On June 1, 2020 Allogene Therapeutics, Inc. (Nasdaq: ALLO), reported the commencement of an underwritten public offering of $450.0 million of shares of its common stock (Press release, Allogene, JUN 1, 2020, View Source [SID1234560836]). In addition, Allogene expects to grant the underwriters a 30-day option to purchase up to an additional $67.5 million of shares of its common stock offered in the public offering. All of the shares of common stock to be sold in the offering will be sold by Allogene. 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.

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Goldman Sachs & Co. LLC, Jefferies LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering.

The securities described above are being offered by Allogene pursuant to a shelf registration statement (including a prospectus) filed on November 5, 2019 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 June 1, 2020 Cleveland BioLabs, Inc. (NASDAQ:CBLI), reported that it has entered into definitive agreements with several institutional and accredited investors for the issuance and sale of an aggregate of 1,515,878 shares of its common stock, at a purchase price of $2.0945 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Cleveland BioLabs, JUN 1, 2020, View Source [SID1234560792]). Cleveland BioLabs has also agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 757,939 shares of common stock. The closing of the offering is expected to occur on or about June 3, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price equal to $2.033 per share, are exercisable immediately upon issuance and will expire five years from the issuance date.

The gross proceeds from the offering are expected to be approximately $3.175 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering of the shares of common stock will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On June 1, 2020 argenx (Euronext & Nasdaq: ARGX) a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the closing of its global offering of an aggregate of 4,600,000 ordinary shares (including in the form of American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 600,000 additional ADSs (Press release, argenx, JUN 1, 2020, View Source [SID1234560762]). The global offering consisted of (i) a public offering of 2,010,057 ADSs in the United States and certain other countries outside the European Economic Area (EEA) at a price to the public of $121.00 and (ii) a concurrent private placement of 2,589,943 of ordinary shares in the EEA at an offering price of €109.18. The gross proceeds from the global offering were approximately $557 million (approximately €502 million).

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Morgan Stanley, Cowen, BofA Securities and Evercore acted as joint bookrunning managers for the offering. Kempen acted as lead manager for the offering and Wolfe Capital Markets and Advisory acted as co-manager.

The securities were offered pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on November 6, 2019 and a final prospectus supplement relating to the securities was filed with the SEC on November 8, 2019 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the global offering may be obtained for free from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, New York 10014, United States, Attention: Prospectus Department; from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at (888) 474-0200.

In addition, argenx announced today the listing of and the commencement of dealings in its 4,600,000 new ordinary shares (including those underlying the ADSs) on the regulated market of Euronext Brussels, effective today, November 12, 2019.

On June 1, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the presentation of two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Meeting (Press release, ERYtech Pharma, JUN 1, 2020, View Source [SID1234560760]).

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Trial in Progress Poster for the ongoing Phase 3 TRYbeCA1 trial (Abstract # TPS4666)

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients in approximately 100 clinical sites in Europe and the U.S. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab paclitaxel or an irinotecan based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA1 is overall survival (OS). The trial is designed to identify a OS hazard ratio (HR) of 0.72 with close to 90% power. An interim efficacy analysis is planned for when approximately two- thirds of events have occurred. To date, approximately 80% of the patients have been enrolled.

Prof Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital in Paris and co-principal investigator of the study, commented, "Patients with advanced pancreatic cancer need new treatment options, particularly in second line treatments after failure of gemcitabine-Nab-paclitaxel or FOLFIRINOX combinations. The Trial-in-Progress poster demonstrates that we are making excellent progress toward completing enrolment of this important international study and I look forward to the outcome of the planned interim analysis for superiority towards the end of 2020."

ctDNA is prognostic and potentially predictive of eryaspase efficacy in patients with advanced pancreatic adenocarcinoma (Abstract #4617)

Eryaspase is composed of L-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized Phase 2 trial1. Prognostic and predictive value of circulating tumor DNA (ctDNA) investigated in this trial.

The analysis from this prospective randomized trial confirmed that the presence of ctDNA at baseline is a strong prognostic factor, and that the early change of ctDNA correlates with treatment outcome. ctDNA could therefore be a potential predictive biomarker of eryaspase efficacy.

Dr Bachet from Sorbonne Université, UPMC Université, IUC, Paris France commented, " The feasibility of this approach and its potential prognostic value provides a rationale for stratifying patients in future clinical trials. Our results suggest that presence of ctDNA could be a predictive biomarker of eryaspase efficacy which needs to be confirmed from the ongoing phase 3 clinical trial."

"We are excited about this state-of-the art ctDNA analysis. We will continue our endeavour to investigate ctDNA and other biomarker platforms in the ongoing Phase 3 trial to further understand the efficacy of eryaspase in different patient subsets." said Dr. Iman El-Hariry, Chief Medical Officer of ERYTECH Pharma.

1 Hammel P, Fabienne P, Mineur L, et al. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2019;124:91- 101

"We continue to be encouraged by the progress of our Phase 3 trial, despite the unprecedented times due to COVID-19. We are thankful to all our investigators who continued to enroll patients in the study and adhere to our guidelines dealing with potential COVID-19 impact."

Both posters are available to view online at the ASCO (Free ASCO Whitepaper) Virtual meeting website: View Source

About pancreatic cancer

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year there are about 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10% and is currently the fourth most common cause of cancer death in the EU for men and women.

On June 1, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported that new interim data from its ongoing Phase II TACTI-002 study (Press release, Immutep, JUN 1, 2020, View Source [SID1234560749]). This data relates to the cut-off date of 4 May 2020 and shows improving efficacy results. The results were presented as a poster short talk by trial investigator, Dr Enriqueta Felip, of Vall d’Hebron University Hospital in Barcelona, Spain, at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting. The poster presentation from Dr. Felip is available on the company’s website (click here).

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TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or Non-Small Cell Lung Cancer (NSCLC) in first and second line.

Immutep CSO and CMO, Dr Frederic Triebel said: "TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with KEYTRUDA. Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less1."

Trial investigator, Dr. Felip said: "It is encouraging to see that patients continue to receive benefit from the combination treatment. We now expect progression free survival to be more than 9 months for patients with 1st line NSCLC, significantly longer than the 5-6 months delivered by pembrolizumab monotherapy. We are alo seeing deeper responses in both arms with patients responding after a number of months of treatment. The improving data in both HNSCC and NSCLC patients supports the use of efti in combination with pembrolizumab as a promising new therapeutic option for patients."

Stage 1 Part A (1st line NSCLC, N=17):

iORR of 53%, with 9 out of 17 patients reporting a Partial Response (iPR) according to iRECIST.

71% (12/17) of patients with target lesion decrease (tumour shrinkage responses in all PD-L1 subgroups. 4 out of 9 patients with PRs had a Tumour Proportion Score less than 50% (typically less responsive to anti-PD-1 monotherapy such as pembrolizumab)

41% (7/17) of patients were still under treatment at data cut-off, indicating an estimated median PFS more than 9 months

All three PD-L1 subgroups present, indicating the trial is a PD-L1 all comer study

About the TACT-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.

Patients participating in three parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.