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Big Money Are Buying Aveo Pharmaceuticals Inc (NASDAQ:AVEO), Sentiment at 2.81
May 12, 2018 - By Andrea Pope
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) Corporate Logo
“Big money” Positions
“Big money sentiment for Aveo Pharmaceuticals Inc (NASDAQ:AVEO) in Q4 2017 increased to 2.81, SEC.gov filings reveal. So its up 1.49, from 2017Q3’s 1.32. 45 funds increased or started new holdings, while 16 sold and decreased positions in Aveo Pharmaceuticals Inc so the sentiment is better. These funds own 59.55 million shares, that’s down from 59.90 million shares in 2017Q3. Funds holding Aveo Pharmaceuticals Inc in top 10 changed to 1 from 3 for a decrease of 2. 4 Investors Sold All; 12 Reduced Holdings; 19 increased stakes while 26 funds bought stakes.
Significant Aveo Pharmaceuticals Inc Investors
As of Q4 2017 Deer Vi & Co. Llc has 100% invested in Aveo Pharmaceuticals Inc. Aveo Pharmaceuticals Inc’s shareholder Nea Management Company Llc owns 16.36 million shares as of Q4 2017. Furthermore, Emory University reported 602,883 shares in Aveo Pharmaceuticals Inc equivalent to 1.44% of its portfolio. New Leaf Venture Partners L.L.C. revealed 964,520 shares position in Aveo Pharmaceuticals Inc. The Massachusetts-based fund Ra Capital Management Llc looks positive on Aveo Pharmaceuticals Inc, owning 5.06 million shares.
AVEO Pharmaceuticals, Inc., a biopharmaceutical company, develops targeted therapies for cancer and related diseases.The firm is valued at $334.51 million. The companyÂ’s pipeline of product candidates include Tivozanib, a vascular endothelial growth factor to optimize VEGF blockade; Ficlatuzumab, a hepatocyte growth factor (HGF) inhibitory antibody, which has completed Phase II trial that inhibits the activity of the HGF/c-Met pathway; and AV-203, an anti-ErbB3 specific monoclonal antibody that has completed a Phase I dose escalation study.Last it reported negative earnings. The Company’s development programs also comprise AV-380, a humanized IgG1 inhibitory monoclonal antibody for the treatment or prevention of cachexia; and the AV-353 platform for the potential treatment of pulmonary arterial hypertension.
AVEO is hitting $2.17 during the last trading session, after decreased 2.25%.AVEO Pharmaceuticals, Inc. has volume of 1.01 million shares. Since May 12, 2017 AVEO has risen 351.31% and is uptrending. The stock outperformed the S&P 500 by 339.76%.
Spark Investment Management Limited Liability Company holds 0.04% or 268,200 shs. Bank Of Ny Mellon reported 91,625 shs or 0% of all its holdings. Bridgeway Cap Mgmt invested in 346,464 shs or 0.01% of the stock. Grimes And reported 22,600 shs or 0.01% of all its holdings. Schwab Charles Inv owns 28,629 shs. Atlantic Gp Ltd Com owns 0% invested in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) for 2,000 shs. The Florida-based Finemark Financial Bank Tru has invested 0% in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO). Susquehanna Intl Grp Llp holds 0% or 292,692 shs in its capital. 1.88M were accumulated by Blackrock Inc. Citigroup Inc reported 2,679 shs or 0% of all its holdings. Essex Mgmt Co Ltd Liability has invested 0.07% of its capital in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO). Moreover, Vanguard Gp has 0% invested in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO). Tower Rech Capital Ltd Limited Liability Company (Trc) invested 0.01% of its capital in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO). Eam Lc owns 626,499 shs or 0.23% of their US capital. Citadel Advsr Limited Liability Company reported 0% in AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO).
