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Spectrum Pharmaceuticals Announces Two Oral Presentations at Upcoming IASLC 2020 World Conference on Lung Cancer

On January 22, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial (Press release, Spectrum Pharmaceuticals, JAN 22, 2021, View Source [SID1234574198]). In addition, Spectrum also announced an oral presentation on the structural classification of atypical EGFR mutations and their patterns of drug sensitivity. These presentations will take place as part of the IASLC 2020 World Conference on Lung Cancer (#WCLC20) hosted by the International Association for the Study of Lung Cancer (IASLC) taking place virtually January 28-31, 2021. Details of the presentations are as follows:

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Title: Updated efficacy, safety, and dosing management of poziotinib in previously treated EGFR and HER2 exon 20 NSCLC patients
Speaker: Robin Cornelissen, Ph.D., M.D.
Session: Expanding Targetable Genetic Alterations in NSCLC Mini Oral Session
Date and Time: January 31, 2021, 14:20 SGT (January 30, 2021 10:20 p.m. PT)
Presentation Number: MA11.04

Title: Structural classification of atypical EGFR mutations identifies four major subgroups with distinct patterns of drug sensitivity
Speaker: Jacqulyne P. Robichaux. Ph.D.
Session: Tumor Biology: Focus on EGFR Mutation, DNA Repair and Tumor Microenvironment Mini Oral Session
Date and Time: January 31, 2021, 17:20 SGT (January 31, 2021 1:20 a.m. PT)
Presentation Number: MA13.07

Access to the presentations is available to members of IASLC and can be found here: View Source

Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial

On January 21, 2021 Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX – CALTX; NASDAQ – CALT) reported that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN) (Press release, Calliditas Therapeutics, JAN 21, 2021, View Source [SID1234576684]).

The NefIgArd trial consists of two parts: Part A and Part B. Part A, which forms the basis for potential regulatory submissions and approvals, provided data on the efficacy and safety of Nefecon. Calliditas read out positive topline data from Part A of the trial on 8 November 2020, announcing that the study met its primary endpoint, reduction in proteinuria, and key secondary endpoint stabilization of eGFR. It also showed that Nefecon was generally well-tolerated.

Part B is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection and assess the difference in kidney function between treated and placebo patients as measured by eGFR over a two-year period from the start of dosing of each patient. The 360-patient population of the Phase 3 trial includes the further 160 patients enrolled in addition to the 200 patients from Part A.

"To have fully enrolled our Phase 3 pivotal trial is a great milestone, even more so as we achieved this during the pandemic, which reflects the commitment of investigators and patients, as well as that of our experienced clinical team." said Renée Aguiar-Lucander, CEO of Calliditas Therapeutics.

The information was sent for publication, through the agency of the contact persons set out above, on January 21, 2021 at 08:30 a.m. CET.

Entry into a Material Definitive Agreement

On January 21, 2021, Precigen Inc. ("Precigen") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated, as representatives of the several underwriters named therein (the "Underwriters"), in connection with the underwritten public offering of 15,000,000 shares (the "Firm Shares") of Precigen common stock, no par value ("Common Stock"), at a price to the public of $7.50 per share (Filing, 8-K, Precigen, JAN 21, 2021, View Source [SID1234574298]). Pursuant to the Underwriting Agreement, Precigen granted to the Underwriters option to purchase up to an additional 2,250,000 shares of Common Stock (together with the Firm Shares, the "Shares") for a period of 30 days from the date of the Underwriting Agreement. The Underwriters fully exercised the option in connection with the closing of the sale of the Firm Shares, which occurred on January 26, 2021.

Net proceeds to Precigen from the offering were approximately $121.2 million after deducting the underwriting discount and other estimated offering expenses payable by Precigen.

The Shares were offered and sold pursuant to Precigen’s shelf registration statement declared effective on July 2, 2020 (Registration No. 333-239366), as supplemented by the final prospectus supplement filed with the Securities Exchange Commission on January 22, 2021.

