On April 7, 2021 Nirogy Therapeutics Inc., a privately-held biotechnology company developing novel small molecules to target cellular transporters, reported that the company will present two e-posters at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, which is being held on April 10-15, 2021 and May 17-21, 2021 (Press release, Nirogy Therapeutics, APR 7, 2021, View Source [SID1234577687]).

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Nirogy will highlight preliminary data that shows that NGY-B, the company’s first-in-class, orally bioavailable small molecule inhibitor, intervenes in two key hallmarks of cancer, metabolism and immunity, providing a potential novel therapeutic modality to combat triple-negative breast cancer (TNBC). Nirogy will also highlight preclinical data that demonstrate the potential of NGY-B to inhibit melanoma by targeting metabolic symbiosis and activating antitumor immune response mechanisms.

"We’re thrilled to be presenting two impactful posters at this year’s AACR (Free AACR Whitepaper) virtual conference," said Vincent Sandanayaka, Ph.D., founder, president and chief executive officer of Nirogy. "These preliminary data show that NGY-B has significant efficacy in ‘immunologically cold’ mouse tumor models, where many drugs fail. We’re also pleased with our findings that NGY-B works synergistically with anti-CTLA4 checkpoint inhibitors, suggesting a potential future combination therapy for patients. We look forward to continuing to evaluate NGY-B as we move closer to the clinic."

Poster Presentation Details:

Title: Dual MCT1/4 inhibition promotes anti-tumor immunity in triple-negative breast cancer
Presenters: Gregory James Goreczny, Jaime Escobedo, Vincent Sandanayaka
Session: Session PO.ET06.04 – Novel Targets and Pathways
Presentation Number: 1335
Date and Time: Saturday, April 10, 2021, 8:30 a.m. – 11:59 p.m. ET

Title: A novel treatment approach for melanoma by dually targeting MCT1 and MCT4 lactate transporters
Presenters: Sambad Sharma, Gregory Goreczny, Satish Kumar Noonepalle, Erica Palmer, Maria Garcia-Hernandez, Daliya Banerjee, Jaime Escobedo, Alejandro Villagra, Vincent Sandanayaka
Session: Session PO.ET06.03 – Novel Antitumor Agents
Presentation Number: 1268
Date and Time: Saturday, April 10, 2021, 8:30 a.m. – 11:59 p.m. ET

On April 7, 2021 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies, reported that, following feedback from the U.S. Food & Drug Administration (FDA), the company has entered into an agreement with Merck to initiate a Phase 2B clinical trial to evaluate its lead compound, maveropepimut-S (DPX-Survivac) in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent/refractory diffuse large B cell lymphoma (r/rDLBCL) (Press release, IMV, APR 7, 2021, View Source [SID1234577686]). The contribution of low dose cyclophosphamide (CPA) as an activator of immune response will also be evaluated in this trial.

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"We are proud to continue working with Merck to deepen the relationship that was built during our basket trial and the prior "SPiReL" study in r/rDLBCL", said Andrew Hall, Chief Business Officer at IMV. "This new agreement continues to leverage our common vision to save and improve lives by delivering better treatments to patients with unmet medical needs. In this collaboration we look forward to collaborating with Merck, beyond the provision of Keytruda, to ensure clinical and regulatory alignment, thus optimizing our probability of success."

In a press release issued on March 17, 2021, the Company announced that the FDA provided valuable feedback on the clinical trial design and the study is expected to begin in Q2 2021.

Frederic Ors, Chief Executive Officer at IMV stated "The guidance from the FDA is an important milestone for the Company and we believe it provides us regulatory clarity and confidence to advance our development strategy for our lead immunotherapy in this difficult-to-treat patient population. We intend to initiate this trial rapidly and will seek to confirm the promising results obtained in the SPiReL study."

The three-arm Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess the combination of maveropepimut-S and KEYTRUDA with or without CPA. A third arm will evaluate maveropepimut-S as a single agent. Across the three arms of this study, IMV’s lead compound will be evaluated in up to 150 subjects with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

The primary endpoint is Objective Response Rate (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression with the goal to validate the SPiReL data that highlighted PD-L1 as a possible predictive biomarker for the combination therapy.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Maveropepimut-S

Maveropepimut-S is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with Maveropepimut-S in association with CPA have demonstrated a favorable safety profile across all clinical studies.

Maveropepimut-S, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX) which is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by maveropepimut-S.

Maveropepimut-S has received Fast Track designation from the FDA as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

On April 7, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that Pierre Belichard, CEO, will present an overview of the Company and take part in 1-on-1 meetings with institutional investors at the following conferences (Press release, Enterome, APR 7, 2021, View Source;utm_medium=rss&utm_campaign=enterome-to-present-at-upcoming-conferences [SID1234577684]):

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European Biotech Investor Days: April 7-8
Jefferies Microbiome-based therapeutics Summit: April 22
Jefferies Virtual Healthcare Conference: June 1-3
Enterome’s CBO, Anne Dagallier, will participate and take part in 1-on-1 meetings with potential business partners at the following conferences:

Digestive Disease Week (DDW): May 21-23
BIO International Convention: June 14-18

On April 7, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis reported that it has successfully completed the acquisition of EMMAC Life Sciences Limited ("EMMAC"), the largest vertically integrated independent cannabis company in Europe, for base consideration of approximately US$50 million in cash and 17.5 million shares of Curaleaf, with additional consideration to be paid based upon the successful achievement of performance milestones (Press release, EMMAC Life Sciences, APR 7, 2021, View Source [SID1234577683]). Curaleaf has simultaneously established Curaleaf International Holdings Limited ("Curaleaf International") in Guernsey to hold the EMMAC investment and further its European expansion.

