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Friday, June 4, 2021

Protalix Shares Hits 52-Week Low After Adverse Event Reported In Fabry Disease Trial

 

  • Protalix BioTherapeutics Inc (NYSE: PLX) and Chiesi Farmaceutici S.p.A. have provided an update on the clinical development of pegunigalsidase alfa (PRX–102) for the proposed treatment of Fabry disease.

  • PRX–102 is currently being studied in Phase 3 BALANCE trial evaluating the safety and efficacy of 1 mg/kg of PRX–102 dosed every two weeks compared to agalsidase beta (Fabrazyme).

  • The primary endpoint of the study is the comparison of mean annualized changes (slope) of the eGFR (CKD-EPI) after completion of at least 12 months of treatment between the two treatment arms.

  • The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments was below the non-inferiority margin pre-specified in the Intention to Treat analysis set and above such limit in the Intention to Treat analysis set.

  • At the time of this analysis (n=77), two patients discontinued participation due to treatment-emergent adverse events - one discontinued participation due to a related adverse event. No deaths were registered.

  • Unblinded final data are anticipated in Q2 of 2022 after all remaining patients have completed the 24-month treatment period.

  • Despite reporting safety issues, the company will move forward with marketing application in Europe PRX–102 in Fabry disease.

  • Regarding the regulatory process in the U.S., the companies plan to submit a Type–A meeting request with the FDA to discuss the path for approval of PRX–102.

  • In April, the companies received FDA Complete Response Letter for PRX‑102 for Fabry disease, though no safety concerns were noted in the letter.

#ASCO21: Merus Presents Clinical Data on Zenocutuzumab in NRG1-fusion Cancers

 61 patients with NRG1+ cancer have been enrolled, including 45 patients evaluable for response as of the April 13, 2021 data cutoff date

- Encouraging early clinical activity observed, with confirmed responses in 5 of 12 patients with pancreatic cancer (42%) and in 13 of 45 patients across several NRG1+ tumor types (29%)
- Zenocutuzumab continues to be well tolerated with a favorable safety profile
- Company to host investor call to discuss interim clinical results and provide a program update on Sunday, June 6 at 6:00 PM ET

Company Conference Call and Webcast Information

Merus will hold a conference call and webcast for investors on Sunday, June 6, 2021 at 6:00 PM ET to discuss the Zeno clinical data. A replay will be available after the completion of the call in the Investors and Media section of our website.

Date: Sunday, June 6 at 6:00 pm ET
Webcast link: available on our website
Dial-in: Toll-Free: 1-877-260-1463 / International: 1-706-643-5907
Conference ID: 9678617

https://finance.yahoo.com/news/merus-presents-clinical-data-zenocutuzumab-160000708.html

#ASCO21: Iovance Clinical Data for Lifileucel Combo in Advanced Melanoma

 86% Overall Response Rate (ORR) and 43% Complete Response Rate in Immune Checkpoint Inhibitor (ICI) Naïve Advanced Melanoma Patients in IOV-COM-202 Clinical Study

Initial 7 Patients Show 3 Complete Responses, 3 Partial Responses and 1 Best Response of Stable Disease

ASCO Update Conference Call and Webcast on Sunday, June 6 at 12 p.m. ET

Webcast and Conference Call
Iovance will host a webcast and conference call on Sunday, June 6, at 12:00 p.m. ET to discuss ASCO clinical data updates for lifileucel alone and in combination with pembrolizumab in patients with advanced melanoma. Iovance senior leadership, together with Dr. Omid Hamid of The Angeles Clinic, will present a summary of the ASCO data from Cohort 1A in the IOV-COM-202 study as well as the upcoming oral presentation of updated Cohort 2 data from the C-144-01 clinical study.

