On January 7, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has enrolled and safely dosed the last patient for stage 2 of Part C of its TACTI-002 Phase II study (Press release, Immutep, JAN 7, 2021, View Source [SID1234573696]).

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This completes recruitment for Part C of the trial which evaluates 2nd line HNSCC patients being treated with Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in combination with MSD’s KEYTRUDA (pembrolizumab).

Immutep reported encouraging interim data from TACTI-002 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary 2020 Annual Meeting on 10 November 2020. The data from 2nd line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this indication.

Also the recruitment of an additional 74 patients with 1st line NSCLC in accordance with the TACTI-002 collaboration trial expansion plans announced on November 19th, 2020, has commenced with now 4 patients newly recruited, adding to the 36 patients already enrolled prior to the expansion. In total 40 of 110 patients with 1st line NSCLC have now been recruited in Part A of TACTI-002.

The Company expects to report more data from TACTI-002 in the first half of CY 2021.

About the TACTI-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 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).

On January 7, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported that it has entered into a definitive purchase agreement with certain institutional accredited investors to purchase in a registered direct offering 19,550,562 shares of its common stock at a purchase price of $0.445 per share (Press release, Onconova, JAN 7, 2021, View Source [SID1234573673]).

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Participating investors include Lincoln Park Capital, and Sio Capital.

The gross proceeds to Onconova from this offering are expected to be $8.7 million. The offering is expected to close on or about January 11, 2021, subject to the satisfaction of customary closing conditions.

Onconova anticipates using the net proceeds from the offering for working capital and general corporate purposes.

The securities are being offered by Onconova pursuant to a "shelf" registration statement on Form S-3 that was filed and declared effective by the Securities and Exchange Commission ("SEC") and the base prospectus contained therein (File No. 333-237844). The offering of the securities will be made only by means of a prospectus. A prospectus supplement and accompanying base prospectus relating to the securities being offered will be filed with the SEC. Copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Onconova Therapeutics, Inc., Inc., 375 Pheasant Run Newtown, PA 18940, Attention: Avi Oler, by phone at 267-759-3680 or email at [email protected].

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation or sale is unlawful. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.

On January 7, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 9:10 a.m. ET (6:10 a.m. PT) (Press release, Vertex Pharmaceuticals, JAN 7, 2021, View Source [SID1234573672]).

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The audio portion of management’s remarks can be accessed live through Vertex’s website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On January 7, 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported that Rami Levin, President and Chief Executive Officer of Saniona, will present in the following three upcoming virtual investor conferences (Press release, Saniona, JAN 7, 2021, View Source [SID1234573671]):

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10th Annual LifeSci Partners Corporate Access Event
Date: Thursday, January 7, 2021
Time: 11:30 a.m. Eastern Time
Presentation and 1×1 Meetings
Webcast Link: View Source

Biotech Showcase
Date: Monday, January 11 – Friday, January 15, 2021
Time: On demand
Presentation and 1×1 Meetings
Webcast Link: https://informaconnect.com/biotech-showcase/digital-experience/

BIO CEO and Investor Digital Conference
Date: Tuesday, February 16 – Thursday, February 18, 2021
Time: On demand
Presentation and 1×1 Meetings
Webcast Link: View Source

As available, these events will be made accessible and archived for approximately 90 days on the Saniona website in the Company Presentations section: View Source

On January 7, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported an update on its pipeline and business (Press release, Affimed, JAN 7, 2021, View Source,on%20its%20pipeline%20and%20business. [SID1234573670]). "Affimed ended 2020 with significant momentum across all major programs and a strong balance sheet that provides cash runway into the first half of 2023," commented CEO Adi Hoess. "With three innate cell engagers in clinical development and multiple active collaborations, Affimed is positioned for numerous catalysts in 2021 and beyond."

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Clinical Stage Program Updates
AFM13 (CD30/CD16A ICE)

AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), remains ahead of schedule and Affimed expects to complete the interim data analysis during the first half of 2021.
The first dose cohort of AFM13-104, an investigator sponsored Phase 1 study at The University of Texas MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK cells (cbNK) followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, is ongoing.
AFM24 (EGFR/CD16A ICE)

AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for treatment of patients with EGFR-expressing solid tumors, has completed dose cohort 3 (80 mg per patient) without showing dose limiting side effects and patients are currently being enrolled and treated in dose cohort 4 (160 mg per patient).
Affimed and NKMax America completed a pre-IND meeting with the U.S. Food and Drug Administration in December 2020. The companies plan to submit an IND in the first half of 2021 for a Phase1/2a study to investigate different dose levels of AFM24 in combination with NKMax America’s autologous NK cell product SNK01 in patients with EGFR expressing solid tumors.
Other Business Updates
As of December 31, 2020, Affimed’s preliminary unaudited cash and cash equivalents were approximately €147 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the first half of 2023.