On June 1, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT) reported entry into agreements that include a $25 million investment by G42 Investments AI Holding RSC Ltd ("G42 Investments") (Press release, vTv Therapeutics, JUN 1, 2022, View Source [SID1234615402]). Under the terms of the agreements, G42 Investments acquired 10,386,274 shares of Class A Common Stock of vTv at an issue price of $2.407 per share, with $12.5 million paid in cash at closing, and the remaining amount of $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30 million in additional shares of Class A Common Stock to G42 Investments (or cash in lieu of such issuance at the option of G42 Investments) if the United States Food and Drug Administration (the "FDA") approves the marketing and sale of a pharmaceutical product containing TTP399, a liver selective glucokinase activator, as the active ingredient for treatment of type 1 diabetes in the United States. The agreements set forth the terms under which vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories outside of the United States and the European Union.

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"We have focused substantial energy and resources on TTP399 since obtaining Breakthrough Therapy designation from the FDA in April 2021 and are thrilled to welcome a partner to work with us to accelerate the development and potential approval and commercialization of this treatment. G42 Healthcare brings a unique combination of strong commitment to the development of new impactful drugs and treatments, as demonstrated by their success and their leadership on COVID-19 testing and other product and service offerings in the healthcare spectrum, and substantial resources, making them an ideal partner for this program. This investment into vTv will fund a substantial portion of our Phase 3 clinical trials for TTP399 in the United States and the collaboration with G42 will fund certain of the Phase 3 clinical trials that will be conducted in other territories. We are excited to partner with the G42 Healthcare team as we launch our Phase 3 clinical trials and work together towards approval and commercialization of this treatment for type 1 diabetes," said Rich Nelson, Interim Chief Executive Officer of vTv.

Dr. Fahed Al Marzooqi, the Chief Operating Officer of G42 Healthcare, noted that "We have a deep commitment to collaborating with international organizations to share our knowledge and expertise in the consumer and clinical health spectrum and we look forward to working together with vTv to further develop and commercialize this important treatment. As we move ahead, we will continue to join forces with the world’s best to innovate and invest in science and create the next wave of medicines to future-proof the health of nations."

A more detailed description of the agreements is set forth in vTv’s Current Report on Form 8-K filed with the SEC. The Stock Purchase Agreement is attached to the Current Report on Form 8-K and the Collaboration and License Agreement will be filed with vTv’s Quarterly Report on Form 10-Q for the second quarter.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.

About TTP399

TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with type 1 diabetes. In a recent phase 2 clinical trial, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of type 1 diabetes. This past October, vTv announced results of a mechanistic study of TTP399 in patients with type 1 diabetes demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects. TTP399 is still in the development phase; the FDA has not reviewed or approved TTP399 for use in the United States.

On June 1, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported the pricing of an underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $4.75 per share (Press release, Concert Pharmaceuticals, JUN 1, 2022, View Source [SID1234615398]). The gross proceeds to Concert, before deducting underwriting discounts and commissions and estimated offering expenses payable by Concert, are expected to be approximately $47.5 million. Concert has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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All shares in the offering are being sold by Concert. The offering is expected to close on or about June 6, 2022, subject to the satisfaction of customary closing conditions.

Concert intends to use the net proceeds from the offering, together with its current cash and cash equivalents, to complete clinical development supporting the filing of its New Drug Application for CTP-543 for the treatment of moderate to severe alopecia areata in adults, conduct pre-commercial activities related to CTP-543 and support its pipeline development, working capital needs and other general corporate purposes.

Jefferies and Truist Securities are acting as joint book-running managers for the offering. JMP Securities, A Citizens Company, and Mizuho Securities are acting as lead managers, and H.C. Wainwright & Co. is acting as co-manager for the offering.

The offering is being made only by means of a written prospectus supplement and prospectus forming part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) and declared effective on November 16, 2020. A preliminary prospectus supplement relating to the offering was filed with the SEC. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected] or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, email: [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 other 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 other jurisdiction.

On June 1, 2022 Servier, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, reported that data will be presented from multiple studies across its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, June 9-12 (Press release, Servier, JUN 1, 2022, View Source [SID1234615395]). Data highlighted at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include multiple company-sponsored and investigator-initiated trials, which underscore the breadth of Servier’s oncology portfolio and commitment to improving outcomes for patients with difficult-to-treat cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), cholangiocarcinoma (CCA), colorectal cancer, pancreatic cancer and lung cancer.

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At both congresses, new data will be presented from Servier’s phase 3 AGILE study, a global, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate the efficacy and safety of TIBSOVO (ivosidenib tablets) in combination with azacitidine compared with placebo in combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy). These data build on the efficacy and safety results presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. Patients with IDH1-mutated AML have a poor prognosis and have fewer treatment options, especially for newly diagnosed patients who are not eligible for intensive chemotherapy. This new AGILE data presentation comes on the heels of the U.S. Food and Drug Administration approval of TIBSOVO in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated AML.