The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 4858337. The live webcast can be accessed in the Investors section of the company’s website at http://www.iovance.com. The archived webcast will be available for a year in the Investors section at www.iovance.com.

https://finance.yahoo.com/news/iovance-biotherapeutics-announces-clinical-data-130800517.html

#ASCO21: Puma Bio Presents Data Comparing Findings from Phase II CONTROL Trial with Neratinib Arm of Phase III ExteNET Trial

 Dose escalation of neratinib lowers the frequency of severe diarrhea and improves overall tolerability in patients with HER2-positive early stage breast cancer

 

Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, presented results at the virtual 2021 ASCO Annual Meeting comparing the diarrhea mitigation strategies investigated in the Phase II CONTROL trial with the neratinib treatment arm of the ExteNET trial where diarrhea prophylaxis was not required. The presentation, entitled “Dose escalation for mitigating diarrhea: Ranked tolerability assessment of antidiarrheal regimens in patients receiving neratinib for early-stage breast cancer,” is included in the Breast Cancer—Local/Regional/Adjuvant Poster Session (#536).

The CONTROL trial is an international, open-label, Phase II study investigating the use of antidiarrheal prophylaxis or dose escalation to improve the tolerability of neratinib-associated diarrhea. The primary endpoint of the trial is the incidence of grade 3 diarrhea. Patients ≥18 years of age with stage I–IIIc HER2-positive breast cancer received neratinib (240 mg/day orally for 1 year) together with one of the regimens investigated: loperamide alone, in combination with budesonide or colestipol, or neratinib dose escalation (DE): 120 mg/day on days 1–7, 160 mg/day on days 8–14, then 240 mg/day thereafter + loperamide PRN.

In the analysis presented at ASCO 2021, five CONTROL cohorts that had completed follow up were evaluated for 13 endpoints related to tolerability. The DE cohort ranked the best among the CONTROL cohorts and was then compared with the neratinib arm of the ExteNET trial, which included patients ≥18 years of age with stage I–III HER2-positive breast cancer receiving neratinib 240 mg/day or matching placebo for one year, without mandated anti-diarrheal treatment. ExteNET was a multicenter, randomized, double-blind, Phase III trial (NCT00878709) of 2,840 HER2-positive early stage breast cancer patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and a trastuzumab-based regimen.

Comparison of the CONTROL DE cohort with the ExteNET neratinib arm demonstrated that grade 3 diarrhea was substantially lower in CONTROL DE compared to ExteNET (13.3% vs. 39.9%). Neratinib DE also resulted in fewer total days of grade 3 diarrhea compared to ExteNET (2.5 days vs 5 days). Dose escalation also led to fewer discontinuations due to diarrhea in the first three months of treatment compared to ExteNET (3.3% vs 14.5%). Additionally, the average duration of treatment with neratinib was much longer in the DE cohort versus ExteNET. Overall, the findings of this analysis suggest that escalating the dose of neratinib in the first 2 weeks of treatment may help patients stay on neratinib longer, allowing them the opportunity to complete the recommended 1-year of treatment.

https://www.biospace.com/article/releases/puma-biotechnology-presents-data-comparing-findings-from-the-phase-ii-control-trial-with-the-neratinib-arm-of-the-phase-iii-extenet-trial-at-the-asco-2021-annual-meeting/

#ASCO21: Spectrum Pharma Presents Poziotinib Data in Patients with Brain Metastases

 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented an e-poster on poziotinib CNS activity in patients with NSCLC with EGFR or HER2 exon 20 mutations. These data from Cohorts 1, 2 and 3 of the ongoing ZENITH20 clinical trial assessed the results from 36 patients with brain metastases at baseline with three patients (8%) achieving intracranial complete responses. The presentation titled "CNS activity of poziotinib in NSCLC with exon 20 insertion mutations" is available on the website for the 2021 ASCO Annual Meeting being held June 4-8, 2021.

"CNS metastases are a common and life-threatening complication of metastatic disease in NSCLC patients," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "These data show clinically meaningful CNS activity for poziotinib treated NSCLC patients with CNS metastases with EGFR or HER2 exon 20 insertion mutations."

https://finance.yahoo.com/news/spectrum-pharmaceuticals-presents-poziotinib-data-130000353.html

Pfizer jab produces less antibodies against Delta variant: Lancet

 People fully vaccinated with two doses of the Pfizer-BioNTech vaccine are likely to have more than five times lower levels of neutralising antibodies against the Delta variant (B16172) when compared to the original strain, according to new laboratory data that supports Pfizer's plans to deliver booster shots in Autumn.

