On May 3, 2021, Oncotelic Therapeutics, Inc. (the "Company") reported that entered into an Equity Purchase Agreement (the "Agreement") and Registration Rights Agreement (the "Registration Rights Agreement") with Peak One Opportunity Fund, L.P. ("Peak One"), pursuant to which the Company shall have the right, but not the obligation, to direct Peak One, to purchase up to $10.0 million (the "Maximum Commitment Amount") in shares of the Company’s common stock, par value $0.01 per share ("Common Stock") in multiple tranches (Filing, 8-K, Mateon Therapeutics, MAY 3, 2021, View Source [SID1234579460]). Further, under the Agreement and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit Put Notices (as defined in the Agreement) to Peak One (i) in a minimum amount not less than $20,000.00 and (ii) in a maximum amount up to the lesser of (a) $1.0 million or (b) 250% of the Average Daily Trading Value (as defined in the Agreement).

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In exchange for Peak One entering into the Agreement, the Company agreed, among other things, to (A) issue Peak One and Peak One Investments, LLC, an aggregate of 250,000 shares of Common Stock (the "the Commitment Shares"), and (B) file a registration statement registering the Common Stock issued as Commitment Shares or issuable to Peak One under the Agreement for resale (the "Registration Statement") with the Securities and Exchange Commission within 60 calendar days of the Agreement, as more specifically set forth in the Registration Rights Agreement.

The obligation of Peak One to purchase the Company’s Common Stock shall begin on the date of the Agreement, and ending on the earlier of (i) the date on which Peak One shall have purchased Common Stock pursuant to this Agreement equal to the Maximum Commitment Amount, (ii) twenty four (24) months after the initial effectiveness of the Registration Statement , (iii) written notice of termination by the Company to Peak One (subject to certain restrictions set forth in the Agreement), (iv) the Registration Statement is no longer effective after the initial effective date of the Registration Statement, or (v) the date that the Company commences a voluntary case or any person commences a proceeding against the Company, a custodian is appointed for the Company or for all or substantially all of its property or the Company makes a general assignment for the benefit of its creditors (the "Commitment Period").

During the Commitment Period, the purchase price to be paid by Peak One for the Common Stock under the Agreement shall be 91% of the Market Price, which is defined as the lesser of the (i) closing bid price of the Common Stock on the trading day immediately preceding the respective Put Date (as defined in the Agreement), or (ii) lowest closing bid price of the Common Stock during the Valuation Period (as defined in the Agreement), in each case as reported by Bloomberg Finance L.P or other reputable source designated by Peak One.

The Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. Among other things, Peak One represented to the Company, that it was an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")), and the Company sold the securities in reliance upon an exemption from registration contained in Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder.

The foregoing descriptions of the Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

On May 3, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that the first patient has been treated in its phase 1/2 dose escalation and expansion trial evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET (Press release, Merus, MAY 3, 2021, View Source [SID1234579118]). EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

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"The initiation of our phase 1/2 trial of MCLA-129 is an important step in our goal to provide meaningful treatments to patients with cancer, including NSCLC," said Dr. Andrew Joe, Chief Medical Officer of Merus. "Despite the successes with targeted therapies, patients will often develop resistance to currently approved treatments. Based on our preclinical data and other data, we are excited to investigate MCLA-129 as a potential new treatment option for patients with lung and other cancers, especially those that do not respond to EGFR inhibitors."

The phase 1/2, open-label clinical trial of MCLA-129 consists of dose escalation followed by dose expansion. Primary objectives of phase 1 are to determine the maximum tolerated dose and/or the recommended phase 2 dose, and the objectives of phase 2 are to evaluate safety, tolerability and potential clinical activity of the recommended phase 2 dose in patients with advanced solid tumors.

More details of the trial can be found at clinicaltrials.gov.

MCLA-129 is the subject of a collaboration agreement between Merus and Betta Pharmaceuticals Co. Ltd. (Betta). In January 2019, Merus and Betta announced this strategic collaboration to develop MCLA-129, where Merus granted Betta an exclusive license to develop and potentially commercialize MCLA-129 in China, with Merus retaining all rights outside of China. In January 2021, Betta announced that the Chinese National Medical Product Administration accepted its Investigational New Drug application of MCLA-129 injection.

