On December 26, 2020, Myovant Sciences GmbH ("Myovant"), a subsidiary of Myovant Sciences Ltd., reported that it entered into a Collaboration and Licensing Agreement (the "Agreement") with Pfizer Inc., pursuant to which Myovant and Pfizer will collaborate to develop and commercialize relugolix – a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist – in oncology and women’s health indications in the U.S. and Canada (Filing, 8-K, Myovant Sciences, DEC 26, 2020, View Source [SID1234573276]). Pfizer will also receive an option to acquire exclusive commercialization and development rights to relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries (the "Pfizer Territory").

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Under the terms of the Agreement, Myovant and Pfizer will jointly develop and commercialize ORGOVYXTM (relugolix) in advanced prostate cancer and, if approved, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada. Myovant and Pfizer will equally share profits and certain expenses for ORGOVYX and relugolix combination tablet with Myovant recording revenues. Myovant will remain responsible for regulatory interactions and drug supply and will continue to lead clinical development for relugolix combination tablet in the women’s health indications, while development for ORGOVYX will be shared equally among both companies.

Myovant is eligible to receive total potential payments of up to $4.2 billion, including an upfront payment of $650 million, regulatory milestones of $100 million upon each potential U.S. Food and Drug Administration approval for relugolix combination tablet in uterine fibroids and endometriosis, and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and the combined women’s health indications. In addition, if Pfizer exercises its option to acquire exclusive commercialization and development rights to relugolix in oncology in the Pfizer Territory, Myovant will receive an option exercise fee of $50 million and will be entitled to receive double-digit royalties on sales of relugolix. Pfizer will bear 100% of costs incurred in the Pfizer Territory. The term of the Agreement continues until either no products are sold and all development activities have terminated or, in the case Pfizer exercises its option for relugolix in the Pfizer Territory, when its obligation to pay royalties expires, in each case subject to early termination under the terms of the Agreement.

On December 25, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained regulatory approval for its humanized anti-PD-L1 monoclonal antibody, Tecentriq Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] from the Ministry of Health, Labour and Welfare (MHLW) for additional dosing for the treatment of chemotherapy-naïve PD-L1-positive unresectable advanced or recurrent non-small cell lung cancer (NSCLC) (Press release, Chugai, DEC 25, 2020, View Source [SID1234573255]).

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VENTANA OptiView PD-L1 (SP142), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression. Expanded use of VENTANA OptiView PD-L1 (SP142) as a companion diagnostic of Tecentriq was approved on December 15, 2020 to allow physicians to identify patients with PD-L1-positive NSCLC who could benefit from Tecentriq.

"We are very pleased with this additional approval for Tecenctriq monotherapy, which demonstrated a significant prolongation of overall survival in patients with chemotherapy-naïve PD-L1-positive NSCLC," said Dr. Osamu Okuda, Chugai’s President & COO. "Tecentriq is approved for five different therapies in NSCLC, including a monotherapy in patients previously treated with chemotherapy, three combination therapies in chemotherapy-naïve patients, and a newly approved monotherapy. We are committed to making our contribution to patients through these different therapies."

This approval is based on the results from the phase III IMpower110 study. The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy alone in patients with high PD-L1 expression (TC3/IC3-WT) (median OS = 20.2 versus 13.1 months; hazard ratio = 0.595, 95%CI: 0.398 – 0.890; p = 0.0106 [stratified log-rank test]; two-sided significance level: 0.0413). The most common adverse events (≥5%) were fatigue, asthenia, nausea, decreased appetite, hypothyroidism, rash, increased ALT, and diarrhea.

As a leading company in the field of oncology in Japan, Chugai will continue to promote the proper use of Tecentriq so that it can contribute to the treatment of unresectable advanced or recurrent NSCLC as a new therapeutic option.

*Tecentriq is approved in patients with chemotherapy-naïve unresectable advanced or recurrent NSCLC for three combination therapies with other anti-neoplastic drugs, including 1) carboplatin + paclitaxel + bevacizumab, 2) carboplatin or cisplatin + pemetrexed, and 3) carboplatin + paclitaxel (albumin-bound), in addition to a newly approved monotherapy.

