On July 27, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and AstraZeneca reported that the companies have entered into a collaboration to research, develop and commercialize small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities (Press release, Regeneron, JUL 27, 2021, View Source [SID1234585231]). The collaboration builds on the recent discovery from the Regeneron Genetics Center of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated soon after discovery of the target so that potential treatments can be developed as quickly as possible. The companies will evenly split research and development costs and share equally in any future potential profits.

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As published in Science, the new target was found by sequencing nearly 650,000 people and identifying individuals with rare protective mutations. Individuals with at least one inactive copy of the GPR75 gene had lower BMI and, on average, tended to weigh about 12 pounds less and faced a 54% lower risk of obesity than those without the mutation. Strong associations were also seen with improvements in diabetes parameters, including glucose lowering. Obesity and insulin resistance are key drivers in the development of type 2 diabetes and often lead to cardiorenal complications, as well as liver disease.

"The next era of medicine is being fueled by important genetics findings that direct drug developers on how to deploy our toolkit of biologics, small molecules and gene editing technologies in order to safely help patients in need," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "As experts on genetics and human biology, Regeneron is excited to join forces with the chemistry and small molecule leaders at AstraZeneca, as we seek to develop new medicines tackling the harmful and costly obesity epidemic."

"We are pleased to announce this important collaboration with Regeneron to identify small molecule modulators against GPR75, a newly identified target with genetic validation in metabolic disorders. Obesity and insulin resistance remain key drivers in the development of type 2 diabetes and areas of significant unmet medical need," said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.

Obesity is associated with many serious health complications and drives organ dysfunction, including in the heart, liver, kidneys and pancreas. Worldwide the prevalence of obesity has more than tripled since 1975, and approximately 650 million adults are estimated to live with obesity today.

On July 27, 2021 Amgen (NASDAQ: AMGN) and Teneobio reported an agreement under which Amgen will acquire Teneobio, a privately held, clinical stage biotechnology company developing a new class of biologics called Human Heavy-Chain Antibodies (Press release, Amgen, JUL 27, 2021, View Source [SID1234585230]). Under the terms of the agreement, Amgen will acquire all outstanding shares of Teneobio at closing in exchange for a $900 million upfront cash payment, as well as future contingent milestone payments to Teneobio equity holders potentially worth up to an additional $1.6 billion in cash.

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The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. These platforms complement Amgen’s existing antibody capabilities with the addition of a heavy-chain only platform that allows a streamlined, sequence-based discovery approach for target binders, as well as Teneobio’s novel T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.

"The acquisition of Teneobio will strengthen our ability to develop innovative medicines to treat patients with serious illnesses and to bring to market best-in-class products, particularly with respect to multispecific and bispecific medicines directed against targets in a wide range of diseases across our core therapeutic areas," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Teneobio’s antibody platform complements our existing capabilities and could potentially give us a more diverse set of building blocks that can be developed into new multispecific therapeutics. In addition, the availability of Teneobio’s CD3 engager technology will allow us to broaden our capabilities in generating bispecifics, and with our own technology, enable customization of the T cell engaging domain of the molecules depending on the disease and target."

AMGEN TO ACQUIRE PRIVATELY HELD TENEOBIO FOR $900 MILLION IN CASH WITH FUTURE CONTINGENT MILESTONE PAYMENTS

The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. TNB-585 complements Amgen’s existing prostate cancer portfolio, which includes acapatamab (formerly AMG 160) and AMG 509, both in Phase 1. Each of these three investigational therapies uses a different approach to treat a highly prevalent disease for which new treatment options are very much needed.

"The Teneobio team is enthusiastic about joining forces with Amgen, a pioneer of biotherapeutics. Amgen’s R&D resources and its extensive clinical experience in immuno-oncology are ideally suited to applying and advancing Teneobio’s differentiated technologies and multispecific antibodies to deliver transformative medicines," said Roland Buelow, Ph.D., chief executive officer of Teneobio. "Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. Together, we share a focused commitment to rapidly discover, develop and deliver novel and meaningful disease-modifying multispecific antibodies to patients in need."

In June 2021, AbbVie Inc. exercised its right to acquire TeneoOne, Inc. (a Teneobio affiliate), which includes TNB-383B, an anti-CD3/BCMA bispecific for the treatment of relapsed or refractory multiple myeloma. Further details of this transaction, including conditions to closing, can be found here. Prior to close of the Amgen acquisition, three Teneobio affiliates will be spun-off to Teneobio’s existing equity holders: TeneoTwo, Inc. (anti-CD19/CD3), TeneoFour, Inc. (anti-CD38 enzyme inhibitor) and TeneoTen, Inc. (anti-HBV/CD3).

The acquisition is subject to customary closing conditions, including applicable regulatory approvals and is expected to close in the second half of 2021. Goldman Sachs & Co. LLC acted as financial advisor to Amgen and Latham & Watkins LLP as its legal advisor. Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP acted as legal advisor to TeneoBio.

On July 27, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data suggesting the Decipher Prostate Biopsy genomic classifier (GC) may help guide treatment decisions for prostate cancer patients who are candidates for active surveillance (AS) (Press release, Veracyte, JUL 27, 2021, View Source [SID1234585229]). The findings, from a retrospective analysis of data from the MUSIC registry, appear online in the journal Prostate Cancer and Prostatic Diseases (PCAN). They provide the first evidence that Decipher scores predict time to definitive treatment and time to treatment failure among men with early-stage prostate cancer.

