On June 4, 2020 Oragenics, Inc. (NYSE American: OGEN), reported that Alan Joslyn, Ph.D., President and CEO of Oragenics, Inc., will give a virtual corporate presentation at the June 2020 Virtual Summer Investor Summit taking place online from June 9th to 12th, 2020 (Press release, Oragenics, JUN 4, 2020, View Source [SID1234560840]).

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The presentation will be held on Wednesday, June 10, 2020 at 2:10 pm ET, followed by a live Q&A session with registered investors and other conference attendees. A live webcast of the presentation will be available here View Source Dr.. Joslyn will be available for one-on-one meetings online as well. Interested investors may request a meeting time by emailing: [email protected].

On June 1, 2020, Humanigen, Inc. (the "Company") reported that entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors (the "Investors") to complete a private placement (the "Private Placement") of the Company’s common stock, par value $0.001 per share (the "Common Stock") (Filing, 8-K, Humanigen, JUN 1, 2020, View Source [SID1234560838]). The closing of the Private Placement occurred on June 2, 2020 (the "Closing Date"). At the closing, the Company issued and sold 82,528,718 shares of Common Stock (the "Shares") at a purchase price of $0.87 per share, for aggregate gross proceeds of approximately $71.8 million. The purchase price represented a 7% discount from the volume weighted average price of the Common Stock over the prior 20 trading days ending May 29, 2020. Effective upon completion of the Private Placement, the Company has an aggregate of 208,931,973 shares of Common Stock outstanding.

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On the Closing Date, the Company and the Investors also entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to prepare and file a registration statement (the "Resale Registration Statement") for the resale of the Shares with the Securities and Exchange Commission (the "SEC"), within 10 business days of the Closing Date, and use reasonable best efforts to have the Resale Registration Statement declared effective by the SEC at the earliest possible date. Subject to certain limitations and an overall cap, the Company may be required to pay liquidated damages to the investors at a rate of 2% of the invested capital for each instance in which:

·The Company fails to make the initial filing of the Resale Registration Statement by June 16, 2020;
·
The Company fails to cause the Resale Registration Statement to be declared effective prior to the earlier of (i) three business days after the SEC informs the Company that no review of the Resale Registration Statement will be made or that the SEC has no further comments on the Resale Registration Statement (but subject to the last sentence of Section 9.7 of the Purchase Agreement), or (ii) July 2, 2020 (or August 31, 2020 if the Staff has informed the Company that it will be reviewing or monitoring the Resale Registration Statement); or

·The prospectus included in the Resale Registration Statement ceases to be available for use by the investors for more than 30 consecutive days or more than 50 days in any 12-month period.

The Purchase Agreement also provides that the Company will use its commercially reasonable efforts to achieve a listing of the Common Stock on a national securities exchange, subject to certain limitations set forth in the Purchase Agreement. The Company’s ability to obtain approval of the listing of the Common Stock on a national securities exchange will require the Company to satisfy a number of conditions, including the effectiveness of the Resale Registration Statement, the Company’s ability to obtain certain stockholder and third party consents and approvals, and the Company’s ability to meet certain listing criteria including a minimum stock price and total value of public float. Accordingly, the Company may not be able to achieve a listing of the Common Stock on a national securities exchange in any particular time frame or at all.

On June 4, 2020 Cullinan Oncology, LLC reported the closing of a $98.5 million Series B financing, which will be used to support ongoing clinical trials across its small molecule and biologics portfolio (Press release, Cullinan Oncology, JUN 4, 2020, View Source [SID1234560837]). New institutional investors and family offices participated in the financing alongside original commitments from founding investors MPM Capital and F2 Ventures. Following the completion of the fundraising, Tim Anderson of Cowen Healthcare investments (CHI) has joined the Board.

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"This capital infusion positions us well to execute our vision of bringing a diversified portfolio of innovative oncology assets into the clinic," stated Owen Hughes, Cullinan’s CEO. "We are encouraged with the pipeline progress to date and appreciate the confidence of both our existing as well as new investors."

