Kamada initiates early-stage study for its plasma-therapy for COVID-19

Kamada (NASDAQ:KMDA) has recruited the first patient to its Phase 1/2 trial of its anti-SARS-CoV-2 plasma-derived immunoglobulin ((IgG)) product for COVID-19 in Israel.

The 12-subject trial will assess the safety, pharmacokinetics, and pharmacodynamics of the Company’s IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia.

Patients will receive Kamada’s product at a single dose of 4g within 10 days of initial symptoms, and will be followed for 84 days.

Additionally, the company intends to further explore the potential of its IgG product as preventive therapy for COVID-19.

https://seekingalpha.com/news/3603391-kamada-initiates-early-stage-study-for-plasma-therapy-for-covidminus-19

Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer? August 10, 2020

Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent in a phase 3 trial.

The CROWN trial pitted Lorbrena (lorlatinib) against Xalkori (crizotinib) in patients with previously-untreated ALK-positive non-small cell lung cancer (NSCLC), and showed that Lorbrena was better at staving off progression of the disease.

There’s no data yet to flesh out just how much better Lorbrena fared on the primary endpoint of progression-free survival (PFS), but the result could be a big step forward for Pfizer as it tries to build sales of Lorbrena, which was approved as a second-line treatment for this type of cancer in 2018.

Xalkori was the first ALK inhibitor to reach the market in 2011 and has been a solid earner for Pfizer, bringing in $530 million in sales for the company in ALK- and ROS1-positive NSCLC last year.

Latterly however it has started to feel the effects of competition from newer drugs in the ALK inhibitor class like Takeda’s Alunbrig (brigatinib), Roche’s Alecensa (alectinib) and Novartis’ Zykadia (ceritinib) – all approved as first-line treatments for ALK-positive NSCLC – and that has stalled its sales growth.

Those rival drugs have outperformed Xalkori in head-to-head trials, and are deemed to be more potent than Pfizer’s drug, as well as penetrating into the brain more readily – allowing them to tackle tumours that have spread into the central nervous system – and having activity against the most common crizotinib resistance mutations.

Added to that Pfizer’s drug is also heading towards the last few years of its patent life, with expiries due to start in 2027.

All that makes Lorbrena an important drug for Pfizer as it attempts to defend its ALK inhibitor franchise, but so far it hasn’t made much progress.

Sales aren’t high enough to be individually broken out in the company’s quarterly results statement, but approval in the first-line setting could kickstart the drug.

At the moment, Alecensa seems to be in the ascendency in the ALK class, with a 38% increase in sales last year to CHF 876 million ($962 million), rising another third to CHF 540 million in the first half of this year despite the brake imposed by the COVID-19 pandemic.

Novartis doesn’t disclose Zykadia sales, while Takeda’s latest financial report for the first quarter ended 31 July of this year records sales of JPY 2 billion (around $19 million) for Alunbrig.

Pfizer says it will share the results of CROWN with regulators around the world with a view to filing for approval in first-line ALK-positive NSCLC.

Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer?

Genentech’s etrolizumab shows mixed results in ulcerative colitis studies

Roche (OTCQX:RHHBY) unit Genentech announces topline results from its Phase III study program evaluating etrolizumab in people with moderately to severely active ulcerative colitis.

Mixed results were seen in studies evaluating etrolizumab as an induction therapy and as a maintenance therapy.

In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint of inducing remission versus placebo and adalimumab.

In contrast, the HIBISCUS II induction study did not meet its primary endpoint.

In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance.

In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint.

Further analyses of the data, including secondary endpoints, are ongoing and will be presented at upcoming meetings.

Pivotal Phase III study of etrolizumab in Crohn’s disease is ongoing. Genentech is studying additional investigational medicines in inflammatory bowel diseases (IBD).

Etrolizumab is the first investigational dual anti-integrin studied in IBD.

https://seekingalpha.com/news/3603175-genentechs-etrolizumab-shows-mixed-results-in-ulcerative-colitis-studies

CureVac B.V. sets terms for IPO

CureVac B.V. (CVAC) has filed an updated preliminary prospectus for its IPO of ~13.3M common shares at $14 – 16. Underwriters’ over-allotment will be an additional ~2M shares.

The Tübingen, Germany-based biopharmaceutical company develops messenger ribonucleic acid (mRNA) therapeutics and vaccines. Lead candidate is Phase 1-stage CV8102 for the treatment of four types of solid tumors. It is also advancing CV7202, a rabies vaccine, and a vaccine against SARS-CoV-2, both in Phase 1. Results from the latter should be available next quarter.

2019 Financials (€): Revenue: 17.4M (+35%); Net Loss: (99.9) (-40%); Cash Consumption: (87.0M) (-17%).

https://seekingalpha.com/news/3603218-curevac-b-v-sets-terms-for-ipo

Pieris Pharma teams up with Lilly in gastric cancer study

Pieris Pharmaceuticals (NASDAQ:PIRS) has entered into a clinical trial collaboration and supply agreement with Eli Lilly (NYSE:LLY) to evaluate the safety and efficacy of combining Pieris’ PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, with Lilly’s ramucirumab, a VEGFR2 antagonist for multiple types of solid tumors, and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a phase 2 study.

Under the terms of agreement, Lilly will supply Pieris with ramucirumab for the study as well as collaborate on data from the trial. PIRS is working towards initiation of a phase 2 single-arm combination study for the treatment of HER2-positive gastric cancer later this year.

Financial details are not disclosed.

https://seekingalpha.com/news/3603214-pieris-pharma-teams-up-lilly-in-gastric-cancer-study

IBio rallies on advancement of COVID-19 vaccine program

IBio (NYSEMKT:IBIO) announces results from ten preclinical study arms assessing a line-up of adjuvants with IBIO-201, its proprietary lichenase carrier molecule (branded as LickM) fused to a coronavirus subunit protein, one of its two COVID-19 vaccine candidates (IBIO-200).

The data, generated on combinations delivered via intramuscular injection and intranasally, showed anti-SARS-CoV-2 spike titers 21 days after immunization which continued to increase over the 42-day study period. Distinct T cell (Th1 and Th2) responses were also observed.

Data analysis is continuing.

https://seekingalpha.com/news/3603292-ibio-rallies-on-advancement-of-covidminus-19-vaccine-program

Seres Therapeutics up big on success of lead drug in C. diff study

Seres Therapeutics (NASDAQ:MCRB) rockets 173% premarket on robust volume in reaction to positive results from a Phase 3 clinical trial, ECOSPOR III, evaluating lead candidate SER-109 for the treatment of recurrent Clostridium difficile (C. diff) infection (CDI).

The study met the primary endpoint demonstrating a statistically significant 30.2% decrease in the proportion of patients who experienced a recurrence in CDI within eight weeks compared to placebo. Specifically, 11.1% of treated patients experienced a CDI recurrence versus 41.3% in the control arm.

88.9% of patients receiving SER-109 showed sustained clinical responses.

SER-109’s safety profile was comparable to placebo.

The results should be sufficient to support a U.S. marketing application.

The company says SER-109 is a highly purified consortia of spore-based commensal bacteria manufactured under GMP conditions, adding that its manufacturing process inactivates a number of potential pathogens, including species of E. coli and viruses like SARS-CoV-2.

Management will host a conference call at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3603258-seres-therapeutics-up-big-on-success-of-lead-drug-in-c-diff-study