AVEO Pharmaceuticals, Inc. registered $21.15 million net activity with 10 insider purchases and 0 sales since April 6, 2018. On Friday, April 6 MOTT DAVID M bought $2.12 million worth of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) or 920,976 shs. BASKETT FOREST had bought 920,976 shs worth $2.12M. 920,976 shs valued at $2.12 million were bought by Viswanathan Ravi on Friday, April 6. $2.12 million worth of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) was bought by MAKOWER JOSHUA. On Friday, April 6 $2.12M worth of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) was bought by BARRIS PETER J. Sakoda Jon also bought $2.12 million worth of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) shs.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) Ratings Coverage
In total 2 analysts cover AVEO Pharma (NASDAQ:AVEO). “Buy” rating has 2, “Sell” are 0, while 0 are “Hold”. 100% are bullish. With $5.0 highest and $500 lowest target AVEO Pharma has $5 average target or 130.41% above the current ($2.17) price. 7 are the (NASDAQ:AVEO)’s analyst reports since November 13, 2017 according to StockzIntelligence Inc. On Thursday, March 22 the firm has “Buy” rating by FBR Capital given. On Tuesday, January 16 the firm has “Buy” rating given by FBR Capital. On Monday, February 12 FBR Capital maintained AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) with “Buy” rating. In Thursday, December 7 report FBR Capital maintained the stock with “Buy” rating. On Tuesday, March 13 the firm has “Buy” rating by FBR Capital given. On Thursday, March 29 the stock of AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) earned “Buy” rating by Piper Jaffray.
More recent AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) news were announced by Nasdaq.com, Seekingalpha.com and Nasdaq.com. The first one has “Here’s Why AVEO Pharmaceuticals Fell as Much as 17% Today” as a title and was announced on May 08, 2018. The next is “3 Things In Biotech, May 9: New AML Therapy Imminent? AVEO Hedges, Rockwell Boosts Iron” on May 10, 2018. And last was announced on May 09, 2018, called “Factors of Influence in 2018, Key Indicators and Opportunity within FNB, Comcast, IZEA, AVEO Pharmaceuticals …”.
But insiders are stepping up:
http://openinsider.com/AVEO
LOL (-;
Notice that last sale EOD for 7600 to bring the share price down to LOD.
I`m going to have to start loading my buys at the EOD to get a better pricing from now on, LOL.......
oltimer
I bought another 10,000 also. I have a large amount of shares and have placed a good till canceled sell order on them at $1.40 so they can not be used buy shorts.
The stock continues to be manipulated, but that can change fast.
Watching the trades on this and it is sold at bid a lot for 1 share to keep the share price down, interesting!
That's what makes this so investable.
Looks as though the stock will fill upper gap near term as i`m seeing some higher interest early on today. The below may be why today the stock is moving.
Reader Inquiry: Is A Run-Up In The Cards For AmpliPhi BioSciences?
https://seekingalpha.com/article/4175717-reader-inquiry-run-cards-ampliphi-biosciences
Some interesting back and forth on Yahoo message board, food for thought!
Johnny D2 hours ago
What could the insider buying possibly mean??
I think HEB and the FDA have struck a deal. What we know: Ampligen is still the only game in town for CFS (Rituximab held promise, but failed), Argentina has approved Ampligen using the same data (plus some) that the FDA rejected. Don't let Tom convince you that Argnetina was some mickey mouse approval -- their approval system closely aligns with the EU system of approval - it's a very big deal. The FDA approved a price increase for ampligen a year or so ago - very telling - the FDA obviously wants hemispherx to succeed. Hemispherx is now producing commercial sized batches of ampligen - another big deal -- they are not only doing one commercial batch, of what 8500 vials, only 2100 of which they have sold (MyTomorrows), but they are doing a 2nd commercial batch, that will be ready in July. No way that between Kalinski's cancer trials and Argentina's non-existent CFS program (MyTomorrow's is already taken care of!) do they need this quantity of drug!
The interesting thing to see --- what form will HEB's deal with the FDA take? If HEB found a big pharma partner to spring for 30 million to do another Phase 3 trial, that would be one way. The conventional way. I don't think this has happened. Big pharma wouldn't touch CFS in the past, why would they now? CFS folks need this drug now, they have needed this drug for the last 30 years. Patients, clinicians, CFS experts have been asking and lobbying for approval for years. IMO, it will be a conditional approval (HEB knows which patients benefit), and the last demand from the FDA has been met - which was, can you produce commercial size batches of this drug, enough drug to satisfy big demand?
Tom is just going to LOVE this!
LOL
william 02 hours ago
Like your thinking but back to the insiders and their quick decision to purchase ALL their outstanding 2028 expiry options allotted to them tells me they likely have a definitive offer of a buyout. That would not be front running just exercising their options, which they did down to the last share. The market caps so low that offering double the cost per share at markets close Friday would be nothing for a deep pocket biotech company that can do all the FDA required research needed.
There's more to the reason of this all in option sweep buyup as 2028 is nearly a decade out from their buy yesterday. You don`t throw $364,982.00 at your options in mass hoping to move the shares price!
