Shangpharma Corp.

Eli Lilly plans to spend $3.2 billion acquiring a Massachusetts-based biotechnology company and its experimental pill for inflammatory bowel disease.Announced Monday, the all-cash deal has Lilly buying all the outstanding shares of Morphic Therapeutics for $57 apiece a nearly 80% premium to the stocks closing price on Friday. The companies expect their deal to close by the end of September.Morphic formed in 2015, built around discoveries from the lab of Timothy Springer, an immunologist and Harvard University professor who was also a founding investor in Moderna. Morphics aim has been to develop oral drugs that inhibit integrins, a type of protein involved with a variety of important body processes, including inflammation.The biotech got off the ground with money from Springer, the software developer Schrdinger, and life science investors Polaris Partners and ShangPharma Investment Group. By mid-2016, it had completed a $52 million fundraising round that involved the venture firms SR One and Omega Funds, as well as the venture arms of Pfizer and AbbVie. Morphic went public three years later, amassing another $90 million in the process.Since then, Morphics most advanced drug, code-named MORF-057, has entered human testing. Three mid-stage studies are now evaluating it as a potential treatment for the two conditions that are collectively termed inflammatory bowel disease: ulcerative colitis and Crohns disease.Of the studies, the two largest aim to enroll between 200 and 300 participants and produce data in 2025 or 2026. The third, much smaller trial remains ongoing, but has already generated positive results in moderate-to-severe ulcerative colitis.Morphics drug works like Entyvio, the top-selling medicine at Japan-based Takeda Pharmaceutical. During Takedas last fiscal year, which ends March 31, Entyvio sales reached 801 billion yen, or roughly $5 billion.Both drugs target an integrin that facilitates inflammation in the intestines. Theyre administered in different ways, however, with MORF-057 taken orally while Entyvio is given as an intravenous infusion or an under-the-skin shot.Analysts have argued that, as a pill, Morphics drug would be more convenient for patients, and therefore could steal market share from Entyvio if it ultimately gains approval.Michael Yee, a Jefferies analyst who has a buy rating on Morphic, highlighted in a note to clients that MORF-057 also achieved a strong clinical remission rate of about 26% in that small ulcerative colitis trial. Notably, the trial is not placebo-controlled.Yee called the Lilly acquisition a good outcome for Morphic investors, as the company now doesnt have to lead the large, expensive studies that would likely be needed for its drug to secure approval. He also guessed there could be other potential buyers, given that many big pharmaceutical firms have recently shown an interest in immunology assets.Lilly itself has been on a bit of a dealmaking tear, acquiring over the past couple of years three biotechs involved, respectively, in cancer, immune system and rare disease research. The companys $2.4 billion purchase of Dice Therapeutics had some parallels to the Morphic deal, as Dice had just disclosed data from an early-stage study evaluating its oral drug against psoriasis.Though Lilly did just secure approvalfor another ulcerative colitis drug, analysts at Jefferies and the investment bank Stifel say they don't expect the Federal Trade Commission to take issue with the proposed Morphic acquisition. They note how that new drug, branded as Omvoh, regulates the immune system differently than MORF-057. '

Molecular and clinical responses observed across multiple cancer types, including those with high replication stress Predictable and manageable safety pro reliable pharmacokinetics offers combination flexibility and continuous and intermittent dosing regimens Initial Phase 2 data from ongoing trial for ART0380 in platinum resistant ovarian cancer is expected for the gemcitabine combination in H1 2025 and for the irinotecan combination in ATM deficient cancers in H2 2024 CAMBRIDGE, United Kingdom and NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Artios Pharma Limited (Artios), a clinical-stage biotech company led by pioneers of DNA damage response (“DDR”) drug development, presented promising monotherapy data from the Phase 1/1b portion of the ongoing Phase 1/2a study (NCT04657068) of its ataxia telangiectasia and Rad-3 related (“ATR”) kinase inhibitor ART0380 in advanced or metastatic solid tumors as part of a poster presentation at the European Society of Medical Oncology