On November 22, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported it has entered into securities purchase agreements with certain institutional investors in connection with a private placement priced at-the-market under Nasdaq rules of 3,000,000 shares of common stock, series A additional investment options (the "Series A AIOs") to purchase up to 1,500,000 shares of common stock, and series B additional investment options (the "Series B AIOs", together with the Series A AIOs, the "AIOs") to purchase up to 1,500,000 shares of common stock at a purchase price of $3.25 per share and associated AIOs for gross proceeds of $9.75 million, before deducting placement agent fees and other estimated offering expenses payable by the Company (Press release, Scopus BioPharma, NOV 22, 2021, View Source(Nasdaq%3A%20%E2%80%9CSCPS%E2%80%9D),private%20placement%20priced%20at%2Dthe%2D [SID1234595886]). The offering is expected to close on or about November 22, 2021, subject to satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

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The Series A AIOs are exercisable immediately with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share. The Series B AIOs are exercisable upon the authorized share increase date with a term of five years following the authorized share increase date and have an exercise price of $3.125 per share.

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 (the "SEC") covering the resale of the shares of the Company’s common stock and the shares of common stock underlying the AIOs no later than January 4, 2022 and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than the later of (i) February 15, 2022 and (ii) 30 days after the authorized share increase date.

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.

On November 22, 2021 Athenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that an abstract for a subgroup analysis of its Phase 3 study of oral paclitaxel and encequidar (Oral Paclitaxel) for the treatment of metastatic breast cancer has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held from December 7 to December 10, 2021 (Press release, Athenex, NOV 22, 2021, View Source [SID1234595885]).

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The abstract and poster provide data from a post hoc, subgroup analysis of safety, progression free survival and overall survival of patients with elevated liver enzymes (AST or bilirubin) from study KX-ORAX-001, a Phase 3 study of weekly Oral Paclitaxel plus Encequidar vs IV Paclitaxel 175mg/m2 every three weeks. 402 subjects were randomized in a 2:1 ratio to Oral Paclitaxel and Encequidar vs IV Paclitaxel.

Prior to treatment, 122 patients out of 402 total study patients (30.3%) had elevated AST or bilirubin, primarily mild hepatic dysfunction. For patients with elevated liver enzymes receiving Oral Paclitaxel, the median survival was 18.9 months compared to 10.1 months for patients receiving IV Paclitaxel: with a hazard ratio of 0.593 (95.5% CI 0.382 – 0.921) favoring Oral Paclitaxel. Although metastatic breast cancer patients with mild hepatic dysfunction at baseline are at increased risk of early serious neutropenic and infectious/septic complications this risk may be counterbalanced by a potential increase in efficacy after treatment with Oral Paclitaxel.

Details of the poster presentation is as follows:

Abstract Title: Oraxol + Encequidar (OPac+E) vs IV paclitaxel (IVPac) in the treatment of patients with metastatic breast cancer (mBC) (Study KX-ORAX-001): Subgroup survival analysis of patients with hepatic dysfunction
Session: 1
Program Number: P1-16-05
Date and Time: Wednesday, December 8, 2021. 7:00 am CT

On November 22, 2021 Lantern Pharma Inc. (NASDAQ: LTRN) ("Lantern" or the "Company"), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that its board of directors has authorized a share repurchase program to acquire up to $7 million of the Company’s common stock (Press release, Lantern Pharma, NOV 22, 2021, View Source [SID1234595882]). The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. As of September 30, 2021, the Company had approximately $73.8 million of cash, cash equivalents and marketable securities. The Company had approximately 11.2 million shares of common stock outstanding as of October 29, 2021.

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"Initiating a share repurchase program at this time is in line with our ongoing focus on creating value for our stockholders, which we are committed to," stated Panna Sharma, CEO and President of Lantern Pharma Inc. "It also demonstrates our confidence in advancing our clinical pipeline and our growing RADR A.I. platform — Lantern is capitalized to achieve its upcoming clinical milestones. In light of our strong balance sheet, the board has decided to implement the share repurchase program enabling Lantern to opportunistically return value to its stockholders."

The timing, amount of shares repurchased and prices paid for the stock under this program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

On November 22, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the acquisition of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, NOV 22, 2021, View Source [SID1234595881]).

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"This is an important and strategic opportunity for our company to continue growing our cardiovascular portfolio and pipeline, that builds on our long and proud legacy in cardiovascular disease and further bolsters our business development strategy," said Rob Davis, chief executive officer and president, Merck. "Fueled by Acceleron’s groundbreaking research, we are excited to explore the opportunities and possibilities ahead to reach even more patients by addressing this critical health need."

Acceleron is focused on harnessing the power of the transforming growth factor (TGF)-beta superfamily of proteins that is known to play a central role in the regulation of cell growth, differentiation and repair. Acceleron’s lead therapeutic candidate, sotatercept, has a novel mechanism of action with the potential to improve short-term and/or long-term clinical outcomes in patients with pulmonary arterial hypertension (PAH), a progressive and life-threatening blood vessel disorder. Sotatercept is in Phase 3 trials as add-on to current standard of care for the treatment of PAH.

On November 22, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the European Commission (EC) has approved QINLOCK (ripretinib) in the European Union (EU) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib1 (Press release, Deciphera Pharmaceuticals, NOV 22, 2021, View Source [SID1234595880]). The EC decision is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein. In September 2021, QINLOCK was added as a fourth-line treatment for GIST patients progressing or intolerant to imatinib, sunitinib, and regorafenib to the ESMO (Free ESMO Whitepaper)-EURACAN-GENTURIS clinical practice guidelines for GIST2.

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"The European Commission’s approval of QINLOCK marks the eighth regulatory approval of this transformative medicine worldwide and is an important milestone for patients with advanced GIST in the EU who are in need of a new treatment option," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We look forward to working with health authorities to ensure that all eligible patients who can benefit from QINLOCK have access as rapidly as possible."

"With a complex disease like advanced GIST, the availability of new efficacious and tolerable treatment options is critical for patients," said Jean-Yves Blay, M.D., Ph.D., professor of Medicine at the Université Claude Bernard, Lyon, France. "The treatment of advanced GIST patients who initially respond to traditional tyrosine kinase inhibitors but eventually develop tumor progression due to secondary mutations has remained an area of high unmet medical need in Europe. In the INVICTUS study, QINLOCK demonstrated compelling clinical benefit in progression-free and overall survival and was well tolerated3. This product brings a new hope for those patients who failed currently approved kinase inhibitors."

"For patients with advanced GIST, the EC approval of QINLOCK offers a much-needed therapeutic option for these patients for whom existing agents have only limited benefit," said Sebastian Bauer, M.D., medical oncologist at the West German Cancer Center in Essen. "The INVICTUS study evaluated QINLOCK in patients who had exhausted all approved options. QINLOCK showed a highly meaningful benefit, not only in terms of disease control, but for the first time in a randomized GIST trial, also overall survival when compared to best supportive care. It is also noteworthy that QINLOCK maintained quality of life in this very advanced group of patients."

The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001)3. Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)3. In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36)3.

The most frequently observed adverse drug reactions (≥25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting1,3.

In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK3.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation4,5. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST4,5.