News briefing: Ziopharm drama continues with new letter from activist group; Alnylam, Centogene join forces on ATTRv screening program

As Friday’s deadline to submit written consent approaches, WaterMill Asset Management Corp is continuing to put the pressure on Ziopharm Oncology in its activist attack.

The 3.3% minority stakeholder sent a new letter to investors Tuesday morning, emphasizing the need for boardroom change ahead of the self-imposed due date. WaterMill again pushed for the full slate of its three board nominees — Jaime Vieser, Holger Weis and WaterMill founder Robert Postma — to be selected, and detailed numerous accounts of what it says are attempts by Ziopharm to “distort” the truth.

WaterMill’s letter provided new details of alleged events that it says justify the need for new board members. This includes an incident earlier this year when Ziopharm CEO Laurence Cooper purportedly hung up on a group of investors representing about 25% of the company’s shareholders on a conference call.

The WaterMill group also stated that Ziopharm had reached out to interview two of the minority investors’ board nominees on Oct 30, but issued a press release on Nov 2 saying the nominees were “unqualified” before the group could respond. WaterMill launched its activist attack on Nov 2 with an 8:45 am press release, and Ziopharm’s release came out that day at 9 am.

Tuesday’s letter comes about two weeks after proxy adviser Institutional Shareholder Services recommended the ascension of Vieser and Weis to the Ziopharm board while excluding Postma. Both sides claimed victory after that report, with Ziopharm saying ISS had rejected WaterMill’s “full slate” of nominees and WaterMill claiming ISS had endorsed their proposal for “boardroom change.”

Ziopharm objected, however, to ISS’s apparent approval of Weis as a nominee, saying Weis had played a key role in the 2018 bankruptcy of the biotech DemeRx. WaterMill on Tuesday again said the company was engaging in “baseless smears” as two former DemeRx executives have vouched for Weis.

Over the last six months, three Ziopharm board members have resigned or been replaced with the latest individual resigning last week. The board has shrunk from eight to seven, and Ziopharm has not nominated any of WaterMill’s proposed candidates. — Max Gelman

Alnylam, Centogene join forces on ATTRv screening program

Centogene and Alnylam have launched a new joint clinical screening program to genetically screen for those at risk of hereditary transthyretin-related amyloidosis.

Also known as ATTRv, the disorder is caused by misfolded proteins which progressively build up and interfere with organ function. The screening program will follow up on a 2017 effort to test 5,000 patients across Germany, Austria and Switzerland with polyneuropathy and/or cardiomyopathy — with no known origin. Over 1% of those patients were eventually diagnosed with ATTRv and were both clinically and regionally mapped.

Since then, Centogene has discovered new ATTRv biomarkers, which will be used to monitor patients in the new screening program over a two-year process. Both symptomatic and asymptomatic transthyretin amyloidosis patients will take part in screenings, which Centogene will use to validate the biomarkers and better understand treatment options. — Conner Mitchell

Melanoma immunotherapies the focus of new Checkmate-Bristol Myers Squibb collaboration

Late-stage melanoma and the immune system’s ability to fight the cancer will be at the forefront of a new clinical collaboration between Checkmate Pharmaceuticals and Bristol Myers Squibb.

Checkmate, the clinical stage biopharmaceutical company, will put CMP-001 — its foremost cancer immunotherapy treatment — to the test through two different trials with Bristol Myers Squibb and Opdivo, the company’s PD-1 blocking antibody.

The first trial will involve a single arm Phase II study using a combination of CMP-001 and Opdivo in subjects who have unresectable or metastatic melanoma that refracts PD-1 blocking both as a monotherapy option or in conjunction with other therapies.

The second trial will involve a randomized Phase II study of CMP-001 as a first-line therapy combined with Opdivo compared to using only Opdivo as a monotherapy in subjects with unresectable or metastatic melanoma.

