On February 10, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported a collaboration with the GOG Foundation, Inc. to conduct a clinical trial of VB10.16 in combination with an immune checkpoint inhibitor for the treatment of advanced cervical cancer in the U.S (Press release, Nykode Therapeutics, FEB 10, 2023, View Source [SID1234627065]). The VB-C-04 trial will evaluate the combination therapies in patients with cervical cancer that have progressed following first line treatment. Nykode has previously reported positive interim data from the Phase 2 VB-C-02 trial in Europe in patients with heavily pre-treated advanced cervical cancer. VB10.16, wholly owned by Nykode, is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of HPV16-positive cancers.

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"Based on the positive interim data and in line with our potential registrational trial strategy, we look forward to starting the VB-C-04 trial in the U.S. The trial is aimed at providing a fast path to making VB10.16 available to patients," said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.

"We are excited to collaborate with the GOG Foundation, a leading organization with unparalleled expertise in bringing best-in-class new treatments to patients," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "The GOG Foundation has a long history of successfully working with innovative companies, gynecologic oncology clinical sites and U.S. regulators. The advice and support from the GOG Foundation will increase the quality and facilitate the execution for bringing VB10.16 forward towards the patients in need. We look forward to engaging with the GOG Foundation on execution of the potential registrational trial, VB-C-04.

" Since 1970, the GOG Foundation has conducted more than 350 clinical trials in the U.S. with 400 participating sites and 115,000 patients. The results of the GOG Foundation’s clinical trials have influenced the standard of care for numerous malignant gynecologic neoplasms.

"We are thrilled to partner with Nykode Therapeutics to conduct VB-C-04, a ground-breaking study to investigate Nykode’s therapeutic cancer vaccine candidate for the treatment of patients with advanced cervical cancer. VB10.16, which utilizes Nykode’s unique immunotherapy platform, has the potential to meaningfully improve standard of care for patients with HPV16-positive cervical cancer whose cancer has progressed after initial immunotherapy. This clinical situation has quickly become an area of high unmet medical need, and while we have made progress with other novel therapies, we remain dedicated to maximizing our patients’ treatment options and choices. We look forward to working with Nykode on VB-C-04 to advance our shared mission of delivering transformative therapies to patients with cervical cancer and other gynecologic malignancies to help our patients live as long as possible and feel as good as possible," said Leslie Randall, MD, MAS, Cervical Cancer Advisor for the GOG Partners in the GOG Foundation.

"Despite recent advances in cervical cancer care, we still have gaps in treatment strategies, particularly those who have received prior checkpoint therapy. As we continue to explore opportunities to capitalize on recent improvements in cervical cancer outcomes, innovative approaches and novel therapies are required. The VB-C-04 study in patients with recurrent cervical cancer with prior checkpoint inhibitor experience delivers this and offers an opportunity to continue to change the landscape and survival impact for our patients," notes principal investigator of the study, Ritu Salani, MD, MBA, Director, Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA.

On February 10, 2023 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 1:40 pm (ET) (Press release, Mannkind, FEB 10, 2023, View Source [SID1234627063]).

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Interested parties can access a link to the webcast from the New & Events section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

On February 10, 2023 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation (Press release, GlaxoSmithKline, FEB 10, 2023, View Source [SID1234627062]).

Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: "This US regulatory action confirms our confidence in Jemperli as an important treatment option for patients with dMMR recurrent or advanced endometrial cancer. We continue to unlock the potential of Jemperli as the backbone for our immuno-oncology development programmes to address the unmet needs of patients, including earlier lines of endometrial cancer and other solid tumours."

In April 2021, Jemperli received accelerated approval for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer that had progressed on or following prior treatment with a platinum-containing regimen.

This approval is based on additional data collected from the A1 expansion cohort of the ongoing GARNET trial, a phase I, multicentre, open-label, single-arm study of Jemperli monotherapy in patients with advanced or recurrent solid tumours. Cohort A1 evaluated the efficacy of Jemperli in 141 patients with dMMR advanced or recurrent endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as assessed by a blinded independent central review according to RECIST v1.1. Confirmed ORR was 45.4% (95% CI: 37.0, 54.0), with a 15.6% complete response rate and a 29.8% partial response rate. Median DOR was not reached (range: 1.2+, 52.8+ months), measured from the time of first response, with 85.9% of patients having duration ≥12 months and 54.7% of patients having duration ≥24 months. Median follow-up for duration of response was 27.9 months.

Treatment-related adverse events were consistent with previous analyses for cohort A1. The most common adverse reactions (≥20%) were fatigue/asthenia, anaemia, rash, nausea, diarrhoea, constipation, and vomiting. The most common Grade 3 or 4 adverse reactions (≥2%) were anaemia, increased transaminases, urinary tract infection, fatigue/asthenia, and diarrhoea.

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer globally, with approximately 417,000 new cases reported each year worldwide[[1]], and incidence rates are expected to rise by almost 40% by 2040.[[2]][[3]] Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis

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On February 10, 2023 CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported the closing of its follow-on public offering of 27,027,028 common shares, at a public offering price of $9.25 per common share, for total gross proceeds of approximately $250 million before deducting underwriting discounts and commissions and offering expenses payable by CureVac (Press release, CureVac, FEB 10, 2023, View Source [SID1234627060]).

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Goldman Sachs & Co. LLC, Jefferies LLC, and SVB Securities LLC acted as bookrunners for the offering. Van Lanschot Kempen (USA) Inc. acted as lead manager for the offering.

The offering was made pursuant to an effective shelf registration statement on Form F-3 filed with the U.S. Securities and Exchange Commission ("SEC") on September 17, 2021. A final prospectus supplement and accompanying prospectus relating to and describing the final terms of the offering has been filed with the SEC and is available from the SEC’s website located at www.sec.gov or from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; and SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

On February 10, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that on February 9, 2023, the Compensation Committee of Crinetics’ Board of Directors granted non-qualified stock option awards to purchase an aggregate of 90,000 shares of its common stock to six new non-executive employees under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan (the "2021 Inducement Plan") (Press release, Crinetics Pharmaceuticals, FEB 10, 2023, View Source [SID1234627059]). The stock options were granted as inducements material to the employees entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

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The 2021 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Crinetics, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Crinetics, pursuant to Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $19.60 per share, which is equal to the closing price of Crinetics’ common stock on The Nasdaq Global Select Market on February 10, 2023. The shares subject to the stock options will vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to each employee’s continued employment with Crinetics on such vesting dates. The options are subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the grant.