1stOncology™: Cancer Intelligence Service – Page 8559 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for Phase 1/1b Clinical Trial of ITK Inhibitor CPI-818 in China

On October 27, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Corvus Pharmaceuticals, OCT 27, 2021, View Source [SID1234592123]).

Schedule your 30 min Free 1stOncology Demo!
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!

Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.

"Our strategy to partner with Angel Pharma to accelerate global development of our products is advancing," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "There is a higher incidence and prevalence of T-cell lymphomas in China, and a significant need for new treatment options. The Angel Pharma team has been efficiently moving the development process forward and has partnered with top lymphoma clinical experts. CPI-818 is the only clinical stage ITK-inhibitor in China, and is positioned to become a potential novel therapy for T-cell lymphoma and more broadly for autoimmune diseases, which we plan to explore over time."

CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As reported in December 2020 at the American Society of Hematology (ASH) (Free ASH Whitepaper), of seven patients with peripheral T cell lymphoma, there has been one complete response lasting over 15 months and one partial response lasting for over five months.

CohBar Announces Proposed Public Offering of Common Stock and Warrants

On October 27, 2021 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported a proposed underwritten public offering of shares of the Company’s common stock and accompanying warrants to purchase common stock (Press release, CohBar, OCT 27, 2021, View Source [SID1234592122]). Each warrant will be exercisable for 5 years from the closing date of the offering. All of the securities to be sold in the offering are being offered by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering, and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-manager.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on August 24, 2020. A preliminary 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. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, 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. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Biomica & Rambam Health Care Campus Sign Agreement for Clinical Trial of Biomica’s Microbiome-Based Immuno-Oncology Drug

On October 27, 2021 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN, TASE: EVGN), and Rambam Health Care Campus reported the signing of a clinical trial agreement (CTA) for initiating a first in-human proof-of-concept (POC) for BMC128, Biomica’s drug candidate (Press release, Evogene, OCT 27, 2021, View Source [SID1234592097]).

The study is titled, "A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of BMC128 in Combination with anti-PD-1 in Patients with Non-small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC)." The study is designed primarily to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti PD-1 agent).

The initiation of this study is pending approval by the Israeli Ministry of Health (MoH).

Dr. Elran Haber, CEO of Biomica, stated: "We are very excited to work with one of Israel’s leading healthcare institutions, the Rambam Health Care Campus, and we look forward to initiating our first in-human POC study for BMC128, for the treatment of refractory cancer patients. Based on the compelling preclinical results achieved to-date, we are thrilled to take this next step in advancing BMC128 through the clinical development process. We hope that this important collaboration will be followed by further partnerships with additional leading medical institutions."

Dr. Ruth Perets, Head of Rambam’s Oncology Phase 1 Clinical Trials, stated: "We are thrilled to lead this clinical trial, aiming to target the important issue of ICI resistance. ICIs have revolutionized the field of oncology, providing prolonged survival in many malignancies. However, resistance to ICI eventually occurs in most patients, and evidence suggests that the gut microbiota plays a role in ICI resistance. We are excited to the test the ability of BMC128 to overcome ICI resistance and help provide patients meaningful and long responses to treatment."

As previously reported, treatment with BMC128 in combination with ICI immunotherapy, significantly enhanced anti-tumor activity in various preclinical models. This resulted in an increased response of tumors to anti-PD1, as demonstrated in an improved Objective Response Rate (ORR) and Percent Tumor Growth Inhibition (%TGI). Response to BMC128 was correlated with a desired anti-tumor immunological profile. BMC128 changed the course of response to ICI, leading to stimulation of the immune system which shifted cold-tumors into hot-tumors.

Biomica’s immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA-4 as suggested in scientific literature1,2. Fecal microbial transplantation has been recently reported to increase response in patients resistant to immune-checkpoint therapy3,4. However, the specific microbial entities driving this response are currently unknown.

BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform.

