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It was a busy week for the biotech sector, with a lot of important data readouts and regulatory updates. Among these, Terns Pharmaceuticals TERN and Summit Therapeutics SMMT surged after reporting positive data on important pipeline candidates.
Recap of the Week’s Most Important Stories:
Terns Surges on Obesity Drug Data: Terns Pharmaceuticals, a clinical-stage company, announced positive top-line data from its phase I single and multiple-ascending dose (SAD and MAD) obesity study. Its shares soared on the news, given the potential of the obesity market. The phase I study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of its investigational, oral, small-molecule GLP-1R agonist, TERN-601, dosed once daily in healthy adults with obesity or overweight.
Treatment with TERN-601 led to dose-dependent, statistically significant placebo-adjusted mean weight loss across all three doses (240 mg, 500 mg and 740 mg) evaluated in the 28-day MAD study.
The maximum placebo-adjusted mean weight loss of 4.9% was observed at the highest dose of TERN-601 (740 mg), administered once daily. It was also observed that 67% of the patients treated with the candidate, lost 5% or more of their baseline body weight at the 740 mg dosage strength of TERN-601.
Additionally, Terns Pharmaceuticals reported that the candidate was generally safe and overall well-tolerated in the phase I obesity study.
TERN currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GSK Vaccine Updates: GSK plc GSK announced that its therapeutic herpes simplex virus (HSV) vaccine candidate, GSK3943104, did not meet the primary endpoint in the combined phase I/II proof-of-concept study.
The company completed the primary objective data analysis from the phase II part of the phase I/II TH HSV REC-003 study, which demonstrated that GSK3943104 failed to meet the study's primary efficacy endpoint.
Following this, GSK decided not to progress with the phase III development of GSK3943104.
The company also announced positive headline data from a phase II study that evaluated certain mRNA-based seasonal influenza vaccine candidates. The study investigated various mRNA formulations of the seasonal influenza vaccine candidates, which can improve immune responses against influenza A and B strains in older and younger adults versus the current standard of care.
The data showed that mRNA formulations in one of the vaccine candidates demonstrated positive A and B strain immune responses compared to the standard of care in both older and younger adults.
GSK’s seasonal influenza vaccine candidate is currently in the phase II development. Building on the success of the above data, the company will now proceed into the phase III development of the vaccine candidate.
Updates From RLAY: Relay Therapeutics, Inc. RLAY announced an underwritten public offering of 28.6 million shares of its common stock at a price of $7.00 per share. However, shares of this clinical-stage precision medicine company were down on the news as investors were not pleased with the pricing. The recent public offering also dilutes the existing shareholders’ base value.
Earlier in the week, RLAY’s shares surged after the company announced positive interim data from the early-stage study of its lead investigational candidate, RLY-2608. The enrolled population included PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer (MBC) patients who received the combo regimen of twice-daily, 600 mg dose of RLY-2608 and Faslodex (fulvestrant). Interim data from the study showed that treatment with this two-drug therapy resulted in a clinically meaningful progression-free survival (PFS).
Per the data readout from the 52 evaluable patients receiving the combo therapy, the median PFS was 9.2 months across all mutations and 10.3 months among patients with kinase mutations. The clinical benefit rate (CBR), defined as the proportion of patients with complete response, partial response or stable disease for at least 24 weeks, was 57% across the 35 CBR-evaluable patients.
Among the 30 patients with measurable disease, one-third achieved a partial response (PR), while nearly three-quarter experienced tumor reductions. Additionally, among the 15 patients with measurable disease who had a kinase mutation, more than half achieved a PR. The median follow-up duration in the MBC study was 7.5 months.
Based on the encouraging data from the doublet arm of the MBC study, Relay Therapeutics is gearing up to initiate a pivotal study of RLY-2608 (in combination with Faslodex) for the same indication in the second-line setting in 2025, following regulatory discussions.
SMMT Stock Surges on NSCLC Data: Summit Therapeutics’ shares skyrocketed on Sept. 9 after it reported data from the primary analysis of the phase III HARMONi-2 study, which compared its investigational antibody ivonescimab (SMT112) with Merck’s blockbuster drug Keytruda (pembrolizumab) in certain patients with non-small cell lung cancer (NSCLC).
Data from the study showed that the drug reduced the risk of disease progression or death by nearly half when compared to Keytruda. This data conforms with the initial results reported by SMMT in May, wherein treatment with ivonescimab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS.
Patients who received the SMMT therapy achieved a median PFS of 11.14 months compared to 5.82 months for those receiving the MRK drug. This difference showed that ivonescimab cuts the risk of disease progression or death by 49% compared with Keytruda. Treatment with the drug achieved an overall response rate of 50% compared with 38.5% for those receiving Merck’s drug. The disease control rate for ivonescimab-receiving patients stood at 89.9% compared with 70.5% for Keytruda.
Following the results, shares of Summit hit an all-time high of $21.50.
IMVT Provides Update: Immunovant IMVT announced positive data from the phase IIa study of its investigational candidate, batoclimab, which is being developed for Graves’ Disease (“GD”).
