Protagonist Therapeutics called ASH standout by BMO

 

• BMO Capital Markets is very positive on the update from Protagonist Therapeutics (PTGX +2.8%) at the ASH Conference.
• "We reiterate our Outperform rating on PTGX shares and increase our target price to $46 following our view of striking updated results from a Phase 2 trial evaluating PTG-300 for treatment of low-medium grade polycythemia vera reported at ASH," updates analyst George Farmer.
• "With no other drugs in clinical development with which to compete and a potential lifetime of therapy for PV patients, we estimate peak sales of $2.7B and increase our probability of PTG-300 success to 30% from 20%," he adds.
• Read the full PTGX date presentation made earlier today.
• https://seekingalpha.com/news/3642150-protagonist-therapeutics-called-ash-standout-bmo-capital

IGM Biosciences stock jumps after ASH presentation, Stifel ups price target

 

• IGM Biosciences (NASDAQ:IGMS) climbs 19%, its biggest jump since February, after preliminary data from its Phase 1 trial evaluating IGM-2323 in non-Hodgkins lymphoma demonstrated tumor size reduction in nine of 14 patients.
• IGM-2323 is a bispecific IgM antibody targeting CD20 x CD3. The data was presented at this year's American Society of Hematology meeting.
• As a result of the presentation, Stifel analyst Stephen Willey lifts his price target on the stock to a Street high $100 from $95. "This weekend's disclosure definitively improves our understanding of the asset/opportunity," he wrote.
• As of Oct. 30, 2020, the data cutoff date for the presentation, 16 patients were enrolled and treated at escalating dose levels of IGM-2323. Dose escalation continues in the study toward the anticipated recommended Phase 2 dose range of 100mg-1000mg.
• Of the 14 patients treated in the 0.5-, 2.5-, 10-, 30- and 50/100 mg dose cohorts, nine showed evidence of tumor size reduction and two patients showed partial responses, including a patient with follicular lymphoma (50/100 mg dose level) and a patient with diffuse large B cell lymphoma (DLBCL) who had failed CAR-T therapy (30 mg dose level).
• Subsequent to the data cutoff, the two patients with follicular lymphoma treated at the 50/100 mg titration dose converted to complete responses.
• Among all patients, IGM-2323 was found to be generally well tolerated, with no dose limiting toxicities, no Grade 3 or higher CRS and no evidence of neurotoxicity observed, despite less steroid pretreatment than used in studies of most other T cell engagers.
• https://seekingalpha.com/news/3642172-igm-biosciences-stock-jumps-19-after-ash-presentation-stifel-lifts-price-target

VBI Vaccines recruits Syneos Health as commercialization partner for hep B vax

 

• VBI Vaccines (VBIV +1.2%) and Syneos Health (SYNH -0.8%)have entered into commercialization partnership for the VBI’s 3-antigen prophylactic hepatitis B (HBV) vaccine in the U.S., Europe, and Canada, pending regulatory approvals.
• VBI and Syneos Health have been working together on the pre-launch strategy and activity since Q4 of 2019, and the companies have expanded their relationship to build the leadership team and field teams and incorporate full service commercialization solutions.
• U.S marketing application was submitted on November 30 and European application was filed on 23 November.
• https://seekingalpha.com/news/3642235-vbi-vaccines-recruits-syneos-health-commercialization-partner-for-hbv-vaccine

Autolus shines after ASH presentations on cell therapy candidates for blood cancer

 

• Thinly traded Autolus Therapeutics (AUTL +11.6%) has announced new data from Phase 1/2 study, ALEXANDER, evaluating company's CD19 and CD22 dual targeting CAR T candidate, AUTO3 in relapsed/refractory diffuse large B cell lymphoma (DLBCL). Data were presented at the American Society of Hematology meeting.
• As of October 30 data cut-off date, 49 patients have been treated and were evaluable for safety.
• Objective response rate (ORR) of 65% and a complete response rate of 51% was observed. Of the 29 evaluable patients receiving the recommended Phase 2 dose (a dose of ≥ 150 x 10⁶ cells) and pre-conditioning with Merck's Keytruda (pembrolizumab) at Day -1, ORR was 66% and the CR rate was 55%.
• On the safety front, AUTO3 was well tolerated, with low rates of cytokine release syndrome and neurotoxicity.
• Additionally, the company announced presentation of additional data from Phase 1 ALLCAR study evaluating AUTO1, CD19 CAR T cell therapy in adult patients with acute lymphoblastic leukemia.
• Of the 19 patients evaluable, 16 patients achieved minimum residual disease-negative complete response at one month. Across all treated patients, event free survival at six and 12 months is 69% and 52%, respectively.
• The company said that due to the pandemic, it now expects to enroll patients throughout 2021 with a full data set in 2022.
• https://seekingalpha.com/news/3642231-autolus-shines-after-ash-presentations-on-cell-therapy-candidates-for-blood-cancer

