On January 20, 2021 GlaxoSmithKline reported that jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda (Press release, GlaxoSmithKline, JAN 20, 2021, View Source [SID1234574227]).

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That drug, originally known as M7824, now bintrafusp alfa, works as a bifunctional fusion protein immunotherapy.

It is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein and to combine co-localized blocking of the two immuno-suppressive pathways: Targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses.

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Early data showing a strong objective response rate (ORR) appeared to be enough for GSK to pen a deal with Germany’s Merck. (Though Pfizer, already partnered with Merck KGaA for their also-ran checkpoint inhibitor Bavencio, appeared to have passed on the med.)

The original deal with London’s GlaxoSmithKline saw Merck gain €300 million upfront, with milestone payments of up to €500 million and potential sales of €2.9 billion, which brought the total to an eye-watering figure of €3.7 billion ($4.16 billion).

RELATED: Merck KGaA, GSK pen $4.2B biobucks pact for next-gen Bavencio

That deal came after a mini deal spree for GSK, coat-tailing its $5.1 billion buyout of cancer biotech Tesaro, all amid a period of major restructuring, new personnel and R&D shifts at the company that has seen it once again refocus on oncology research.

But today, GSK’s decision looks poor: In a late-stage test of the drug in PD-L1-expressing non-small cell lung cancer patients, an independent monitoring committee has told the pair the drug will likely not hit its primary endpoint, which was progression-free survival, in the trial known as INTR@PID Lung 037.

The drug was going head-to-head with Merck’s rival U.S. pharma, also called Merck, and its winner-takes-all checkpoint inhibitor Keytruda, in newly diagnosed late-stage lung cancer patients. Beating out Keytruda, which has a strong track record in lung cancer, was always going to be a tough ask.

Other trials for the drug appear to be ongoing. "The recommendation by the Independent Data Monitoring Committee and the Company’s decision is related only to this Clinical Trial," the pair said in a statement.

Germany’s Merck was down more than 3% on the news, with GSK down 1.5% premarket.

"We have pioneered the science behind bintrafusp alfa, and now through a strategic alliance, multiple non-correlated parallel hypotheses are being evaluated across numerous indications in our extensive INTR@PID clinical program," said Danny Bar-Zohar, M.D., global head of development for the healthcare business of Merck KGaA.

"We remain committed to further evaluation of bintrafusp alfa, and these data from INTR@PID Lung 037 will provide important insights that may be applied to future studies."

Analyst at Jefferies said that Merck remains confident the drug is "active" but are unclear why it was hit by a failure, although they said it is not due to any safety issues.

In a call with analysts, the pharma said it remains optimistic about the franchise and other indications ongoing including biliary tract cancer, cervical, urothelial, and first-line and second-line lung combinations with radiation, TIGIT, and so on, there is a second-line biliary tract cancer topline result also coming in the coming weeks, with an ORR analysis "and the bar is low to beat," according to analysts.

Michael Yee from Jefferies added in his note to clients: "Bottom line: We are perplexed why Merck KGaA failed early at an interim despite very positive phase 2 data. This goes to why single-agent, uncontrolled studies must be taken with a grain of salt."

On January 20, 2021 Aclaris Therapeutics, Inc. (Nasdaq:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the pricing of its underwritten public offering of 5,483,714 shares of its common stock at a price to the public of $17.50 per share (Press release, Aclaris Therapeutics, JAN 20, 2021, View Source [SID1234574135]). In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 822,557 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $96.0 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ option. The offering is expected to close on or about January 22, 2021, subject to customary closing conditions.

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Cantor Fitzgerald & Co. and William Blair & Company, L.L.C. are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) on March 13, 2020 and declared effective by the SEC on April 29, 2020. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 20, 2021 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, including COVID-19, cancer and HPV-associated diseases, reported the pricing of an underwritten public offering of 17,700,000 shares of its common stock at a public offering price of $8.50 per share (Press release, Inovio, JAN 20, 2021, View Source [SID1234574151]). In addition, INOVIO has granted the underwriters a 30-day option to purchase up to an additional 2,655,000 shares of common stock at the public offering price, less underwriting discounts and commissions. Gross proceeds to INOVIO from the offering are expected to be approximately $150.5 million, before deducting underwriting discounts and commissions and estimated offering expenses, but excluding any exercise of the underwriters’ option. All of the shares are being sold by INOVIO.

