On December 19, 2022 iPSirius reported the company got $2M Award from European Innovation Council to Develop a Novel Stem Cell Vaccine to Help Cancer Patients Worldwide (Press release, iPSirius, DEC 16, 2022, https://bioinformant.com/ipsirius/ [SID1234640999]).

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Pivotal to the company bringing these new cancer vaccines to the clinic is the innovative technology that won a very competitive Pathfinder Award from the European Innovation Council. This secured $2M to translate the technology to the clinic. The European Innovation Council gives out the EIC Pathfinder award to "support research teams to develop emerging breakthrough technologies".

"We are very grateful to European Innovation Council for this necessary financial support that will accelerate access of our stem cell vaccine pipeline to the clinic. Our team at iPSirius is eager to develop off-the-shelf, cell-based vaccines that can improve the quality of life for patients with aggressive cancers worldwide. We hope that these new cancer vaccines will be transformative to the field of cancer therapy," said co-Founder and Chief Medical Officer, Prof Ali Turhan.

iPSirius is addressing key challenges in treating non-immunogenic solid tumors, based on the immunogenic properties of stem cells.

More details can be found at the company website, www.iPSirius.com.

On December 16, 2023 Hervolution Therapeutics reported that the company advance its understanding of the potential applications of IPT001 in enhancing oncological immunotherapy, ultimately contributing to the development of more effective treatment strategies for cancer patients (Press release, Hervolution Therapeutics, DEC 16, 2022, View Source [SID1234637207]).

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"Significant progress has been made as Hervolution secures a substantial EU fund to expand its research efforts into utilizing IPT001 within the field of oncological immunotherapy. This funding is part of the Eurostars-3 collaborative project, in conjunction with esteemed partners ORYZON and the University of Copenhagen. The project, boasting a total budget of 1.4 million euros, has allocated up to 300,000 euros to Hervolution. The primary objective of this initiative is to evaluate the effectiveness of IPT001 when combined with checkpoint inhibitors and/or oncological vaccines for the treatment of diverse solid tumors.

December 16th, 2022, marked an important milestone for Danish institution Hervolution as it announced the approval of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) by the EU-intergovernmental organization EUREKA secretariat, under the Eurostars-3 program. Collaborating with ORYZON and the University of Copenhagen, Hervolution is embarking on a comprehensive investigation into the role of IPT001 within various immunotherapy strategies targeting solid tumors. These strategies include leveraging checkpoint inhibitors and oncological vaccines.

The project is set to commence on May 1, 2023, and will be executed over a span of two years.

Dr. Peter Holst, Chief Scientific Officer of Hervolution, highlighted the potential of checkpoint inhibitors and targeted oncological vaccines as viable alternatives for solid tumors that demonstrate poor response to chemotherapy or limited responsiveness. However, the effectiveness of these strategies largely depends on the successful immune presentation of antigens by tumor cells. Certain tumors, known as "cold tumors," manage to evade this requirement. Through the utilization of IPT001, an immunotherapy agent that specifically targets Human Endogenous Retro Virus, researchers anticipate enhanced immune response, opening doors for improved efficacy when combined with these immunotherapy approaches. These approaches has the potential to revolutionize the treatment of a number of cancer types that have not yet benefitted substantially from immunotherapies.

On December 16, 2022, Humanigen, Inc. (the "Company"), and Catalent Pharma Solutions, LLC ("Catalent") reported that it has entered into a Settlement Agreement (the "Settlement Agreement") resolving certain previously reported disputes between the Company and Catalent that had arisen under the Multiple Facility Clinical Supply and Services Agreement (the "MSA") dated July 31, 2020, by and between Catalent and the Company, pursuant to which Catalent had agreed to perform certain services relating to the manufacturing of lenzilumab, the Company’s lead product candidate (Filing, 8-K, Humanigen, DEC 16, 2022, View Source [SID1234625539]).

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Pursuant to the Settlement Agreement, the Company agreed to make a one-time payment of $12 million (the "Settlement Payment") to Catalent in full satisfaction of all of the Company’s payment obligations under the MSA for products and prior services, as well as cancellation fees Catalent claimed to be owed. In consideration of its receipt of the Settlement Payment, which the Company made on December 22, 2022, Catalent waived and released Catalent’s rights to pursue all payments, claims, or invoices for such products and services and cancellation fees, as well as for some limited additional work to be performed by Catalent, quantified at approximately $23.5 million in the aggregate.

The terms and conditions of the MSA generally will remain in full force and effect with respect to any ongoing activities and additional work to be performed by Catalent.

The foregoing description of the material terms of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, to be filed with the Securities and Exchange Commission as an exhibit to the Company’s 2022 Annual Report on Form 10-K.

