On March 10, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the year ended December 31, 2020 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 10, 2021, View Source [SID1234576413]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Throughout 2020, we made significant progress advancing our DNAbilize platform technology in a variety of important indications, bringing us one step closer to bringing this potentially lifesaving therapy to patients with limited treatment options," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We are particularly proud to have made these advances amidst the backdrop of the global pandemic, knowing that cancer continues to be a leading killer with an ongoing great need for new therapies."

"We recently strengthened our intellectual property portfolio and our balance sheet, giving us the patent protection and financial underpinning to support these clinical programs through to a number of value-creating inflection points," continued Mr. Nielsen.

Recent Corporate Highlights

Raised $13.0 Million in Public Offering. In February, Bio-Path announced the closing of a public offering for the offering of 1,710,600 shares of common stock at a price to the public of $7.60 per share, for aggregate gross proceeds to the Company of approximately $13.0 million, before deducting the fees and estimated offering expenses payable by the Company.

Received Third U.S. Patent Grant Related to Manufacture of Platform Technology. In February, Bio-Path announced that the United States Patent and Trademark Office granted U.S. Patent No. 10,898,506 titled, "P-ethoxy nucleic acids for liposomal formulation." The new patent builds on earlier patents granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug.

Announced First Patient Dosed in Phase 1 Clinical Trial of BP1002. In November, Bio-Path announced the enrollment and dosing of the first patient in a Phase 1 clinical trial evaluating the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients.
Financial Results for the Year Ended December 31, 2020

The Company reported a net loss of $10.9 million, or $2.83 per share, for the year ended December 31, 2020, compared to a net loss of $8.6 million, or $3.24 per share, for the year ended December 31, 2019.

Research and development expenses for the year ended December 31, 2020 increased to $6.6 million, compared to $4.6 million for the year ended December 31, 2019, primarily due to increased enrollment for our Phase 2 clinical trial of prexigebersen in AML, startup costs related to our Phase 1 clinical trials for BP1002 in lymphoma and prexigebersen-A in solid tumors, increased preclinical expenses for BP1003 and increased drug material manufacturing activities.

General and administrative expense for the year ended December 31, 2020 increased to $4.3 million, compared to $4.1 million for the year ended December 31, 2019, primarily due to increased franchise tax expense.

As of December 31, 2020, the Company had cash of $13.8 million, compared to $20.4 million at December 31, 2019. Net cash used in operating activities for the year ended December 31, 2020 was $11.0 million compared to $8.4 million for the comparable period in 2019. Net cash provided by financing activities for the year ended December 31, 2020 was $4.3 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full-year 2020 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 6296959. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On March 10, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s fourth quarter 2020 financial results will be released on Tuesday, March 16, 2021 (Press release, Calithera Biosciences, MAR 10, 2021, View Source [SID1234576412]). Company management will host a conference call on Tuesday, March 16, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 6250035. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On March 10, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas K. Equels, AIM’s Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M Vest LLC and Maxim Group LLC (Press release, AIM ImmunoTech, MAR 10, 2021, View Source [SID1234576411]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference will take place March 17-19, from 9:00 am to 5:00 pm ET, and feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers, both domestically and internationally.

During this virtual conference, AIM ImmunoTech will present along with many other important voices in the health care industry. To attend and access exclusive content, sign up to become an M-Vest member HERE and stay tuned for more updates. The presentation will be available on the investor relations section of AIM’s website at View Source

On March 10, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported its decision to continue enrollment in the REDIRECT trial, which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (Press release, Affimed, MAR 10, 2021, View Source [SID1234576410]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The decision to continue the trial followed a preplanned interim futility analysis. The interim analysis was triggered following enrollment of 20 patients in both Cohort A (³10% CD30) and Cohort B (>1% to <10% CD30). The futility boundary was derived from response rates for previous therapies that have received accelerated approval in relapsed or refractory (R/R) PTCL. The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The safety analysis was consistent with previously reported data from Affimed’s Phase 1 trials of AFM13, with infusion related reactions (IRRs) representing the main side effect. Following the introduction of mandatory premedication, IRRs were markedly reduced, resulting in fewer dose reductions and a trend towards better activity.