Checkmate will sponsor the collaboration while Bristol Myers Squibb supplies its drug, according to the terms of the agreement. — Conner Mitchell

Athira Pharma awarded $15M NIA grant for clinical trial of Alzheimer’s therapeutic

The Phase II clinical trial for a potential Alzheimer’s disease theraputic received a boost Tuesday.

Seattle-based Athira Pharma announced that it received a $15 million grant from the National Institute on Aging to support the clinical trial for its small molecule therapeutic, ATH-1017. A potential candidate for treating those with mild-to-moderate cases of Alzheimer’s, ATH-1017 will be studied over the next three years thanks in part to the grant funding, Athira Pharma said.

The study will assess the impact of ATH-1017 on certain brain wave signals related to learning, memory formation and higher cognitive functions, the company said. — Conner Mitchell

Non-small cell lung cancer drug receives breakthrough therapy designation

A leading drug candidate for treating patients with non-small cell lung cancer has been given a breakthrough therapy designation by the FDA.

Repotrectinib, a creation of San Diego, California-based Turning Point Therapeutics, showed positive results during initial data from Phase 1 and Phase 2 portions of clinical studies — enough to expedite the drug’s further development through the FDA designation, the company said Tuesday.

Repotrectinib has already received three fast track designations from the FDA for uses tangentially related to non-small cell lung cancer patients after the drug was found to promote antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, Turning Point Therapeutics said.

The company will present new Phase 2 study data at a mini-oral presentation at the World Conference on Lung Cancer on Jan 31, 2021.—Conner Mitchell

Novo Nordisk Foundation initiative gains status as own foundation to support, fund research and start-ups

BioInnovation Institute, a 2017 initiative of the Novo Nordisk Foundation, is now an independent foundation.

Based in Copenhagen, BII was established as an extension of the NNF to advance research and entrepreneurship within the biotechnology sphere. In just two years, BII funded some 85 research projects and startups thanks to $77.6 million from NNF.

Over the next 10 years, NNF can award $569.9 million to BII for support of early-stage life science projects and startup opportunities. However, designating BII as its own foundation will allow other organizations and foundations to take part in financing its outputs.

BII said Tuesday it expects to employ roughly 500 researchers, innovators and entrepreneurs over the coming years. — Conner Mitchell

Sutro Biopharma proposes public offering of 5 million shares of common stock two years after $85M IPO

A California-based biopharmaceutical company on Monday proposed a public offering of 5 million shares of common stock — two years after filing for an $85 million IPO.

Sutro Biopharma, which focuses on protein engineering to create cancer and autoimmune therapeutics, announced the proposed underwritten public offering of the 5 million common stock shares and said it would also offer underwriters a 30-day option to purchase up to an additional 750,000 shares.

Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers for the offering.

Proceeds from the proposed offering will allow Sutro Biopharma to continue its clinical development of STRO-001 and STRO-002, two antibody-drug conjugates focused on patients with non-Hodgkin lymphoma and ovarian cancers, respectively.

In Sutro Biopharma’s 2018 IPO, it offered 5.67 million common stock shares priced at $15 per share. The company’s stock is currently priced at $21.13. — Conner Mitchell

Florida blank check company to file $75M IPO, focus on investing in novel life science companies

A blank check company based in Miami, Florida is wading into life science investment opportunities through a $75 million initial public offering.

Big Cypress Acquisition, founded just this year, expects to call on a market value of $95 million. The company will offer 7.5 million units of common stock — priced at $10 — and each unit will also hold one-half of a warrant, which can be exercised at $11.50.

Ladenburg Thalmann is the only bookrunner on the offering, BCA said. The company is led by Samuel Reich, who co-founded Biscayne Neurotherapeutics in 2011 (it was later acquired by Supernus). Reich is joined at BCA by chairman Jeffrey Spragens, who co-founded SafeStitch Medical in 2005 and was its CEO until 2013.

BCA says it plans on targeting growth-oriented life science companies that offer products with the potential to address unmet needs in the medical field. — Conner Mitchell

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