Roche’s Tecentriq improves overall survival as a first-line monotherapy in certain people with advanced non-small cell lung cancer (Press release issued by Roche on September 27, 2019)
View Source

Prescribing Information *In case of non-small cell lung cancer. The underlined parts were newly added.

Indications: Unresectable, advanced or recurrent non-small cell lung cancer
Dosage and administration:
For patients with chemotherapy-naïve unresectable advanced or recurrent non-squamous non-small cell lung cancer
The usual adult dosage is 1200 mg of atezolizumab (genetical recombination) in combination with other anti-neoplastic drugs by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
For patients with chemotherapy-naïve PD-L1 positve unresectable advanced or recurrent non-small cell lung cancer
The usual adult dosage is 1200 mg of atezolizumab (genetical recombination) by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
For patients with unresectable advanced or recurrent non-small cell lung cancer previously treated with chemotherapy
The usual adult dosage is 1200 mg of atezolizumab (genetical recombination) by intravenous infusion over 60 minutes once every 3 weeks. If the initial infusion is well tolerated, subsequent infusions can be delivered over 30 minutes.
About non-small cell lung cancer (NSCLC)
In Japan, 125,100 people (84,500 men and 40,600 women; 2018 predicted values) are estimated to be afflicted with lung cancer each year. 77,500 people in Japan (55,100 men and 22,400 women; 2018 predicted values) die as a result of the disease. Lung cancer is the leading cause of cancer death. Lung cancer can be broadly divided into small cell lung cancer and NSCLC according to the tissue type. NSCLC has the largest number of patients, accounting for about 85% of all lung cancer cases.

About approval status of Tecentriq in Japan
Tecentriq was launched in April 2018 with an indication of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC), followed by an approval for the additional dosing for the treatment of untreated unresectable, advanced or recurrent NSCLC in December 2018. In addition, an approval of extensive-stage small cell lung cancer has been obtained in August 2019, an approval of PD-L1 positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer has been obtained in September 2019, and an approval for the additional dosing for the treatment of chemotherapy-naïve unresectable advanced or recurrent non-squamous NSCLC has been obtained in November 2019. In September 2020, Tecentriq was approved for the treatment of unresectable hepatocellular carcinoma.

Trademarks used or mentioned in this release are protected by law.

On December 24, 2020 Foresee pharmaceuticals (TPEx: 6576.TWO) ("Foresee") reported that it has successfully completed an underwritten public offering of 15,000,000 shares of its common stock to the public at a price of NT$88 per share (Press release, Foresee Pharmaceuticals, DEC 24, 2020, View Source [SID1234573254]). The aggregate gross proceeds to Foresee from the offering were approximately US$47 million (NT$1.32 billion).

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The proceeds of the Public Offering will be used for general corporate purposes, which include supporting Foresee’s existing drug research and development programs – such as FP-025, for which a Phase II/III clinical trial IND application was recently submitted to the FDA for the treatment of acute respiratory distress syndrome (ARDS) in COVID-19 patients.

In addition to the progress of FP-025, Foresee’s Camcevi 42 mg, a ready-to-use 6-month depot formulation of leuprolide mesylate, is currently under review process by the FDA and EMA, which will soon be followed by Camcevi 3-month depot; FP-045, an orally bioavailable ALDH2 activator, which previously obtained permission from the FDA to proceed with the clinical study, is planned to enter into a Phase 1/2 dose-finding study in adolescent and pediatric patients with Fanconi anemia.

Previously this year, Foresee has completed a round of private placement financing, raising approximately US$3 million (NT$90 million) by the issuance of 1,200,000 shares of common stock at a price of NT$75.

On December 24, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution using a new class of synthetic medicines, reported its financial results for the fiscal year ended September 30, 2020 (Press release, NeuBase Therapeutics, DEC 24, 2020, View Source [SID1234573253]).