"We are very encouraged by the observed activity of AFM13 in this heavily pretreated patient population, where more than half of the patients had three or more lines of previous therapy. These data reinforce our strategy to broadly develop AFM13 across CD30-positive lymphomas both as monotherapy and in combination with other therapies," said Dr. Andreas Harstrick, Affimed’s Chief Medical Officer. "Having successfully met the criteria for continuation, the trial will move forward by merging the CD30 high- and low-expressing PTCL cohorts for evaluation of the safety and efficacy of AFM13."

"We are excited by this progress and by AFM13’s potential as monotherapy for patients with PTCL," said Dr. Won Seog Kim, Principal Investigator of REDIRECT and Professor of Hematology and Oncology at the Samsung Medical Center, Sungkyunkwan University, Seoul, Korea. "PTCL is an aggressive and challenging cancer to treat in patients who relapse or do not respond favorably to current therapies, which often have high toxicity profiles, and new therapeutic approaches are needed."

AFM13 is also being evaluated in combination with cord-blood derived natural killer cells in CD30-positive lymphomas at MD Anderson Cancer Center (MDACC). Initial data from this investigator sponsored study will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021.

Investor Conference Call and Webcast Details Affimed will host an investor conference call and webcast today, Wednesday, March 10, at 8:30 a.m. EST, to review the REDIRECT study interim analysis. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 6065008 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

About AFM13-202 and the REDIRECT Trial Design

REDIRECT (also known as AFM13-202, NCT04101331) is a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with R/R CD30-positive PTCL and Transformed Mycosis Fungoides (TMF).

The study enrolls patients who suffer from CD30 expressing PTCL or TMF and who have relapsed after an earlier standard of care treatment or have refractory disease. Dependent on their disease type and the magnitude of CD30 expression on their tumor cells, study participants are assigned to one of three study cohorts, each cohort receiving the same treatment of weekly AFM13 infusions (a 200mg dose per infusion). The three cohorts are comprised of Cohort A, which includes PTCL patients with ³10% CD30 expression on tumor cells; Cohort B, which includes PTCL patients with >1% to< 10% CD30 expression on tumor cells; and, Cohort C, currently on hold, which includes TMF patients with ³1% CD30 expression on tumor cells.

The main goal of the study is to assess the efficacy of AFM13 treatment as judged by the rate of objective responses. Further goals of the study are to assess the safety of AFM13 treatment, the immunogenicity of AFM13 (as measured by the formation of anti-AFM13 antibodies) and the concentration of AFM13 in the blood.

The study began recruitment in October 2019 at sites in the United States, Australia, South Korea and seven European countries. The TMF arm of the study (Cohort C), which is exploratory only and not relevant to the potential consideration for accelerated approval, will remain paused, due to COVID-19 and the high number of assessments and site visits necessary for this group of patients. To date, no TMF patients have been recruited into the study.

On March 10, 2021 Genmab A/S (Nasdaq: GMAB) reported that two posters evaluating investigational medicines created using Genmab’s DuoBody technology will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place virtually April 10-15 and May 17-21 (Press release, Genmab, MAR 10, 2021, View Source [SID1234576409]). The posters summarize data from a preclinical evaluation of the investigational medicine, epcoritamab (DuoBody-CD3xCD20) in combination with standard of care therapies for the treatment of B-cell lymphomas, and a preclinical mechanism of action evaluation of GEN1042 (DuoBody-CD40x4-1BB). The abstracts have been published on the AACR (Free AACR Whitepaper) website and may be accessed via the Online Meeting Planner. All e-poster presentations will be made available on the on-demand Virtual Congress platform on www.aacr.org. Epcoritamab is being co-developed by Genmab and AbbVie. GEN1042 is being co-developed by Genmab and BioNTech.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to present data showcasing the progress we are making with key investigational medicines in our product pipeline utilizing the innovative DuoBody bispecific antibody platform," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Together with our partners, we continue to employ the DuoBody technology platform to effectively create opportunities for innovative antibody drug design and development with the goal of transforming cancer treatment."

Epcoritamab (DuoBody-CD3xCD20):
Preclinical evaluation of epcoritamab combined with standard of care therapies for the treatment of B-cell lymphomas

GEN1042 (DuoBody-CD40x4-1BB):
DuoBody-CD40x4-1BB (GEN1042) induces dendritic-cell maturation and enhances T-cell activation and effector functions in vitro by conditional CD40 and 4-1BB agonist activity

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.1 CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.2,3 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About GEN1042 (DuoBody-CD40x4-1BB)
GEN1042 (DuoBody-CD40x4-1BB) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It is being co-developed under an agreement in which the companies share all costs and future profits for the product on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody format.