Cullinan Oncology utilizes a portfolio approach to shepherd externally sourced as well as internally developed oncology assets from bench to bedside, focusing primarily on single asset opportunities that can be efficiently developed through the company’s global network of strategic partners. Since the company’s founding in October 2017, Cullinan has progressed a total of 7 assets through in vivo proof-of-concept studies or into human clinical testing, most notably Cullinan Pearl, an orally available tyrosine kinase inhibitor that targets EGFR (Epidermal Growth Factor Receptor) exon 20 mutations.

Concurrent with the financing, Cullinan has hired Jon Wigginton, M.D. as its Chief Medical Officer to lead the clinical development of its small molecule and biologics programs. "We are delighted to have someone of Jon’s caliber and experience join Cullinan at this point time," stated Patrick Baeuerle, Cullinan’s Chief Scientific Officer, Biologics and Co-Founder. "Alongside our existing team, Jon rounds out a distinguished group of senior researchers at Cullinan who have dedicated their careers to developing breakthrough therapeutics for cancer patients."

"I am very excited to be joining the talented team here at Cullinan Oncology," said Dr. Wigginton. "I look forward to serving as the Chief Medical Officer for all of the Cullinan portfolio companies. With such a diversified portfolio, including targeted small molecules, novel, first-in-class immunotherapies, bispecific antibodies and unique multifunctional fusion proteins, I’m hopeful that we will be able to deliver real advances for those living with cancer." In addition to his role at Cullinan Oncology LLC, Dr. Wigginton will serve as an Advisor to MPM Capital, where he will provide input on potential oncology investments and clinical development plans for portfolio companies.

Dr. Wigginton most recently served as the Chief Medical Officer at MacroGenics (NASDAQ:MGNX), where he led the company’s evolution of a fully-integrated, clinical-stage cancer immunotherapy organization. This included the translation of ten new molecules into the clinic, including early phase and/or proof-of-concept studies with bispecific molecules, checkpoint inhibitors, Fc-optimized antibodies and antibody drug conjugates, as well as the design and execution of registration-directed studies. Previously, he served as the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research at Bristol-Myers Squibb (NYSE: BMY). There, he oversaw early clinical development of the BMS Immuno-Oncology portfolio and co-led the BMS International Immuno-Oncology Network (II-ON). These efforts included several studies defining proof-of concept for both anti-PD-1 and anti-PD-L1 antibodies in patients with melanoma, lung cancer and renal cancer, and for the anti-PD-1/anti-CTLA-4 combination in patients with melanoma, work published subsequently in the New England Journal of Medicine. Additional trials from his group established proof-of-concept for anti-PD-1 in patients with hepatocellular carcinoma and Hodgkin’s disease.

During his academic career, Dr. Wigginton served as Head of the Investigational Biologics Section, Center for Cancer Research, NCI, where he led an integrated basic, translational and clinical research effort focused on combination immunotherapy in preclinical models and early clinical studies. He also served previously as president of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Dr. Wigginton received his M.D. and B.S. in Biology, with distinction, from the University of Michigan.

Lastly, Cullinan is very pleased to announce the promotion of Jennifer Michaelson, Ph.D. to Chief Development Officer, Biologics. "Jen is a key contributor to the Cullinan team; her expertise, knowledge and bandwidth are second-to-none," stated Hughes. "We are quite fortunate to have Jen leading the early development of our biologics programs and her promotion is simply a reflection of her importance to the Cullinan team across multiple functions and her many contributions to our emerging pipeline."

Prior to joining Cullinan, Dr. Michaelson served as Senior Director and Executive Program Leader at Jounce Therapeutics, where she led their flagship anti-ICOS antibody program, JTX-2011, from inception into Phase 2 development. An employee since company launch, she built and led multiple disciplines at Jounce, including Tumor Immunology, Pharmacology, and Preclinical Development. Jennifer was also a member of the Leadership Team at Jounce.

Previously, during her 10-year tenure at Biogen, Dr. Michaelson served as project leader for several monoclonal antibody and bispecific antibody programs in both the Oncology and Immunology therapeutic areas. She has also worked as a consultant at Third Rock Ventures for multiple stealth companies.

