Three biotech companies focusing on cancer and eye diseases have collectively raised more than $300 million (Press release, FierceBiotech, SEP 28, 2017, View Source;utm_medium=rss [SID1234520700]).

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Kinase inhibitor biotech Deciphera Pharmaceuticals raised $128 million, at the high-end of the range, with British cancer oncology NuCana, which is working on second-generation chemotherapies for resistant tumors, raising $100 million, and within the range.

Fellow British biotech Nightstar Therapeutics, a gene therapy player working on rare retinal diseases, also got off a $75 million IPO, within the midpoint of the range.

After a lackluster biotech IPO market in 2016 and a slow start to this year, public offerings for life sciences have started to take off in the second half.

Deciphera has a pipeline of oral drug candidates that include three clinical-stage and two research-stage programs. Its lead drug candidate, DCC-2618, is designed to stop mutant or amplified KIT and PDGFRα kinases that drive cancers such as gastrointestinal stromal tumors, or GIST.

It’s currently in phase 1, and at this year’s ASCO (Free ASCO Whitepaper) Deciphera posted data showing that in GIST patients shown to harbor a broad range of KIT and PDGFRα mutations, it saw a disease control rate of 85% at eight weeks in 27 patients, 78% at 12 weeks in 23 patients and 60% at 24 weeks in 15 patients.

The biotech is also working on small molecule drug candidates, DCC-3014 and rebastinib, as immuno-oncology kinase, or immunokinase, switch control inhibitors targeting colony stimulating factor receptor 1, or CSF1R, and the TIE2 kinase, respectively.

Back in June, Deciphera raised $52 million in a series C, building on the $75 million it raised in 2015 during its series B round. Its largest stakeholder had been Brightstar Associates, which owned nearly 68% of the company.

At the time of its B round, its pipeline was led by altiratinib, which acts on the MET/TIE2/VEGFR2 pathways, but that asset no longer appears in the company’s R&D pipeline and seems to have been canned.

Edinburgh, U.K.-based NuCana, meanwhile, had been seeking a top $115 million IPO, but got a little less at $100 million.

The cash boost should still be enough to help fund late-phase trials of NuCana’s reformulated cancer candidates, including a version of Eli Lilly’s Gemzar it hopes will supplant the veteran chemotherapy in some indications.

The biotech has built its pipeline upon the same phosphoramidate chemistry approach that underpins Gilead’s hepatitis C blockbuster Sovaldi.

NuCana has used the approach to add a phosphate group protected by groupings of aryl, ester and amino acids to existing drugs. In doing so, NuCana thinks it has created drugs free from the membrane transport, activation and breakdown issues that render cancers resistant to the products they are based on.

The company was down to the last $16 million of its $57 million series B by the end of June, meaning this IPO was a key financial driver for its future, as it eyes later stage tests across a broad range of tumors.

And finally Nightstar, which had filed for an $86 million IPO and managed $75 million, will equip the biotech to complete a phase 3 trial of its choroideremia gene therapy and advance two other eye disease candidates through early-stage clinical studies.

London-based Nightstar, also known as NightstaRx, is set to move the choroideremia asset into phase 3 in the first half of next year. The therapy, NSR-REP1, is advancing into the 140-patient trial on the strength of data on 32 subjects treated in investigator-sponsored studies. Those trials found 90% of patients either maintained or improved their visual acuity in the year after receiving the gene therapy.

The biotech was originally spun out of the University of Oxford in 2014, starting life with a £12 million raise from Syncona.

It pulled in a further £5 million when it named former Johnson & Johnson VP David Fellows as CEO early in 2015, with a $35 million series B round following later that year. And Nightstar broadened its investor base and raised a further $45 million in a series C round just a few months ago.

Megamerger deal speculation has swirled around Novartis as the Swiss drugmaker eyes its operations—particularly Alcon—for cash-generating sales or spinoffs (Press release, FiercePharma, SEP 28, 2017, View Source;utm_medium=rss [SID1234520701]). But all along, CEO Joe Jimenez has been pledging bolt-on deals instead, and the latest buzz says he has one on tap.

