On July 30, 2020 NeuBase Therapeutics, Inc. (NASDAQ: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, reported that Dietrich Stephan, Chief Executive Officer of NeuBase, will participate in a virtual fireside chat at the BTIG Virtual Biotechnology Conference 2020, being held on August 10 – 11 (Press release, NeuBase Therapeutics, JUL 30, 2020, View Source [SID1234562564]).

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BTIG Virtual Biotechnology Conference 2020:
Date: Tuesday, August 11th
Time: 9:30 a.m. ET
Location: Webcast Link – or at the company’s website (click here)

On July 30, 2020 Piramal Pharma Solutions a contract development and manufacturing organization (CDMO) and San Francisco-based biotech Bolt Bioterapeutics reported that have signed a production agreement in which Piramal will be handling the manufacturing of Bolt’s Boltbody Immune-Stimulating Antibody Conjugate (ISAC), BDC-1001 (Press release, Bolt Biotherapeutics, JUL 30, 2020, View Source [SID1234562560]).

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Bolt Biotherapeutics’ Platform Technology, exclusively licensed from Stanford University, is applicable to a broad spectrum of antibodies targeting tumor antigens expressed on all types of cancer and consists of Immune-Stimulating Antibody Conjugates (ISAC), a new class of immuno-oncology therapeutics, that harnesses the ability of innate immune stimulants to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells.[1] The promise of Immunological memory. Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) selectively target tumors for destruction by the immune system. Tumor-associated myeloid cells engulf ISAC-bound tumors, become armed with tumor neoantigens, and migrate to the lymph nodes where they mediate the activation and expansion of tumor-reactive T-cells. In preclinical tumor models, ISAC therapy leads to the regression of established tumors and generation of immunological memory, which guards against the recurrence of tumors that express tumor neoantigens even if they no longer express the ISAC target antigen. Image courtesy: © 2020 Bolt Biotherapeutics. Used with permission.

BDC-1001 In preclinical studies, researchers at Bolt demonstrated profound antitumor efficacy for BDC-1001, the company’s lead HER2-targeted ISAC therapeutic program when administered as a monotherapy. Treatment results in activation of the innate immune system that subsequently generates an adaptive immune response leading to complete and durable T-cell mediated clearance of large tumors. These Piramal Pharma Solutions and Bolt Biotherapeutics Sign Production Agreement By ADC Review | Editorial Team-July 29, 2020  preclinical studies also showed that BDC-1001 produces an immunologic memory – the immune system retained the ability to attack tumors even after the Boltbody was no longer present in the body, even protecting against tumors that had lost HER2 expression.[1]

BDC-1001, Bolt’s first Boltbody has entered clinical development and is currently being evaluated a first-in-human phase I/II study in patients with human epidermal growth factor receptor (HER2-) expressing solid tumors.

Agreement
Under the terms of the agreement, Piramal manufactures Bolt’s BDC-1001 ISAC for the ongoing Phase I/II clinical study in cancer patients.

Piramal will apply its integrated drug development model to Bolt’s BDC-1001. The program includes formulation development and ISAC development and manufacturing at Piramal’s Grangemouth, UK site. Following the manufacturing phase, the materials are further processed into lyophilized, sterile fill-finish vials at Piramal’s Lexington, Kentucky (USA) site.

This seamless integration across two of Piramal’s manufacturing facilities, which is expected to shorten delivery timelines and expedites distribution to the clinic, is part of the company’s patientcentric philosophy.

"Bolt’s technology platform has demonstrated significant, positive data in preclinical models, including the development of immunological memory against tumors, and is now in a human clinical trial. The manufacturing of ISACs utilizes essentially the same process as antibody-drug conjugate (ADC) manufacturing, enabling us to capitalize on our deep expertise in this space," said Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions.

"Our ability to produce these novel ISACs and package them for clinical trials in one efficient, integrated process compresses the timeline of the development of Bolt’s drug. We remain committed to our patient-centric approach and are proud to partner with an industry-leader like Bolt to help reduce the burden of disease on patients," he added.

Reliable partner "We’re a leader in ISAC technology, and our partnership with Piramal Pharma Solutions is important to bring our technology to the clinic. Piramal’s experience in the manufacture of commercial ADCs provides Bolt with a reliable partner for the development of BDC-1001," noted Nathan Ihle, Vice President CMC & Quality for Bolt Biotherapeutics.