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INOVIO intends to use the net proceeds from this offering for the development of its clinical pipeline, including clinical development expenses relating to INO-4800 and research and development expenses, and for general corporate purposes, including working capital and general and administrative expenses.

BofA Securities, Jefferies and Cantor are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering. The Benchmark Company, Maxim Group LLC and National Securities Corporation are acting as co-managers for the offering. The offering is expected to close on or about January 25, 2021, subject to customary closing conditions.

The shares were offered by INOVIO pursuant to a shelf registration statement filed by INOVIO with the Securities and Exchange Commission (SEC) that became automatically effective on January 20, 2021. This offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting: BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 20, 2021 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported a business update and financial highlights for Q4 2020 for Nicox SA and its subsidiaries (the "Nicox Group"), as well as key expected value-inflection milestones in 2021 (Press release, NicOx, JAN 20, 2021, View Source [SID1234574120]).

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Key Expected Milestones
NCX 470 first Phase 3 trial, Mont Blanc: Nicox’s lead clinical product candidate, NCX 470 is a novel nitric oxide (NO) donating prostaglandin analog. Mont Blanc is a 3-month safety and efficacy trial evaluating NCX 470 ophthalmic solution, 0.1%, against latanoprost ophthalmic solution, 0.005%, for lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Top-line results are now prudently expected in H1 2022, instead of Q4 2021, given probable delays in recruitment due to COVID-19.
NCX 4251 Phase 2b trial, Mississippi: NCX 4251 is a novel patented ophthalmic suspension of fluticasone propionate nanocrystals. Mississippi is evaluating once-daily dosing NCX 4251 0.1% versus placebo for the treatment of acute exacerbations of blepharitis. Top-line results are currently expected in Q4 2021.
We expect to enter into additional agreements for ZERVIATETM (cetirizine ophthalmic solution), 0.24%, further enlarging the licensed territories and increasing potential future revenue.
Fourth Quarter 2020 and Recent Operational Highlights
Innovative pipeline

The second Phase 3 trial of NCX 470, Denali, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. on November 9, 2020. Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% and will also include a long-term safety extension. The trial is financed jointly and in equal parts by Nicox and its Chinese partner Ocumension. Top-line results are currently expected in Q4 2022.
The Phase 2b trial of NCX 4251, Mississippi, for the treatment of acute exacerbations of blepharitis was initiated in the U.S. on December 14, 2020. Top-line results are currently expected in Q4 2021.
A Phase 3 trial of ZERVIATETM (cetirizine ophthalmic solution), 0.24%, for the treatment of ocular itching associated with allergic conjunctivitis, conducted and financed by Nicox’s Chinese partner Ocumension, was initiated in China in December 2020. This trial will support the submission of a Chinese New Drug Application.
NCX 1728 was selected as the first development candidate in a new class of agents for IOP lowering where NO-mediated effects are enhanced by concomitant action of phosphodiesterase-5 (PDE5) inhibition within the same molecule. Further optimization of the ophthalmic formulations of NCX 1728 will continue prior to initiating formal pre-Investigational New Drug (IND) tests required for the filing of an IND application.
Commercial products

The total number of prescriptions1 for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. increased by 29% in the fourth quarter of 2020 compared to the fourth quarter of 2019 and by 16% compared to the third quarter of 2020 despite the challenging situation due to the COVID-19 pandemic. Along with the U.S., Canada and Argentina, VYZULTA has also been launched by Nicox’s global partner Bausch + Lomb in Mexico and was recently approved in Colombia.
ZERVIATETM (cetirizine ophthalmic solution), 0.24%, U.S. prescriptions2 increased by 56% in the fourth quarter of 2020 over the third quarter of 2020. ZERVIATE has been commercialized in the U.S. since March 2020 by Nicox’s U.S. partner Eyevance Pharmaceuticals, which was acquired in September 2020 by Santen Holdings U.S. Inc., a wholly owned subsidiary of Santen Pharmaceutical Co., Ltd of Japan, for $225 million.
Corporate

The Company completed a €15 million private placement with investors including long-term shareholder HBM Healthcare Investments alongside specialist institutional investors in the U.S. and Europe.
The European Patent Office granted a formulation patent for NCX 470, extending the European exclusivity to 2039. The equivalent U.S. patent has already been granted, and NCX 470 is also covered by granted composition of matter patents.
Fera Pharmaceuticals, Nicox’s partner for naproxcinod, will evaluate naproxcinod as a potential adjuvant treatment for patients with COVID-19 infection. Fera plans to initiate pre-clinical proof-of-concept studies in models of COVID-19 infection in early 2021.
Ora and Nicox have agreed to terminate their license agreement for the development of NCX 4280 targeting lid swelling, or morning eye congestion. All rights to NCX 4280 will return to Nicox and there are no current plans to continue the development.
We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays.