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"Throughout 2020, we successfully executed against our development strategy, most notably with the generation of two very exciting datasets supporting our initial therapeutic pipeline, including our DM1 and Huntington’s disease programs. These initial data are a clear validation of our transformative platform and provide a strong foundation on which to build our IND-enabling studies for both programs," said Dietrich A. Stephan, Ph.D., chief executive officer of NeuBase. "In addition, these data support the broad potential of our PATrOL platform as a viable synthetic approach to genetic medicine. We believe the platform’s unique capabilities, which include increasing, decreasing and changing protein function, have the potential to redefine treatment for a multitude of patients suffering from both common and rare genetic conditions with insufficient or no therapeutic options."

"As we plan for the future, we’ve expanded our team with several key hires in the second half of the year, including the appointments of Drs. Curt Bradshaw and William Mann as chief scientific officer and chief operating officer, respectively. The expanded capabilities across our entire clinical team are expected to be a positive driver of our development activities as we enter the new year, and advance and expand our pipeline. In order to support this larger team, we recently signed a lease for a new headquarters which will offer more space and state-of-the-art lab facilities to support the rapid development of our pipeline. We look forward to providing greater insight into these activities during an investor R&D day expected to take place in the first half of CY2021," continued Dr. Stephan.

Fourth Fiscal Quarter of 2020 and Recent Operating Highlights

Announced positive preclinical in vitro and in vivo data for PATrOL-enabled anti-gene for the treatment of myotonic dystrophy type 1 (DM1), which further validate the potential of the Company’s proprietary platform to develop highly targeted genetic therapies
Appointed Curt Bradshaw, Ph.D., seasoned industry veteran and former chief scientific officer at Arrowhead Pharmaceuticals, as the new chief scientific officer of NeuBase
Further strengthened the management team with the appointment of William Mann, Ph.D., MBA, an experienced executive with a track record that spans the biopharma life cycle, as chief operating officer
Expanded the Company’s Scientific Advisory Board (SAB) with the appointments of Peter Nielsen, Ph.D., inventor of peptide nucleic acid technology, Eriks Rozners, Ph.D., an expert in alternative binding modes of peptide nucleic acids, and Randy Davis, MBA, a leader in biotech development, which complement the SAB’s existing team of renowned experts
Signed a lease for a new headquarters with office and lab space in Pittsburgh that will offer more space to support the Company’s expanding development activities around its rapidly advancing pipeline of PATrOL-enabled therapies
Financial Results for the Fiscal Year Ended September 30, 2020:

At September 30, 2020, the Company had cash and cash equivalents of approximately $32.0 million, compared with cash and cash equivalents of approximately $10.3 million at September 30, 2019. NeuBase estimates its cash and cash equivalents are sufficient to fund the currently planned operating and capital expenditures into the first quarter of CY2022;
For the fiscal year ended September 30, 2020, the Company reported a net loss of approximately $17.4 million, or a net loss of $0.89 per share, compared with a net loss of approximately $26.1 million, or a net loss of $3.16 per share, for the fiscal year ended September 30, 2019; and
For the fiscal year ended September 30, 2020, total operating expenses were approximately $17.1 million, consisting of approximately $10.1 million in general and administrative expenses and $6.9 million of research and development expenses. This compares with total operating expenses of $25.5 million for the fiscal year ended September 30, 2019, which was comprised of approximately $9.1 million in general and administrative expenses, $3.4 million in research and development expenses, and $13.0 million in research and development-license acquired expenses.

On December 24, 2020 Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a company focused on the creation of the Terra CoV-2 vaccine candidate to combat the novel coronavirus pandemic, reported it has entered into definitive agreements with investors for the purchase and sale of 14,444,444 shares of its common stock at a purchase price of $0.45 per share in a registered direct offering (Press release, Oragenics, DEC 24, 2020, View Source [SID1234573252]). The closing of the offering is expected to occur on or about December 29, 2020, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333- 235763) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.