Immunocore Shares Fall After Early Solid Cancer Trial Data Of TCR Therapy

 

• Immunocore Holdings plc 
  IMCR-22.5%+ Free Alerts
   released initial Phase 1 data for the first off-the-shelf ImmTAC targeting PRAME, demonstrating that IMC-F106C is well tolerated and resulted in durable responses across multiple solid tumor types.
• Fifty-five patients have been treated across ten dose cohorts. IMC-F106C was well-tolerated, with treatment-related adverse events that were manageable and consistent with the mechanism of action. 
• In the clinically active dose cohorts, durable partial responses (PR) were observed in 2/6 patients with cutaneous melanoma, 2/4 with ovarian cancer, and 3/6 with tebentafusp-naïve uveal melanoma (UM) (0/5 response in patients with UM who had progressed on prior tebentafusp). 
• All ovarian patients were platinum-resistant, and all cutaneous melanoma patients had progressed on prior anti-PD1 and anti-CTLA4. Six of the seven PRs are ongoing, including two for over seven months. 
• Ten additional efficacy evaluable patients across four other tumor types had a best RECIST response of stable or progressive disease. A majority of patients evaluable for circulating tumor DNA (ctDNA) had at least a 50% reduction.

https://www.benzinga.com/general/biotech/22/09/28813981/immunocore-shares-fall-after-early-solid-cancer-trial-data-of-tcr-therapy

Adaptimmune Cancer Candidate: 44% Response Rate In Pretreated Ovarian, Urothelial, Head & Neck Cancers

 

• Adaptimmune Therapeutics plc 
  ADAP-5.15%+ Free Alerts
   announces data from its signal-finding Phase 1 SURPASS trial of ADP-A2M4CD8 in solid tumor settings. The data will be presented at the European Society for Medical Oncology (ESMO) 2022 Congress.
• The Phase 1 SURPASS trial is ongoing, and the overall response rate for the 43 evaluable people is 33% (including confirmatory scans for two people with unconfirmed partial responses).
• Most people experienced meaningful antitumor activity with a disease control rate of 81%. The median duration of response was 12 weeks.
• For the subset of 25 people with ovarian, urothelial, and head & neck cancers, the response rate is 44%.
• In ovarian cancer patients, most people had reductions in target lesions and an 86% disease control rate, and 5 (36%) had confirmed clinical responses, including one complete response.
• The company plans to start Phase 2 SURPASS-3 trial in late 2022/early 2023 in ovarian cancer.
• In urothelial cancer, 6 out of 7 people had reductions in target lesions, and three had confirmed responses. In addition, one unconfirmed response was received after the data cut-off.
• In head & neck cancer, three confirmed responses out of 4 people were observed.
• In gastroesophageal cancers, one confirmed and one unconfirmed response was subsequently confirmed after the data cut-off. There is clear antitumor activity in these cancers with an encouraging disease control rate (10 out of 13 people) in this heavily pre-treated advanced population.

https://www.benzinga.com/general/biotech/22/09/28810796/adaptimmunes-cancer-candidate-shows-44-response-rate-in-pretreated-ovarian-urothelial-head-neck-c

Allakos misses co-primary endpoint in Phase 3 trial

 Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, today reported data from EoDyssey, a 24-week, Phase 3, randomized, double-blind, placebo-controlled study of lirentelimab in patients with biopsy confirmed eosinophilic duodenitis (EoD). The trial met its histologic co-primary endpoint, but it did not achieve statistical significance on the patient reported symptomatic co-primary endpoint, in both the intent to treat (ITT) population and in a prespecified subpopulation.

The prespecified subpopulation was based on a post hoc analysis of the Company’s phase 3 ENIGMA2 study and excluded certain patients with conditions that could confound the patient reported symptomatic endpoint (e.g., non-eosinophilic/non-mast cell driven esophageal disorders or active irritable bowel syndrome). Although positive numerical trends in the symptomatic endpoint were observed in this prespecified subpopulation, the results were not statistically significant.

The safety results of the trial were generally consistent with previously reported intravenous lirentelimab studies. Mild to moderate infusion-related reactions (including flushing, feeling of warmth, headache, nausea, and/or dizziness) occurred in 19.6% of lirentelimab-treated patients and 14.9% of placebo-treated patients.

