On February 1, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that the Company executed a Two Million Dollar Convertible Promissory Note Purchase Agreement with Convergent Therapeutics, Inc., securing an early investment in Convergen (Press release, Spherix, FEB 1, 2021, View Source [SID1234574715])t. Convergent has exclusive rights to technology related to next generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. and foreign patents.

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Convergent is currently conducting advanced human trials relating to prostate cancer treatments involving peptide receptor radionuclide therapy ("PRRT") that targets the prostate-specific membrane antigen ("PSMA") present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.

The key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-α, a monoclonal antibody conjugated with 225Ac, a radioactive alpha particle emitter. The function of CONV 01-α is unique in that it not only binds specifically to the PSMA receptor on prostate cancer cells, but also stimulates the internalization of the receptor along with itself and its powerful radioactive payload directly into tumor cells. Convergent is presently conducting two sets of human clinical trials using CONV 01-α as a single agent treatment for prostate cancer. The first is a Phase 1a/2a Single Ascending Dose Trial of CONV 01-α and the results are expected to be released in Q2 2021. In August of 2020, Convergent began a second Phase 1b/2a trial to test the efficacy of multiple ascending doses of CONV 01-α. If FDA approved, CONV 01-α would be the first antibody drug approved to direct a radioisotope into prostate cancer cells, and the first drug approved for the use of 225Ac in cancer treatment.

Leveraging the ability of CONV 01-α to internalize the PSMA receptor along with molecules bound to it, Convergent has also developed a proprietary dual therapy by adding a second molecule that specifically binds to PSMA and also contains a radioactive isotope. Convergent has identified certain small molecules that bind to PSMA, but at a different epitope than does CONV 01-α, and therefore do not interfere with the binding of CONV 01-α or its ability to internalize PSMA. The result is that two different radioactive drugs are internalized directly into prostate cancer cells. Importantly, Convergent identified small molecules, with a current focus on the molecule PSMA I&T, that have different biodistributions in the body than does CONV 01-α, so as to reduce additive damage from using two radioactive agents. PSMA I&T is a molecule routinely used clinically to perform imaging to show the presence and distribution of PSMA in a prostate cancer patient. Preliminary animal data using this proprietary dual action PRRT indicate that the two molecules administered together act in a truly synergistic fashion, i.e., the effect of using both drugs together is significantly higher than the expected additive effects of using each separately.

Convergent now has approval to begin human trials using CONV 01-α and PSMA I&T in a dual therapy, which are anticipated to begin in February of 2021. In these trials, Convergent will test PSMA I&T containing either 177Lu, a beta particle emitter, or 225Ac, the same alpha emitter in CONV 01-α. Convergent has approval to perform the three human trials listed below for this dual therapy, anticipated to begin in February of 2021:

(1) a Phase 1b/2a with the combination of CONV 01-α and PSMA I&T-β;

(2) a Phase 2b with the combination of PSMA I&T-β ± CONV 01-α, and

(3) a Phase 1b/2a with PSMA I&T-α ± CONV 01-α (i.e., both drugs with 225Ac, the α-particle emitter).

Another company is currently studying PSMA I&T-β, containing 177Lu, and has just completed a phase 3 trial in prostate cancer. Separately, Novartis is pursuing FDA approval for another 177Lu-small molecule drug for prostate cancer treatment, designated 177Lu-PSMA-617, which also binds PSMA. Novartis has recently completed a phase 3 registration trial for treatment of metastatic castration-resistant prostate cancer (mCRPC), a form of advanced prostate cancer. Like PSMA I&T-β, Novartis’s 177Lu-PSMA-617 may also be a promising candidate for use with CONV 01-α in the proprietary dual PRRT therapy.

Anthony Hayes, CEO of Aikido, stated, "This is by far the most advanced technology in which the Company has participated. The first of the human trials is wrapping up, with data to be reported shortly, and with the remaining trials either underway or scheduled to begin imminently. Participation in this advanced work represents a major and potentially transformative step for the Company and we are honored to be a part of it. I optimistically anticipate the first of the results to be released next quarter. We will update our shareholders as soon as the data is released."

