On December 6, 2021 Akeso, Inc. (9926.HK) reported that the company will support an investigator-initiated study (IIS) to evaluate the efficacy and safety of Akeso’s novel, first-in-class anti-PD-1/CTLA-4 bispecific antibody, cadonilimab, for the treatment of neuroendocrine cervical carcinoma in the United States (Press release, Akeso Biopharma, DEC 6, 2021, View Source [SID1234596523]).

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Following a review of the efficacy data from the Akeso-sponsored Phase 2 clinical trial of Cadonilimab in recurrent or metastatic cervical cancer, this study was initiated and will be led by Michael Frumovitz, M.D., M.P.H., FACOG, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center.

INFORMATION ABOUT CADONILIMAB

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bispecific PD-1/ CTLA-4 immunooncology backbone drug developed by Akeso Biopharma. It is one of Akeso’s core assets within the company’s broad pipeline of therapeutic monoclonal antibodies. It is being developed for various indications such as lung cancer, gastric cancer, hepatocellular carcinoma, cervical cancer, esophageal squamous carcinoma, and nasopharyngeal carcinoma. Clinical data from ongoing studies demonstrate that Cadonilimab has promising efficacy against a wide variety of tumor types while exhibiting lower toxicity and a more favorable safety profile when compared to the co-administration of anti-PD-1 plus anti-CTLA-4 therapies.

On December 6, 2021 The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, reported the U.S. Food and Drug Administration (FDA) decision to expand eligibility of Merck’s Keytruda (pembrolizumab) to include patients with Stage IIB and IIC melanoma (Press release, Melanoma Research Alliance, DEC 6, 2021, View Source [SID1234596520]).

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Melanoma, the deadliest skin cancer, is the fifth most common cancer in the U.S. While surgery is curative for most patients with early-stage disease, an estimated 27% percent of patients with Stage II melanoma will experience a disease recurrence in the first five years following surgery.1 Reducing the risk of recurrence after surgery represents a major opportunity to eliminate melanoma suffering and death.

"Over the last decade the treatment landscape for patients facing advanced melanoma has been dramatically changed by checkpoint immunotherapies," says MRA Chief Science Officer Marc Hurlbert, PhD. "It’s great to see those same advancements now become available to patients with Stage II melanoma at risk for recurrence."

Pembrolizumab, an anti-PD-1 antibody, works by stimulating the patient’s immune system to attack melanoma by promoting the tumor-killing effectiveness of T cells. It was first approved for the treatment of unresectable or metastatic melanoma in 2014 and has since gained FDA approval to treat multiple cancers, including certain cancers of the lung, bladder and blood.

FDA approval of pembrolizumab in the adjuvant setting is based on results from the KEYNOTE-716 trial. In this randomized, Phase 3 study, patients with resected stage IIB or IIC melanoma who were treated with pembrolizumab demonstrated a 35% reduced risk of disease recurrence or death compared with patients receiving placebo.

"By giving patients a new option to prevent recurrence – at even earlier stages of disease – we are marking a new milestone in achieving MRA’s mission of ending suffering and death due to melanoma," says MRA President & CEO Michael Kaplan.

On December 6, 2021 bioAffinity Vice President of Research David Elzi, Ph.D., reported that it will discuss how bioAffinity successfully uses RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells at Cell Bio, a joint meeting of the American Society for Cell Biology (ASCB) and European Molecular Biology Organization (EMBO), held virtually Dec. 6-11, 2021 (Press release, BioAffinity Technologies, DEC 6, 2021, View Source [SID1234596519]).

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"bioAffinity’s research expands the use of RNAs in the fight against cancer."

Dr. Elzi will present a poster titled "Silencing of two LDL-family receptors, CD320 and LRP2, results in cancer cell toxicity, while normal cells seem unaffected" and will be available for questions from meeting participants on Monday, Dec. 6, at 4 p.m. CST. A video presentation by Dr. Elzi will be available for viewing throughout the conference.

"bioAffinity’s discovery of a fundamental vulnerability of cancer opens the way to new therapies that kill cancer without harm to normal tissue," Dr. Elzi said. "In particular, bioAffinity’s research shows how the Company has designed and used siRNAs to kill multiple cancers at the cellular level, including prostate, lung, breast, brain and skin cancers, without harm to normal cells."

"Recent scientific discoveries related to RNAs and their application in medicine have been astonishing, leading to life-saving therapies including the use of mRNA vaccines to eradicate the SARS-Cov-2 virus causing the COVID-19 pandemic," said bioAffinity President and CEO Maria Zannes. "bioAffinity’s research expands the use of RNAs in the fight against cancer."

Cell Bio, the joint meeting of ASCB and EMBO, showcases the diverse global community engaged in cell biology by focusing on scientific discovery, research, education, professional development, and diversity and inclusion.

On December 6, 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has closed the previously announced underwritten public offering of 20,125,000 shares of its common stock, which includes 2,625,000 shares of common stock sold as a result of the full exercise by the underwriters of an option to purchase additional shares of common stock, at $2.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $52,325,000 (Press release, MEI Pharma, DEC 6, 2021, View Source [SID1234596518]).

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. LifeSci Capital and H.C. Wainwright & Co. acted as co-managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus.

When available, copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does 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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On December 6, 2021 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 17,486,364 shares of its common stock, which reflects the exercise in full by the underwriters of their option to purchase up to 5,850,000 additional shares of common stock, and pre-funded warrants to purchase 27,363,636 shares of its common stock (Press release, ImmunoGen, DEC 6, 2021, View Source [SID1234596517]). The shares of common stock were sold at a price of $6.60 per share and the pre-funded warrants were sold at a price of $6.59 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant, in each case before underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering were sold by ImmunoGen.

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The total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) were $295.7 million.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities acted as joint book-running managers for the offering. Canaccord Genuity acted as lead manager for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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 other jurisdiction. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.