On December 9, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported it has entered into a strategic collaboration with POINT Biopharma, Inc. (POINT) to use Lantheus’ investigational prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent, PyL, to determine PSMA-avidity during patient selection in POINT’s Phase 3 clinical trial to treat metastatic castration resistant prostate cancer (mCRPC) (Press release, Lantheus Medical Imaging, DEC 9, 2020, View Source [SID1234572535]). The collaboration directly aligns with an important Lantheus strategy to advance cancer precision medicine by enabling partners to use PyL in prostate cancer therapeutic trials.

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As part of the agreement with POINT, Lantheus’ subsidiary, Progenics Pharmaceuticals, Inc., will supply PyL at a predetermined supply price.

"While there have been great advances in the treatment of prostate cancer, there remains an important unmet medical need for therapies that can more specifically target metastatic prostate cancer," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "The inclusion of PyL in POINT’s Phase 3 trial reinforces our belief in the potential utility of PyL, not just in assessing metastatic disease, but also in selecting the most appropriate patients for PSMA-targeted therapy."

POINT will conduct a Phase 3, multicenter, open-label, randomized clinical trial to evaluate the efficacy and safety of their novel PSMA-targeted radioligand, 177Lu-PNT2002, in patients with mCRPC. PyL will be used to select patients with PSMA-avid tumors for treatment with 177Lu-PNT2002, and in a subset of patients also be used to evaluate progression.

"The combination of diagnostic imaging and radioligand therapy is a validated approach and an important development in cancer treatment," said Joe McCann, Chief Executive Officer of POINT. "POINT is very excited to be enrolling our study using PyL. We believe this promising biomarker will help identify the patients with prostate cancer who will best respond to PNT 2002, our next generation radioligand therapy."

About PSMA

PSMA is a protein that has been found to be amplified on the surface of greater than 95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer.1

About PyL for PET Imaging of Prostate Cancer

PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus filed with the U.S. Food and Drug Administration a New Drug Application for PyL.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 192,000 new cases of prostate cancer will be diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the U.S. currently count themselves among prostate cancer survivors.3

On December 9, 2020 TVAX Biomedical (TVAX), is a cancer immunotherapy company reported that is moving into its pivotal glioblastoma study for FDA regulatory approval (Press release, TVAX Biomedical, DEC 9, 2020, View Source [SID1234572552]). TVAX Immunotherapy could fundamentally change the way cancer is treated as T cells can kill all cancer cells, including cancer stem cells, without the toxicity of current treatments. With early promising outcomes, TVAX received Fast Track Designation and Orphan Product Designation from the FDA.

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Glioblastoma is an incurable brain cancer affecting >12,000 people annually in the US. This form of brain cancer killed Beau Biden, the son of President-elect Biden, and Senators John McCain and Ted Kennedy and countless others. TVAX is working to change that.

TVAX Immunotherapy is a cutting-edge approach to cellular therapy. The individualized therapy first helps the patient develop immunity against their cancer and the unique "neoantigens" that cancer cells produce. Next, T cells are removed from patient’s blood and activated in TVAX’s specialized manufacturing facility. Patients are then treated with billions of their own "killer" T cells that attack their cancer. Dr. Wayne Carter, TVAX Biomedical’s CEO, explains it like this, "TVAX’s technology uses ‘killer’ T cells that function like billions of smart bombs hunting and destroying cancer cells throughout the body. TVAX Immunotherapy has very few side effects because ‘killer’ T cells kill cancer cells, not normal cells."

This therapy has shown promising results for four-legged friends too. The ability to treat multiple types of cancer prompted TVAX to spin-off its animal health division into Elias Animal Health, an affiliate pursuing similar treatments in dogs. Elias is using the technology to treat osteosarcoma, an incurable bone cancer and is currently enrolling dogs for their registration study with the USDA.

TVAX Immunotherapy has been administered to more than 120 patients and has demonstrated efficacy against several cancers, producing numerous long-lasting complete and partial responses with none of the "off-target" short and long-term toxicity seen with CAR-T cell therapy, checkpoint inhibitors, and chemotherapies.

TVAX worked closely with the FDA to plan its critical glioblastoma registration study. Fast Track Designation affords many advantages, including a pathway to accelerated marketing approval. TVAX Immunotherapy has dramatically lower manufacturing costs compared to other cellular immunotherapies such as CAR-T therapies and manufacturing can be easily automated to facilitate large-scale commercialization.