Congress (ESMO) 2023. ART0380 is a clinically advanced, oral, highly potent, and selective ATR inhibitor with best-in-class potential. The Phase 1/1b portion of the trial presented at ESMO assessed the safety and tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ART0380 monotherapy in patients with advanced or metastatic solid tumors. The patient population was enriched for cancers harboring DNA damage response deficiencies as identified by the Artios DcoDeR platform (n = 49). Dr. Niall Martin, Chief Executive Officer at Artios, said: “As a master regulator of replication stress, ATR inhibition can increase DNA damage and powerfully suppress tumor growth across broad cancer types harboring genetic defects. However, durability and long-term use with first-generation ATR inhibitors has been limited by challenges with toxicity and tolerability. Our next-generation ATR inhibitor ART0380 has demonstrated highly encouraging molecular and clinical responses as a monotherapy particularly in patients with DDR deficiency and high replication stress alterations. We believe the predictable and manageable safety pro reliable pharmacokinetics of ART0380 offers combination flexibility as well as continuous and intermittent dosing regimen options. We look forward to further evaluating the therapeutic potential of ART0380 alone and in combination with chemotherapies in patients with selected cancer biologies as part of the ongoing Phase 2 trial. We expect initial Phase 2 combination data with gemcitabine in patients with platinum resistant ovarian cancer in the first half of 2025, and with irinotecan in ATM deficient cancers in the second half of 2024.” Key Phase 1/1b efficacy data support ART0380 is active across tumor types: Molecular responses and reduction in tumor size observed in multiple cancer types, including those harboring molecular alterations or biology consistent with high replication stress Molecular responses were associated with longer progression free survival (PFS) Durable confirmed responses in all enrolled patients with high grade endometrial cancer Potent tumor-specific DNA damage detected by selective increases in γH2Ax in circulating tumor cells but not normal cells in DDR deficient tumors predicted through Artios’ DcoDeR platform Key Phase 1/1b safety and PK data demonstrate ART0380 is well-tolerated and predictable: Safe and well tolerated at intermittent and continuous doses Predictable, manageable, and reversible on-target anemia Dose proportional increases in exposure with rapid absorption and relatively rapid elimination and low variability The global, open-label, multi-center, Phase 1/2a study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ART0380 as a monotherapy or in combination with gemcitabine or irinotecan in patients with advanced or metastatic solid cancers. In the Phase 1/1b portion of the trial, patients with advanced solid cancers receiving escalating doses of ART0380 on a continuous daily (QD) or intermittent (3 days on, 4 days off) schedule will be evaluated. Patient enrollment was enriched for those with cancers harboring DNA damage response deficiencies as identified by the Artios DcoDeR platform. The Phase 2 portion will evaluate intermittent dosing of ART0380 in combination with gemcitabine in patients with platinum-resistant high grade serious ovarian, primary peritoneal or fallopian tube carcinoma, and in combination with irinotecan in ATM deficient cancers. Up to 250 patients are expected to be enrolled in the Phase 1/2a study which will be conducted at multiple oncology centers across the United States and Europe. ART0380 is being developed as an oral anti-cancer agent for the treatment of cancers that harbor defects in DNA repair and in combination with agents including those that cause DNA damage. ART0380 was originally in-licensed by Artios from The University of Texas MD Anderson Cancer Center and ShangPharma Innovation in 2019. The molecule was jointly developed as part of a collaboration between ShangPharma and MD Anderson’s Therapeutics Discovery Division. For more information about Artios Pharma Ltd., please contact: Media & Investor Relations Contact: LifeSci Advisors Ligia Vela Reid E: lvela-reid@lifesciadvisors.com About Artios Artios is on a mission to kill cancer by exploiting DNA damage response (DDR) and repair pathways that are leveraged by cancer cells to promote their survival. Our specialized DcoDeR platform integrates Artios’ leadership capabilities, expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. We have built an extensive DDR focused pipeline designed to address areas of high