ADC Therapeutics defended by BofA after ASH presentation

 

• Bank of America reiterates a Buy rating on ADC Therapeutics (ADCT -2.8%) after taking in the company's drug data presentation at ASH and accompanying conference call.
• BofA's Ionca update: "An August 2020 cut of LOTIS-2, the pivotal ph 2 trial in relapsed or refractory (r/r) diffuse large B-cell lymphoma, showed an ORR of 48.3% (24.8% CR) with a mDOR of 12.6 months in 70 responders, and mDOR of 13.4 months for pts with a CR. Key subset analyses showed efficacy in pts who progressed after CAR-T (46.2% ORR), double or triple hit pts (33.3% ORR), and transformed DLBCL (44.8%). No new TEAEs were identified at the cutoff. We continue to view lonca as competitive for treating third-line DLBCL, and think subset analyses answer key questions doctors have been asking about targeting CD19 after CAR-T."
• The firm keeps a Buy rating on ADCT and price objective of $50 as it waits for the May 21 PDUFA date for Ionca. The stock is thinly covered on Wall Street.
• https://seekingalpha.com/news/3642147-adc-therapeutics-defended-bofa-after-ash-presentation

ASTRAZENECA Upgraded to Buy by Morgan Stanley

 Morgan Stanley's analyst Mark Purcell has upgraded his rating from Neutral to Buy. The target price has been raised to GBX 9900 from GBX 9400.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/ASTRAZENECA-Upgraded-to-Buy-by-Morgan-Stanley-31953266/

India speeding up review of Pfizer, AstraZeneca COVID-19 vaccines

 

India is accelerating its review of COVID-19 vaccines developed by Pfizer Inc and AstraZeneca to authorise for emergency use, a senior official said on Monday, as the world's second-hardest hit country seeks to contain the virus outbreak.

The government is pinning its hopes for mass supply on the Serum Institute of India, the world's largest vaccine producer by volume, which lodged the first formal application for emergency-use approval of AstraZeneca's shot on Monday.

Pfizer had already applied for emergency-use approval for its vaccine in India over the weekend, the government official said, declining to be identified due to the confidential nature of the information.

"We are in the process of reviewing. It is an accelerated reviewing process, which is there for Serum too," said the official. "It is the need of the hour. We have to review at the earliest."

India's Bharat Biotech also filed an application on Monday seeking emergency-use authorization for its COVID-19 vaccine, the official said.

The private pharmaceutical company based in the southern city of Hyderabad is developing a shot called Covaxin that it plans to launch by the second quarter of 2021.

The company could not immediately be reached for comment.

The country of over 1.3 billion people has 9.68 million infections, putting it second only to the United States for COVID-19 cases, while more than 140,000 people have died.

Lockdowns imposed to contain the spread of the virus have plunged the economy into one of its worst downturns in decades.

Serum Institute CEO Adar Poonawalla tweeted that the move to apply for emergency use "will save countless lives", but did not give any other details.

The company declined to reply to Reuters' follow-up questions about the process.

GLOBAL VACCINE SPRINT

AstraZeneca, Pfizer and Moderna Inc are among the drugmakers seeking advanced approvals for their vaccines, which are increasingly being seen by governments as the only way to stop the pandemic.

AstraZeneca's vaccine, called "Covishield" by Serum Institute, has less stringent storage requirements and is expected to be easier to distribute and faster to scale up in low-income countries.

But it is also facing queries from scientists over the robustness of some of its trial data, which showed a 1.5 dose regimen delivered more than 90% efficacy and a full two-dose regimen just 62%, both administered over two stages.

Britain and some other nations have pressed on with plans to roll out the AstraZeneca vaccine, while the Philippines and Thailand secured millions of doses, giving the shot a vote of confidence.

AstraZeneca said two weeks ago that it could launch an additional trial to evaluate the lower dose regimen, but Serum Institute has said it would continue to test only the two full doses as it would delay trials.

Poonawalla has said the company will first focus on supplying the vaccine in India before distributing it to other countries, pricing it at 1,000 rupees per dose ($13.50) for private markets.

Serum Institute has also said an emergency-use approval could preface a full rollout by February or March.

https://www.marketscreener.com/news/latest/India-speeding-up-review-of-Pfizer-AstraZeneca-COVID-19-vaccines-senior-official--31950312/