This antibody's response was even lower in people who had only received one dose. After a single dose of Pfizer-BioNTech, 79 per cent of people had a quantifiable neutralising antibody response against the original strain, but this fell to 50 per cent for Alpha variant (B117), 32 per cent for Delta variant (B16172) and 25 per cent for Beta variant (B1351), showed the study, published as a Research letter in The Lancet on Thursday.

The results also show that levels of these antibodies are lower with increasing age and that levels decline over time, while no correlation was observed for sex or body mass index.

Although laboratory results such as these are needed to provide a guide as to how the virus might be evolving to escape the first generation of vaccines, levels of antibodies alone do not predict vaccine effectiveness and prospective population studies are also needed. Lower neutralising antibody levels may still be associated with protection against Covid-19, said researchers from the Francis Crick Institute and the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre in the UK.

"This virus will likely be around for some time to come, so we need to remain agile and vigilant. Our study is designed to be responsive to shifts in the pandemic so that we can quickly provide evidence on changing risk and protection," said Emma Wall, UCLH Infectious Diseases consultant.

"The most important thing is to ensure that vaccine protection remains high enough to keep as many people out of hospital as possible. And our results suggest that the best way to do this is to quickly deliver second doses and provide boosters to those whose immunity may not be high enough against these new variants," she added.

The findings also support current plans to reduce the dose gap between vaccines since they found that after just one dose of the Pfizer-BioNTech vaccine, people are less likely to develop antibody levels against the Delta variant as high as those seen against the previously dominant Alpha (B117) variant.

For the study, the team analysed antibodies in the blood of 250 healthy people who received either one or two doses of the Pfizer-BioNTech Covid-19 vaccine, up to three months after their first dose.

The researchers tested the ability of antibodies to block entry of the virus into cells, so called 'neutralising antibodies', against the original strain first discovered in Wuhan, China; the dominant strain in Europe during the first wave in April 2020 (D614G); and the Alpha, Beta and Delta variants.

The study will be extended to participants vaccinated with the Oxford/AstraZeneca vaccine.

Researchers have submitted their findings to the Genotype-to-Phenotype National Virology Consortium (G2P-UK), the New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) and the Joint Committee on Vaccination and Immunisation (JCVI), as evidence of the level of protection people might receive against the new variants after one dose and both doses of the Covid-19 vaccine.

https://www.business-standard.com/article/current-affairs/pfizer-jab-produces-less-antibodies-against-delta-variant-lancet-121060400516_1.html

Why Cullinan Oncology Is Soaring

 Shares of Cullinan Oncology (NASDAQ:CGEM) were skyrocketing 19.5% higher as of 11:21 a.m. EDT on Friday. The big jump came after the company announced additional data for its ongoing phase 1/2a study evaluating CLN-081 in treating non-small cell lung cancer (NSCLC).


Cullinan stated that objective partial response (significant tumor shrinkage) was observed in 21 of the 42 evaluable patients in the phase 1/2a study of CLN-081 across all dose levels. The company said that 76% of all patients showed at least some tumor regression at six weeks.

CLN-081 also appeared to have a relatively good safety profile. Cullinan said that no patients experienced any treatment-related rash of grade 3 (severe) or higher. All adverse events were "manageable with conventional supportive care," according to the company.

Investors were clearly happy with both the efficacy and safety data released by Cullinan. The company's management team was upbeat as well, with CEO Owen Hughes stating, "We remain encouraged with CLN-081's emerging profile."


Cullinan's data is being featured in an on-demand poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. The biotech stock could have other catalysts on the way. Cullinan hopes to soon file for approvals to initiate clinical studies of experimental drugs CLN-619 and CLN-049. 

https://www.fool.com/investing/2021/06/04/why-cullinan-oncology-stock-is-skyrocketing-today/