Dr. Michaelson received her B.A. in Biology from Princeton University and her Ph.D. from the Department of Cell Biology at Albert Einstein College of Medicine and completed a post-doctoral fellowship in Philip Leder’s laboratory in the Department of Genetics at Harvard Medical School.

On June 4, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), reported a recap of a Key Opinion Leader (KOL) call sponsored by Canaccord Genuity and held on June 2, 2020 (Press release, Oncolytics Biotech, JUN 4, 2020, View Source [SID1234560835]). The call focused on recently announced clinical data from Oncolytics’ AWARE-1 study presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Virtual Meeting 2020 and highlighted the ability of pelareorep to induce a pro-inflammatory tumor microenvironment across multiple breast cancer subtypes.

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Featured on the KOL call was Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study.

"I am highly encouraged by the recently announced AWARE-1 data, which demonstrate the potential of pelareorep to address pressing unmet needs in multiple breast cancer subtypes and treatment settings," said Dr. Prat. "Immunosuppressive tumor microenvironments are known to limit the efficacy of checkpoint inhibitor therapies and highlight the need for synergistic co-therapies to promote tumor inflammation. The data presented at the ESMO (Free ESMO Whitepaper) meeting show that pelareorep induces a rapid and persistent immune response and thus has the potential to address this critical need. Importantly, the data also validate T cell clonality as a biomarker of pelareorep response, which may ultimately accelerate pelareorep’s approval by facilitating the efficient design of pivotal studies."

The AWARE-1 study combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq), followed by surgery in early-stage breast cancer patients. Patients are biopsied on day one (followed immediately by treatment), then again on day three, and for a final time three weeks post-treatment (just prior to mastectomy). Biomarker data from the paired patient biopsies are then collected and analyzed. At the time of data presentation at ESMO (Free ESMO Whitepaper) Breast Cancer, 13 patients had been enrolled in AWARE-1, and biopsy data were available on 6 of these.

Clinical findings highlighted during Dr. Prat’s discussion included:
•Intravenous administration of pelareorep led to robust, tumor-specific pelareorep replication.
•Pelareorep systemic administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase two study of pelareorep in metastatic breast cancer patients. Pelareorep-induced responses were both rapid (present three days after treatment) and persistent (remained through day twenty-one).

•Pelareorep-induced increase in tumor PD-L1 expression demonstrates the synergistic potential between pelareorep and checkpoint inhibitor therapies. Many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.
•AWARE-1 data further support T cell clonality as a biomarker of pelareorep response. Peripheral T cell clonality correlated with changes in the tumor microenvironment as well as CelTIL, which is associated with favorable clinical response. These data highlight T cell clonality’s potential as a biomarker of pelareorep response and are consistent with data from a prior clinical study of pelareorep in pancreatic cancer. Use of T cell clonality as a predictive biomarker may facilitate the design of registrational trials and improve chances of trial success across multiple indications.
•Data suggest that pelareorep treatment has multiple therapeutic mechanisms in cancer. These mechanisms include the induction of an adaptive immune response, direct tumor cell killing, and induction of a durable immune memory effect against cancer cells. The multiple mechanisms of pelareorep may expand its clinical opportunity across multiple breast cancer subtypes (e.g. triple negative and HR+/HER2- breast cancer) and treatment settings (e.g. as an anti-PD-L1 co-therapy or neoadjuvant treatment).

Oncolytics would like to thank Dr. Prat for his time and insightful commentary, as well as Canaccord Genuity for hosting the call. A replay of the call can be found on the company website at View Source

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

•Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
•Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
•Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
•Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
•Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive

biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On June 4, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX intravenous (IV) formulation indications in frontline and relapsed / refractory settings (Press release, Halozyme, JUN 4, 2020, View Source [SID1234560834]). The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX, which is given over several hours. Patients currently on IV DARZALEX will have the choice to switch to the SC formulation.

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"We are delighted that the subcutaneous formulation of DARZALEX has been granted marketing authorization in the EU with a broad label so soon after the CHMP positive opinion," said Dr. Helen Torley. "DARZALEX SC has the potential to improve the treatment experience for multiple myeloma patients and physicians in the European Union as patients may benefit from a shorter treatment time when compared with a multi-hour intravenous infusion."

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which evaluated SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.