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.

On January 7, 2021 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, reported that it has been invited to attend the 39th annual JP Morgan Healthcare Conference, scheduled to take place January 10-14, 2021 (Press release, Taiwan Liposome Company, JAN 7, 2021, View Source [SID1234573669]).

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JP Morgan Healthcare Conference has been and is the largest and most information healthcare investment symposium in the industry, with attendance of over 8,000 participants each year. This year, the conference will be conducted entirely virtually over the internet instead of physically taking place at the Westin St. Francis Hotel in San Francisco as per tradition, in an effort to impede the spread of COVID-19.

TLC will be attending the conference for the seventh year in a row at the invitation-only event. Members of TLC’s management team will provide updates on the status of the Company’s innovative product candidates, including TLC599 and TLC590, which are non-opioids with the potential to provide extended relief of osteoarthritis pain and postsurgical pain, respectively.

On January 7, 2021 Alteogen Inc. (KOSDAQ:196170) reported that it has entered into an exclusive license agreement with Intas Pharmaceuticals Ltd. to use ALT-B4, Alteogen’s novel hyaluronidase – derived utilizing the Hybrozyme technology – to develop and commercialize two products (Press release, Alteogen, JAN 7, 2021, View Source [SID1234573668]).

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Under the terms of the agreement, Alteogen has granted worldwide rights, except for a few Asian countries, for Intas to develop two products in combination with ALT-B4. Alteogen will receive an initial payment of USD 6 Million and is also eligible to receive additional milestones upon Intas’ achievement of specified development, regulatory and sales milestones, totaling up to USD 109 Million. In addition, Alteogen will be entitled to receive a tiered royalty ranging from mid-single digit to low double digit on sales of commercialized products. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4 to Intas.

"We are pleased to enter into this agreement with Intas, a fast growing and leading pharmaceutical company," said Dr. Soon Jae Park, Chief Executive Officer of Alteogen, "we look forward to collaborating with Intas in bringing two products to the market for the benefit of patients".

"We are truly excited by this partnership, which brings together the expertise and heritage of Alteogen with Intas’ strong development and manufacturing capabilities as well as extensive commercial reach," said Mr. Binish Chudgar, Vice Chairman of Intas Pharmaceuticals, "this agreement underlines our vision and commitment to increasing access to life-changing medicines that can make a real difference to patient lives."

About ALT-B4

ALT-B4 is Alteogen’s proprietary human recombinant human hyaluronidase enzyme developed utilizing the Hybrozyme technology. ALT-B4 can enable the large volume subcutaneous administration of drugs that are typically administered as an IV injection. ALT-B4 does this by temporarily hydrolyzing hyaluronan in the extracellular matrix.

On January 7, 2021 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to- treat cancers, reported the acceptance of two presentations on clinical data from the ongoing Phase I study of their lead asset UniCAR-T-CD123 in relapsed/refractory acute myeloid leukemia (rrAML) at the 2021 EHA (Free EHA Whitepaper)-EBMT 3rd European CAR T-Cell Meeting, being held from February 4-6 (Press release, GEMoaB, JAN 7, 2021, View Source [SID1234573667]).

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So far, CAR-T cell therapy in AML has been impacted by the lack of antigens differentially expressed on malignant blasts. Targeting CD123, which is also expressed on hematopoietic progenitor cells, with conventional CAR-T products has led to promising response rates but also to long-lasting aplasias, with the frequent need for subsequent allogeneic hematopoietic cell transplantation.

The Phase I data of UniCAR-T-CD123 in rrAML presented at the congress highlight the unique product profile of UniCAR-T-CD123 in heavily pretreated rrAML patients as well as the key features of GEMoaB’s rapidly switchable universal CAR-T platform, UniCAR. The UniCAR platform promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors.

"We are pleased to present important clinical data for UniCAR-T-CD123, the lead asset of our rapidly switchable UniCAR platform, at the 2021 EBMT/EHA European CAR-T meeting", said Professor Gerhard Ehninger, Chief Medical Officer of GEMoaB. "Our data nicely support our UniCAR key platform claims and provide the clinical proof of UniCAR’s rapid switch on/off and re-activation capability, potentially leading to a highly differentiated product for rrAML patients in need for better treatment options."

The clinical data further support the ongoing development of UniCAR in hematological malignancies and solid tumors. A Phase IA dose-finding study of the first UniCAR asset, UniCAR-T-CD123, for the treatment of relapsed/refractory AML, is ongoing. A Phase IA study with UniCAR-T-PSMA directed against CRPC and other PSMA-expressing late-stage solid tumors, has been initiated.

GEMoaB’s presentations at the 3rd EHA (Free EHA Whitepaper)/EBMT European CAR-T Meeting:

(1) Oral Presentation: ID33: Martin Wermke et al., "Proof-of-Concept for Rapidly Switchable Universal CAR-T Platform with UniCAR-T-CD123 in Relapsed/Refractory AML".

(2) Poster Presentation: AS-Cart-2021-00068: Sabrina Kraus et al., "Re-activation of UniCAR-T-Cells with 2nd Cycle of Targeting Module TM123 in a Patient with Relapsed/Refractory AML".

About the UniCAR-T-CD123 Phase IA Study

This first-in-human phase I study is an open-label, non-randomized, dose-finding study designed to evaluate the safety and activity of UniCAR-T-CD123 in up to 16 CD123 positive patients with relapsed/refractory AML. Its purpose is to determine the maximum tolerated dose (MTD) as well as Dose limiting toxicities (DLT) of the combined application of a single dose of UniCAR-T and the continuous infusion of TM123 over 25 days. Application follows post salvage therapy and lymphodepletion. The study also investigates response rates, response duration, persistence of UniCAR-T cells over time as well as the ability to rapidly switch UniCAR-T cells on and off in case of side effects through stopping TM infusion. The study takes place at selected Phase I, Acute Leukemia and CAR-T experienced University centers in Germany. The study is supported by a grant from the German Federal Ministry for Education and Research (project "TurbiCAR"). To learn more about the trial, please visit clinicaltrials.gov.

About UniCAR

GEMoaB is developing a rapidly switchable universal CAR-T platform, UniCAR, to improve the therapeutic window and increase efficacy and safety of CAR-T cell therapies in challenging cancers, including acute leukemias and solid tumors. Conventional CAR-T cells depend on the presence and direct binding of cancer antigens for activation and proliferation. An inherent key feature of the UniCAR platform is a rapidly switchable on/off mechanism (less than 4 hours after interruption of TM supply) enabled by the short pharmacokinetic half-life and fast internalization of soluble adaptors termed TMs. These TMs provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T) and consist of a highly flexible antigen binding moiety, linked to a small peptide motif recognized by UniCAR-T.

On January 7, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, CEO of CNS Pharmaceuticals, will present at the virtual H.C. Wainwright BioConnect 2021 Conference being held January 11-14, 2021 (Press release, CNS Pharmaceuticals, JAN 7, 2021, View Source [SID1234573666]).

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H.C. Wainwright BioConnect 2021 Conference:

Date: Monday, January 11th, 2021
Time: 6:00 AM ET
Link: View Source

The webcast will be available on demand starting Monday, January 11th, 2021 at 6:00 AM ET. Replays of the presentation will be available on the Company’s website for 90 days following the event.