A spokesperson for Piramal confirmed that the first cycle of trial drugs manufacturing has been successfully completed through Piramal’s integrated program. Additional cycles are in progress, as are further developments that will benefit future indications and new clinical programs.

Both Biotherpeutics was founded by Edgar G. Engleman, M.D., Director, Immunology & Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Programs, Stanford Cancer Institute and Bolt Biotherapeutics founder and board member.

Clinical trials A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors – NCT04278144

Reference
Gingrich J.How the Next Generation Antibody Drug Conjugates Expands Beyond Cytotoxic Payloads for Cancer Therapy. JADC 4.7.2020 [Article] Featured Image: Piramal’s Piramal’s Lexington, Kentuky (USA) site (formerly Coldstream Laboratories) Photo Courtesy: © 2014 – 2020 Piramal Pharma Solutions. Used with permission.

On July 30, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2020 (Press release, MacroGenics, JUL 30, 2020, View Source [SID1234562563]).

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"We are excited about the momentum we have built to date in 2020. We have presented promising initial clinical data at ASCO (Free ASCO Whitepaper) from the MGD013 and MGC018 programs. We have defined a potential registration path for flotetuzumab and we have received FDA clearance to initiate clinical testing of our novel antibody-drug conjugate targeting ADAM9 being co-developed with ImmunoGen. Furthermore, we were able to extend our cash runway into 2023," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In the coming months, we anticipate presentation of clinical data from other investigational product candidates in our pipeline, including MGD019, a PD-1 × CTLA-4 DART molecule, and retifanlimab, an anti-PD-1 antibody. Additionally, the PDUFA goal date for the margetuximab BLA is in December."

Key Highlights from Investigational Product Candidates

MGC018 (B7-H3 antibody-drug conjugate): At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting in May, data were presented from the ongoing Phase 1/2 dose escalation study of MGC018 that suggested manageable safety and preliminary activity in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company expects to commence the enrollment of an expansion cohort of patients with mCRPC as part of the Phase 1/2 study in the third quarter of 2020.

Flotetuzumab (bispecific CD123 × CD3 DART molecule): In May, MacroGenics announced that the trial of flotetuzumab designed to support registration in the U.S. will be a single arm study in up to 200 patients with AML whose disease is refractory to induction treatment (primary induction failure) or has relapsed after a remission of less than six months (early relapse). The trial will be conducted as an expansion of the ongoing Phase 1/2 study. The primary endpoint is a response rate comprised of complete remission (CR) and CR with partial hematological recovery (CRh). The Company plans to submit updated data for presentation at a scientific conference in the fourth quarter of 2020.

Margetuximab (Fc-engineered, anti-HER2 mAb): The Food and Drug Administration (FDA) notified MacroGenics in May that it no longer plans to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020.

In July, The Lancet Oncology published results from a Phase 2 study of margetuximab and pembrolizumab in second-line patients with advanced HER2-positive gastric or gastroesophageal junction cancer. These data formed the basis for conducting the ongoing Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade in front-line patients.
MGD013 (bispecific PD-1 × LAG-3 DART molecule): At the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting, results were presented from dose escalation and select expansion cohorts from the ongoing Phase 1 study of MGD013 in advanced solid tumors as well as the combination of MGD013 and margetuximab in a cohort of patients with advanced HER2-positive tumors. MacroGenics is expanding enrollment of the combination cohort.

MGD019 (bispecific PD-1 × CTLA-4 DART molecule): Data from the Phase 1 dose escalation study of MGD019 are scheduled to be presented during an oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 to be held September 19-21.

IMGC936 (ADAM9 antibody-drug conjugate): In July, MacroGenics received FDA clearance of the Investigational New Drug (IND) application for IMGC936 that is being advanced under a co-development agreement with ImmunoGen, Inc. ADAM9 is a cell surface protein over-expressed in several solid tumor types. ImmunoGen expects to initiate a Phase 1 dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020.

Enoblituzumab (Fc-engineered, anti-B7-H3 mAb): MacroGenics expects to initiate a Phase 2 study of enoblituzumab in combination with retifanlimab as a chemo-free regimen in front-line patients with advanced head and neck cancer in the first quarter of 2021.