On December 9, 2020 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported an oversubscribed $8 million financing (Press release, Qu Biologics, DEC 9, 2020, View Source [SID1234574979]). With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer.

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"We are pleased to have oversubscribed our bridge round based on the promising interim data from our RESTORE trial and we are looking forward to the important full data from our two studies, which will both complete in the first half of 2021", said Hal Gunn, MD, CEO of Qu. "Our first-in-paradigm platform is designed to safely achieve immune balance and healing by restoring multiple important immune functions simultaneously – we are excited about our unique and novel treatment’s transformational potential in preventing and treating cancer and chronic disease."

Qu Biologics will use the funds raised to expand its team and capacity and progress its proprietary immunotherapy platform.

On December 9, 2020 Oasmia reported that Interim report1 for the period May 1, 2020 – October 31, 2020(Press release, Oasmia, DEC 9, 2020, View Source [SID1234572492])

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SIGNIFICANT EVENTS DURING THE SECOND QUARTER
In August Oasmia appointed Peter Selin as Chief Business Officer.
Oasmia’s CFO Michael af Winklerfelt resigned from his role in August and Fredrik Järrsten was appointed as Chief Financial Officer in September.
In September Oasmia’s Nomination Committee revised its proposal for the AGM regarding Board of Directors and Sven Rohmann notified that he is no longer available for re-election.
In September Oasmia brought an action against the company’s former Board of Directors as a direct result of findings from an investigation into the former Board of Directors’ responsibilities by the auditing firm Deloitte.
In October Oasmia’s partner Elevar Therapeutics signed an agreement with Taiba Middle East FZ LLC for commercialization of Apealea in the Middle East and North Africa Region.
In October the disciplinary committee of Nasdaq Stockholm ordered Oasmia to pay a fine due to the former Board of Directors, in connection with the EGM in March 2019, in several respects violating generally accepted behavior in the securities market.
Oasmia announced in October that the company has continued to secure IP rights, including the approval of XMeNa patent in India and soon in Australia as well as approved Apealea trademark registrations in Switzerland, Israel, South Africa, Malaysia and Indonesia.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In November Robert Maiorana joined Oasmia as acting CFO, with effect from December 1, 2020 until Fredrik Järrsten commenced in the role. Thereafter, Robert will work as Finance Manager and support Fredrik.
On 3rd December Oasmia shared an update from its partner Elevar Therapeutics on the development plan for Apealea (paclitaxel micellar) in ovarian cancer.
SECOND QUARTER[2]: AUGUST 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 154 (252)
Operating profit/loss was TSEK -53,693 (-47,436)[3]
Net profit/loss after tax amounted to TSEK –53,538 (-18,309)[3]
Earnings per share was SEK -0.12 (-0.06)[3],[4]
THE PERIOD2: MAY 1, 2020 – OCTOBER 31, 2020
Consolidated net sales amounted to TSEK 362 (433)
Operating profit/loss was TSEK -102,914 (-83 201)[3]
Net profit/loss after tax amounted to TSEK –106,643 (-58,093)[3]
Earnings per share was SEK -0.24 (-0.18)[3,4]
CEO’S COMMENTS
The last quarter at Oasmia has seen us focusing on building on the solid foundations we have laid so far this year following the implementation of recommendations highlighted by the strategic review initiated following my appointment as CEO in March. Since then, we have focused our activities on R&D and lab testing in line with our new strategy and reduced our rate of cash burn as the consequence of the rightsizing of our Company. Throughout the period we have continued to make progress on delivering our vision of creating a sustainable specialty pharma company.

In early December Elevar Therapeutics, our global strategic partner shared an update on the development plan for Apealea (paclitaxel micellar) in ovarian cancer. Following interactions with the FDA Elevar has decided to complete two new studies with Apealea which will be initiated in the first half of 2021 before filing the new drug application (NDA). These studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label.

Over the period we have also been working with Elevar to support their partnering efforts for Apealea in key global territories. In October, Elevar announced an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea in the Middle East and North Africa region. This is the first regional partnership deal for Apealea and Elevar is in late stage discussions with a number of potential partners for other regions around the world. Most recently, Elevar and Tanner Pharma Group announced the launch of a global Named Patient program to provide access to Apealea in areas outside of the United States and Middle East North Africa (MENA) where Apealea is not yet commercially available.