About BMC128:

Developed as a Live Bacterial Product (LBP), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

1 Zitvogel et al. 2018, Science 359 (6382)
2 Thompson J, et al. Microbiome & immunotherapy: Antibiotic use is associated with inferior survival for lung cancer patients receiving PD-1 inhibitors. J Thorac Oncol 12(suppl 2):S1998, 2017
3 Baruch E, et al. 2021. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science, 371 (6529)
4 Davar D, et al. 2021. Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients. Science, 371 (6529)

Valneva Announces Launch of Proposed Global Offering of American Depository Shares and Ordinary Shares

On October 26, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (the "Company"), a specialty vaccine company, reported its intention to issue and sell, subject to market conditions, 5,500,000 of its ordinary shares in a global offering to specified categories of investors comprised of (i) a public offering of its American Depositary Shares ("ADSs"), each representing two ordinary shares, in the United States (the "U.S. Offering") and (ii) a concurrent private placement of its ordinary shares in certain jurisdictions outside of the United States (the "European Private Placement" and together with the U.S. Offering, the "Global Offering") (Press release, Valneva, OCT 26, 2021, View Source [SID1234592082]).

Goldman Sachs, Jefferies, Guggenheim Securities and Bryan, Garnier & Co. are acting as joint bookrunners for the Global Offering.

The Company intends to grant the underwriters for the Global Offering (the "Underwriters") a 30-day option to purchase additional ADSs (each representing two ordinary shares) in an aggregate amount of up to 15% of the total number of ordinary shares (including in the form of ADSs) proposed to be sold in the Global Offering.

All securities to be sold in the Global Offering will be offered by the Company. The ADSs are listed on the Nasdaq Global Select Market under the ticker symbol "VALN," and the Company’s ordinary shares are listed on the regulated market of Euronext in Paris ("Euronext") under the symbol "VLA."

The offering price per ADS in U.S. dollars and the corresponding offering price per ordinary share in euros, as well as the final number of ADSs and ordinary shares sold in the Global Offering, will be determined following a book building process commencing immediately. The price per ordinary share (and corresponding offering price per ADS) will be at least equal to the weighted average price of the Company’s ordinary shares on Euronext over a period, chosen by the Management Board, of between three (3) and ninety (90) consecutive trading days preceding the determination of the offering price, reduced by a maximum discount of 15%, if applicable.

The ADSs and/or ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights and for the benefit of a specified category of persons within the meaning of Article L.225-138 of the French Commercial Code (Code de commerce) and pursuant to the 17th and 18th resolutions of the Company’s annual combined general meeting held on June 23, 2021. Under the authority granted by the shareholders in the 17th resolution, the ordinary shares and ADSs may only be purchased initially by (i) natural persons and legal entities, including companies, trusts or investment funds, organized under French or foreign law, that routinely invest in the pharmaceutical, biotechnological or medical technology sector; and/or (ii) companies, institutions or entities of any type, French or foreign, that do a significant part of their business in the pharmaceutical, cosmetic, chemical or medical devices and/or technologies or research in these sectors. In order to purchase ordinary shares and/or ADSs in the Global Offering, potential investors will be required to execute and provide to the Underwriters an investor letter representing that they satisfy the foregoing investor criteria.

The European Private Placement will be open only to qualified investors as such term is defined in article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017.

The closings of the U.S. Offering and the European Private Placement will occur simultaneously, will be conditioned on each other and are expected to occur on the third trading day after the final pricing and allocation of the Global Offering. The underwriting agreement to be entered into among the Company and the Underwriters will not constitute a performance guarantee (garantie de bonne fin) within the meaning of Article L225-145 of the French Commercial Code.

The Global Offering will commence immediately and the Company plans to announce the result of the Global Offering as soon as practicable after pricing thereof in a subsequent press release. The Company expects to use the net proceeds from the Global Offering, together with its existing cash and cash equivalents, as follows (assuming an exchange rate of €1.00 = $1.1603, the exchange rate on October 25, 2021, as reported by the European Central Bank):

Approximately $50 million to fund further development of its Lyme VLA15 vaccine candidate through completion of Phase 2 clinical trials including handover to Pfizer;
Approximately $60 million to complete development of its chikungunya VLA1553 vaccine candidate through BLA approval;
Approximately $100 million to fund further development of its COVID-19 VLA2001 vaccine candidate through conditional licensure and commercial launch, including capital expenditure into production facilities;
Approximately $20 million to fund advancement of preclinical vaccine candidates towards clinical development; and
The remainder, if any, for working capital and general corporate purposes.