Also remember the 1MM plus daily shares exchanging back and forth of late? Shares went from weak hands to new acquirer to establish a majority stake!!!!!!
This is even better and I checked it against the SEC filings, it's correct.
If insiders have this much confidence to purchase those options this early then i`m going to take a chance with them to purchase more. They know what's going on and it must be pretty good to buy up all those options on the same day before market close Friday. (-;
Found this on the Yahoo message board this morning:
Insiders showing their hand on $HEB:
As of business close 5/18/2018, six insiders purchased their options that expire 5/16/2028, "that's right expire 2028." They purchased 1,216,607M shares at $0.30 for $364,982.00 in cash. So them purchasing these shares all on the same day long before the expiry date is one heck of a positive tell for the company. Loading up more Monday. GLTA that are hanging in this......
I remember back when there were concerns about $MJ`s listing and now a few short months later we have a major Canadian cannabis company looking to list on the NYSE.
Legal weed could mean fewer opioid prescriptions: Cannabis CEO
Jim Cramer sits down with Canopy Growth CEO Bruce Linton after his company applied to list its shares on the New York Stock Exchange.
https://www.cnbc.com/video/2018/05/17/legal-weed-fewer-opioid-prescriptions-cannabis-ceo.html
Insider and CFO Adam Pascale picked up his option to buy 83,334 at $0.30 a share on 05/16/2018.
http://insideri.com/1613377_000161337718000006_0001613377-18-000006
A little more than a year after its initial public offering, Tocagen Inc (NASDAQ: TOCA) has traded down 26 percent, but experts are decidedly bullish on the company’s prospects and potential valuation.
The Rating
B Riley analyst Madhu Kumar initiated coverage on Tocagen with a Buy rating and a $15 price target.
The Thesis
As Kumar sees it, Toca 511/FC has potential to transform the treatment of recurrent high-grade glioma (RHGG), a brain cancer affecting about 14,000 per year with limited-efficacy treatment options.
“Overall, RHGG remains a key clinical opportunity for novel therapies that can demonstrate improved therapeutic response,” Kumar wrote in a Wednesday note.
The failures of comparable candidates for RHGG, such as Vascular Biogenics Ltd (NASDAQ: VBLT)’s VB-111, have little read-across to Toca 511/FC, he said.
Given that Phase 1 data demonstrated positive enough results to merit Breakthrough Therapy Designation and PRIME Designation, Kumar anticipates success in Tocagen’s ongoing Phase 3 TOCA 5 trial.
Interim readouts due in the second half of 2018 and first half of 2019 are seen to propel the stock, with the latter milestone driving a key inflection point. The analyst assumes a 30-percent probability of launch with a 30-percent market share but notes improvements to the estimates could support a $90 share price.
Price Action
Tocagen shares traded up 3 percent to $9.74 at time of publication.
5/16/2018
Tocagen (NASDAQ:TOCA) initiated with Buy rating and $15 (59% upside) price target at B Riley FBR. Shares up 2% premarket.
Immune Design Nearing Critical Point In Valuation
May 11, 2018 3:03 PM ET|8 comments | About: Immune Design (IMDZ)
Clover Biotech Research
https://seekingalpha.com/article/4173012-immune-design-nearing-critical-point-valuation
Biotech, momentum, short-term horizon, event-driven Summary
Immune Design has been stagnant all year, but is nearing a critical point.
The company provided pipeline and financial first-quarter updates.
Immune Design is a compelling investment opportunity for risk-tolerant investors.
Immune Design (NASDAQ:IMDZ) is up 15% since I penned my thesis article in early February.
Overview
This immuno-oncology play has been virtually stagnant all year. This is despite a ridiculous amount of insider buys (akin to what took place with a similar company, ADAP) after the share price plummeted in October due to dilution and trial delays.
Its technicals now appear primed for significant appreciation in the near term:
Quarter 1 Clinical Updates
CMB305
The company's lead drug candidate, CMB305, is currently targeting two indications: monotherapy (awaiting phase 3 initiation) and combination (ongoing phase 2) for soft tissue sarcomas.
In March, Immune Design updated investors on its clinical prospects.
We had discussed CMB305 in the previous article, concerning the following data:
Source: Immune Design Corporate Overview, January 2018
Assessing the data, we proposed at the time:
Pazopanib, approved and marketed for soft tissue sarcomas, donned a median OS of 12.5 months. Meaning, after 12.5 months of treatment 50% of the patient cohort remained alive. To contrast, CMB305 at 18 months has an overall survival rate of 76.2%. The data suggests a major improvement over current treatment. The trial is ongoing to determine median OS.
