Ash 2019 Prediction: First Winners and Losers Appear

For followers of biotechnology and innovative therapies, major pharmaceutical companies are focusing on research results presentations and trend forecasts at the annual meeting of the American Hematology Society (ASH) in Decembertable ASH2019 summary excerptsthis year ASH will be held on December 7-10, this year's last major pharmaceutical results release, for many companies are crucial, and even affect their stock movementsThe mythical bubble surrounding the next generation of BTK inhibitors is bursting, with shares in Both Arqule and Sunesis falling sharply, according to a summary of the results released on November 6thAn early positive data release on the first-line treatment of bone marrow fibrosis patients with BET inhibitors sent a 90 percent rise in the share price of Constellation, a research and development drugmaker, as an unexpected winnercell therapythe new base (Celgene) for CAR-T cell therapy lisocabagene maraleucel (liso-cel; The results of JCAR017's registration will be closely related to the "expected value right" (CVR) that Wasme's Squibb acquired the new base will eventually payOne of the key conditions for Pay-so-Squibb pays CVR is that the U.Sapproves Liso-cel for lymphoma by the end of 2020, and the company has pledged to submit the CAR-T program to the FDA by the end of the yearThe Study of Transcend CLL 004 for Recurrent/Incurable Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Liso-cel shows that the overall patient response rate (ORR) is 82%, the results of another study of Liso-cel's Transcend NHL-001 were released more than a year earlier than expected, and the ASH Summary shows that if cell therapy is excluded from death before infusion, Liso-cel's ORR for the treatment of recurrent/incurable large B-cell lymphoma patients is 73%, roughly in line with gilead and Novartis's already-listed CAR-T therapy Yescarta, KyemriahHowever, with two CAR-T treatments already available, a major question for investors is: Will the FDA approve a third without significantly stronger data? Therefore, Liso-cel should focus on safety, and the results do look good, such as the incidence of severe cytokine release syndrome is only 2%But the four previous treatment-related deaths will no doubt be of concernanti-BCMA therapyin other research and development assets of the new base, few investors pay attention to its anti-B cell mature antigen (BCMA) bispecific CC-93269, but this meeting may be used to treat recurrent/incurable multiple myeloma patients in clinical Phase 1 trial 83% ORRBluebird's BCMA research and development focused on bb21217, this update shows that the treatment for recurrent refractory multiple myeloma patients clinical phase 1 trial ORR is 83%, but one-third of the patients relapsethe conference will release more than 25 different research assets for BCMA, and the current state of research and development in this area has even led small business Autolus to stop developing its Auto2 projectGlaxoSmithKline's Antibody-Drug Coupling (ADC) belantamab mafodotin (GSK2857916) is also closely watched, and in August the company announced that the drug was used in clinical phase 2 trials of clinically difficult multiple myeloma patients to reach the main endpoint, with overall clinical remission ratesThis or will be released whether the therapy is suitable for fourth-line or future treatmentGlaxoSmithKline said its Dreamm-2 findings had been submitted to the ASH ConferenceBTK inhibitorsthe shares of Sunesis and Arqule, two non-covalent BTK inhibitors, fell 23 percent and 18 percent, respectively, due to a lack of effective clinical dataSunesis' vecabrutinib study of 1B / 2 dose increments and cohort expansion for the treatment of B-cell malignancies showed that no one in the treatment responded, Sunesis or provided more data at meetingsArqule's ARQ 531 is used for less than 30% of clinical partial reactions (Pr) for recurrent or refractory B-cell lymphoma Phase 1, Lilly's acquisition of Loxo's asset Loxo-305, released its first early results to date, with 87.5 percent tumor response in eight patients with chronic lymphocytic leukemia (CLL) and set cell lymphoma, five of which produced PRin fact, this year's most-watched BTK inhibitor sought the possibility of AstraZeneca's Calquence (acalabrutinib), whose Elevate-TN Clinical Phase 3 trial showed that roche's anti-CD20 monogama (obi) was combined with the chemotherapy drug ChlorambucilCompared to acalabrutinib, the combination of obinutuzumab and acalabrutinib single-line treatment of chronic lymphocytic leukemia significantly improved the patient's progression less than survival (PFS) and was tolerated in untreated patientsBoth acalabrutinib groups observed a trend towards OS improvement and still required longer follow-up timesThis result will pose a serious challenge to AbbVie's Imbruvicaother areasin addition to oncology, bluebird gene therapy Lentiglobin updated the slow gloprotein data obtained in the HGB-206 trial, and Sanofi/Sangamo's ST-400 also had positive results, but at least it does not appear to be a threat to LentiglobinAnother challenge for sickle cell disease is Vertex/Crispr's CTX001, which is not currently updatedwho was the biggest winner of this YEAR's ASH early results? The Evaluate website predicts constellation, a small-trade biotech company that went public only a year ago, but its main asset, CPI-0610, is impressive Constellation clinical phase 2 results published in this ASH summary show that this BET inhibitor combined with Incyte JAK inhibitor Jakafi (Ruxolitinib) for untreated bone marrow fibrosis patients, all of the four assessable patients achieved a spleen volume reaction (SVR) of 35% and total symptom score (TSS) of more than 50% of the total spleen reduction threshold and improved the total spleinal threshold Constellation's shares rose 90 percent on the day after the data was released, but the study involved only four subjects over at least four treatment cycles, and the final outcome still needed to be looked at reference source: s1, Ash 2019, first and losers emerge
2, Constellation official website 3 31 ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinut Obiuuzumab (O) or Vs O Plus Perambucil (Clb) in Patients (Pts)