Ivosidenib monotherapy has breakthrough therapy designation in IDH1 mutated R/R MDS and Servier will be presenting updated efficacy and safety results at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

"Several of the studies being presented at this year’s ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) highlight the potential role of IDH inhibition and the company’s overall innovative research portfolio in generating new therapies based on precision approaches," said David K. Lee, CEO, Servier Pharmaceuticals. "Servier Pharmaceuticals has made immense progress since we’ve launched our oncology program in 2018, and we will continue to move the needle for patients with difficult-to-treat cancers."

In the short time the company has been in the U.S., Servier Pharmaceuticals has established a presence in oncology. The company has tripled its oncology portfolio since 2021 with 21 oncology assets at varying stages of clinical development, and 20 research projects.

"Our significant presence at these key congresses demonstrates our long-term commitment to developing innovative therapeutic solutions to meet the needs of patients with difficult-to-treat cancers," said Claude P. Bertrand, Executive Vice President of Research and Development, Servier Group. "We look forward to presenting to the scientific community data across our diverse portfolio, including research on the potential of IDH inhibition in the treatment of cancers with high unmet needs."

Key highlights of data from Servier and its partners at ASCO (Free ASCO Whitepaper) are listed below and are available online on the ASCO (Free ASCO Whitepaper) website: View Source

Abstract #7042/Poster #273: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia.

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: H. Dohner
Abstract #7019/Poster #250: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Saturday, June 4 at 1:15 p.m. CDT; poster will be on display in the poster hall from 8 – 11 a.m.
Poster Discussion: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract/Publication Only: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine.

Author: A. Schuh
Abstract #7053/Poster #284: Ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS): Updated enrollment and results of a phase 1 dose escalation and expansion substudy

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: D. Andrew Sallman
Abstract #7005/Oral Presentation: Overall survival by IDH2 mutant allele (R140 or R172) in patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib or conventional care regimens in the phase 3 IDHENTIFY triali

Date & Time: Tuesday, June 7 at 11:33 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: S. de Botton
Abstract #7032/Poster #263: Health-related quality of life (HRQoL) with enasidenib vs conventional care regimens in older patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia (R/R AML)i

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Dinardo
Abstract #3568/Poster #362: Trifluridine/tipiracil plus bevacizumab (FTD/TPI + BEV) and trifluridine/tipiracil (FTD/TPI) monotherapy in metastatic colorectal cancer (mCRC): results of a meta-analysisii

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: T. Yoshino
Abstract/Publication Only: Characterizing Platinum Sensitivity among Medicare FFS Patients with Limited vs Extensive Stage Small Cell Lung Cancer Receiving NCCN Category 1 Regimensiii

Presenting Author: G. Dieguez
Abstract/Publication Only: Patient Characteristics and Outcomes Associated with Small Cell Lung Cancer by Treatment Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract/Publication Only: Treatment Patterns and Outcomes Associated with Small Cell Lung Cancer by Platinum Sensitivity Status in a U.S. Medicare Populationiii

Presenting Author: P. Cockrum
Abstract #8584/Poster #210: Trends in Treatment Patterns Associated with Small Cell Lung Cancer in a U.S. Medicare Populationiii

Date & Time: Monday, June 6 at 8 a.m. CDT
Poster Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Presenting Author: R. Ramirez
Abstract #7018/Poster #249: A phase Ib/II study of ivosidenib with venetoclax +/- azacitidine in IDH1-mutated hematologic malignancies

Date & Time: Saturday, June 4 at 8 a.m. CDT
Oral Abstract Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Presenting Author: C. Lachowiez
Abstract #3612/Poster #406: Phase II, multicenter, open-label, non-randomized study of neoadjuvant chemotherapy NALIRINOX (5-FU/LV + oxaliplatin + nal-IRI) followed by chemoradiotherapy in patients with rectal cancer in a watch-and-wait program

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Colorectal and Anal
Presenting Author: C. Gregorio Muñoz
Abstract #TPS4185/Poster #157b: A randomized phase II study of gemcitabine and nab-paclitaxel compared with 5-fluorouracil, leucovorin, and liposomal irinotecan in older patients with treatment-naïve metastatic pancreatic cancer (GIANT): ECOG-ACRIN EA2186—Trials in progress

Date & Time: Saturday, June 4 at 8 a.m. CDT
Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: E. Dotan
Abstract #4005/Oral Presentation: NET-02: A multi-centre, randomised, phase II trial of liposomal irinotecan (nal-IRI) and 5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients (pts) with progressive poorly differentiated extra-pulmonary neuroendocrine carcinoma (PD-EP-NEC)