Retifanlimab (anti-PD-1 mAb also known as MGA012 or INCMGA0012): Data from POD1UM-201, the ongoing study of retifanlimab monotherapy in patients with Merkel cell carcinoma, are scheduled to be presented during a poster session at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. In addition, data from POD1UM-202, the fully-enrolled, potentially registration-enabling monotherapy study in patients with squamous cell carcinoma of the anal canal, are expected to be presented at a medical congress in the second half of 2020. Retifanlimab was invented by MacroGenics and licensed to Incyte.
Corporate Highlights

Stephen Eck, M.D., Ph.D. joined the senior leadership team at MacroGenics as Senior Vice President, Clinical Development and Chief Medical Officer.
Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2020, were $232.8 million, compared to $215.8 million as of December 31, 2019. During the quarter ended June 30, 2020, $96.5 million in net proceeds were received from the sale of 4,060,482 shares of the Company’s common stock pursuant to its at-the-market (ATM) offering. Subsequent to June 30, 2020, an additional $21.3 million net proceeds were received from the sale of 726,380 shares pursuant to the Company’s ATM offering and $12.0 million was received from Boehringer Ingelheim GmbH under a 2010 license and collaboration agreement.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.3 million for the quarter ended June 30, 2020, compared to $10.6 million for the quarter ended June 30, 2019. This increase was primarily due to $12.0 million recognized from the agreement with Boehringer Ingelheim.

R&D Expenses: Research and development expenses were $57.4 million for the quarter ended June 30, 2020, compared to $51.4 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.

G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended June 30, 2020, compared to $12.1 million for the quarter ended June 30, 2019. This decrease is primarily due to a decrease in consulting costs, with a smaller decrease in travel-related costs due to COVID-19.

Net Loss: Net loss was $46.9 million for the quarter ended June 30, 2020, compared to net loss of $31.8 million for the quarter ended June 30, 2019.

Shares Outstanding: Shares outstanding as of June 30, 2020 were 53,365,003.

Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020, plus the additional proceeds referred to above which were subsequently received, combined with anticipated and potential collaboration payments, should enable it to fund its operations into 2023, assuming the Company’s programs and collaborations advance as currently contemplated.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended June 30, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 3236629.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On July 30, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported that the Company will participate in the William Blair Biotech Focus Conference, a virtual conference, taking place August 4-6 (Press release, Cardiff Oncology, JUL 30, 2020, View Source [SID1234562559]).

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Chief Executive Officer, Dr. Mark Erlander, is scheduled to participate in a fireside chat on Thursday, August 6, at 10:00 a.m. PT / 12:00 p.m. CT / 1:00 p.m. ET.

The fireside chat will take a deeper look into Cardiff Oncology’s investigational drug, onvansertib, an oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, which is currently in clinical trials for three different cancer indications – KRAS-mutated metastatic colorectal cancer, castration-resistant prostate cancer, and acute myeloid leukemia. The discussion will specifically focus on the scientific rationale behind patient selection strategies, synergies with existing treatments, and the data released to date.

A live webcast may be accessed by visiting the Investor Relations events section of the Cardiff Oncology website or by clicking on the link View Source A replay of the webcast will be available shortly after the conclusion of the fireside chat and will be archived on the Company website for 90 days.

On July 30, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) reported that it will report fiscal 2020 third quarter financial results after market close on Thursday, August 6, 2020 (Press release, Applied DNA Sciences, JUL 30, 2020, View Source [SID1234562558]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. EDT that same day. Presentation slides will also be posted to the Investors section of the Company’s website and embedded into the webcast at that time.

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Conference Call and Webcast Information – Live
Date: Thursday, August 6, 2020, at 4:30 p.m. Eastern Daylight Time
Dial in: 844-887-9402; 412-317-6798 (international); Conference ID: 10146786
Hosts: Dr. James A. Hayward, chairman, president, and CEO; Beth Jantzen, chief financial officer
Webcast: View Source

Conference Call and Webcast Information – Replay
A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Dial in: 877-344-7529; 412-317-0088 (international); Conference ID: 10146786
Webcast: View Source
Availability: Telephonic replay: until Thursday, August 13, 2020; webcast replay: 1 year

The webcast will also be archived within the ‘IR Calendar – Events and Presentations’ portion of the ‘Investors’ page to the company’s website.