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"We believe this real-world study and the resulting findings fill a critical gap in prostate cancer treatment, which is the need for an objective tool that can help physicians identify those early-stage patients who are good candidates for active surveillance as well as those who should move directly to definitive treatment with surgery or radiotherapy," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, Scientific and Clinical Operations, Urologic Cancers.

MUSIC (Michigan Urological Surgery Improvement Collaborative) is a large, prospective, observational, statewide registry created to optimize urologic care across the state of Michigan. Between February 2015 and October 2019, 855 MUSIC registry participants with newly diagnosed prostate cancer underwent testing with the Decipher Prostate Biopsy test.

For the analysis published today, researchers retroactively reviewed the Decipher risk scores from these 855 men to evaluate the independent association of Decipher high scores with the time to conversion from AS to radical therapy (TTT) and the time to treatment failure (TTF; biochemical failure or receipt of salvage therapy).

Of the 241 evaluable patients who elected to undergo active surveillance, a high-risk Decipher score was independently associated with shorter TTT (HR 2.51, 95% CI 1.52-4.13, p<0.001). Men with high-risk scores spent significantly less time on AS than men with Decipher low/intermediate risk scores (13.6 months vs. 33 months; p<0.001). Similarly, among the 479 evaluable patients who underwent definitive treatment either initially or after a period of AS, those with a Decipher high-risk score had a significantly shorter TTF as compared to those with lower scores (p=0.007).

"We have long needed better risk stratification tools for early-stage prostate cancer patients to reduce the uncertainty that is often part of initial treatment decisions," said Randy Vince Jr., M.D., MS Society of Urologic Oncology (NCI T32) Fellow, University of Michigan, and the paper’s lead author. "The findings from our analysis, which show that men with high Decipher scores are more likely to transition off of active surveillance and are over two-fold times more likely to experience treatment failure after initial therapy, provide evidence that molecular testing could have significant utility in this setting."

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

Veracyte did not sponsor the MUSIC study nor play a role in the risk analysis.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On July 27, 2021 Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company exploiting a broad DDR-based platform and small molecule drug discovery capabilities to develop a diverse pipeline of product candidates for the treatment of cancer, reported the completion of a US$153 million (£110 million) Series C financing to fund further development of its promising clinical-stage pipeline (Press release, Artios Pharma, JUL 27, 2021, View Source [SID1234585228]).

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The financing was co-led by Omega Funds and TCG X. Additional investors include Avidity Partners, Invus, Deep Track Capital, Sofinnova Partners, Tetragon Financial Group, RTW Investments LP, Soleus Capital, Piper Heartland Healthcare Capital, CaaS Capital Management, and Schroders Capital. These new investors join existing investors Arix Bioscience plc, SV Health Investors, Andera Partners, LSP (Life Sciences Partners), M Ventures, Pfizer Ventures, IP Group plc, and Novartis Venture Fund who also continue to support Artios through their participation.

In connection with the close of the Series C financing, Michelle Doig, Partner, Head of Corporate Development, Omega Funds and Chen Yu, Founding Managing Partner, TCG X, will join Artios’ Board of Directors.

Michelle Doig, Partner, Head of Corporate Development, Omega Funds, said: "Artios’ deep expertise in DNA damage response and novel approach to drive the search for new and better cancer treatments is an ideal match for Omega Funds. Supporting Artios in its mission to advance its portfolio of best-in-class and first-in-class small molecule DDR programs, including its DNA polymerase theta (Polθ) inhibitor, which is poised to enter the clinic, is a welcome addition to our portfolio of life science investments targeting our world’s most urgent medical needs."

Dr. Chen Yu, Founding Managing Partner, TCG X said: "Artios’ DDR programs have been validated by large pharma partnerships which speak to the promise of their science and strategy. Artios’ first-in-class platform for developing novel DDR drugs, including their targeted novel Polθ inhibitor with synergies with PARP inhibitors, provides a new potential mode of targeted cancer treatment in identified DDR-defective tumor populations. By investing in this financing round we are creating multiple avenues of value creation for our funds’ investors."

Dr. Niall Martin, Chief Executive Officer, Artios, said: "We are thrilled to have such great investors support our vision in this latest Series C fundraise co-led by Omega Funds and TCG X alongside a premier group of new and existing investors. This is an exciting time for Artios as we continue to progress our potential best-in-class ATR program in the clinic and prepare to launch our Polθ program into first-in-human studies in the second half of 2021. By ensuring that our DDR platform and pipeline programs are well-funded, we have successfully cleared a runway to execute our near-term clinical objectives. Having this caliber of strategic investors supporting our mission to bring next-generation DDR programs targeting hard to treat cancers to market adds further validation to Artios’ cancer-killing DDR Platform."

Artios is actively developing a pipeline of highly promising potentially best-in-class and first-in-class DDR therapies identified from a global network of leading researchers in the DDR field, including through Cancer Research UK. The inhibition of novel DNA repair targets, like Polθ, in tumors where DNA damage response factors have been lost or down regulated will lead to cancer cells being selectively destroyed without harming normal cells. This creates an opportunity for such products to be used with existing and future therapies to kill cancer.

This financing follows an $84 million (£65 million) Series B fundraise concluded in August 2018 and yields total capital raised to date from investors and strategic partners of more than US$320 million.

On July 27, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.65 per share of the company’s common stock for the fourth quarter of 2021 (Press release, Merck & Co, JUL 27, 2021, View Source [SID1234585227]). Payment will be made on October 7, 2021 to shareholders of record at the close of business on September 15, 2021.

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