On February 1, 2021 Bristol Myers Squibb’s Yervoy reported that it received approval for previously untreated non-small cell lung cancer in a combination of Opdivo and Yervoy (Press release, Bristol-Myers Squibb, FEB 1, 2021, View Source [SID1234574701]). Today, Merck released first-time data from the Phase III KEYNOTE-598 trial of Keytruda in combination with Yervoy (ipilimumab) compared to Keytruda alone as first-line therapy for metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations and whose tumors express PD-L1. Adding Yervoy to the therapy did not improve overall survival (OS) or progression-free survival (PFS) but did add toxicity to Keytruda monotherapy.

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In the study, median OS was 21.4 months in the Keytruda-Yervoy group compared to 21.9 months for the Keytruda only group. Also, the median PFS was 8.2 months in the combination cohort compared to 8.4 months for patients receiving Keytruda alone.

The trial enrolled 568 patients randomized 1:1 to receive Keytruda 200 mg intravenously on Day 1 of each three-week cycle for up to 35 cycles in combination with 1 mg/kg IV on Day 1 of each six-week cycle for up to 18 cycles of Yervoy, or Keytruda alone. There were no new safety signals for the Keytruda monotherapy arm, but in the combination arm, 76.2% reported treatment-related adverse events (TRAEs) compared to 68.3% of the Keytruda monotherapy arm. Of the TRAEs, 35.1% versus 19.6% were Grade 3-5, 27.7% versus 13.9% were serious, and 6.0% versus 3.2% led to discontinuation of Yervoy or placebo, and 19.1% versus 7.5% led to discontinuation of both drugs, while 2.5% versus 0.0% led to death.

There were also immune-mediated adverse events and infusion reactions in 44.7% of patients receiving the combination compared to 32.4% received Keytruda alone.

"In KEYNOTE-598, the addition of ipilimumab to Keytruda did not improve overall survival or progression-free survival, and patients who received the combination were more likely to experience serious side effects than those who received Keytruda monotherapy," said Michael Boyer, chief clinical officer and conjoint chair of thoracic oncology, Chris O’Brien Lifehouse, Camperdown, NSW, Australia. "Keytruda monotherapy remains a standard of care for the first-line treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1."

So basically, adding Yervoy to Keytruda failed to extend the lives of first-line NSCLC patients whose tumors expressed PD-L1 at a proportion of at least 50%, while increasing the serious side effects.

It has been hypothesized that by adding a CTLA-4-targeted antibody to a PD-1 checkpoint inhibitor would create more benefits in some cancers, but this is the first well-designed comparison trial. And it completely undercuts the hypothesis.

"The results are clear," said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. "The combination did not add clinical benefit but did add toxicity."

The results were presented at the Presidential Symposium at the IASLC 2020 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The data was also published in the Journal of Clinical Oncology.

The trial was discontinued after a futility analysis by an independent Data Monitoring Committee (DMC), which declared the benefit/risk profile of the combination did not support continuing the trial.

Two primary forms of lung cancer are non-small cell and small cell. NSCLC is the most common type of lung cancer, making up about 85% of all lung cancer cases.

Sabine Maier, Bristol Myers Squibb’s head of oncology clinical development, noted that the benefit of the Opdivo-Yervoy combination "has been well established in Phase III trials across lung cancer, melanoma, renal cell carcinoma and mesothelioma" and those trials "clearly demonstrate that combining Yervoy and Opdivo can help patients achieve durable, long-term survival outcomes."

On February 1, 2021 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported that it has commenced a global offering of $750 million (approximately €618 million) of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, FEB 1, 2021, View Source [SID1234574666]). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are expected to close simultaneously.

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In addition, argenx intends to grant the underwriters of the offering a 30-day option to purchase additional ordinary shares (which may be represented by ADSs) in an aggregate amount of up to 15% of the total number of ordinary shares (including represented by ADSs) proposed to be sold in the offering, on the same terms and conditions.