Bear in mind, overall survival (OS) is the length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
In the update, Immune Design announced a 23.7-month median OS following CMB305 monotherapy. This is nearly an entire year improvement over current standard of care.
The company plans to initiate a phase 3 trial assessing CMB305 as maintenance therapy in synovial sarcoma patients.
G100
It also provided an update for G100 in treatment of follicular non-Hodgkin's lymphomas. The combination of G100 and pembrolizumab provided an ORR of 54% while the historical pembrolizumab ORR showed 11% in a separate study.
The company intends to discuss G100's future with the FDA.
First-Quarter Financial Updates
Immune Design ended the first quarter of 2018 with $131.0 million in cash and cash equivalents, short-term investments, and other receivables. Net loss for the latest quarter was $13.3 million. The company is funded into 2H 2020.
With a market cap of $180 million and $131 million in assets with no debt obligations, the market is valuing the entire pipeline for very little. Concerning the field (immuno-oncology) and the data, Immune Design seems very undervalued.
Lucky Seven Portfolio
We will initiate a buy in Immune Design at whatever the EOD price may be on 5/11 and add it to the Lucky Seven portfolio.
Risks
Immune Design has no or little means of revenue and, therefore, may resort to diluting to raise funds.
Shares may continue to fish for new bottoms. Timing "when to buy" may be difficult.
An investment in Immune Design may take a while to become profitable/may never become profitable.
Clinical data may disappoint.
The company may experience significant delays in advancing therapeutics through clinical trials.
Its share price movement is highly influenced by the overall biotech sector.
CMB305's viral vector was constructed from genetic sequences derived from HIV and may cause patients to test false positive for HIV. This may make patients reluctant to choose this therapy due to public's negative perception.
If its products are to ever reach the market, they will likely be met with larger competitions.
MoMo algo`s going to kick in. Breaking out and looking for another 20% push higher form $4.30 close......
Totally agree. Also with the insiders buying and the two upcoming conferences i`m expecting a nice move. If the stock can not get any traction, then i`ll be concerned and have to reassess my position. There are too many bio plays to let this sit as dead money.....
No i`d say it was covering from a hedged short position. Nice to see also the open short interest getting smaller too.
Short Interest
April 2018
Current Month 589.4K
Previous Month 1.3M
Percent of Float 1.55%
Days to Cover 0.9483 Days
M&A SPECIAL SITUATIONS
AKRX/Fresenius: Dispute Will Center on Materiality of Alleged FDA Data Integrity Issues
https://event-driven.com/akrx-fresenius-dispute-will-center-on-materiality-of-alleged-fda-data-integrity/
https://seekingalpha.com/article/4171157-sa-interview-event-driven-investing-donostia
SA Interview: Event-Driven Investing With Donostia
May 12, 2018 7:30 AM ET
Bull bet on this under the radar pharma stock
"Halftime Report" trader Jon Najarian spots unusual options activity in shares of Akorn Inc.
https://pdl-iphone-cnbc-com.akamaized.net/VCPS/Y2018/M05D11/7000019028/6ED3-FMHR-UNUSUAL-ACTIVITY-051118_L.mp4
One large institutional player selling out to another institution player can cause this type of trading. Looking for the upcoming conference to see if the stock can get some traction from new investors. The insiders see likely approval still and stock being undervalued as they buy shares in the open market.
Position: Accumulating
Hemispherx to Present at the 8th Annual LD Micro Invitational
Thu May 10, 2018 8:30 AM|GlobeNewswire|About: HEB
ORLANDO, Fla., May 10, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB) announced today that it will be presenting at the 8th Annual LD Micro Invitational on Monday, June 4 at 11:00 AM PT (the time may be subject to changes depending on the conference organizers) at the Luxe Sunset Boulevard Hotel in Bel Air, California. Hemispherx is a research and development company focused on unmet medical needs in immunology, with a special emphasis in immuno-oncology. It is also an emerging commercial development company, based upon commercial approvals of Alferon in the United States and Argentina for refractory or recurring external genital warts and Argentina for patients refractory to or intolerant to recombinant alpha interferon, as well as regulatory approval of Ampligen in Argentina for severe Chronic Fatigue Syndrome (CFS).
Thomas K. Equels, M.S. J.D., Chief Executive Officer of Hemispherx, will be presenting and meeting one-on-one with investors. Mr. Equels’ presentation will focus on immuno-oncology, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and immune system amplification for enhanced viral vaccines. Mr. Equels will discuss the completed production of a commercial size batch (~8,500 vials) of Ampligen for the company’s Early Access Programs for patients with Pancreatic Cancer and ME/CFS, as well as expanded clinical programs. Additional commercial size batches are planned for future commercial sales and clinical trials. The company projects an increase in revenues over the next twelve months of more than 300 percent compared to the preceding twelve months.
Hemispherx has two flagship products: Alferon N Injection®, approved in the United States and Argentina, and Ampligen®, approved in Argentina with an NDA pending in the United States. The company also has six orphan drug designations, with four in the United States and two in the European Union. Ampligen® has the potential to address multiple indications, including various cancers, ME/CFS and influenza. Alferon N Injection® also has multiple potential indications, including MERS and as a component of an immune modulating cocktail designed to favorably improve the microenvironment of several solid tumors. The potential combined market for these products is estimated to be in the billions.
View Hemispherx’s webcast here: http://wsw.com/webcast/ldmicro14/heb/
About LD Micro
LD Micro was founded in 2006 with the sole purpose of being an independent resource in the microcap space. LD Micro are investors, first and foremost.
What started out as a newsletter highlighting unique companies has transformed into several influential conferences annually (Invitational, Summit, and Main Event).
In 2015, LD Micro launched ldmicro.com as a portal to provide exclusive intraday information on the entire sector, including the first pure microcap index (LDMi) which covers stocks in North America with market capitalizations between $50-$300m.
About Hemispherx Biopharma (HEB)
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include the FDA approved drug Alferon N Injection® and the Argentina approved drug rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is a ribonucleic acid (RNA) being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod has not been designated safe and effective by the FDA for general use, it is legally available in the United States only through clinical trials, however, Ampligen has been approved in Argentina for ME/CFS and the company is working toward legal access in other countries where early access programs exist for serious diseases such as ME/CFS where there are unmet medical needs. Ampligen is the only therapy approved anywhere in the world for ME/CFS. Also, an Ampligen EAP approval has been obtained for therapeutic use in the Netherlands for pancreatic cancer.
Cautionary Note Regarding Forward-Looking Statements
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Contact:
Hemispherx Biopharma, Inc.
Phone Number: 800-778-4042
Email: IR@hemispherx.net
https://resource.globenewswire.com/Resource/Download/ead08275-4de6-45cf-814c-f0f83a2abd61?size=1
Source: Hemispherx Biopharma, Inc. 2018 GlobeNewswire, Inc.
Understand. I`ve already flipped it. I believe the stock run up to fast and is due a correction at least to fill the gap. No position yet!!! GLTY
News to stay informed in the field of current CLL drugs:
Roche digs its heels into CLL just a bit more
Company: Roche (OTCQX:RHHBF)
Therapy: Rituximab
Disease: Chronic lymphocytic leukemia
News: Results of the open-label MABLE study were published in the journal Haematologica, giving a look at the use of bendamustine-rituximab in patients who are ineligible for fludarabine-based standard therapy. Compared with rituximab-chlorambucil, rituximab-bendamustine yielded improved complete remission rates and progression-free survival in the first-line setting. Tolerability was generally similar, overall, although more patients did discontinue rituximab-bendamustine due to toxicity.
Looking forward: These findings may not be that sexy to a biotech investor, since rituximab is generally on its way out for RHHBF as a key moneymaker due to the loss of patent protection. However, in the world of CLL, the question as to what therapy should be used for which patients remains critical, and a lot of patients with this disease are elderly and have comorbidities. So this kind of news helps clinicians nail down ideal treatment selection that balances toxicity and efficacy for each patient. This has important implications for other drugs in the space, like obinutuzumab (made by Roche) and ibrutinib (made by AbbVie (NYSE:ABBV)), which are currently infiltrating the first-line treatment space. And it is possible that we'll see studies comparing the regimens in the near future.
Not immediately and obviously impactful, but it's still important news for patients and clinicians, and the astute investor will be as knowledgeable in the whole field of CLL management as he/she can.
Thanks Rogerthat1 to many positions going. Did pick up 3000 shares of $AVEO. Oversold and the gap will be filled, good for a swing trade!
Agree, has a massive gap to fill.