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That would be Advanced Accelerator Applications, a maker of radioactive tracers used in diagnostic scans, Bloomberg reports. But the target’s real attraction might be its pipeline. Its lead candidate is an actual cancer therapeutic in a field Novartis already knows: neuroendocrine tumors (NETs).

The in-development med, Lutathera, is at the regulatory filing stage, and it would come with two marketed NET diagnostic agents, NetSpot and Somakit. It’s a radiotherapy based on the rare earth metal leutetium, which is now used primarily as a catalyst for cracking hydrocarbons in oil refineries, according to the Royal Society of Chemistry.

"We believe a Novartis acquisition of AAAP for Lutathera in neuroendocrine tumors would be highly synergistic with [its] existing franchise, including Sandostatin and Afinitor, making a potential deal very logical," Canaccord Genuity analyst John Newman said in a Thursday morning note to investors.

With its $16 billion deal for GlaxoSmithKline’s oncology assets in 2015, Novartis beefed up its cancer portfolio, and the recent approval of its CAR-T drug Kymriah gave it another boost. It moved into the CDK 4/6 cancer therapy market with Kisqali earlier this year, and it’s also been racking up new indications for Afinitor, including nods in gastrointestinal and lung NETs last February.

RELATED: New Novartis CEO Narasimhan will face plenty of obstacles despite CAR-T triumph

Right now, AAA’s products are marketed mostly in Europe, with NetSpot its only U.S.-approved agent. Presumably, Novartis would use its expertise at advancing products through the FDA to bring AAA’s meds to the U.S., all while reaping sales in AAA’s established markets. The Big Pharma is adept at winning initial approvals in small patient populations and then expanding into follow-up indications that add significantly to sales prospects.

AAA, which went public in 2015, saw its American depositary receipts surge on the M&A reports, hitting a valuation of $2.6 billion on Thursday morning, Bloomberg says.

Whether Novartis moves forward with a deal remains to be seen; the company has been actively scouting for deals for some time, and various potential buys have been buzzed about over the past couple of years. One of those was Amneal, a generics maker said to be a Novartis target late last year; it’s now reportedly in the sights of Impax Laboratories, the generics maker that recently brought in Actavis/Allergan vet Paul Bisaro as CEO.

But AAA does look like the sort of deal that Big Pharmas have been shopping lately: companies with current revenue streams and late-stage pipeline meds. And if Newman is correct, AAA’s top med could be a boost for Novartis sales for years. "We see very long-duration revenues for Lutathera due to the extremely high barrier for generics, limited supply of leutetium and very high efficacy benefit over current therapies," he wrote.

Just what Novartis plans to do going forward is up in the air, however; Jimenez recently announced his departure, planning to hand the reins to current R&D chief Vas Narasimhan in February.

On September 28, 2017 Tanvex BioPharma, Inc. reported its plans for an international Phase 3 trial of its biosimilar drug candidate, TX05, its investigational trastuzumab biosimilar (a proposed biosimilar to Herceptin) in patients with early stage breast cancer (Press release, Tanvex BioPharma, SEP 28, 2017, View Source [SID1234524596]). In accordance with advice from the US Food and Drug Administration, the global Phase 3 trial, "A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety and immunogenicity of TX05 with Herceptin in subjects with HER2 positive early breast cancer", has been designed to compare the therapeutic equivalence of biosimilar candidate TX05 to Herceptin in HER2-positive, early-stage breast cancer patients based on the pathological complete response rate following neoadjuvant therapy. Approximately 800 patients are anticipated to be enrolled from about 209 study centers in 19 countries. The primary efficacy endpoint, pCR, will be assessed through specimens obtained during surgery and analyzed by a central review of local histopathology reports. Equivalence will be considered to be demonstrated if the 95% confidence interval of the risk ratio of the pCR rates (TX05/Herceptin) is within a predefined interval agreed between Tanvex and FDA.

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Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. Approximately 20% to 30% of primary breast cancers are HER2-positive.

"This represents another major milestone for our company. TX05 will be our second biosimilar product to enter Phase 3 trials and reinforces our commitment to expand access to affordable, high quality products to patients with serious illness," said Allen Chao, PhD, CEO of Tanvex.

US sales of Herceptin were US$2.7 billion in 2016.

(Filing, 10-K, Propanc, 2017, SEP 28, 2017, View Source [SID1234520831])

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On September 28, 2017 — MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX) a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that its Special Meeting of Stockholders scheduled for and convened on September 28, 2017 (the "Special Meeting"), was adjourned to achieve a quorum on the proposals to be approved (Press release, MabVax, SEP 28, 2017, View Source [SID1234520692]).

The Special Meeting has been adjourned to 3:00 p.m. Pacific Daylight Time/6:00 p.m. Eastern Daylight Time on Monday, October 2, 2017, at the offices of the Company at 11535 Sorrento Valley Road, Suite 400, San Diego, CA 92121, to allow additional time for MabVax stockholders to vote on proposals to approve the following:

1. A reverse stock split of the Company’s issued and outstanding common stock by a ratio of not less than one-for-two and not more than one-for-twenty at any time prior to September 28, 2018, with the exact ratio to be set at a whole number within this range as determined by the Board of Directors;

2. The potential issuance of up to an aggregate of 3,400,000 shares of common stock, in excess of 19.99% of the number of shares of common stock that were issued and outstanding on August 11, 2017, consisting of (i) 2,386,360 shares of common stock issuable upon conversion of Series J Preferred Stock, issued to investors in a financing consummated in August 2017 and (ii) 1,013,640 shares of common stock available for issuance under designated but unissued shares of Series J Preferred Stock;

3. If the Proposal 2 is approved, to approve the potential issuance of up to 6,500,000 shares of common stock upon conversion of Series K Preferred Stock issuable in connection with a financing consummated in August 2017, in excess of 19.99% of the number of shares of common stock that were issued and outstanding on August 11, 2017;

4. The issuance of securities in one or more non-public offerings where the maximum discount at which securities will be offered will be equivalent to a discount of 30% below the market price of the common stock, as required by and in accordance with Nasdaq Marketplace Rule 5635(d);

5. The issuance of securities in one or more non-public offerings where the maximum discount at which securities will be offered will be equivalent to a discount of 20% below the market price of the common stock, as required by and in accordance with Nasdaq Marketplace Rule 5635(d); and

6. The Fifth Amended and Restated MabVax Therapeutics Holdings, Inc. 2014 Employee, Director and Consultant Equity Incentive Plan, including the reservation of 6,128,406 shares of common stock for issuance, each as set forth in the MabVax’s proxy statement filed with the Securities and Exchange Commission ("SEC").

The affirmative vote of over 50% of the issued and outstanding voting power of MabVax’s outstanding voting shares is required for the approval of the reverse stock split; a majority of the votes cast is required for the approval of Proposal 2, provided however, that no shares of common stock underlying the Series J Preferred Stock may be counted towards approval of this proposal; a majority of the votes cast is required for the approval of Proposal 3, provided however, that no shares of common stock underlying the Series K Preferred Stock may be counted towards approval of this proposal; and a majority of the votes cast is required for the approval of each of the remaining proposals.

During the period of the adjournment, MabVax will continue to solicit proxies from its stockholders with respect to the proposals set forth in the proxy statement. Only stockholders of record on the record date of August 28, 2017, are entitled to and are being requested to vote. If a stockholder has previously submitted its proxy card and does not wish to change its vote, no further action is required by such stockholder.

No changes have been made in the proposals to be voted on by stockholders at the Special Meeting. The Company’s proxy statement and any other materials filed by the Company with the SEC remain unchanged and can be obtained free of charge at the SEC’s website at www.sec.gov.

MabVax encourages all stockholders that have not yet voted to vote their shares by 11:59 p.m. on Sunday, October 1, 2017, Eastern daylight time. If you have not voted, or have mislaid your proxy materials or are uncertain if you have voted all the shares you are entitled to vote please see "How You Can Vote," below. Every single vote counts.

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