Baillie Gifford Overseas Limited and entities affiliated with it have indicated an interest in purchasing an aggregate of up to $415 million (approximately €342 million) of ordinary shares in this offering at the offering price per share and on the same terms as the other purchasers in this offering. However, because indications of interest are not binding agreements or commitments to purchase, the underwriters could determine to sell more, fewer or no ordinary shares to these potential purchasers, and these potential purchasers could determine to purchase more, fewer or no shares in this offering.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX." and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX.".

J.P. Morgan, Morgan Stanley, BofA Securities and Cowen are acting as joint bookrunning managers for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities being offered in the United States may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made following pricing of the offering.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.

On February 1, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, FEB 1, 2021, View Source [SID1234574482]).

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BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Fireside Chat on Thursday, February 18, 2021 at 10:30 a.m. EST
Citi Healthcare Services, Medtech, Tools, & HCIT Virtual Conference
Fireside Chat on Wednesday, February 24, 2021 at 9:50 a.m. EST
SVB Leerink Global Healthcare Virtual Conference
Fireside Chat on Thursday, February 25, 2021 at 1:40 p.m. EST
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On February 1, 2021 Magellan Rx Management, a division of Magellan Health, Inc. (NASDAQ: MGLN), reported that preliminary results from its oncology biosimilar medical pharmacy solution that targets new-to-market oncology therapeutic biosimilars (Press release, Magellan Health Services, FEB 1, 2021, View Source [SID1234574476]). These results further demonstrate Magellan Rx Management’s innovative capabilities and expertise in the specialty drug market. As of May 2020, health plan customers who were quick to partner with Magellan Rx have achieved a 90% rate for authorization for the first two therapies with biosimilar availability. In early 2019, Magellan Rx developed a management program designed to prepare customers, members, and providers for the market entry of oncology biosimilars ahead of their availability in July 2019. Since then, ten oncology biosimilar agents have launched in the United States.

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"These results, less than one year after implementation, highlight Magellan Rx’s passion and commitment to developing forward-thinking, industry-leading solutions to manage one of the most complex and evolving areas of healthcare—medical pharmacy drug spend," said Steve Cutts, PharmD, senior vice president and general manager, specialty, Magellan Rx Management. "Given our 17-year history in medical benefit management, combined with innovative comprehensive oncology solutions and our prior success in advancing biosimilar utilization, we are uniquely qualified to support our health plan customers to deliver true savings while maintaining or expanding member access to clinically-effective, lower-cost treatments."

Health plan customers implemented this program throughout the fall and winter of 2019, shortly after the July 2019 arrival of oncology biosimilars on the market, with several more opting into this innovative program through early 2020. The 90% rate is measured by the number of authorizations approved for the biosimilars compared to the reference brands. Due to the cost differential between oncology biosimilars and their reference brands, savings are expected to be at least 15%,1 but could be greater depending on plan benefit design and other factors. As oncology and oncology support drugs continue to be the largest driver of specialty pharmacy spend on the medical benefit—43% of total medical drug spend for both the Commercial and Medicaid populations and 55% in Medicare2—and given the billions of dollars that are spent on these treatments, significant additional savings are anticipated with full results expected in early 2021.

To learn more about how Magellan Rx Management’s solution can increase the use of less-expensive biosimilars, view this poster that was presented at the Academy of Managed Care Pharmacy Annual Spring Conference in April 2020. For more information on the oncology biosimilar landscape, watch this webisode of MRx Events @ Home featuring one of our in-house specialty experts, Rebecca Borgert, PharmD, BCOP, senior director, clinical strategy and programs.

Amgen Inc. (2019) Amgen And Allergan’s MVASI (bevacizumab-awwb) And KANJINTI (trastuzumab-anns) Now Available In The United States [Press release]. 18 July. Available at: View Source (Accessed: 26 August 2020).
2019 Magellan Rx Management Medical Pharmacy Trend Report, ©2020.