Date & Time: Sunday, June 5 at 9 a.m. CDT
Oral Abstract Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Presenting Author: M. McNamara
Servier will be hosting a continuing medical educational program at ASCO (Free ASCO Whitepaper) focused on hematology:

"Advantage with Innovation in AML: Guidance on Developing and Delivering Effective and Highly Personalized Care," administered by PeerView, June 3, 2022
In addition, encore presentations from ASCO (Free ASCO Whitepaper) will be presented at EHA (Free EHA Whitepaper):

Poster #2209: Hematologic improvements with ivosidenib + azacitidine compared to placebo + azacitidine in patients with newly diagnosed acute myeloid leukemia

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: H. Dohner
Poster #2374: Changes in health-related quality of life in patients with newly diagnosed acute myeloid leukemia receiving ivosidenib + azacitidine or placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: A. Schuh
Poster #2356: Molecular characterization of clinical response in newly diagnosed acute myeloid leukemia patients treated with ivosidenib + azacitidine compared to placebo + azacitidine

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: S. de Botton
Poster #P765: Updated enrollment and results from the phase 1 substudy of ivosidenib in patients with IDH1-mutant relapsed/refractory myelodysplastic syndrome (R/R MDS)

Date & Time: Friday, June 10 at 4:30 p.m. CET
Presenting Author: C. DiNardo

On June 1, 2022 Jubilant Therapeutics Inc. a clinical stage precision therapeutics Company advancing small molecule therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported data to be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Jubilant Therapeutics, JUN 1, 2022, View Source [SID1234615394]). The data report on the pharmacokinetic and in vitro and in vivo anti-cancer properties of JBI-2174, the Company’s lead oral, brain penetrant PD-L1 inhibitor, which is in IND-enabling studies for the treatment for solid tumors. The poster will be presented by Luca Rastelli, Ph.D., Company’s Chief Scientific Officer, during the Developmental Therapeutics — Immunotherapy session at 8:00 a.m. CDT on June 05, 2022. The abstract is available here.

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"Checkpoint inhibitors, such as anti-PD-1 and anti-PDL1 antibodies, have revolutionized cancer treatment by enabling the immune system to attack tumor cells," said Luca Rastelli. "However, these antibodies have poor brain penetrance and shown limited efficacy in brain cancers. Employing our structure-based drug design and computational algorithms, we have designed oral small molecule checkpoint inhibitors that address this limitation. We are focused on completing our IND-enabling studies and hope to initiate shortly the clinical trials with JBI-2174 in patients with specific brain tumors." he further added.

The potency, pharmacokinetics and in vivo activity of rationally designed small molecule inhibitors of PD-L1 were evaluated. The Company’s lead anti-PD-L1 candidate, JBI-2174, demonstrated strong affinity for PD-L1 with an IC50 of approximately 1 nM. In selectivity assays for immune-oncology targets, JBI-2174 was highly selective for PD-L1 and also inhibited PD-L1/PD-1 mediated signaling essential for T-cell modulation. In multiple animal models where tumor cells were injected in the brain, JBI-2174 demonstrated sustained brain exposure, efficacy equivalent to an anti-PD-L1 antibody and increased survival compared to control. The results suggest an orally administered brain penetrant small molecule PD-L1 inhibitor could achieve efficacy in brain tumors that do not usually respond to immune-checkpoint antibodies

On June 1, 2022 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology drug development company, reported the successful completion of the first stage of a Simon 2 stage Phase 2a clinical trial of naptumomab estafenatox (NAP), in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs) (Press release, NeoTX, JUN 1, 2022, View Source [SID1234615393]). The patients were treated with NAP (10 μg/kg/day x 4, days 1-4) and with docetaxel 75mg/m2, on day 5. The first stage of this trial required a minimum of two responses out of ten patients and the second stage is now enrolling.

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"These early observations are encouraging as patients with advanced disease previously treated with chemotherapy and checkpoint inhibitors have limited treatment options and new alternatives are needed. In addition, this clinical milestone occurs just as the acquisition of InterX has been recently completed, adding a computer-aided drug discovery arm (CADD) to the pre-clinical and clinical capabilities of NeoTX. So, this has been a crucial time for us" said Asher Nathan, CEO of NeoTX. "NeoTX’s drug discovery capabilities are strengthened by a world-class team that includes three Nobel Laureates. InterX technologies have the potential to significantly increase the speed of drug discovery. InterX also provided a pipeline that includes an oral PD-L1 inhibitor, which aligns with our current development plan of investigating NAP in combination with CPIs in various indications."