The Underwriting Agreement includes certain customary representations, warranties, and covenants by Precigen, and it provides that Precigen will indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or contribute to payments the Underwriters may be required to make because of any of those liabilities. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated herein by reference.

Caladrius Biosciences Announces $25.0 Million Private Placement

On January 21, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to raise $25.0 million through the issuance of an aggregate 12,500,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 6,250,000 shares of common stock, at a purchase price of $2.00 per share of common stock (or common stock equivalent in lieu thereof) and associated warrant in a private placement priced at-the-market under Nasdaq rules (Press release, Caladrius Biosciences, JAN 21, 2021, View Source [SID1234574258]). The closing of the private placement is expected to occur on or about January 25, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.90 per share, are exercisable immediately and have a term of five and one-half years.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including the advancement of its CD34+ technology-based clinical programs.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Under an agreement with the investors, the Company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors within ten calendar days and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after today in the event of a "full review" by the Securities and Exchange Commission.

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

Merck KGaA Discontinues Trial of Cancer Drug Co-Developed With GSK

On January 21, 2021 Merck KGaA reported that it will discontinue a Phase III clinical trial studying its cancer drug hopeful bintrafusp alfa (Press release, Merck KGaA, JAN 21, 2021, View Source [SID1234574230]). The decision was made based on an Independent Data Monitoring Committee recommendation which indicated the study was unlikely to meet its specified primary efficacy endpoint of progression-free survival.

Bintrafusp alfa (anti-PD-L1/TGF-beta trap) is an investigational bifunctional immunotherapy co-designed with GlaxoSmithKline (GSK) to manage hard-to-treat cancers. Merck KGaA was studying the therapy in the ongoing INTR@PID Lung 037 clinical trial as a first-line therapy for patients with stage IV non-small cell lung cancer (NSCLC) and high expression of PD-L1.

"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 Merck KGaA’s Global Head of Development for the Healthcare business Danny Bar-Zohar, M.D., in a statement. "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."

The discontinuation of the trial threatens the cancer drug development goals of GSK, which is developing bintrafusp alfa with Merck under a 2019 collaboration agreement. The partnership agreement held the potential of paying the German company up to $4.5 billion.

Following the news of the trial’s failure, American depositary receipts (ADRs) in Merck KGaA fell 1.7%, while ADRs in GSK fell 1.6%. Merck shares remained unchanged at $83.19.

Despite this setback, Merck KGaA is still investigating the utility of bintrafusp alfa in other clinical trials for other indications. The therapy is being investigating in biliary tract cancer in the INTR@PID BTC 047 study as well as another planned Phase II/III study. In addition, the company is investigating the efficacy of bintrafusp alfa in a Phase II study focused on cervical cancer and two studies focused on non-small cell lung cancer (INTR@PID LUNG 005 and INTR@PID LUNG 024).

Meanwhile, Merck KGaA recently announced it had acquired Hamburg-based AmpTec, a deal that Merck says will increase its ability to produce mRNA for vaccines, diagnostics and treatments focused on COVID-19, among other diseases. This may place Merck in the running toward developing another mRNA-based COVID-19 vaccine, aside from approved vaccines from Pfizer/BioNTech and Moderna.

"By combining AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing, we are able to provide a truly differentiated and integrated offering across the mRNA value chain, which will significantly decrease supply chain complexity and enhance speed-to-market," said CEO Stefan Oschmann. "This transaction is another important step to support the constant growth of our Life Science business through tailored, small-scale acquisitions with high impact."

AmpTec offers Merck a differentiated PCR-based technology for mRNA manufacturing. The company suggests its technology has significant advantages over technologies from other companies, boasting benefits such as greater purity and flexibility, increased quality and higher performance.

Last month, Merck also announced a partnership with Artios to produce several precision cancer drugs over a three-year period. Under terms of the collaboration deal, Artios will receive an upfront $30 million payout and will be eligible for future payments of $860 million per treatment target.