On December 16, 2022, Midatech Pharma PLC (the "Company") and a certain institutional investor (the "Investor") entered into a first amendment (the "Purchase Agreement Amendment") to the securities purchase agreement (the "Purchase Agreement"), dated as of December 13, 2022, by and between the Company and the Investor (Filing, 6-K, Midatech Pharma, DEC 19, 2022, View Source [SID1234625408]). Pursuant to the Purchase Agreement Amendment, the Company and the Investor agreed (i) to increase the exercise price of the Series A warrants and Series B warrants that are expected to be issued to the Investor at the second closing provided for therein (the "Second Closing") to $1.10; (ii) to change the purchase price of the Company’s American Depositary Shares expected to be issued to the Investor at the Second Closing to the lesser of (x) $1.00 or (y) 20-Day VWAP (as defined in the Purchase Agreement Amendment) minus 10.0%; (iii) that the Company may terminate the Purchase Agreement and the Registration Rights Agreement, dated as of December 13, 2022, by and between the Company and the Investor, if the 20-Day WVAP on the proposed date of the Second Closing is less than $1.00; and (iv) that the Investor shall not execute any short sales of the Company’s securities prior to the occurrence of the Second Closing.

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In addition, on December 18, 2022, the Company and Bioasis Technologies Inc. ("Bioasis") entered into a first amendment (the "Arrangement Agreement Amendment") to the arrangement agreement (the "Arrangement Agreement"), dated as of December 13, 2022, by and between the Company and Bioasis. Pursuant to the Arrangement Agreement Amendment, the Company and Bioasis agreed that (i) the loan to Bioasis shall now be made in three tranches of $250,000 payable on each of December 19, 2022, January 3, 2023 and February 6, 2023 as opposed to one payment of the loan in full; and (ii) provide the Company the sole discretion to seek shareholder consent to the proposed cancellation of the Company’s ordinary shares to trading on AIM, a market of the London Stock Exchange.

The foregoing descriptions of the Purchase Agreement Amendment and Arrangement Agreement Amendment are not complete and are qualified in their entirety by reference to the full text of the form of Purchase Agreement Amendment and the Arrangement Agreement Amendment, which are filed as Exhibits 10.1 and 10.2, respectively, to this Report on Form 6-K and are incorporated by reference herein.

On December 19, 2022, the Company issued a press release announcing the closing of its previously announced registered direct offering and the amendments to the Purchase Agreement and Arrangement Agreement. A copy of such press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.

On December 16, 2022 Zhejiang Daoer Biotechnology Co., Ltd. A clinical-stage biopharmaceutical company developing innovative biotherapeutics, reported that a clinical trial collaboration agreement with Merck & Co. A clinical trial of combination therapy with Merck’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with gastric or gastroesophageal junction cancer (Press release, Doer Biologics, DEC 16, 2022, View Source [SID1234625370]).

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According to the agreement, Daoer Bio will conduct clinical trials based on the clinical protocol agreed and finalized by both parties to evaluate the combination of DR30303 and KEYTRUDA in the treatment of Claudin18.2 positive, locally advanced unresectable or metastatic gastric cancer or gastroesophageal junction cancer (GC/ GEJ) patient safety and efficacy.

Dr. Huang Yanshan, founder and CEO of Doer Bio, said: "DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein developed by Doer Bio based on its proprietary SMART-VHHBody platform ( VHH-Fc). We believe that DR30303 exhibits strong affinity and highly selective binding to Claudin18.2, while enhancing antibody-dependent cellular cytotoxicity (ADCC) activity, and has a low risk of immunogenicity. Its small The molecular weight of DR30303 may allow DR30303 to penetrate into solid tumors faster and deeper. We believe that DR30303 may be a potential best-in-class anti-Claud in 18.2 antibody." Dr. Yong Liang, Chief Operating Officer of Doyle Bio, commented on this DAO: "DR30303 has demonstrated a favorable safety profile in ongoing monotherapy trials and an encouraging anti-tumor signal in patients with Claudin18.2-positive solid tumors. We are very excited to be exploring DR30303 with KEYTRUDA combination therapy for Claudin18.2-positive gastric cancer or gastroesophageal junction cancer (GC/GEJ) patients."

KEYTRUDA is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Lowe, NJ, USA.

About DR30303

DR30303 is a humanized anti-Claudin18.2 single domain antibody Fc fusion protein (VHH-Fc) developed by Doyle Bio based on its proprietary SMART-VHHBody platform. Due to its tumor specificity and abnormally high expression in gastric and pancreatic cancers, Claudin18.2 is an attractive target for cancer therapy. DR30303 showed strong and highly selective binding to the Claudin18.2 target, enhanced antibody-dependent cellular cytotoxicity (ADCC) activity by engineering its Fc, and algorithm-based T cell epitope prediction showed its have a lower risk of immunogenicity. Preclinical studies have shown that DR30303 has shown strong anti-tumor activity and good pharmacokinetics when administered alone or in combination with chemotherapy drugs or PD-1 inhibitors in various mouse tumor models academic characteristics.