About MCLA-129
MCLA-129 is an antibody-dependent cellular cytotoxicity-enhanced Biclonics that is designed to inhibit the EGFR and c-MET signaling pathways in solid tumors. Preclinical data have shown that MCLA-129 can effectively treat TKI-resistant NSCLC in xenograft models of cancer. MCLA-129 is designed to have two complementary mechanisms of action: blocking growth and survival pathways to stop tumor expansion and recruitment and enhancement of immune effector cells to eliminate the tumor.

On May 3, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that it has executed a definitive agreement with New Life Therapeutics Pte. Ltd. (NLT ) of Singapore for the license of low-dose Interleukin 6, or IL-6, for the treatment of Diabetic Peripheral Neuropathy (DPN) (Press release, Sonnet BioTherapeutics, MAY 3, 2021, View Source [SID1234579084]). The licensed territory includes the ASEAN countries of Singapore, Malaysia, Indonesia, Thailand, The Philippines, Cambodia, Brunei, Vietnam, Myanmar and Lao PDR.

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Under the terms of the agreement, Sonnet is entitled to an upfront payment of $1.0 Million from NLT (including the $500,000 previously paid during 2020). Sonnet is also eligible to receive potential additional amounts up to a maximum of $20.0 Million, in the aggregate, in regulatory and commercial milestone payments, and tiered royalties ranging from 12% to 30% on net sales. NLT will be responsible for conducting a Phase 1b/2a pilot-scale efficacy study with low-dose IL-6 in DPN, to include the ASEAN region, expected to commence during the second half of 2021. Sonnet will continue to be the manufacturer of low-dose IL-6 for clinical development and commercial purposes. NLT has an option to negotiate a license for commercial rights in Chemotherapy-Induced Peripheral Neuropathy. NLT also has an option to negotiate a license for expanding the exclusive territory to include China and India.

Pankaj Mohan, Ph.D., Founder and CEO of Sonnet commented, "We are excited about the opportunity to partner with NLT to advance our diabetic peripheral neuropathy program. The agreement affords Sonnet reach into territories with compelling commercial market dynamics, and also removes some of the development burden from the Company. Most importantly, this is one step closer to a new treatment to benefit patients suffering from diabetic peripheral neuropathy."

"We founded NLT to address the critical unmet medical needs in treating neuropathies across the ASEAN region, said Rakesh Aggarwal, CEO of NLT. "With the explosion of diabetes in this part of the world, we are looking forward to the opportunity to advance low-dose IL-6, which has the potential to help diabetic patients recover from the debilitating effects of peripheral diabetic neuropathies, subject to successful clinical trials and regulatory approval in the territory. This is an important first step as we join forces with Singapore and other ASEAN countries to fight the war on diabetes."

Data from various animal models of neuropathy have demonstrated the potential of low-dose IL-6 as a disease modifier. In proof-of-concept studies, treatment with low dose IL-6 displayed neurorestorative properties, including nerve regrowth, reinstatement of physiological nerve conductance and restoration of nerve fiber density, which consequentially reduced pain and aberrant sensations in animals suffering from neuropathy. In addition, safety monitoring of previous clinical trials in thrombocytopenia that had enrolled more than 200 cancer patients undergoing chemotherapy concluded that low-dose IL-6 was generally safe and well tolerated.

Gael Hedou, Ph.D., COO of Sonnet BioTherapeutics C.H. S.A. and one of the early developers of low-dose IL6 stated, "I have worked on the IL-6 program for the treatment of neuropathies for several years, and this partnership with NLT is an exciting step toward potentially bringing this critically needed treatment to patients and to demonstrate the therapeutic potential of low-dose IL-6." Dr. Hedou further commented, "We believe the low levels of IL-6 that are naturally released by the muscles upon exercise are a key mediator of nerve health. The ability to release IL-6 is often hindered in diabetic patients and, furthermore, the intensity of exercise needed to release therapeutic levels of IL-6 is not generally possible in the daily routine of these patients. Low-dose IL-6 intermittently administered to DPN patients reaching physiologically active levels has the potential to alleviate a patient’s symptoms by regrowing nerves and ultimately by normalizing sensations that are affected by neuropathic disease."