Currently Allakos is not planning to conduct additional studies in eosinophilic gastrointestinal diseases, but may do so in the future. Allakos is focusing development efforts for lirentelimab in atopic dermatitis and chronic spontaneous urticaria and on AK006.

https://finance.yahoo.com/news/allakos-announces-topline-phase-3-110000198.html

FDA and EMA Accept Submission for Pfizer Ritlecitinib for Alopecia

 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for ritlecitinib in the same patient population with a decision anticipated in the fourth-quarter 2023. Ritlecitinib is an investigational oral once daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).

https://finance.yahoo.com/news/fda-ema-accept-regulatory-submission-104500204.html

Kim Jong Un suggests North Korea may begin COVID-19 vaccinations

 North Korean leader Kim Jong Un has suggested that the isolated country could begin COVID-19 vaccinations in November, state media reported on Friday.

In a speech on Thursday to the North Korean national assembly, Kim cited World Health Organization warnings that the winter could see a resurgence in coronavirus infections.

"Therefore, along with responsible vaccination, we should recommend that all residents wear masks to protect their health from November," he said, without elaborating.

North Korea has not confirmed administering any COVID-19 vaccinations, although customs records show that it has imported some unspecified vaccines from China this year.

Last month Kim declared victory over COVID-19 and ordered the lifting of maximum anti-epidemic measures imposed in May though adding that North Korea must maintain a "steel-strong anti-epidemic barrier."

North Korea has never confirmed how many people caught COVID, apparently because it lacks the means to conduct widespread testing.

Instead, it has reported daily numbers of patients with fever, a tally that rose to some 4.77 million, out of an estimated population of about 25 million. But it has registered no new such cases since July 29, and says its death toll stands at 74.

Experts, including the WHO, have cast doubt on those numbers, citing an apparent lack of testing capacity in North Korea.

https://www.ctvnews.ca/health/coronavirus/kim-jong-un-suggests-north-korea-may-begin-covid-19-vaccinations-1.6061368

U.S. orders 100 million COVID tests

 The United States will boost its stockpile of at-home COVID-19 tests, ordering more than 100 million tests from domestic manufacturers, the White House said on Thursday, but warned it was a short-term solution.

President Joe Biden's administration has repeatedly and unsuccessfully asked Congress for more pandemic money. It said last week it would request $22.4 billion in emergency funding for COVID-19 relief ahead of a potential case surge in autumn.

"The administration is acting, within its limited funding, to increase the supply of at-home COVID-19 tests in the Strategic National Stockpile (SNS) by purchasing over 100 million additional at-home, rapid tests from domestic manufacturers," the White House said in a statement.

The administration has warned it would be unable to provide enough tests, vaccines and treatments without more funding. Thursday's announcement comes a week after it suspended orders of free tests from its COVIDTests.gov website as of September 2.

"While insufficient to adequately replenish our existing stockpile of at-home tests, this procurement will help meet some testing needs in the months ahead and will put us in a better position to manage a potential increase in testing demand this fall and winter," the White House said of the new tests.

It did not say if ordering from COVIDTests.gov, through which 600 million tests have been delivered, would resume as a result. It said last week that orders through the website would resume if Congress provides funding.

The administration is also launching a telehealth "Test to Treat" program that will allow people in 15 rural and high-risk communities to get tests delivered to their homes, use telehealth to consult a clinician, and get antiviral treatments prescribed and delivered if necessary at no cost, it said.

There are currently 2,800 "Test to Treat" sites where people can be tested at a pharmacy and immediately receive free pills if they test positive.

https://www.voanews.com/a/us-orders-100-million-covid-tests-white-house-says-more-needed-/6736908.html

Third Harmonic Bio to offer 9 million shares in IPO priced at $16 to $18 each

 Third Harmonic Bio Inc. , a biotech specializing in treatment for allergic and inflammatory diseases, set terms for its initial public offering on Thursday, with plans to offer 9 million shares priced at $16 to $18 each. Morgan Stanley, Jefferies, Cowen and Lifesci Capital are underwriting the deal. The company has applied to list on Nasdaq under the ticker 'THRD.' Proceeds will be used to finance clinical development and R&D, as well as for working capital and general corporate purposes. The company is still pre-revenue and does not expect to generate revenue in the near future. The Renaissance IPO ETF has fallen 46% in the year to date, while the S&P 500 has fallen 17%.

https://www.morningstar.com/news/marketwatch/20220908264/third-harmonic-bio-to-offer-9-million-shares-in-ipo-priced-at-16-to-18-each