The Week in Review #23  ASCO  2018 - Small  publicly-­traded  oncology  biotech  firms,  large  oncology  biotech  firms,  and  giant  biopharmaceutical  firms,  in  addition  to  some  private  biotech  companies,  all  presented  results  and  observations  about  their  cancer  drugs  at  the  2018  American  Society  of  Clinical  Oncology  (ASCO)   meeting.  Most  presentations  were  useful,...

Bellicum Pharmaceuticals (BLCM): The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events. Bellicum will be working with U.S. clinical sites to resume patient recruitment based on the amended protocols. The FDA clinical hold did not affect the BP-004 …

AT ASCO CAR-T Was Created to Stay BlueBird Bio CAR-T Results Bluebird Bio (BLUE) presentation was well received at ASCO after the firm stated results demonstrating that all the 15 evaluable patients in the clinical trial of its chimeric antigen receptor T cell (CAR-T) drug “bb2121 responded to treatment. Data were convincing demonstrating 89% of the patients observed their tumors shrink with 27% seeing their …

Making Sure that CAR-T Therapy for Cancer Succeeds Academic Researchers Identify a New Process to Raise Natural Armies of Cancer-Targeting T Lymphocytes Outside the Body Unleashing More Power to the Immune System to Fight All Types of Cancers GOOD NEWS FOR CAR-T IMMUNOTHERAPY DEVELOPERS Researchers from Mayo Clinic and the University of Washington have developed a new culture process to improve the efficacy of engineered …

The U.S. Food and Drug Administration (FDA) has removed the partial clinical hold it put on Adaptiimmune’s (ADAP) planned study of its NY‑ESO SPEAR™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS). The move cleared Adaptimmune to start enrolling patients with the MRCLS cancer in a trial of NY‑ESO T-cell therapy partnered with GlaxoSmithKline (GSK) Adaptimmune will initiate a study …

Immunotherapy Engineered T-Cell Therapy Is Here to Stay Articles aimed at undermining the value of the firms’ chimeric antigen receptor T (CAR T) cells as immunotherapy for cancer are less and less convincing to savvy investors. Most of the bloggers who attack the procedure admit at the end of their articles that the approach is promising, but still needs this or that for the sake of perfection, …

EMA’s created Priority Medicines (PRIME) regulatory initiative for products which the European agency rules they are of unmet needs. PRIME makes them eligible for support, possible regulatory applications and potential accelerated reviews. PRIME has accepted Adaptimmune’s (ADAP) drug NY-ESO-targeting T-cell therapy. The drug became the 8th accepted for EMA’s PRIME program. The PRIME status has been awarded to Adaptimmune’s NY-ESO-targeting T-cell therapy for the treatment …

Le CompaGnon Part 2 Wednesday June 22, 2016 From the  American Society of  Clinical  Oncology (ASCO)               Checkpoint inhibitors the CAR T Approach Adoptive cell therapy Oncolytic virus therapy Therapeutic vaccines Cytokines. Le CompaGnon Part 1 dealt with: - The two firms, MERK and BMY, who were the first to get approvals of their checkpoint inhibitors. These two . . . This content is for paid …

Prohost Letter #393 IMMUNOTHERAPY - PROHOST PORTFOLIO - NEW PICKS? - A Brief Reminder of the CAR T –TCR Immunotherapy Approaches In this issue we continue our journey inside the territory of cancer immunotherapy. We remind that in the Prohost Letter issue #391, we dealt with the immunotherapy based on genetically engineered T Cells, enabling them to seek out, attack and neutralize cancer cells. The immune system’s T …

The Market is Surely Ignoring the Historical Summit Biotech achievements are standing on Right Now     The latest biotech sector’s breakthroughs we presented was the novel powerful gene editing techniques CRISPR/cas9 and TALEN. Our article in the Prohost Letter #390 meant to enable the reader to understand that the evolution in biological sciences, especially in sequencing and analyzing the genome of the sick and healthy cells, has reached a stage …

Prohost Letter #388 TOPICS - 1. AN INDISPENSABLE SHORT INTRODUCTION 2. GENE EDITING 3. GENE THERAPY 4. CANCER IMMUNOTHERAPY 1. GENE EDITING Exon Skipping: Biomarin (BMRN); Sarepta (SRPT); These firms are waiting FDA approvals for Duchenne Muscular Dystrophy (DMD) Gene Editing Technology Competitors: Cellectis S.A. (CLLS); CRISPR; PTC Therapeutics (PTCT) Firms Using Different Approaches For DMD Treatment (see Below) Zink Finger Tech: Sangamo (SGMO); RNAi …

Prohost Letter #383 The Market - Recent tails about the market and the biotech sector are true thrillers. By true we mean no-fiction. The accounts lack common sense. Professionals' interpretations of the stocks' and of the market's moves are bizarre and misleading. General investors complain only when the stocks' volatility gets out of hand, yet, do not object to the hype, or interferes against the baseless …

The moment the new IPO NantKwest (NK) landed in the town of publicly traded firms, some called it the “New Golden Boy”. During the IPO, investors who knew about this firm and were waiting for that day seemed confident that the stock would surge. As a matter of fact, the stock did surge. On July 27, NantKwest, Inc. (formerly Conkwest, Inc.), Issued a press release …

For those who ask whether immunotherapy will have a dominant presence at ASCO, we confirm that yes; immunotherapy therapeutics will have a presence and a lot of audience, especially oncologists. There is big reason for oncologists’ interest in the subject. Their patients who have exhausted all standard of care treatments and would usually go home to die, did not lose hope this time. Instead, many …