As previously communicated Oasmia retains marketing rights for Apealea in the Nordic countries and has made the product commercially available earlier this year. The COVID-19 pandemic continues to significantly impact the ability of our medical scientific liaisons to meet oncologists in the Nordics. However, we are pleased to report that as of November we have started to record initial sales in Finland. In Sweden a positive interest for Apealea has been shown in a few centres in a highly competitive oncology ward environment that is mostly closed to any face-to-face interactions with the Industry. In Denmark, against a negative outcome from the health technology assessment submission we are working on alternatives to generate clinical data.

A central pillar of our new strategy is to explore licensing and partnering opportunities for our existing assets. To drive this process forward in a timely manner I have appointed consultancy firms that will aid us in finding and selecting partners for our Animal Health division as well as the wider XR-17 platform.

To maximise the value of our platform we have hired a strategic firm to assist Oasmia and facilitate analysis, selection and engagement with potential partners related to licensing/M&A. A four-step project has therefore been initiated with developing a positioning analysis of the XR-17 platform against competing alternatives based on identification and validation of perceived industry needs among potential licensees.

I have also appointed an international investment bank focusing on healthcare with animal health experts to provide us strategic advisory services related to our Animal Health portfolio.

Our pipeline of development programmes continues to progress well. Docetaxel micellar is poised to enter on time in clinical development for advanced prostate cancer with the renowned Swiss Group for Clinical Cancer Research (SAKK). We are also working on adding a novel product candidate in pre-clinical development, using our XR-17 technology. I hope to be able to disclose further details soon provided a positive outcome.

Protecting intellectual property is critical at any innovative company in our sector, and during the period we worked to bolster our already strong position in this area. In October we announced that our XMeNa patent was approved in India and will soon to be approved in Australia. The XMeNa patent protects an improved method for producing our technology platform XR-17, which is a unique carrier system for anticancer drugs. We have also secured new trademark registrations for Apealea in Switzerland, Israel, South Africa, Malaysia and Indonesia during the year.

A key objective for Oasmia is to ensure that we have the right people in place to execute our plans and deliver success. We have made several senior level executive appointments over the last few months including the appointment of two senior scientists to our technical operations team. We believe that investing in this crucial area of the business will enable us to further develop and potentially upgrade our XR-17 platform.

In September we announced that Peter Selin would be joining us as Chief Business Officer and he is now on board since the start of November. His expertise in business development and strategy in the life sciences sector will be invaluable to Oasmia as we continue to pursue growth by seeking M&A and licensing opportunities that complement our technology and business model. Another key addition to the team, announced in October, was the appointment of Fredrik Järrsten as Chief Financial Officer. He has over 25 years of experience across the financial, medical technology and life sciences sectors in the Nordic region and internationally. I know that Fredrik will be an incredible asset to Oasmia when he joins us early next year.

With this experienced new senior team in place I look forward to the remainder of 2020 and beyond with confidence and optimism. Oasmia is in great shape to deliver our strategic objectives as a business and I look forward to keeping you up to date on our progress.

Dr. Francois Martelet, M.D., CEO of Oasmia

The report is available on the company’s website: View Source

Conference call
The company will hold a conference call and an online presentation on December 9, 2020 at 10.00 am CET. The call will be hosted by CEO Francois Martelet, CEO and Acting CFO Robert Maiorana. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
View Source

On December 9, 2020 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million (the "Offering") (Press release, Curis, DEC 9, 2020, View Source [SID1234572518]). Curis has granted the underwriters a 30-day option to purchase up to an additional 3,847,826 shares of common stock on the same terms and conditions. The Offering is expected to close on or about December 11, 2020, subject to customary closing conditions.

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Cantor Fitzgerald & Co. and JonesTrading Institutional Services LLC are acting as joint book-runners for the Offering. H.C. Wainwright & Co., LLC and Laidlaw & Company (UK) Ltd. are acting as co-lead managers for the Offering.

Curis intends to use the net proceeds from the Offering, together with its existing cash and cash equivalents, to continue development of CA-4948, in collaboration with Aurigene, and CI-8893, in collaboration with ImmuNext, and for general working capital and capital expenditures.

The securities in the Offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-224627) that was filed with the United States Securities and Exchange Commission ("SEC") on May 3, 2018, and declared effective by the SEC on May 17, 2018 and an additional registration statement on Form S-3 (File No. 333-224627) filed pursuant to Rule 462(b) which became automatically effective on December 9, 2020. A final prospectus supplement and accompanying prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022 or by email at [email protected].

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