The Food and Drug Administration (FDA) grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma

On December 15, 2020 IO Biotech reported that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy IO102 and IO103 with anti-PD-1 mAb for patients with unresectable/ metastatic melanoma (Press release, IO Biotech, DEC 15, 2020, View Source [SID1234572863]).

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IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy was based on data from the MM1636 Phase 1/2 clinical trial with 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.

"A breakthrough designation is an expedited program in which FDA will work closely with IO Biotech to provide guidance on subsequent development of "Synthetic Peptide Vaccines (IO103) Encoding Human PD-L1 (9-27) and (IO102), targeted to IDO, Indoleamine 2,3-dioxygenase and anti-PD-1" for treatment of unresectable/metastatic melanoma, including providing advice on generating evidence needed to support approval of the drug in an efficient and potentially expedited manner"," said Mai-Britt Zocca, PhD, Chief Executive Officer and founder of IO Biotech. "This is an important achievement for IO Biotech’s clinical program and we are committed to bring this forward to patients as soon as possible."

About MM1636 trial
The MM1636 trial is an investigator-initiated trial at the Copenhagen University Hospital, Herlev which entered 30 patients with metastatic melanoma. In this Phase 2 clinical trial, patients were treated with IO Biotech’s multi antigen vaccine, IO102-IO103 in combination with anti-PD-1 antibody, as first line treatment. IO102-IO103 are administered every second week until 12 weeks and thereafter every fourth week up to one year. The trial objectives are to assess safety, immune responses in blood and biopsies as well as efficacy.

About Melanoma
Globally, about 290,000 new cases of cutaneous melanoma, the most aggressive type of skin cancer, are diagnosed and annually more than 60,000 will die (Bray et al. 2018). The incidence of cutaneous melanoma is increasing (Forman et al. 2014) and advanced melanoma (unresectable or metastatic) will have a fatal outcome if left untreated. The median overall survival (OS) in patients with stage IV melanoma (untreated or treated with BRAF inhibitor and MEK inhibitor) is between 22-25 months and a 3-5-year OS is around 40% (Ascierto et al. 2016; Long et al. 2017).

Therefore, there is a clear unmet need for improved combination therapies enhancing anti-PD-1 efficacy without a significant increase in toxicity.

Veracyte Announces Expansion of Collaboration with the Lung Cancer Initiative at Johnson & Johnson

On December 15, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported it has expanded its long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson1 (Press release, Veracyte, DEC 15, 2020, View Source [SID1234572864]). The collaboration will include a focus on the NOBLE trial, a 9,000-patient, prospective, multicenter clinical study designed to distinguish genomic and other differences in lung cancer development and progression among patients with lung nodules detected by CT imaging.

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As Veracyte plans for the 2021 launch of the first noninvasive nasal swab test to guide the work-up of patients with potentially cancerous lung nodules, this new study will position the company to develop future tests that benefit broader patient populations, including nonsmokers and those with pre-cancerous changes who are likely to develop lung cancer.

"We are pleased to expand upon our collaboration in our goal of reducing lung cancer deaths," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "The NOBLE trial will provide a robust biorepository of genomic, clinical and outcome data, which we plan to translate into future tests that can help diagnose lung cancer at its earliest stages. It will also further our ability to address a nearly $40 billion global lung cancer market that is now more accessible to Veracyte through our own distributed testing platform, which enables advanced genomic testing to be performed locally by laboratories worldwide."

The NOBLE trial is a prospective, multicenter study involving up to 50 sites globally. It is anticipated to enroll 9,000 individuals with lung nodules detected through CT imaging either via lung cancer screening or incidentally and will include patients who are benign at initial nodule diagnosis but who subsequently develop lung cancer. Researchers will collect nasal-swab, longitudinal blood and other samples, as well as imaging and clinical information at enrollment and at multiple points throughout the study. Patients will be followed according to current guidelines for three years or until a lung cancer diagnosis.

"We are proud to participate in the NOBLE trial," said Kim Rieger-Christ, Ph.D., chief scientific officer and director of translational research at Lahey Hospital & Medical Center and the study’s principal investigator. "We believe this study will shed important new light on the natural progression of lung cancer and, more importantly, may enable development of new tests and treatments that will help physicians provide better care for patients and ultimately save more lives."

In January 2019, Veracyte announced a long-term strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration has focused on accelerating two key lung cancer programs for Veracyte: the commercialization of its Percepta Genomic Sequencing Classifier on the company’s RNA whole-transcriptome sequencing platform, which was achieved in June 2019, and the development of the first noninvasive nasal swab test for early lung cancer detection.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

Forma Therapeutics Announces Closing of Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On Tuesday December 15, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 15, 2020, View Source [SID1234572869]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

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Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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.

Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

Forma Therapeutics Announces Closing of Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On December 15, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 15, 2020, View Source [SID1234572869]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

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Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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.

Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

Forma Therapeutics Announces Closing of Public Offering and Exercise in Full of the Underwriters’ Option to Purchase Additional Shares

On December 15, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 15, 2020, View Source [SID1234572869]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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.

Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].