On November 4, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported multiple abstracts highlighting its Iomab-B and Actimab-A clinical programs have been accepted for presentation at the 63 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held in person and virtually in Atlanta, Georgia, December 11 – 14, 2021 (Press release, Actinium Pharmaceuticals, NOV 4, 2021, View Source [SID1234594502]).

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"We have made good progress this year in advancing Iomab-B and Actimab-A across our three active clinical trials including completing patient enrollment of the pivotal Phase 3 SIERRA trial for Iomab-B. Specifically, with Iomab-B we look forward to presenting the interim data update from full trial enrollment at ASH (Free ASH Whitepaper) prior to top line results in 2022. We are thrilled to have the opportunity to highlight the differentiated nature of our targeted radiotherapies in improving patient outcomes. We believe Iomab-B’s ability to enable near universal access to bone marrow transplant in patients who do not respond to targeted therapies can lead to a paradigm shift in targeted conditioning via both improved access and outcomes of this potentially curative procedure. Actimab-A has the potential of becoming a backbone therapy for patients with AML by leveraging the unique mechanism of targeted radiotherapy with other treatment modalities such as chemotherapy and targeted therapies which have different mechanisms of action. We have previously shown high rates of minimal residual disease negativity in patients receiving Actimab-A with CLAG-M and the mechanistic synergy of Actimab-A with Bcl-2 targeting Venetoclax. We look forward to show casing the latest data from these combination trials as well at ASH (Free ASH Whitepaper)," said Sandesh Seth, Actinium’s Chairman and CEO.

Iomab-B and Actimab-A ASH (Free ASH Whitepaper) presentation details are as follows:

Clinical Experience in the Randomized Phase 3 SIERRA Trial: Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Active, Relapsed/Refractory AML Patients Not Responding to Targeted Therapies

Session Name: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Poster I
Date: Saturday, December 11, 2021
Presentation Time: 5:30 PM – 7:30 PM
Location: Georgia World Congress Center, Hall B5

Lintuzumab-Ac225 in Combination with CLAG-M Yields High MRD (-) Responses in R/R AML with Adverse Features: Interim Results of a Phase I Study

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5

Early Clinical Evaluation of Potential Synergy of Targeted Radiotherapy with Lintuzumab-Ac225 and Venetoclax in Relapsed/Refractory AML

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Date: Monday, December 13, 2021
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Hall B5

On November 4, 2021 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported the first patient has been dosed in its global ACE-Breast-03 Phase 2 clinical study of ARX788 in patients with HER2-positive metastatic breast cancer (Press release, Ambrx, NOV 4, 2021, View Source [SID1234594519]).

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ARX788 is an anti-HER2 antibody drug conjugate (ADC) that is being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumors. The FDA has granted ARX788 Fast-Track Designation for the treatment of HER2-positive metastatic breast cancer in December 2020.

"Dosing the first patient in this Phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer marks an important milestone for Ambrx," said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. "We have made excellent progress with our clinical development pipeline over the last few months, highlighted by our positive data of ARX788 for HER2-positive gastric cancer, as well as the dosing of the first patient in a Phase 1 trial of ARX517 for PSMA expressing tumors. Our growing clinical programs, coupled with an influx of capital from our IPO in June 2021, leaves Ambrx well-positioned to potentially attain several near-term clinical and corporate milestones."

The global ACE-Breast-03 Phase 2 clinical study is a multicenter study to evaluate the efficacy and safety of ARX788 in HER2-positive, metastatic breast cancer patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens. The primary outcome measure of the study will be the objective response rate.

On November 4, 2021 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ending September 30, 2021 (Press release, Transgene, NOV 4, 2021, View Source [SID1234594537]).

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KEY EVENTS OF THE THIRD QUARTER 2021

In July 2021, Transgene announced its participation in PERSIST-SEQ, a new international consortium of academic and industrial leaders in the field of cancer research. This collaborative research program aims to provide the cancer research community with a new gold standard workflow for single-cell sequencing by developing and validating best practices as well as generating and analyzing high-quality data. The project aims to empower the scientific community to unravel drug resistance and develop smarter therapeutic strategies to better treat cancer and prevent resistance. PERSIST-SEQ is a five-year public-private partnership, funded by the Innovative Medicines Initiative (IMI), and led by the Oncode Institute and AstraZeneca.

In September 2021, Transgene presented initial Phase I data providing clinical proof of concept for the intravenous administration of Transgene’s patented oncolytic virus (Invir.IO platform) at the ESMO (Free ESMO Whitepaper) 2021 congress. These data demonstrate that the TG6002 Vaccinia Virus, which is the same viral backbone as the Invir.IO platform, can reach the tumor, replicate within its cancer cells and induce the local production of 5-FU when administered intravenously. These initial data support the feasibility of IV administration and aim to enlarge the number of solid tumors that could be addressed by Transgene’s oncolytic viruses.

UPCOMING MILESTONES EXPECTED
IN THE FOURTH QUARTER 2021

Transgene and BioInvent will present preclinical data on their novel dual mechanism-of-action oncolytic Vaccinia Virus BT-001 (Invir.IO platform) at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2021), which takes place on November 12–14, 2021.

The first data from the two ongoing Phase I clinical trials of the individualized cancer vaccine TG4050 (myvac platform) will be communicated in the second half of November 2021. Transgene expects to communicate safety and immunogenicity (T-cell induction) data.

OPERATING INCOME

During the first nine months of 2021, operating income amounted to €6.8 million compared to €7.8 million in the same period in 2020.

