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Merck's HIV Trials Put On Clinical Hold, Vifor Gets A Suitor, VERU Scores FDA Nod...

pharma 032618 14dec21 lt

Today's Daily Dose brings you news about the clinical hold imposed by the FDA on Merck's trials; CSL Limited evincing interest for a Swiss based biotech, Atara's ALLELE trial results, FDA approval of Veru's ENTADFI and the Leukemia & Lymphoma Society's findings regarding the need for a third primary dose of mRNA COVID-19 vaccine for blood cancer patients.

Read on…

1. FDA Imposes Clinical Hold On Merck's Islatravir in HIV Trials

The FDA has imposed a clinical hold on Merck's (MRK) investigational oral and implant formulations of Islatravir for HIV-1 pre-exposure prophylaxis, the injectable formulation of Islatravir for HIV-1 treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) HIV-1 once-daily treatment.

The clinical hold has been imposed following observations of decreases in total lymphocyte and CD4+ T-cell counts in some participants receiving Islatravir in clinical studies.

The following studies of Islatravir have been placed on full clinical hold:

A Phase 2a pre-exposure prophylaxis study evaluating the safety and pharmacokinetics of oral Islatravir once-monthly in participants at low risk of HIV-1 infection
A Phase 3 pre-exposure prophylaxis study evaluating oral Islatravir once-monthly in cisgender women at high risk for HIV-1 infection
A Phase 3 pre-exposure prophylaxis study evaluating oral Islatravir once-monthly in cisgender men and transgender women who have sex with men, and are at high risk for HIV-1 infection
A Phase 1 study evaluating injectable Islatravir (dosing complete)
A Phase 2 pre-exposure prophylaxis study evaluating once-monthly oral Islatravir in trans and gender diverse individuals (study had not yet opened enrollment)
A Phase 2a pre-exposure prophylaxis study evaluating Islatravir implant once-yearly in individuals at low risk for HIV-1 infection (study had not yet opened enrollment)

The following studies have been placed on partial clinical hold

A Phase 2 dose ranging study of oral DOR/ISL once-daily and lamivudine (3TC) in treatment-naïve adult participants with HIV-1 infection (fully enrolled)
A Phase 3 oral once-daily, open label study evaluating a switch from antiretroviral therapy (ART) to DOR/ISL in adults with HIV-1 who are virologically suppressed (fully enrolled)
A Phase 3 oral once-daily study evaluating a switch from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to DOR/ISL in adults with HIV-1 who are virologically suppressed (fully enrolled)
A Phase 3 study evaluating oral Islatravir and DOR/ISL once-daily in heavily treatment-experienced (HTE) participants with HIV-1 infection
A Phase 3 study evaluating oral Islatravir and DOR/ISL once-daily in treatment-naïve participants with HIV-1 infection
A Phase 2 open label study evaluating oral DOR/ISL once-daily for the treatment of HIV-1 infection in pediatric participants who are virologically suppressed on ART for =3 months or are treatment-naive
A Phase 3 open label follow up of adult and pediatric participants with HIV-1 who were treated with oral DOR/ISL once-daily in earlier clinical studies

Merck added that participants, who are currently receiving Islatravir, in any form, as part of the studies, will no longer receive the study drug and their CD4+ T-cell and total lymphocyte counts will be monitored for recovery.

MRK closed Monday's trading at $73.42, up 1.10%.

2. CSL Limited Eyeing Vifor Pharma

Australian biotech CSL Limited (CSLLY.OB) has announced a tender offer to acquire Swiss based Vifor Pharma AG (GNHAF.OB) for US$179.25 per share in cash, which equates to an aggregate equity value of US$11.7 billion.

Patinex AG, Vifor Pharma's largest shareholder holding 23.2% has agreed to tender its shares into the offer.

The tender is currently expected to commence around January 18, 2022 and the transaction is expected to complete around mid-2022.

GNHAF.OB closed Monday's trading at $144.50, up 7.36%.

