2 Genomic Stocks That Ark Funds Highlighted On Investor Day

 Ark Funds hosted an investor webinar Tuesday, sharing ideas on several industries and portfolio components, including a discussion on some names in the genomics space.

Ark Funds On Genomics: Ark Funds is well-known for its bullish thesis on the genomics market. The company has the Ark Genomic Revolution ETF (BATS: ARKG), an ETF devoted to the growth of the segment.

Exact Sciences EXAS 1.3% was highlighted by Ark Funds analyst Simon Barnett.

The company has made a series of acquisitions that could help the company’s position in the market, he said. 

“Incorporating it all together, Exact can broaden out their portfolio [and] determine market share.”  

Exact Sciences acquired the companies Thrive Earlier Detection Corp. and Base Genomics in 2020.

“Base is a really interesting company,” Barnett said, adding that he expects this acquisition in particular to “bear fruit” for Exact Sciences in the future.

In January 2021, Exact Sciences announced it acquired the license to the TARDIS technology from The Translational Genomics Research Institute.

The acquisition gives Exact Sciences technology that can be used to assess how a cancer is responding to treatment and not just pre-cancer screening technology.

One of the companies mentioned in the discussion was Quantum-Si, a company that's going public in a SPAC deal that includes a PIPE in which Ark Funds was involved. The company is merging with HighCape Acquisition Corp CAPA 1.46%.

Quantum-Si has a sequencing approach that could help improve speed without the use of complex information algorithms, Barnett said.

“Improvements in semiconductor manufacturing is one of the ways to improve and unlock portions of the addressable market.”

The Ark Funds: The Ark Innovation ETF ARKK 0.05% owns 4.7 million shares of Exact Sciences worth $580.7 million. The stock represents 2.6% of the fund's assets. 

The Ark Genomics ETF owns 3.6 million shares of Exact Sciences worth $448.3 million. The stock represents 4.9% of assets in ARKG.

https://www.benzinga.com/general/biotech/21/03/20101269/2-genomic-stocks-that-ark-funds-highlighted-on-investor-day

Lilly’s Covid-19 combo is better at low doses

 A new cut of data from the Blaze-1 study of Lilly’s Covid-19 MAb combo has posted even better data than a prior cut looking at higher doses. This is good news as the dose involved in the latest analysis, 700mg of bamlanivimab and 1,400mg of etesevimab, is the one authorised by the US FDA. In a 769-strong cohort of high-risk patients aged 12 and older with mild to moderate Covid-19 the lower-dose combo provided an 87% reduction in risk of hospitalisation or death versus placebo. This improves on the data from a different cohort in the phase III part of the trial released in January with a 2,800mg dose of each antibody. The four deaths in the new cut all occurred in the placebo arm, meaning that so far in Blaze-1 no patient given the MAb combo has died, whereas 13 of the total 14 deaths in placebo patients in the trial have been deemed Covid-19-related. The FDA granted emergency use authorisation for the new regimen in February, but the sellside sees competition for Lilly’s MAbs in the shape of Regeneron’s REGN-COV, Evaluate Pharma consensus forecasts show.

Phase III Blaze-1 data cuts so far
Date of data cut	Jan 26		Mar 10
Regimen	bamla 2,800mg + ete 2,800mg	Placebo	bamla 700mg + ete 1,400mg	Placebo
N	1,035		511	258
No of hospitalisations and deaths	11 (2.1%)	36 (7.0%)	4 (0.8%)	15 (5.8%)
Risk reduction vs placebo (p value)	70% (0.0004)		87% (<0.0001)
Source: company releases.