unmet needs across solid tumour indications including our ATR inhibitor, ART0380, and our Polθ inhibitors, ART4215 and ART6043, as monotherapies and with combination treatments. Together with our strategic partnerships with Merck KGaA and Novartis, and research collaborations with premiere institutions like Cancer Research UK, The Institute of Cancer Research, The Netherlands Cancer Institute, and the Crick Institute we are pioneering validated approaches to DDR drug discovery. Visit our website at for more information about the company and our pipeline. About ART0380 ART0380 is a competitive, potentially best-in-class, oral, highly potent, and selective ATR inhibitor. Ataxia telangiectasia and Rad3-related (ATR) is a master regulator of DNA replication stress response that promotes cell death by destabilizing replication forks, inducing DNA damage, or inhibiting checkpoint activation. ART0380 has broad clinical potential and is being investigated alone and in combination with other targeted therapies, chemotherapies and radiosensitiser opportunities in DDR deficient and high replication stress tumors. ART0380 was in-licensed from MDACC and ShangPharma in 2019. About the DcoDeR platform Artios has developed a specialized DcoDeR platform which exploits its expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. Our world class DNA damage response discovery platform allows us to understand disease biology, identify novel targets, develop new medicines, and select and treat patients who will benefit most. DcoDeR is being leveraged in ongoing research collaborations and licensing agreements with Merck KGaA to identify novel DDR nuclease inhibitors and with Novartis to identify DDR targets to use in combination with radioligand therapies.

ART0380 demonstrated a tolerable and manageable safety profile, with monotherapy clinical activity in tumors predicted to be sensitive to ATR inhibition in Phase 1 dose escalation First of three Phase 2 solid tumor expansion cohorts evaluating ART0380 as a monotherapy and in combination with chemotherapy Initial Phase 2 data in patients with platinum resistant ovarian cancer expected in 1H 2025 CAMBRIDGE, United Kingdom and NEW YORK, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Artios Pharma Limited (Artios), a clinical-stage biotech company pioneering the development of novel small molecule therapeutics that target the DNA damage response (“DDR”) process in order to treat patients with a broad range of cancers, announces the initiation of a randomized, Phase 2 expansion cohort in the ongoing Phase 1/2 trial evaluating its ataxia telangiectasia and Rad3-related (“ATR”) Inhibitor, ART0380, in combination with gemcitabine for the treatment of platinum resistant ovarian cancer. The initiation of the Phase 2 trial follows the successful Phase 1 dose escalation demonstrating a favorable safety and tolerability profile, clinical activity, and preferred pharmacokinetics with ART0380 in advanced solid tumors. The recommended Phase 2 dose of ART0380 monotherapy has been defined for both intermittent and continuous daily dosing schedules together with the regimen of ART0380 in combination with gemcitabine. Clinically active RECIST confirmed responses occurred across doses and in tumors harboring DDR deficiencies as predicted through Artios’ DcoDeR platform. Dr. Niall Martin, Chief Executive Officer at Artios, said: “This is the first of three proof of concept Phase 2 studies planned to evaluate our potentially best-in-class ATR inhibitor, ART0380, that has demonstrated a favorable safety and tolerability pro clinical activity in the Phase 1 dose escalation. We are delighted to be collaborating with ovarian cancer experts at GEICO in Spain on this important study that will help bolster our understanding of the therapeutic potential of ART0380 and further inform our clinical development strategy. We look forward to initial Phase 2 data expected in the first half of 2025.” Antonio Gonzalez-Martin, MD, PhD, President and Founding member of the Spanish Ovarian Cancer Research Group (GEICO), Principal Investigator for the trial, said: “Ovarian cancer continues to be a difficult to treat cancer that ultimately leads to relapse. We are excited to collaborate with Artios to help bring an ATR targeted therapy with the potential to be highly effective in patients with platinum-resistant disease who are in much need of innovative treatment options. The favorable pharmacokinetic pro combination with DNA damaging agents offers the potential of a new treatment option for patients with platinum resistant ovarian cancer. We at GEICO are