On June 25, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency ("EMA") has recommended the granting of orphan medicinal product designation ("OMPD") in the European Union ("EU") for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma (Press release, Y-mAbs Therapeutics, JUN 25, 2021, View Source [SID1234584372]). The positive opinion from the EMA’s COMP has been sent to the European Commission ("EC"), which is expected to grant the orphan drug designation within 30 days.

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Obtaining OMPD for 177Lu-omburtamab-DTPA is part of an overall plan to expand the Company’s European development programs and ultimately obtain orphan drug exclusivity to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.

Under the EMA’s Regulation (EC) No. 141/2000 an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet European regulatory requirements and thereby maximize the chance of approval at the time of marketing authorization. Once approved, an orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed on the market.

The EMA grants orphan medicinal product designation based upon several criteria, including: the life threatening and debilitating nature of the condition; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than five cases for each 10,000 of population; no satisfactory method of diagnosis, prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that condition.

Y-mAbs’ founder, Chairman and President, Thomas Gad said, "We are very pleased that the COMP has issued a positive opinion for an orphan drug designation to 177Lu-omburtamab-DTPA which will give us a string of development incentives."

Dr. Claus Moller, Chief Executive Officer further notes, "We believe that the orphan designation strengthens our opportunity to bring 177Lu-omburtamab-DTPA to patients who desperately need alternative methods of treatment. Further, the designation marks a substantial milestone in Y-mAbs’ expansion into European development."

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

On June 25, 2021 Prescient Therapeutics (PTX) reported that it has slipped on the ASX despite some key developments for its CAR-T cancer therapy programs (Press release, Prescient Therapeutics, JUN 25, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-manufactures-new-range-of-binders-for-car-t-cancer-therapy [SID1234584323]).

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The oncology company said today it has manufactured and delivered "crucial components" of its OmniCAR platform for its in-house programs of the next generation of CAR-T therapies.

Specifically, Prescient has developed and manufactured a range of binders against several cancer cells, including CLL-1 and CD33, each expressed in types of leukemia cells; Her2, a gene that can play a role in the development of breast cancer; and EGFRviii, which is associated with brain tumours.

Prescient has incorporated SpyTag and SpyCatcher molecular binding system, which it is licenced to use from Oxford University, into each of the binders.

This next phase of CAR-T programs is focussed on making the therapy safer and broadening its application, particularly into solid tumours.

"Demonstrating that novel components can be manufactured is a crucial milestone in the development of an innovative next-generation CAR platform like OmniCAR," Prescient CEO and Managing Director Steven Yatomi-Clarke said.

"Successfully producing binders for CLL-1; CD33; Her2 and EGFRviii will enable our research team to produce CAR-T cells for our three in-house programs."

Prescient is taking on the CAR-T research program in partnership with the Peter MacCallum Cancer Centre in Melbourne.

What does it all mean?
Essentially, Prescient’s CAR-T programs, based on the OmniCAR platform, are designed to be the next step in the world of cell therapy for cancer treatment.

Cell therapy works by modifying a cancer patient’s own cells to recognise and then kill cancer cells that would normally be hidden from the immune system. This type of treatment has been groundbreaking for certain types of cancers around the world.

However, an issue with cell therapy is that it can typically only direct cells to target and kill a single cancer antigen — meaning if the cancer mutates or expresses different types of antigens, cell therapy becomes less effective.

The OmniCAR platform is designed to mitigate this issue by administering cancer-killing CAR-T cells and "binders" to a patient separately.

The CAR-T cells, when administered, are inactive in the immune system until "armed" with a binder.

The cancer-killing agent has no effect on the body until a specific binder is administered — say, a CLL-1, CD33, Her2, or EGFRviii binder, as announced by PTX today. The binder then directs the CAR-T cells to target a specific cancer antigen.

With this method, cell therapy treatments can attack several types of cancers by simply switching out the arming binder.

As Prescient puts it, the CAR-T cell activity is now "controllable" and its target can be switched at will.

Despite the update on its CAR-T treatment development, shares in PTX slipped over 11 per cent in early action today.

The company has since recovered some of the lost ground, with shares down 4.44 per cent and trading at 22 cents each at 10:59 am AEST.

On June 25, 2021 Alvotech Holdings SA reported that it has entered into an amendment and restatement agreement with bondholders of its $300m covertible bond issued on December 14, 2018 (Press release, Alvotech, JUN 25, 2021, View Source [SID1234584373]). Bondholders have exercised their conversion rights on approximately one quarter of the value of the bond, converting $106m of principal and accrued interest into equity at an exercise price that gives the company a pre-money valuation of $2.7bn.

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The company and bondholders also agreed to improve terms on the remaining bond and extend its maturity to 2025, thereby decreasing the company’s cost of capital and freeing resources to apply to the execution of its business strategy. Further terms were amended to add additional capital to the company.

Robert Wessman, Chairman of Alvotech commented: "With this transaction our stakeholders have reiterated their longstanding confidence in and commitment to our mission: to increase access to the highest quality biologics medicines for patients around the world."

In November of 2020, the U.S. Food and Drug Administration and European Medicines Agency accepted Alvotech’s regulatory submissions for AVT02, a candidate interchangeable biosimilar to AbbVie’s Humira. A decision from the FDA regarding the company’s Biologics License Application (BLA) for AVT02 is expected in September of 2021 and an EMA decision for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVie’s key patents. The lawsuit also argues that AbbVie’s patent strategy, which has been under recent Congressional scrutiny, renders its Humira patents unenforceable. Further, the lawsuit points out that AbbVie has failed to sue Alvotech’s US affiliate (the actual BLA applicant) at all. At stake are billions of dollars of cost to the US healthcare system, negatively impacting consumers and taxpayers.

In June of 2021, Alvotech’s switching study for AVT02 reached primary completion. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira and is executing a switching study to support approval as an interchangeable product. Top-line results from the switching study are expected later this year.

On June 24, 2021 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a 39-cent third-quarter 2021 dividend on the company’s common stock, payable September 7, 2021, to holders of the Common Stock of record at the close of business on July 30, 2021 (Press release, Pfizer, JUN 24, 2021, View Source [SID1234584307]). The third-quarter 2021 cash dividend will be the 331st consecutive quarterly dividend paid by Pfizer.

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On June 24, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported the pricing of its initial public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share (Press release, Elevation Oncology, JUN 24, 2021, View Source [SID1234584340]). All of the shares are being offered by Elevation Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Elevation Oncology, are expected to be $100 million. The shares are expected to begin trading on the Nasdaq Global Select Market on June 25, 2021 under the ticker symbol "ELEV." The offering is expected to close on June 29, 2021, subject to the satisfaction of customary closing conditions. In addition, Elevation Oncology has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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J.P. Morgan Securities, Cowen, and SVB Leerink are acting as joint bookrunning managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on June 24, 2021. The offering is being made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, Attention: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 jurisdiction.