 Etesevimab (Eli Lilly): 521

https://www.evaluate.com/vantage/articles/news/snippets/lillys-covid-19-combo-better-low-doses

Relief for gene therapies as Bluebird exonerates busulfan

 Bluebird had largely ruled out the role of its lentivirus in an AML case that has caused Lentiglobin sickle cell trials to be halted, but there was another vital snippet of information in today’s analyst call on the matter. This concerned the possible role of busulfan preconditioning – separately posited as a possible cause of the AML – which now too has apparently been ruled out. On the call, seemingly convened to formalise what the company had controversially told an investor conference two weeks ago, Bluebird’s chief medical officer, Dave Davidson, said vector was present in the AML blasts. This suggested that these cells were not in the patient during preconditioning so, barring a role for residual busulfan, preconditioning was not to blame. This is important for the entire gene therapy field, which frequently uses busulfan with lentiviral gene transfer. Bluebird also said the vector in the AML patient had integrated in the VAMP4 gene, which has no known association with AML. As for a separate MDS case, Bluebird again strongly hinted that this might not have been MDS since no blasts were present. It is not clear when trials might restart, but Bluebird’s business split could be back on.

Bluebird share price, via Nasdaq.

https://www.evaluate.com/vantage/articles/news/snippets/relief-gene-therapies-bluebird-exonerates-busulfan

bluebird bio upped to Buy from Neutral by Mizuho

 Target to $69 from $34

https://finviz.com/quote.ashx?t=BLUE

Vertex Announces FDA Fast Track, Phase 1/2 Start for Cell Therapy for Type 1 Diabetes

– VX-880 is the first investigational stem cell-derived therapy utilizing fully differentiated, insulin-producing pancreatic islet cells for the treatment of type 1 diabetes –

– VX-880 is the first and only pancreatic islet replacement therapy known to receive Fast Track Designation –

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for VX-880 and that the company has initiated a clinical trial for VX-880 in patients who have type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemic awareness.

https://finance.yahoo.com/news/vertex-announces-fda-fast-track-125500071.html

CEPI, VBI Vaccines To Develop COVID-19 Vaccine Candidates Against Variants

 The Coalition for Epidemic Preparedness Innovations (CEPI) and VBI Vaccines Inc (NASDAQ: VBIV) entered into a partnership for the development of VBI's enveloped virus-like particle (eVLP) vaccine candidates against SARS-CoV-2 variants, including the South African B.1.351 variant, also known as 501Y.V2.

• CEPI is an international coalition set up to prepare for future infectious disease threats.

• It will provide up to $33 million to support the advancement of VBI-2905, a monovalent eVLP candidate, through Phase 1 development. Phase 1 trial will start in mid-year 2021.

• As part of the agreement, this funding will also support the preclinical expansion of additional multivalent vaccine candidates. 

• VBI Vaccines is advancing a suite of coronavirus vaccine candidates under the VBI-2900 program, developed in collaboration with the National Research Council of Canada.

• An adaptive Phase 1/2 study of VBI-2902 is already ongoing at nine clinical sites in Canada.

https://finance.yahoo.com/news/cepi-vbi-vaccines-collaborate-develop-142601244.html

Second Sight Eyes 1,500%-Plus Gains on FDA RP Treatment Approval

 Shares of Second Sight Medical Products  (EYES) - Get Report surged on Tuesday, racking up additional double-percentage-point gains following the Food and Drug Administration’s approval of the company's treatment of retinitis pigmentosa, better known as RP.

At last check, Second Sight shares were up 28.5% at $15.12, down from earlier gains but still putting the stock on track to exceed more than 1,500% since its Argus 2s retinal prosthesis for RP was approved by the FDA last Friday.

The stock closed at $1.43 a share last Thursday.

RP is a rare genetic disorder that involves the breakdown and loss of cells in the retina of the eye. It causes vision loss that worsens over time and can eventually lead to blindness.

Second Sight’s Argus 2s is a set of external hardware, glasses and a video processing unit that assists in offsetting the effects of the condition.

The Argus 2 is a tiny implant that goes in behind the eye and is then combined with patient-worn camera glasses to help provide a form of vision the patient otherwise would not have.

The unit converts images captured by a miniature video camera mounted on the glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes implanted on the surface of the patient's retina.

The patient must learn to interpret these visual patterns, giving them the potential to regain some visual function.

Shares of Second Sight are up about 529% so far this year as of Monday’s close. The company's current market cap is roughly $135 million.

https://www.thestreet.com/investing/second-sight-eyes-stock-fda-approval-030921