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. The securities sold will not be part of a public offering in France. The registration statement can be accessed by the public on the website of the SEC.

The securities referred to in this press release will be offered in the United States only by means of a prospectus approved by the SEC. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at [email protected].
Application will be made to list the new ordinary shares to be issued pursuant to the Global Offering on the regulated market of Euronext in Paris.

The Global Offering was not subject to a prospectus to be approved by the French financial markets authority (Autorité des marchés financiers – the "AMF"). The Company draws the public’s attention to the risk factors related to the Company and its activities set forth in section 1.5 of the universal registration document of the Company registered with the AMF under number D.21-0286 on April 9, 2021, as completed by the risk factors set forth in the Company’s half year financial report published on August 10, 2021 and the risk factors set forth in section 1.5 of the amendment to the universal registration document of the Company registered with the AMF under number D.21-0286-A01 on October 26, 2021. Copies of the Company’s 2020 universal registration document, as amended, will be available free of charge on the Company’s website (www.valneva.com) and on the AMF’s website (www.amf-france.org).

Lupin Quarter II FY2022 Results

On October 27, 2021 Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter ending September 30, 2021 (Press release, Lupin, OCT 27, 2021, View Source [SID1234592081]). These unaudited results were taken on record by the Board of Directors at a meeting held today.

Income Statement highlights – Q2 FY2022
Gross Profit was INR 23,769 mn compared to INR 27,094 mn in Q1 FY2022, with margin of 59.4%.
Personnel cost was 18.9% of sales at INR 7,586 mn compared to INR 7,837 mn in Q1 FY2022
Manufacturing and other expenses were 28.5% of sales at INR 11,425 mn compared to INR 10,309 mn in Q1 FY2022
Investment in R&D for the quarter was INR 3,300 mn (8.2% of sales)
EBITDA for Q2 FY2022 includes an adverse impact of ~80bps for one-time costs related to US Specialty Restructuring
During the quarter, the company booked a provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups as well as Impairment expense of INR 7,077 mn for Solosec IP
Balance Sheet highlights
Operating working capital was INR 60,526 mn as on September 30, 2021
Capital Expenditure for the quarter was INR 1,451 mn and was INR 2,508mn for H1 FY2022
Net Debt as on September 30, 2021 stands at INR (-)715 mn
Net Debt-Equity for the company as on September 30, 2021 stands at (-)0.01
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said,"Our sustained efforts to drive growth have helped us cross INR 4,000cr sales this quarter. We remain focused on ramping up our revenues in the U.S. while continuing our robust growth in India. With the restructuring in the U.S., we have significantly scaled down the Specialty burn. We remain committed to our journey of margin improvement through sustainable growth and cost optimization, while ensuring the safety of our people and the highest standards of compliance."

Consolidated Financial Results – Q2 FY2022

*Adjusted for NCE Licensing income of INR 3,734 mn in Q1, Gross Margin in Q1 FY2022 would be 60.5% to sales, EBITDA Margin would be 16.0% to sales and PBT Margin would be 9.8% to sales. Further, on an adjusted basis, sales growth in Q2 FY2022 is 3.6% and EBITDA as well as Adjusted PBT Growth is 1.5%

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 62.7% of sales in Q2 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 29.1% of sales in Q2 FY2021.
Includes one-time costs related to US Specialty Restructuring of INR 326 mn
Includes Provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups
Impairment Expense of INR 7,077 mn for impairment of Solosec IP
Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 62.7% of sales in H1 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 28.1% of sales in H1 FY2021.
Includes one-time costs related to US Specialty Restructuring of INR 326 mn
Includes Provision of INR 18,796 mn [including INR 387 mn towards litigation and settlement related expenses] under Glumetza class actions towards business compensation expense based on the agreement to settle the dispute with two plaintiff groups
Impairment Expense of INR 7,077 mn for impairment of Solosec IP
Operational Highlights
North America
Lupin’s North America sales for Q2 FY2022 were INR 14,291 mn, up 7.2% compared to INR 13,330 mn in Q1 FY2022, up 2.2% as compared to INR 13,984 mn in Q2 FY2021; accounting for 36% of Lupin’s global sales.