New Preclinical Data for Novel Immunotherapy Bispecific Candidate ALG.APV-527 Presented by Aptevo Therapeutics and Alligator Bioscience at
Prominent Industry Conferences
https://www.nasdaq.com/press-release/new-preclinical-data-for-novel-immunotherapy-bispecific-candidate-algapv527-presented-by-aptevo-20180508-00944
9:02 am ET May 8, 2018 (Globe Newswire) Print
ALG.APV-527 is Designed to Strategically Target and Engage the Immune System for the Potential Treatment of Multiple Solid Tumor Indications
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, and Alligator Bioscience (Nasdaq Stockholm:ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, today announced the presentation of new preclinical data supporting ALG.APV-527 as a promising new immunotherapeutic candidate for the treatment of a variety of 5T4-expressing solid tumors.
ALG.APV-527 is designed to simultaneously target 5T4 and the co-stimulatory receptor 4-1BB (CD137) to promote potent, tumor-directed immune T-cell activation. 5T4 is a well-defined tumor antigen expressed on many different types of malignancies including, non-small cell lung, renal, pancreas, prostate, breast, colorectal, gastric, ovarian and cervical cancers. Conversely, 5T4 has limited expression on normal tissues, making it an attractive target for cancer immunotherapy.
New ALG.APV-527 preclinical data show that ALG.APV-527 has the potential to selectively activate and enhance tumor specific T cell responses at the tumor site without triggering systemic immune activation. Notably, the preclinical in vitro and in vivo data show that ALG.APV-527:
The data were recently presented at the PEGS Summit 2018 and American Association of Immunologists (AAI) annual meeting and will be presented next week at the Annual Meeting of Cancer Immunotherapy (CIMT).
"Taken together, the accumulating preclinical data package for ALG.APV-527 support its potential to provide effective tumor-directed immune activation with reduced systemic side effects. We are continuing to advance this candidate and look forward to commencing clinical development in 2019," said Christina Furebring, Senior Vice President Research at Alligator.
"Our collaboration with Alligator Bioscience continues to yield encouraging data supporting the advantages of this novel pathway for targeted immunotherapy of cancer," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "As a first-in-class molecule, ALG.APV-527 showcases the versatility of our ADAPTIR platform in generating bispecific antibodies with unique mechanisms of action and a therapeutic profile that is more consistent with traditional antibodies, including an extended half-life, desirable antibody-like manufacturing characteristics and increased potency and stability."
Aptevo and Alligator believe that the precise targeting of 4-1BB within the tumor microenvironment can potentially overcome some of the limitations seen with other 4-1BB therapies. ALG.APV-527 employs a novel mechanism of action, 4-1BB x 5T4 binding, to direct the therapeutic immune response towards the tumor, thereby potentially reducing the harmful side effects of systemic immune stimulation while providing a strong tumor-directed immune activation.
About ALG.APV-527
ALG.APV-527 is a bispecific antibody (4-1BB x 5T4) intended for tumor-directed treatment of solid cancers. ALG.APV-527 was built using Aptevo's ADAPTIR(TM) bispecific platform and combines binding domains sourced from the ALLIGATOR-GOLD(R) human scFV library. The ALG.APV-527 bispecific antibody consists of two parts, one part activating tumor-specific T cells through the co-stimulatory receptor 4-1BB, the other part binding to the 5T4 protein expressed on the surface of tumor cells. This enables the immune-activating effect of ALG.APV-527 to be directed specifically to the tumor and not against normal tissue.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's growing pipeline includes four lead clinical and pre-clinical drug candidates (ADC-1013, ATOR-1015, ATOR-1017 and ALG.APV-527). ADC-1013 (JNJ-7107) is licensed to Janssen Biotech, Inc., part of J&J, for global development and commercialization. Alligator's shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 50 employees. For more information, please visit www.alligatorbioscience.com.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on novel oncology and hematology therapeutics to meaningfully improve patients' lives. Aptevo has a commercial product, IXINITY coagulation factor IX (recombinant), approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology - the ADAPTIR(TM) modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action to treat cancer or autoimmune diseases. Aptevo has two ADAPTIR antibody candidates currently in clinical development and a broad pipeline of novel investigational-stage bispecific antibody candidates focused in immuno-oncology and autoimmune disease and inflammation. For more information, please visit www.aptevotherapeutics.com
BiotechGuy, Contributor
TOCA has 3 presentations at the upcoming ASGTC conference later in May and one presentation at ASCO in June. (albeit minor catalysts)
The major catalyst that was surprisingly not acknowledged in this article is the upcoming ph3 interim analysis at 50% events, which could be as early as July (guided sometime in 2H 2018). At this point there is a small chance the trial could be halted early for efficacy. Here is a response I got from the company regarding this upcoming event:
"Tocagen is currently studying Toca 511& Toca FC in the Phase 3 Toca 5 trial. This is an events-driven trial with two interim analyses built into the protocol. The interim analyses will occur at 50% and 75% of events, respectively. Because it is an events-driven trial, there is no specific date for trial results. That said, Tocagen has given some guidance on anticipated timing of the interim analyses.?Tocagen anticipates that the first interim analysis will occur in the 2nd half of 2018 and that the second interim analysis will occur in the 1st half of 2019.