looking forward to offering this novel treatment approach to our patients in the trial.” The ongoing global, open-label, multi-center, Phase 1/2 study is investigating the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of ART0380 (GEICO-114-O trial) as a monotherapy or in combination with gemcitabine or irinotecan. The randomized, Phase 2 portion is designed to evaluate intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles in patients with high grade serous ovarian, primary peritoneal or fallopian tube carcinoma. The Phase 2 expansion in combination with gemcitabine is expected to enroll up to 60 patients and will be conducted at multiple oncology centers across the United States and Spain. ART0380 is a potent, selective, oral inhibitor of ATR, a master regulator of DNA replication stress response. ART0380 is being developed as an oral anti-cancer agent for the treatment of cancers that harbor defects in DNA repair and in combination with agents including those that cause DNA damage. ART0380 was originally in-licensed by Artios from The University of Texas MD Anderson Cancer Center and ShangPharma Innovation in 2019. The molecule was jointly developed as part of a collaboration between ShangPharma and MD Anderson’s Therapeutics Discovery Division. For more information, please contact: Investor Contact: Abid Ansari, Chief Financial Officer E: aansari@artios.com Media Contact: LifeSci Advisors Ligia Vela Reid E: lvela-reid@lifesciadvisors.com About Artios Artios is on a mission to kill cancer by exploiting DNA damage repair (DDR) responses that are leveraged by cancer cells to promote their survival. Our specialized DcoDeR platform integrates Artios’ leadership capabilities, expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. We have built an extensive DDR focused pipeline designed to address areas of high unmet needs across solid tumour indications including our ATR inhibitor, ART0380, and our Polθ inhibitor, ART4215, as a monotherapy and with combination treatments. Together with our world-class strategic partnerships with Merck KGaA and Novartis, and research collaborations with premiere institutions like Cancer Research UK, The Institute of Cancer Research, The Netherlands Cancer Institute, and the Crick Institute we are pioneering validated approaches to DDR drug discovery. Visit our website at for more information about the company and our pipeline. About ART0380 ART0380 is a potential best-in-class oral, highly potent, and selective ATR inhibitor. Ataxia telangiectasia and Rad3-related (ATR) is a master regulator of DNA replication stress response that promotes cell death by destabilizing replication forks, inducing DNA damage, or inhibiting checkpoint activation. ART0380 has broad clinical potential and is being investigated alone and in combination with other targeted therapies, chemotherapies or radiosensitizer opportunities in DDR deficient and high replication stress tumors. In a completed Phase 1a dose escalation study, ART0380 demonstrated RECIST confirmed responses, a favorable safety and tolerability profile, and a favorable PK profile. About the DcoDeR platform Artios has developed a specialized DcoDeR (“Decoding the DNA Damage Response”) platform which exploits its expertise and experience in DNA damage biology and drug discovery to systematically discover and develop medicines targeting the totality of the DDR. Our world class DNA damage response discovery platform allows us to understand disease biology, identify novel targets, develop new medicines, and select and treat patients who will benefit most. DcoDeR is being leveraged in ongoing research collaborations and licensing agreements with Merck KGaA to identify novel DDR nuclease inhibitors and with Novartis to identify DDR targets to use in combination with radioligand therapies. About GEICO The Spanish Ovarian Cancer Research Group (GEICO) is a non-profit organization, whose main purposes are to promote and develop research, training, and education in Gynecological Cancer. GEICO is a leader in clinical and translational research, particularly ovarian cancer. It currently enjoys international prestige and is an active member of the Gynecologic Cancer InterGroup (GCIG) and the European Network of Gynecological Oncological Trial Groups (ENGOT). It is currently made up of more than 300 experts working in around 130 hospitals throughout Spain. Since its constitution in 1999, GEICO has participated in more than 100 research projects and is highly committed to the fight against this disease. Visit our website at for more information about the group and its activities.