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MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab

On November 17, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration announced the approval of the Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody that was previously developed by MacroGenics (Press release, MacroGenics, NOV 17, 2022, View Source [SID1234624240]). Teplizumab was acquired by Provention Bio, Inc. in May 2018 pursuant to an asset purchase agreement.

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"We are very pleased to see the culmination of years of effort by Provention, MacroGenics, and tireless champions in academia and government, with the achievement of the approval of teplizumab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We applaud this outcome, which represents an advancement for individuals and their families dealing with the risks and consequences of type 1 diabetes."

Under the agreement, Provention is obligated to pay MacroGenics contingent milestone payments totaling $170 million upon the achievement of certain regulatory approval milestones, including $60 million for the approval of a BLA for a first indication in the United States. In addition, Provention is obligated to make contingent milestone payments to MacroGenics totaling $225 million upon the achievement of certain sales milestones as well as a single-digit royalty on net sales of the product.

Based on MacroGenics’ cash, cash equivalents and marketable securities balance as of September 30, 2022, plus projected and anticipated payments from partners, including timely receipt of the milestone payment from Provention, MacroGenics currently anticipates having a cash runway into late 2024.

SynRx Raises $14 Million to Develop Drugs for Solid Tumor Cancers with DNA Damage

On November 17, 2022 SynRx Therapeutics, a Hangzhou biopharma startup, reported that closed a $14 million Series Pre-A financing round to advance its portfolio of five oncology candidates (Press release, SynRx Therapeutics, NOV 17, 2022, View Source [SID1234624234]). The company focuses on solid tumor cancers with homologous recombination deficiency (HRD) – tumors that are unable to repair double-strand breaks (DSBs) in DNA, a condition that ultimately causes cancer . The company’s technology is based on original research from the lab of Founder and Chairman Xiaochun Yu. The round’s investors include Lapam Capital, Fenghua Venture, Westlake Innovation Capital and Long Yield Venture Capital.

In Latest PARP Probe, FDA Asks Clovis to Limit Rubraca’s Label

On November 17, 2022 Clovis Oncology reported The FDA has requested that the indication of its PARP inhibitor Rubraca (rucaparib) as second-line maintenance therapy in recurrent ovarian cancer, the company revealed in an SEC filing this week (Press release, Clovis Oncology, NOV 17, 2022, View Source [SID1234624232]).

The proposed changes to Rubraca’s label would limit its use to only patients harboring tumor BRCA mutations.

If the FDA and Clovis do not reach an agreement over the revisions, the Agency will convene a meeting of the Oncologic Drugs Advisory Committee to re-scrutinize the drug. Clovis is currently considering the FDA’s request, according to the SEC filing.

Rubraca is approved for use in patients in complete or partial response to platinum-based chemotherapy and is also indicated for fallopian tube and primary peritoneal cancer.

This indication is responsible for a "substantial portion" of Clovis’ Rubraca revenue, the company indicated in a 10-Q filing posted early this month.

"We would expect that a limiting of our second line maintenance indication could result in a significant impact on our revenue," the company stated.

The FDA made the revision request on Monday when it met with Clovis via teleconference to discuss overall survival data from the company’s Phase III ARIEL3 clinical trial. Findings from ARIEL3 formed the basis for Rubraca’s regulatory green light in 2018. Complete and final data were submitted in September.

If Clovis concedes to the FDA’s request, it would not be the first time that Rubraca has lost an indication. In June, the company voluntarily withdrew its blockbuster drug from the U.S. market as a treatment option for patients with BRCA-mutation ovarian cancer who have received at least two prior lines of chemotherapy, citing concerns about excess mortality risk in this patient population.

At the time, Clovis said this indication "represents a very small portion of the Company’s total sales" in U.S. and Europe.

Still, times have been tough for the Colorado-based biotech. Earlier this month, amid increasing regulatory scrutiny on Rubraca, Clovis signaled it was at risk of bankruptcy. To stay afloat, the company laid off 115 employees.

Putting the Pressure on PARP Inhibitors

Rubraca is only the latest casualty in the FDA’s intensified probe into safety concerns surrounding PARP inhibitors.

In August, AstraZeneca voluntarily withdrew its Lynparza (olaparib) for the treatment of highly pre-treated patients with advanced ovarian cancer bearing BRCA mutations. The decision follows a subgroup analysis of the Phase III trial SOLO3, which found that treated patients were 33% more likely to die than comparators who received standard chemotherapy.

Meanwhile, GlaxoSmithKline also restricted the use of its PARP inhibitor Zejula earlier this month. Following an FDA request, Zejula as a second-line therapy is now only usable in ovarian cancer patients with deleterious or suspected deleterious germline BRCA mutations. The drug retains its first-line indications in epithelial ovarian, fallopian tube or primary peritoneal cancer.

RAPT Therapeutics Announces Pricing of Public Offering of Common Stock

On November 17, 2022 RAPT Therapeutics, Inc. (Nasdaq: RAPT) ("RAPT" or the "Company"), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported the pricing of its previously announced underwritten public offering of 4,054,055 shares of its common stock at a price to the public of $18.50 per share. All of the shares of common stock are being offered by RAPT (Press release, RAPT Therapeutics, NOV 17, 2022, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-pricing-public-offering-common-0 [SID1234624228]). Gross proceeds to RAPT from the offering are expected to be $75 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 608,108 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on November 22, 2022, subject to customary closing conditions.

J.P. Morgan, Evercore ISI, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (the "SEC"), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 6th Floor, New York, New York 10022, or by email at [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 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.

MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab

On November 17, 2022 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration announced the approval of the Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody that was previously developed by MacroGenics (Press release, MacroGenics, NOV 17, 2022, View Source [SID1234624227]). Teplizumab was acquired by Provention Bio, Inc. in May 2018 pursuant to an asset purchase agreement.