There are three possible outcomes at each of the interim analysis:
Independent Data Monitoring Committee recommends that the trial continues as planned
Independent Data Monitoring Committee recommends that the trial be stopped early because there is a statistically significant difference in survival between the trial arms
Independent Data Monitoring Committee recommends that the trial be stopped early because there is a safety imbalance between the trial arms."
You might like the read in this article with follow up Q&A if you have not it yet had a chance to see it........
Reader Inquiry: Tocagen Is Looking Cheap But Is It A Buy?
May 6, 2018 12:03 AM ET|12 comments | About: Tocagen Inc (TOCA)
Jonathan Faison
https://seekingalpha.com/article/4170313-reader-inquiry-tocagen-looking-cheap-buy
Long only, biotech, event-driven
MARKETPLACEROTY
Summary
Recent reversal in the stock price has investors concerned.
We take a look at recent developments as well as previous data.
Contributors to the decline include a potential ¨catalyst desert¨ and possible dilution in the medium term.
Despite receiving both Breakthrough Therapy and PRIME designations, when cash is backed out the valuation looks quite cheap.
While admittedly high risk, I greatly admire what they are seeking to accomplish, will be keeping tabs on the firm and reevaluate later in the year.
This idea was discussed in more depth with members of my private investing community, ROTY .
Shares of Tocagen (TOCA) have declined by over 40% in the past year. While the stock rose by as much as 45% after my article in late October, the reversal has been quite sickening to watch and can´t be attributed to weakness in the biotech sector alone.
Chart
Figure 1: TOCA daily advanced chart (source: Finviz)
Figure 2: TOCA 15 minute advanced chart (source: Finviz)
When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels and get a feel for what is going on. In the first chart (daily advanced) the selloff and sea of red since March sticks out like a sore thumb. In the second, we can see the stock has tried to bottom at the $9 level but the ensuing bounce has been short-lived. I wouldn't be surprised in the near term if it breaks support and heads lower.
Reader Inquiry
In the marketplace service ROTY (Runners of the Year), we search for stocks that are attractive across multiple time frames with high % upside potential within the near to medium term. Catalyst ideas typically have upcoming material events (such as clinical results reading out or regulatory action date) that could push shares significantly higher- on the other hand, revaluation ideas involve stocks where the core business (or core assets) and recent events have not been fully factored into the share price AND future appreciation is expected.
Figure 3: Wholly-owned pipeline (source: corporate presentation)
In the case of Tocagen, several ROTY members have been discussing the stock in Live Chat and I´ve received a few questions regarding future prospects. After the recent decline I agree it's a good time to take a second look to determine if there's more to this story that merits a position or if we root for them from the sidelines.
Recent Developments
There's been some news flow since the beginning of the year- in March the company announced that the European Medicines Agency granted orphan medicinal product designation to Toca 511 and Toca FC for the treatment of patients with glioma.
At the American Association for Cancer Research Annual Meeting the company presented early data (poster) from the Toca 6 phase 1 study in advanced solid tumors. As of the cutoff date of March 27th 7 patients had been treated with Toca 511 & Toca FC intravenously with 4 of these also receiving Toca 511 via intratumoral administration. Highlights included cancer-selective expression of the Toca 511 trasgene following IV administration in metastatic tumors of 5 patients who underwent tissue analysis (indicating successful delivery of the retroviral replicating vector), clearing of Toca 511 from blood plasma within 6 weeks (indicating virus is well controlled outside of tumors) and the solid safety profile observed thus far.
Many biotech companies have been inking China deals and Tocagen is not the exception- in April they entered into a license with ApolloBio to develop and commercialize Toca 511 & Toca FC within the greater China region. In return Tocagen received $16 million in cash upfront plus potential near term payments of $4 million. They also stand to receive up to $111 million in development and commercial milestones plus low double-digit tiered royalty payments based on net sales.