On May 3, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported that members of the management team will participate in the following upcoming investor conferences (Press release, bluebird bio, MAY 3, 2021, View Source [SID1234579032]):

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BofA Securities 2021 Health Care Conference, Thursday, May 13, at 9:30 am ET
2021 RBC Capital Markets Global Healthcare Conference, Wednesday, May 19, at 1:55 pm ET
To access the live webcast of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcasts will be available on the bluebird bio website for 90 days following the event.

On May 3, 2021 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTC: BVAXF) ("BioVaxys" or "Company") reported that it has signed the definitive exclusive bioproduction agreement ("Agreement") with BioElpida S.A.S. ("BioElpida") of Lyon, France, to begin the clinical-grade bioproduction and aseptic packaging for BXV-0918A, BioVaxys’ vaccine candidate for Stage III/Stage IV ovarian cancer (Press release, BioVaxys Technology, MAY 3, 2021, View Source [SID1234579031]). BioVaxys and BioElpida executed a Term Sheet in February outlining the commercial relationship, with todays definitive Agreement focusing on the GMP facility build-out in Lyon, and technical aspects of the bioproduction protocol such as process design and validation, quality control and quality assurance steps, batch test runs, stability testing, and aseptic fill. BioVaxys expects to be able to prepare its regulatory submission for a EU Phase I study of BVX-0918A in Stage III/Stage IV ovarian cancer near the end of this year, with vaccine supply for the planned clinical study available early May 2022.

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BioElpida is a biotechnology contract development and manufacturing company ("CDMO") which applies single-use bioprocessing for development and manufacturing of biological and cell-based products. BioElpida’s expertise extends from R&D to pharmaceutical manufacturing and release of clinical batches, and intermediate steps such as process development, feasibility studies, analytical method validation, as well as aseptic fill & finish and other bioproduction services. BioElpida’s facility is certified for clinical bioproduction by France’s National Security Agency of Medicines and Health Products (ANSM).

"Early on we made the decision to seek a bioproduction partner with the ability to quickly move from smaller-yield GMP-grade clinical study supplies to large-scale manufacturing if our clinical trials prove successful and EU regulatory approval is granted," said Kenneth Kovan, Co-Founder, President and Chief Operating Officer of BioVaxys. "BioElpida’s technical experience and previous work on early generations of our cancer vaccine platform will be a significant advantage in our efforts to provide hope to those suffering from advanced ovarian cancer."

BioVaxys is collaborating on the ovarian cancer vaccine clinical program with Spanish biopharma company ProCare Health Iberia S.A.S., which plans to submit a Clinical Trial Application ("CTA") for BVX-0918A to the European Medicines Agency ("EMEA") later this year for a compassionate use approval in Stage III & Stage IV ovarian cancer. ProCare Health will have marketing rights to BVX-0918A in the EU and UK, whereas BioVaxys will market its ovarian cancer vaccine in North America and Rest of World.

Globally, there remain significant unmet therapeutic needs for ovarian cancer treatment. Worldwide, over 300,000 women are diagnosed with ovarian cancer each year (World Cancer Research Fund, 2020), with ovarian cancer the leading cause of death from gynecologic malignancy in the United States (American Cancer Society Facts & Figures 2020). An estimated 21,750 new cases of ovarian cancer were expected in the US in 2020 with 13,940 deaths (National Cancer Institute, Surveillance and Epidemiology Program, 2020). The majority of women with Stage III or Stage IV cancer will ultimately have recurrent disease resistant to chemotherapy. Patients who have relapsed after platinum-based chemotherapy have limited life expectancy even with multiple salvage regimens. This large group of non-responders to first line therapy, or those who relapse after first line therapy, are the initial target market for BioVaxys.

The global ovarian cancer drugs market was valued US$1.2B in 2017 and is expected to reach US$4.6B by 2026, at a CAGR of 18.29 % (www.medgadget.com/2020/11/ovarian-cancer-drugs-2020-global-market-to-reach-us-4-6-bn-and-growing-at-cagr-of-18-29-by-2026.html).