma, and ovarian. Tumors with MSI-H status have shown higher response rates for immune checkpoint inhibitor (ICI) therapies such as anti-PD-1 mAb drugs. MSI-H is therefore becoming an important biomarker for the immunotherapy predictions of patients with solid tumors, providing oncologists, pathologists, and patients more information to determine the best treatment path.

Promega MSI Global Portfolio

Promega MSI "for research use only" technology is one of the leading standard tests for MSI status detection in research laboratories. The company’s PCR method has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications.

Promega continues to advance the promise of MSI technology globally. The company’s OncoMate MSI Dx Analysis System (OncoMate MSI) has been cleared by the US Food and Drug Administration (FDA) as an IVD medical device to determine MSI status in colorectal cancer tumors. OncoMate MSI is a CE-marked IVD medical device in the United Kingdom and select European countries. Promega has received innovation status and priority review by the NMPA in China and also intends to seek regulatory clearance for a Promega MSI IVD in China.

To learn more about Promega MSI technology, visit www.promega.com/CompanionDiagnostic

On August 5, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported an update on the clinical development and timelines of its lead asset NOX-A12 (Press release, NOXXON, AUG 5, 2021, View Source [SID1234585939]).

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As NOX-A12 recently reported promising data from the second cohort of patients with glioblastoma (brain cancer), NOXXON is advancing and broadening the clinical programs with the upcoming expansion of the ongoing GLORIA study in patients with brain cancer and the initiation of a Phase 2 study in pancreatic cancer patients over the coming 12 months:

Brain cancer:

the ongoing Phase 1/2 GLORIA trial (NCT04121455), evaluating NOX-A12 in combination with radiotherapy in first-line MGMT unmethylated brain cancer patients, has already reported positive data from the first 2 cohorts of 3 patients each treated with weekly doses of 200 and 400 mg of NOX-A12. The third cohort of 3 patients dosed at 600 mg per week has been fully recruited with data expected in Q4 2021, but due to the drop out of one of the patients unrelated to NOX-A12, recruitment of a replacement patient has been initiated and the data from this third cohort are now expected in Q1 2022,
the expansion of the Phase 1/2 GLORIA trial with NOX-A12 in MGMT unmethylated brain cancer patients is expected to be initiated in September 2021 at the 6 clinical sites in Germany which are already participating. First patients are expected to be recruited in Q4 2021. The trial will (i) expand the patient population to those with completely resected tumors for the combination of NOX-A12 with radiotherapy and (ii) evaluate a new NOX-A12 treatment combination in patients with incompletely resected tumors.
Pancreatic cancer:

a new Phase 2 trial (OPTIMUS) with NOX-A12 in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), is now expected to start in Q2 2022, from the initial expected start in H2 2021. Although the collaboration with MSD was signed in July 2021, delays due to COVID-19 and other issues beyond NOXXON’s control at raw materials and active ingredient services providers mean that the NOX-A12 batches needed to initiate the Phase 2 will only be available in Q1 2022 with first patients therefore expected to be dosed in Q2 2022.
Aram Mangasarian, CEO of NOXXON commented: "The unexpected manufacturing delay affecting the pancreas cancer program is naturally disappointing, but we have worked tirelessly to address the issues to ensure the NOX-A12 batches are released as fast as possible while maintaining the highest standards in quality. We are very excited that Merck reiterated their trust in our collaboration by entering into a second collaboration with NOXXON and we look forward to delivering on our new expanded clinical program with NOX-A12. Recruitment of the brain cancer expansion cohort would be unaffected by these drug manufacturing and supply issues."

On August 5, 2021 Versant Ventures reported that portfolio company Vividion Therapeutics has been acquired by Bayer AG for $1.5 billion up front and up to $500 million in potential future milestone payments (Press release, Versant Ventures, AUG 5, 2021, View Source [SID1234585938]). This acquisition represents one of the largest transactions for a preclinical-stage biotechnology company.

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Versant’s Series A investment in Vividion builds on a successful track record of San Diego-based start-ups including Amira Pharmaceuticals, Quanticel Pharmaceuticals, Jecure Therapeutics, Crinetics Pharmaceuticals and multiple spinouts launched from the firm’s San Diego-based Inception Therapeutics Discovery Engine.

"San Diego possesses a world-class academic community for discovery research and access to high-quality entrepreneurs for company creation," said Thomas Woiwode, Ph.D., managing director at Versant and a Vividion board member. "The result is a tremendous environment for venture capital investment."

"The field of chemical proteomics is uniquely positioned to translate modern scientific discoveries in human biology into first-in-class therapeutics for patients suffering from cancer and other debilitating diseases," said Benjamin Cravatt, Ph.D., Gilula Chair of Chemical Biology at the Scripps Research Institute and a co-founder of Vividion.

Vividion represents one of several Versant portfolio companies focused on developing better cancer therapies through discovery platforms for previously intractable drug targets. Since the firm’s initial investment in Vividion in 2017, Versant has launched four other start-ups in this field. Monte Rosa Therapeutics recently completed a successful IPO. Other Versant-created companies in the field include Stablix Therapeutics and two stealth companies, all launched within the past 12 months.

On August 5, 2021 Kite, a Gilead Company (Nasdaq: GILD), and Appia Bio, Inc., an early stage biotechnology company developing engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients, reported a collaboration and license agreement to research and develop HSC-derived cell therapies directed toward hematological malignancies (Press release, Kite Pharma, AUG 5, 2021, View Source [SID1234585937]). Under the partnership, Kite and Appia Bio will develop chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-iNKT) cells using Appia Bio’s ACUA technology platform for allogeneic cell therapy.

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Founded in 2020, Appia Bio recently announced the completion of its Series A financing to support the advancement of the company’s pipeline of allogeneic CAR-iNKT cell therapy candidates into the clinic. With its ACUA technology platform, Appia Bio leverages the biology of lymphocyte development to generate CAR-iNKT cells from HSCs. The ACUA platform offers the potential for improved efficacy and safety, streamlined manufacturing, and off-the-shelf accessibility of HSC-derived CAR iNKT-cell therapies.

"We are thrilled to partner with a leader in cell therapy such as Kite, who shares our vision for the potential of iNKT cells in off-the-shelf allogeneic cell therapy," said JJ Kang, PhD, Chief Executive Officer of Appia Bio. "Our partnership with Kite is an important step toward establishing the broad pipeline potential of our ACUA platform and bringing new treatment options to patients."

"As a pioneer in cell therapy, Kite is deeply commited to developing the next-generation of cell therapies to treat and potentially cure cancer patients," said Mert Aktar, Vice President of Corporate Development and Strategy at Kite. "Through our collaboration with Appia Bio, we’re excited to harness unique biological properties of invariant natural killer T cells to research and develop allogeneic cell therapies for cancer."

Under the terms of the agreement, Appia Bio will be responsible for preclinical and early clinical research of two HSC-derived CAR-iNKT product candidates engineered with CARs provided by Kite. Appia Bio will receive an upfront payment, an equity investment, and additional milestone payments for a total value of up to $875 million as well as tiered royalties. Kite will be responsible for the development, manufacturing, and commercialization of the product candidates identified through the collaboration.

On August 5, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that its second quarter 2021 financial results will be released after the markets close on Wednesday, August 11th (Press release, DiaMedica, AUG 5, 2021, View Source [SID1234585936]). DiaMedica will host a live conference call on Thursday, August 12th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 19, 2021, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), and entering the replay passcode: 4148874.