Other Information
For the fourth quarter the company reported cash and equivalents of $88.7 million (doesn't include funds received from China collaboration) and management has guided for cash used in operations to come in at or under $50 million. Net loss for the full year 2017 totaled $38.9 million.
It's quite confounding to consider that the company´s lead product candidate has received both the coveted Breakthrough Therapy Designation from the FDA and PRIority MEdicines designation from the EMA, and yet when cash is backed out the market believes it's worth less than $100 million.
As for upcoming catalysts of note, management is guiding for enrollment of the phase 3 Toca 5 study in recurrent high-grade glioma (NYSE:HGG) to finish up before the end of the year. We should also receive an update on the European regulatory pathway and management will outline their development plan for newly diagnosed HGG.
I remind readers that phase 1 results have shown survival significantly exceeding historical data at both the low and high doses.
Figure 4: Phase 1 resection study OS trend by dose (source: corporate presentation)
Importantly, Toca 511 was associated with relatively low occurrence of treatment-related adverse effects (trAE) and for Toca FC trAE were mainly in the grade 1 to 2 range. Impressively, at higher doses (n=23) durable response rate was 21.7% with all five patients experiencing complete responses (median duration of response not reached at 35 months and counting).
Figure 5: Long term survival in higher dose cohort (source: corporate presentation)
Final Thoughts
In the end, I believe this is definitely a story to keep tabs on as later in the year we receive updated data in solid tumors and enrollment hopefully finishes up for the pivotal Toca 5 study. While lead indications being targeted are high risk, I believe they have a good shot at success and that present weakness is more a function of what's known as a "catalyst desert" (where there is not much in the way of near-term material events). This could lead to continued downside in the near term, but late in 2018 Tocagen will merit a revisit for possible entry.
Considering their current cash position and burn rate, dilution in the medium term is possible. Delays in enrollment or other setbacks would likely pressure shares even futher, while disappointing results in the Toca 5 study would be devastating to the bullish thesis. Disapointing data in other trials such as Toca 6 would also weigh on shares.
While I won't be currently adding this one to the ROTY Contenders List, I imagine we will continue to discuss it especially after earnings in May are reported and we receive more guidance from management.
Keep in mind that when any stock is selected for ROTY the corresponding article appears only to current subscribers, and for the purposes of due diligence subscribers are able to access all of my archived work (getting around the 10 day paywall).
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Bernstein: fund flow indicator that monitors the pace of sentiment deterioration at 2nd most pessimistic level in 14 years $SPX
Barron`s
MONDAY, MAY 7, 2018 INVESTOR SENTIMENT READINGS
High bullish readings in the Consensus stock index or in the Market Vane stock index usually are signs of Market tops; low ones, market bottoms.
http://www.barrons.com/public/page/9_0210-investorsentimentreadings.html
May 4, 2018
Are Investors Overlooking The Forest Due To The Volatile Trees?
MOVING PAST DAY TO DAY VOLATILITY
https://www.ccmmarketmodel.com/short-takes/
Looking like a new uptrend for $TNA with Friday's close!!!!!!!!!!
I believe so too.... (-;
It's about Management executing now. They laid out what's going down so now we wait, accumulate and assume the street will see the prospects of the trials.
In the meantime company`s making money on $Ampligen. If you only see today's closing figure, you would say "nothing happened today." If you watched tick-by-tick their`s a different story from an emotional and mental capital perspective.
Charting at this point as much as I myself like to do the technicles is fruitless until we have some meaningful movement in the shares price. We have better than 50% chance of doubling or better in the stocks price than selling off or a reverse split happening. JMO
gr8db8
Thanks for the link. I like the science here........
Tocagen to Report First Quarter 2018 Financial Results on Thursday, May 10
Thu May 3, 2018 4:05 PM|PR Newswire|About: TOCA
SAN DIEGO, May 3, 2018 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced it will report its first quarter 2018 financial results and business progress on Thursday, May 10, 2018, after the close of the U.S. financial markets.
https://mma.prnewswire.com/media/524567/Tocagen_Logo.jpg
To receive Tocagen's press releases and other investor information, please visit the Investor Relations page of the company's website and register for email alerts.
About Tocagen (TOCA)
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG and the European Medicines Agency (EMA) has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma. For more information about Tocagen, visit www.tocagen.com.
Media Contact:
Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com
Investor Contact:
Gitanjali Jain Ogawa
Solebury Trout
(646) 378-2949
Gogawa@troutgroup.com