The enrolled patient population comprised uncontrolled GD patients who were hyperthyroid despite anti-thyroid drugs (ATD) therapy. The data showed that treatment with the batoclimab 680 mg dose led to a mean Immunoglobin G (IgG) reduction of 77%, translating to a response rate of 76% in the GD patient population after 12 weeks. Additionally, it was observed that at the end of the first 12 weeks, 56% of the patients treated with the high-dose of the candidate achieved an ATD-Free Response.
During the next 12 weeks of treatment with the batoclimab 340 mg dose, the mean IgG level was further reduced by 65%, with a correspondingly lower responder rate of 68%. Additionally, the ATD-Free Response rate dropped to 36% in the second 12 weeks.
IMVT also announced that it has aligned with the FDA regarding the impending pivotal study design and secured investigational new drug application clearance for IMVT-1402 to treat GD. Shares were up on the news.
Performance
The Nasdaq Biotechnology Index has gained 0.16% in the past five trading sessions and MRNA’s shares have risen 9.68%. In the past six months, shares of AMGN have rallied 21.53%. (See the last biotech stock roundup here: Biotech Stock Roundup: NVAX Vaccine Approval, ALNY, ATHA Stock Dive on Updates & More Updates)
What's Next in Biotech?
Stay tuned for more pipeline updates.
Zacks Investment Research
GSK plc GSK announced that its therapeutic herpes simplex virus (HSV) vaccine candidate, GSK3943104, did not meet the primary endpoint in the combined phase I/II proof-of-concept study.
The phase I/II TH HSV REC-003 study evaluated the clinical efficacy of the early-stage HSV vaccine candidate GSK3943104.
The company completed the primary objective data analysis from the phase II part of the phase I/II TH HSV REC-003 study, which demonstrated that GSK3943104 failed to meet the study's primary efficacy endpoint.
Following this, the company decided not to progress with phase III development of GSK3943104.
Shares of GSK have rallied 18.1% so far this year against the industry's decline of 1%.
Positive Data From GSK’s mRNA-based Flu Vaccine Program
In a separate press release, GSK announced positive headline data from a phase II study that evaluated certain mRNA-based seasonal influenza vaccine candidates.
The study investigated various mRNA formulations of the seasonal influenza vaccine candidates, which can improve immune responses against influenza A and B strains in older and younger adults versus the current standard of care.
The data showed that mRNA formulations in one of the vaccine candidates demonstrated positive A and B strain immune responses relative to the standard of care in both older and younger adults.
Per the company, the above data shows that the mRNA platform elicits strong overall antibody titers with an acceptable safety profile.
GSK’s seasonal influenza vaccine candidate is currently in phase II development. Building on the success of the above data, the company will now proceed into phase III development of the vaccine candidate.
GSK’s New Licensing Agreement With CureVac
GSK restructured its existing collaboration with German vaccine maker, CureVac CVAC into a new licensing agreement in July 2024.
Per the terms of the new agreement, GSK will assume full control of developing and manufacturing mRNA candidate vaccines for influenza and COVID-19, along with commercialization rights. CVAC retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration.
In addition, CureVaC has the liberty to independently develop and partner mRNA vaccines in any other infectious disease or other indication.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 60.3%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.53. Year to date, shares of FULC have jumped 31.1%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
Zacks Investment Research
Thursday, GSK plc (LSE/NYSE:GSK) announced headline results of a phase 2 trial for its mRNA seasonal influenza vaccine program.
The trial studied a range of mRNA formulations in older and younger adults to evaluate vaccine candidates that could improve immune responses against influenza A and B strains, compared to the current standard of care.
The data demonstrated positive immune responses against influenza A and B strains compared to the current standard of care, meeting all predefined success criteria in the tested age groups of older and younger adults.
Also Read: GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech.
Interim data suggest the vaccine candidates have an acceptable safety and reactogenicity profile for all mRNA formulations tested.
These results build on the previous phase 2 trial and confirm the mRNA platform elicits strong overall antibody titres with an acceptable safety profile.
With these results, the GSK mRNA seasonal influenza vaccine program will progress into late-stage clinical development.
Vaccine candidate based on CureVac N.V.’s proprietary second-generation mRNA backbone
The Phase 2 study was initiated following interim data reported in April from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza.
In July, GSK and CureVac restructured their existing collaboration into a new licensing agreement, allowing the companies to prioritize investment and focus on their respective mRNA development activities.
Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases.
Price Action: GSK stock is down 0.91% at $43.37, and CVAC stock is down 1.98% at $2.97 at last check Thursday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
U.S. stocks were mixed, with the Dow Jones index falling around 50 points on Thursday.
Shares of Signet Jewelers Limited rose sharply during Thursday's session after reporting better-than-expected second-quarter earnings and stronger than anticipated third-quarter revenue outlook.
Signet reportedasecond-quarter sales decline of 7.6% year-on-year to $1.49 billion, missing the analyst consensus estimate of $1.50 billion. Adjusted EPS of $1.25 beat the analyst consensus estimate of $1.14.
Signet Jewelers shares jumped 18.8% to $92.83 on Thursday.
Here are some other big stocks recording gains in today's session.
Now Read This:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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