Q2 FY2022 sales were USD 184 mn compared to USD 172 mn in Q1 FY2022 and USD 180 mn in Q2 FY2021

The Company filed 4 ANDAs in the quarter, received 1 ANDA approval from the U.S. FDA, and launched 3 products in the quarter in the U.S. market. The Company now has 165 products in the U.S. generics market.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and US total market by prescriptions (IQVIA MAT September 2021). Lupin is the market leader in 55 products in the U.S. generics market and amongst the Top 3 in 120 of its marketed products (market share by extended units, IQVIA June 2021)

During the quarter, we scaled down the US Specialty operations and have reduced the burn going forward. We also booked one-time costs of INR 326 mn related to US Specialty business.

India

Lupin’s India formulation sales for Q2 FY2022 were INR 15,435 mn, down 5.7% as compared to INR 16,362 mn in Q1 FY2022, up 15.9% as compared to INR 13,323 mn in Q2 FY2021; accounting for 38% of Lupin’s global sales.

India Region Formulations sales grew by 16.0% in the quarter as compared to Q2 FY2021.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2021).

Growth Markets (LATAM and APAC)

Lupin’s Growth Markets registered sales of INR 3,490 mn for Q2 FY2022, up 4.9% compared to INR 3,328 mn in Q1 FY2022, up 19.6% as compared to INR 2,918 mn in Q2 FY2021; accounting for 9% of Lupin’s global sales.

Lupin’s Brazil sales were BRL 48 mn for Q2 FY2022 compared to BRL 63 mn for Q1 FY2022 and BRL 59 mn for Q2 FY2021.

Lupin’s Mexico sales were MXN 172 mn for Q2 FY2022 compared to MXN 163 mn for Q1 FY2022 and MXN 155 mn for Q2 FY2021.

Lupin’s Philippines sales were PHP 643 mn for Q2 FY2022 compared to PHP 362 mn for Q1 FY2022 and PHP 341 mn for Q2 FY2021.

Lupin’s Australia sales were AUD 18.3 mn for Q2 FY2022 compared to AUD 17.1 mn for Q1 FY2022 and AUD 14.4 mn for Q2 FY2021.

Europe, Middle-East and Africa (EMEA)

Lupin’s EMEA sales for Q2 FY2022 were INR 3,484 mn, up 33.3% compared to INR 2,613 mn in Q1 FY2022, up 6.9% compared to INR 3,259 mn in Q2 FY2021; accounting for 9% of Lupin’s global sales.

Lupin’s South Africa sales for Q2 FY2022 were ZAR 357 mn, compared to ZAR 273 mn in Q1 FY2022 and ZAR 304 mn in Q2 FY2021.

Lupin is the 6th largest player in South Africa in the total generics market (IQVIA August 2021).

Lupin’s Germany sales for Q2 FY2022 were EUR 7.9 mn, compared to EUR 7.4 mn in Q1 FY2022 and EUR 8.1 mn in Q2 FY2021.

Global API

Lupin’s Global API sales for Q2 FY2022 were INR 2,678 mn, up 8.9% compared to INR 2,459 mn in Q1 FY2022, down 28.4% as compared to INR 3,739 mn in Q2 FY2021; accounting for 7% of Lupin’s global sales.

Research and Development

Investment in R&D amounted to INR 3,300 mn (8.2% of sales) for Q2 FY2022 as compared to INR 3,737 mn (8.8% of sales) for Q1 FY2022.

Lupin received approval for 1 ANDA from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 444 as of September 30, 2021, with the company having received 292 approvals to date.

The Company now has 51 First-to-File (FTF) filings including 20 exclusive FTF opportunities. Cumulative U.S. DMF filings stand at 202 as of September 30, 2021.