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To accelerate the expansion of Curaleaf International, Curaleaf has secured an investment of US$130 million from a single strategic institutional investor in exchange for 31.5% equity stake in Curaleaf International, implying a $413 million Post Money valuation, with US$80 million in cash available to spend. The subscription will fund the entire cash portion of the EMMAC acquisition consideration of US$50 million with the remaining US$80 million to be used to fund Curaleaf International’s current capital expenditures plan through 2022, as well as its pipeline of potential acquisitions. This infusion of outside capital into Curaleaf International significantly accelerates Curaleaf’s expansion plans in Europe by fully funding Curaleaf’s cash outlay for the EMMAC acquisition and providing the capital required to support Curaleaf International’s near-term European rollout. With its foreseeable expansion budget fully funded, Curaleaf’s new international business can focus on executing its further European expansion.

Curaleaf and the strategic investor have entered into a shareholders’ agreement regarding the governance of Curaleaf International pursuant to which Curaleaf will have control over operational issues as well as raising capital and the ability to exit the business. In addition, the strategic investor’s stake is subject to put/call rights which permits either party to cause the stake to be bought out by Curaleaf for Curaleaf equity starting in 2025.

Boris Jordan, Executive Chairman of Curaleaf, stated, "The successful completion of our acquisition of EMMAC, and the formation of our new Curaleaf International business, marks a transformational launching point for our entrance into the European cannabis market. Building on our market leading position in the U.S., this transaction establishes Curaleaf as the global, pure play, cannabis market leader by revenue and geographic reach. With our single strategic institutional investor, we have set a strong foundation for Curaleaf International’s future growth trajectory. On behalf of the Curaleaf Board of Directors and management team, we are thrilled to welcome Antonio Costanzo, co-founder and CEO of EMMAC, as the CEO of Curaleaf International, and the entire EMMAC team to Curaleaf."

The new Curaleaf International platform includes cultivation, EU GMP-certified processing, distribution, and R&D operations across several key European medical cannabis markets, including the United Kingdom, Germany, Italy, Spain and Portugal. Terra Verde, Curaleaf International’s European market cultivation facility in Portugal, is one of the oldest licensed cannabis growing facilities in Europe with approximately 2 hectares of cultivation area and is an industry leader on the cannabis production cost efficiency front. The Portugal based cultivation facility provides Curaleaf International with the potential to serve customers across key European medical cannabis markets as well as supporting exports to countries such as Israel, among others. Curaleaf International plans to significantly increase its cultivation capacity in 2021, and to exceed 10 tons per year by 2022, in order to accommodate future growth related to the expansion of access to cannabis across the major European medical and adult-use, as well as export markets. Curaleaf International also has an operational presence and partnerships in European Union countries that are enacting new medical cannabis access programs. Curaleaf International will also serve as the platform for other possible acquisitions in Europe and adjacent areas, and for its participation in pilot adult use programs.

Joseph Bayern, CEO of Curaleaf, commented, "As the consumer and political liberalization trends around cannabis that are sweeping the U.S. are increasingly taking hold across Europe, our expansion into the international cannabis market presents tremendous new long-term growth opportunities for Curaleaf. With the European population of nearly 748 million[1], the potential European addressable market is more than twice the size of the U.S. addressable market[2]. With the ability to operate our new European business across country borders, with one or two cultivation sites and one manufacturing center to serve the entire region in most cases, combined with our ability to leverage the strength of our consumer packaged goods strategies and innovations from our U.S. operations, we see enormously positive implications for our ability to quickly and efficiently scale the business across Europe."

Following the successful completion of the transaction, Mr. Antonio Costanzo has been appointed as the new Chief Executive Officer of Curaleaf International, with the former EMMAC management team continuing to lead Curaleaf’s new European presence as well as driving local European strategy and day-to-day operations.

Antonio Costanzo, CEO of Curaleaf International, commented, "This is an important day for the European cannabis market as EMMAC transitions to Curaleaf International. I look forward to working closely with the Curaleaf team to shape the future of cannabis for our patients and customers around the world. We will retain our science-led approach to continue to deliver best in class cannabis products for Europe’s growing medical cannabis market, and will work closely to leverage the consumer packaged goods experience and innovation from the U.S. to capitalize on the emerging adult-use market as legislation allows. We are now very well positioned to realize our aggressive growth ambitions."

On April 7, 2021 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 the pricing of an underwritten public offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share (Press release, Crinetics Pharmaceuticals, APR 7, 2021, View Source [SID1234577682]). All of the shares to be sold in the offering are being sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $75.0 million. The offering is expected to close on or about April 12, 2021, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink is acting as sole bookrunning manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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