3. Atara Rises on ALLELE Study Data

Atara Biotherapeutics Inc.'s (ATRA) phase III study investigating Tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease following solid organ transplant or hematopoietic cell transplant has yielded positive results.

In the study, dubbed ALLELE, Tabelecleucel demonstrated a 50% objective response rate, consistent with previous results, and the one year survival rate was 89.2% for patients responding to Tabelecleucel compared with 32.4% among non-responders. The results were based on 38 evaluable patients in the ongoing ALLELE study.

ATRA closed Monday's trading at $15.66, down 2.00%. In after-hours, the stock was up $18.68, up 19.28%.

4. Gilead's Yescarta Promising As 1st Line Treatment for B-cell lymphoma

Gilead Co.'s (GILD) CAR-T therapy Yescarta as part of first-line treatment in patients with high-risk large B-cell lymphoma has demonstrated encouraging results in a phase II trial.

In the phase II trial, dubbed ZUMA-12, after a single infusion of Yescarta, of the 37 evaluable patients, 89% achieved a response, including 78% of patients with a complete response at a median follow-up of 15.9 months.

Yescarta is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. It has not yet been approved by any regulatory agency for the treatment of patients in the first-line setting.

Commenting on the ZUMA-12 trial results, Frank Neumann, Global Head of Clinical Development of Glead's Kite, said, "The high rate of durable response to a one-time infusion of Yescarta in newly diagnosed patients with high-risk LBCL is exceptional."

GILD closed Monday's trading at $70.61, up 0.51%.

5. Legend Reports Data On CARTITUDE Program

Legend Biotech Corp. (LEGN) has reported new and updated data from its CARTITUDE clinical development program of Ciltacabtagene Autoleucel in the treatment of multiple myeloma.

The data from a Phase 1b/2 study in 97 patients with relapsed or refractory multiple myeloma, dubbed CARTITUDE-1, showed that after 21.7 months of follow-up, patients treated with Ciltacabtagene Autoleucel achieved a 98 percent overall response rate and 83 percent stringent complete response rate. Further, 95 percent of patients achieved a very good partial response (VGPR) or better, the company noted.

Ciltacabtagene Autoleucel is also under a phase II multicohort study in patients with multiple myeloma, dubbed CARTITUDE-2.

Cohort A of the CARTITUDE-2 trial is examining the efficacy and safety of Ciltacabtagene Autoleucel in patients with progressive multiple myeloma after 1-3 prior lines of therapy and who are lenalidomide-refractory. According to the company, at a longer median follow-up of 14.3 months, the overall response rate was 95 percent, which included 85 percent of patients achieving complete response or better and 90 percent achieving very good partial response or better.

LEGN closed Monday's trading at $50.67, up 0.26%.

6. VERU Gets FDA Nod

The FDA has approved Veru Inc.'s (VERU) ENTADFI for the treatment of urinary tract symptoms caused by an enlarged prostate called benign prostatic hyperplasia.

ENTADFI, with a dosing regimen of one capsule orally once a day, is expected to be available in early calendar year 2022.

Veru's own direct to patient telemedicine and telepharmacy services platform will be marketing and distributing ENTADFI. The company has also partnered with GoodRx (GDRX), a US based digital resource for healthcare, to market the drug.

VERU closed Monday's trading at $6.11, down 2.24%.

7. Here's what the LLS has to say

New data from The Leukemia & Lymphoma Society's National Patient Registry shows that most blood cancer patients benefit from a third primary dose of mRNA COVID-19 vaccine.

According to the data, one in four blood cancer patients do not produce detectable antibodies after their first two doses of the COVID-19 vaccine, but 43% of them will produce antibodies after a third dose. That said, even after the third dose, about 20% of blood cancer patients still had no measurable COVID-19 antibodies, revealed the data.

Lee Greenberger, LLS chief scientific officer, said, "Our data shows a clear benefit of giving blood cancer patients three primary vaccine doses, but there is still a large portion of patients who will remain at risk even with the additional dose".

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