Fourth Quarter 2020 Financial Highlights
As of December 31, 2020, the Nicox Group had cash and cash equivalents of €47.8 million as compared with €28.0 million at December 31, 2019 and €42.2 million at September 30, 2020. Net revenue3 for the fourth quarter of 2020 was €5.8 million (consisting of €0.3 million of royalty payments and €5.5 million of license payments recognized from €14.0 million paid by Ocumension in March 2020 and initially recorded as prepaid income pursuant to accounting principles). Net revenue3 for the fourth quarter of 2019 was €0.6 million and consisted entirely of royalty payments. Net revenue3 for the full year 2020 was €8.9 million (€2.4 million in net royalties, €6.5 million in license payments), compared to €6.9 million (€2.1 million in net royalties, €4.8 million in license payments) for the full year 2019.

As of December 31, 2020, the Nicox Group had financial debt of €18.4 million in the form of a bond financing agreement with Kreos Capital signed in January 2019 and a €2 million credit agreement with Société Générale and LCL, guaranteed by the French State, and granted in August 2020 in the context of the COVID-19 pandemic.

Only the figure related to the cash position of the Nicox Group as of December 31, 2019 is audited; all other figures of this press release are non-audited.
Notes

Bloomberg data, comparing the period of the weeks ending October 2, 2020 to January 1, 2021 with the periods of the weeks ending July 3, 2020 to September 25, 2020 and October 4, 2019 to December 27, 2019
Bloomberg data, comparing the period of the weeks ending October 2, 2020 to January 1, 2021 with the period of the weeks ending July 3, 2020 to September 25, 2020
Net revenue consists of revenue from collaborations less royalty payments, which corresponds to Net profit in the consolidated statements of profit or loss

On January 20, 2021 MobileODT, a FemTech company producing the latest digital innovation in cervical screening, reported that it has been awarded a prestigious Small Business Innovation Research Authority grant of $2.3 million (Press release, MobileODT, JAN 20, 2021, https://www.mobileodt.com/press-releases/13493/ [SID1234574136]). This grant is presented by the United States National Cancer Institute (NCI) to leading companies that are technologically and clinically advanced to support the NCI’s goal of reducing suffering and death due to cancer. This grant is a tribute to the groundbreaking advances of MobileODT as an innovative company commercializing a novel cervical cancer screening technology utilizing complex machine learning (ML) and artificial intelligence (AI) algorithms. The company’s technology offers an alternative screening modality to the current standard-of-care with significantly improved accuracy. It allows for a broader range of physicians, to perform cervical cancer screening, while defining the actual status of the patient and reducing loss to follow-up.

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The grant was awarded to MobileODT to perform a large-scale clinical trial validating the efficacy of the company’s EVA VisualCheck (TM) AI technology, as a cervical screening Clinical Decision Support Tool at the Point of Care and providing results in under 60 seconds. The VisualCheck AI technology will be compared to standard of care methods such as Pap smear, and visual inspection of the cervix.

"This award offers MobileODT a great opportunity to independently validate it’s VisualCheck AI technology against the standard of care check with NIH quality" says David Levitz PhD. Principal Investigator of the study. The trial will commence in Q3 2021 and will be conducted in cooperation with the Basic Health International organization (BHI) on a population of 10,000 subjects.

"AI has a lot of potential to revolutionize care for women worldwide. We are excited to test the technology and validate its accuracy and clinical feasibility " says Miriam Cremer MD., MPH, Associate Professor of Obstetrics and Gynecology from Cleveland Clinic, one of the key researchers who will be leading the trial.

"We are honored to receive such a prestigious grant, especially from National Cancer Institute. It’s a recognition of the value that our technology is bringing to women’s health". Says Leon Boston, MobileODT CEO. "The results of the trial are especially important in light of the World Health Organization’s recent global strategic decision to accelerate the elimination of cervical cancer. We see these results bringing our technology to the forefront of women’s health".