Revenue from collaborative and licensing agreements amounted to €1.6 million in the first nine months of 2021, compared with €2.7 million in the same period in 2020. These revenues are mainly derived from Transgene’s collaboration agreement with AstraZeneca on the Invir.IO program, whose recognized income represents €1.5 million as of September 30, 2021. This amount corresponds to €1.0 million recognized out of the initial payment of €8.9 million ($10 million) received in 2019 for the activity carried out over the period; the remaining corresponds to the payment of contract-defined milestones.
During the first nine months of 2021 government financing for research expenditures, mainly in the form of a research tax credit, amounted to €4.9 million, compared to €4.5 million for the same period in 2020.

CASH, CASH EQUIVALENTS
AND OTHER FINANCIAL ASSETS

Cash, cash equivalents and other financial assets stood at €40.9 million as of September 30, 2021, compared to €26.3 million as of December 31, 2020. In the first nine months of 2021, Transgene’s cash burn amounted to €18.7 million (excluding the net proceeds of €33.3 million from a private placement conducted in June 2021) compared to a positive €2.0 million for the same period in 2020 (including the receipt of a net amount of €18.2 million in July 2020, following the first partial sale of Transgene’s stake in Tasly BioPharmaceuticals).

In October 2021, the Company’s cash position was improved when it received €17.4 million following the second partial sale of Tasly BioPharmaceuticals shares signed in September 2021. Transgene still owns shares of this company, valued €18.2 million based on the price of the current share sale. This sale of Tasly BioPharmaceuticals shares led to the contractual cancellation of the €15 million credit facility with Natixis in October 2021.

Transgene has financial visibility until the end of 2023.

On November 4, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that Maurice Zauderer, Ph.D., President and Chief Executive Officer, is scheduled to present virtually at the 12th Annual Jefferies London Healthcare Conference and invites investors to participate in virtual one-on-one meetings on Thursday and Friday, November 18th and 19th (Press release, Vaccinex, NOV 4, 2021, View Source [SID1234594566]). Please see Presentation details below:

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12th Annual Jefferies London Healthcare Conference
Date: November 18th to 19th, 2021
Time: Virtual presentation available Thursday, November 18 at 8:00am GMT/3:00am ET through Friday, November 19 at 5:00pm GMT / 12:00pm ET
Presenter: Maurice Zauderer, Ph.D., President and Chief Executive Officer
Webcast Link: View Source;group=TbkBHEif
Replay: The presentation and a replay of the webcast will be available on Vaccinex’s website shortly after the event at: View Source
Please contact your Jefferies representative or Vaccinex if you would like to participate in a virtual one-on-one meeting during the conference.

For more information about the Jefferies London Healthcare Conference, please refer to the Jefferies conference website. Vaccinex’s presentation will also be available on the Jefferies website for 30 days after the conference.

On November 4, 2021 Clover Biopharmaceuticals, Ltd. (the "Company"; Stock code: 2197.HK) reported the allotment results of the global offering of the Company (the "Global Offering") (Press release, Clover Biopharmaceuticals, NOV 4, 2021, View Source [SID1234594660]). The Offer Price has been determined at HK$13.38 per Offer Share (exclusive of brokerage of 1.0%, SFC transaction levy of 0.0027% and Stock Exchange trading fee of 0.005%).

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The Hong Kong Offer Shares initially offered under the Hong Kong Public Offering have been over- subscribed. A total of 17,687 valid applications have been received pursuant to the Hong Kong Public Offering through the White Form eIPO service and through the CCASS EIPO service for a total of 66,001,500 Hong Kong Offer Shares, representing approximately 4.40 times of the total number of 15,000,000 Hong Kong Offer Shares initially available for subscription under the Hong Kong Public Offering.

As the number of Offer Shares validly applied for under the Hong Kong Public Offering represents less than 15 times of the number of Offer Shares initially available for subscription under the Hong Kong Public Offering, the reallocation procedures as described in the section headed "Structure of the Global Offering" in the Prospectus has not been effected.

The Offer Shares initially offered under the International Offering have been over-subscribed, representing approximately 3.21 times of the total number of Offer Shares initially available under the International Offering. The final number of Offer Shares under the International Offering is 135,000,000 Offer Shares, representing approximately 90% of the total number of Offer Shares initially available under the Global Offering (before any exercise of the Over-allotment Option). There has been an over-allocation of 22,500,000 Offer Shares in the International Offering and there are a total of 126 placees under the International Offering.

Based on the Offer Price of HK$13.38 per Offer Share, the net proceeds from the Global Offering to be received by the Company, after deduction of the underwriting fees and expenses payable by the Company in connection with the Global Offering, are estimated to be approximately HK$1870.2 million (assuming the Over-allotment Option is not exercised).

Assuming that the Global Offering becomes unconditional in all respects at or before 8:00 a.m. on Friday, November 5, 2021 (Hong Kong time), dealings in the Shares on the Stock Exchange are expected to commence at 9:00 a.m. on Friday, November 5, 2021 (Hong Kong time). The Shares will be traded in board lots of 500 Shares each. The stock code of the Shares is 2197.

Goldman Sachs (Asia) L.L.C. and China International Capital Corporation Hong Kong Securities Limited are the Joint Sponsors. Goldman Sachs (Asia) L.L.C., China International Capital Corporation Hong Kong Securities Limited and Credit Suisse (Hong Kong) Limited are the Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers.